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Textbook of Medical Laboratory Technology
Ramnik Sood
CHAPTER 1:
Laboratory
INTRODUCTION
Primary Laboratory
Secondary Laboratory
Tertiary Laboratory
LABORATORY SET-UP
Laboratory Building and Space
Physical Aspects of a Laboratory
Provisions and Precautions
Fire Prevention
Electrical Installations
Liquefied and Compressed Gases
Chemicals and Radioactive Substances
Stores
Staff Safety and Facilities
Basic Laboratory Safety
CODE OF CONDUCT FOR MEDICAL LABORATORY PERSONNEL
ACCIDENTS SAFETY MEASURES IN THE LABORATORY
HAZARDS IN THE CLINICAL LABORATORY
Physical Hazards
Electricity
Fire
Usual Causes of Fire in the Laboratory
Fire Fighting Equipment
Should a Fire Occur
Laboratory Equipment
Glassware
Equipment-Related Hazards
Equipment/Materials Employed to Eliminate/Reduce Hazards
SAFETY WITH CHEMICALS/REAGENTS
LABELING OF HAZARDOUS REAGENTS/CHEMICALS
Incompatible Chemicals
Acids
Vapourizing Substances
Others
Flammable Chemicals
Storage
Safe Use
Control of Fire Caused by Flammable Chemicals
Corrosive Chemicals
Storage
Safe Use
Toxic, Harmful, and Irritating Chemicals
Storage
Safe Use
Oxidising Chemicals
Storage
Safe Use
Explosive Chemicals
Carcinogens
Storage
Safe Use
ACCIDENTS IN THE LABORATORY
FIRST AID IN LABORATORY ACCIDENTS
Acid Burns
Acid Splashes on the Skin
Acid Splashes in the Eye
Swallowing Acids
Alkali Burns
Alkali Splashes on the Skin
Alkali Splashes in the Eye
Swallowing Alkalis
Poisoning
Burns Caused by Heat
Severe Burns
Minor Burns
Injuries Caused by Broken Glass
Contamination by Infected Material
Bodily Damage by Electric Shock
Precautions for the Avoidance of Accidents
Suggested List of First Aid Equipment for Laboratory
CONTAMINATION FROM INFECTIVE MATERIAL
PRECAUTIONARY MEASURES
UNIVERSAL WORK PRECUATIONS (UWP) FOR LAB PERSONNEL (ESPECIALLY IN RELATION TO HIV TRANSMISSION)
Introduction
Components of UWP
Guidelines of Basic Practices and Procedures
Biosafety Regulations for Laboratory Procedures
Sterilization (For Nondisposable Items)
Waste Disposal
Final Disposal
Post-Exposure Care
First Aid
Report
Initial Consultation
Laboratory Testing
Clinical Follow-up
Containing Spills
Collection of Specimen
Transport of Specimen
MEDICO-LEGAL ASPECTS OF CLINICAL PRACTICE
LABORATORY INSTRUMENTS
Microscope
Parts of the Microscope
Stand
Mechanical Adjustments
Microscope Optics
Light Source
SPECIAL APPLICATIONS OF THE MICROSCOPE
Phase Contrast Illumination
Equipment Needed
Method
Importance
Demerits
Dark Ground Illumination
Equipment Needed
Method
Demerits
Importance
Fluorescence Microscopy
Equipment Needed
Importance
ELECTRON MICROSCOPE
Basic Principle
WEIGHING SCALES OR ANALYTICAL BALANCE
Use and Care
CENTRIFUGE
Relative Centrifugal Force (RCF)
TYPES OF CENTRIFUGE
GLASSWARE (MANY ITEMS ARE NOW MADE OF PLASTIC)
OTHER NECESSARY EQUIPMENT
REPORTING LABORATORY TESTS AND KEEPING RECORDS
Standardisation
Use of Rubber Stamps
Format
Keeping Records in the Laboratory
Lab Reporter
It Reduces Overload
It Helps Referencing Doctor
It Makes Working Easy
The Computerised System is Easy to Operate
Features and Provisions
Graphs
Accounts
Address Manager
CHAPTER 2:
Sterilisation
METHODS COMMONLY USED FOR STERILISATION
Sterilisation by Heat
Dry Heat
Moist Heat
Cold
Ultraviolet Radiation
Ionising Radiations
Filtration
Chemical Sterilisation
Chemicals Used
GLASSWARE PREPARATION FOR USE
Syringes
Choice of Syringes and Needles
Disposable Sterile Syringes
CHAPTER 3:
SI Units
LITRE
GRAM
MOLE (MOL)
INTERNATIONAL UNIT (U)
CONVERSION FACTORS BETWEEN CONVENTIONAL AND SYSTÈME INTERNATIONAL UNITS (SIU)
Hematology
Chemistry
Enzyme
Therapeutic and Toxic Drugs
CHAPTER 4:
Fundamental Chemistry
INDICATORS
Solutes, Solvents and Solutions
STRENGTH OF A SOLUTION
Per cent Solutions
Part Dilutions
Molar Solutions
Normal Solutions
Abbreviations and Definition
CHAPTER 5:
Urine Analysis
COMPOSITION OF URINE
Physicochemical Characteristics of Urine
Inorganic Constituents per 24 Hours
Organic Constituents per 24 Hours
Cells and Casts
Collection of Urine
Preservation of Specimen
GROSS EXAMINATION OF URINE
Colour and Appearance
Interfering Factors
Reaction
Urine pH
Acidic Urine
Alkaline Urine
Interfering Factors
Be Careful
Odour
Specific Gravity
Interfering Factors
Urinary Volume
Polyuria
Oliguria
Turbidity
Interfering Factors
CHEMICAL EXAMINATION OF URINE
Tests for Protein
Heat and Acetic acid Test
Sulphosalicylic Acid Test
Paper Strip Method
Quantitative Estimation of Protein in Urine
Bence Jones Protein Tests
Interpretation of Proteinuria
Other Important Related Aspects
Interfering Factors
MECHANISMS OF PROTEINURIA
MICROALBUMINURIA
Definition
Microalbuminuria: Diagnostic Relevance
MICROALBUMINURIA DETECTION
Indirect Latex Slide Test for Detection of Microalbuminuria Microtex® (Courtsey: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
For Qualitative Method
For Semiquantitative Method
Materials Provided with the Kit
Reagents
Accessories
Additional Materials Required
Test Procedure
Qualitative Method
Semiquantitative Method
Interpretation of Results
Qualitative Method
Semiquantitative Method
Remarks
TESTS FOR GLUCOSE
Significance of Sugars in Urine
Glycosuria with Hyperglycaemia
Glycosuria without Hyperglycaemia
Nonglucose Sugars in Urine
Interfering Factors
KETONE BODIES IN URINE
Tests for Ketone Bodies
Causes of Ketonurla
Clinical Implications
Interfering Factors
Clinical Relevance
Bile Salts
Method
Interpretation
Bile Pigments
Causes of Hyperbilirubinuria
Urobilinogen and Urobilin
Urobilinogen
Urobilin (Schlesinger's Test)
Estimated Urobilinogen
Urobilinogen (Quantitative)
Clinical Relevance
Increase in Urinary Urobilinogen
Decrease in Urinary Urobilinogen
Interfering Factors
PORPHYRINS
Causes
Normal Values
Clinical Relevance
Porphyria
Lead Poisoning
Other Conditions with Increased Levels of Porphyrins
Interfering Factors
BLOOD IN URINE (HAEMATURIA)
NITRITE/BACTERIA
Procedure
Clinical Implications
RAPID DIAGNOSTICS
SPECIAL URINE TESTS
Calcium in Urine (Sulkowitch Test)
Clinical Relevance
Increased Levels
Decreased Levels
Interfering Factors
Be Careful
SEROTONIN (5-HYDROXYTRYPTAMINE)
Carcinoids
Test
Method
Clinical Relevance
Interfering Factors
CYSTINE
Clinical Relevance
FAT IN URINE
HEREDITARY METABOLIC DISORDERS
Errors of Carbohydrate Metabolism
Errors of Amino Acid Metabolism
Abnormal Porphyrin Metabolism
FERRIC CHLORIDE TESTING
URIC ACID
Clinical Relevance
Increased Levels (uricosuria)
Decreased Levels
Interfering Factors
VANILLYLMANDELIC ACID (VMA)
Method/Principle
Clinical Relevance
Interfering Factors
Interfering Factors in Determining Catecholamine Levels
17-ketosteroids (17-KS)
17-Ketogenic Steroids (17-KGS)
17-Hydroxycorticosteroids (17-OHCS)
Method/Principle 17 KS
Method/Principle 17-OHCS
Clinical Relevance
Interfering Factors
CHLORIDES
Clinical Relevance
Interfering Factors
SODIUM
Clinical Relevance
Interfering Factors
POTASSIUM
Clinical Relevance
Interfering Factors
FOLLICLE-STIMULATING HORMONE (FSH) LUTEINISING HORMONE (LH)
PREGNANEDIOL
Clinical Relevance
PREGNANETRIOL
Clinical Relevance
OESTROGEN FRACTIONS
Clinical Relevance
Interfering Factors
HEAVY METALS, BLOOD AND 24-HOURS URINE
TOXIC/POISONING SYMPTOMS AND TREATMENT
Symptoms
Treatment
Usage
Description
MICROSCOPY OF THE URINARY SEDIMENT
DETAILED STUDY OF IMPORTANT URINARY MICROSCOPY CONSTITUENTS
Red Cells and Red Cell Casts
Clinical Relevance
Interfering Factors
White Cells and White Cell Casts
Clinical Relevance
Interfering Factors
Epithelial Cells and Epithelial Cell Casts
Clinical Relevance
Hyaline Casts
Clinical Relevance
Granular Casts
Clinical Relevance
Waxy Cysts
Oval Fat Bodies and Fatty Casts
Clinical Relevance
CRYSTALS
COMMON PATTERNS OF ABNORMAL URINE COMPOSITION IN DISEASE
Bacteria, Fungus and Parasites
Parasites and Parasitic Ova
Casts in Urine
Hyaline
Red Cell
White Cell
Epithelial Cell
Granular
Waxy Casts
CHAPTER 6:
Renal Function and Its Evaluation
CONCENTRATION: DILUTION TESTS
Principle
Concentration Test
Dilution Test (Water Test)
Mosenthal Modification of Concentration—Dilution Tests
Vasopressin Concentration Test
Conditions that Impair Concentrating Ability
PHENOL RED TEST [Phenolsulphonphthalein (PSP)]
Principle
Intravenous Method
Interpretation
Ureteral Catheterisation Method (Cystoscopy)
Phenol Red Test for Residual Urine
Interpretation
CLEARANCE TESTS
Creatinine Clearance
Methods
Interpretation
Creatinine Clearance Test
PRINCIPLES OF PRECISE TESTS OF RENAL FUNCTION
Glomerular Filtration Rate (GFR)
Renal Plasma Flow (RPF)
Filtration Fraction
Maximal Tubular Capacity (Tm)
CHAPTER 7:
Stool Examination
COMMERCIALLY AVAILABLE KIT OCCULT BLOOD (HEMOSPOT®) Courtesy: Tulip Group of Companies
Summary
Reagents
Reagent Storage and Stability
Principle
Note
Quality Control
PREPARATION AND SAMPLE COLLECTION
Preparation of the Patient
Sample Collection
Material Provided with the Kit
Additional Material Required
Test Procedure
Interpretation of Results
Remarks
Faecal Fat
Titrimetric Method
Electrical Capacitance Method
Interpretation
Interfering Factors
Other Methods of Assessing Malabsorption
MICROSCOPIC EXAMINATION OF STOOL SPECIMENS
Stool Concentration Methods
Concentration Methods may be Used
Flotation Concentration Methods
Zinc Sulphate Concentration Method
Reagents
Method
Sedimentation Concentration Methods
Simple Sedimentation Method
Formol-saline Ether Sedimentation Method
Reagents
Method
CHAPTER 8:
Medical Parasitology
MEDICAL PARASITES
Importance of Morphologic Identification
INTESTINAL PROTOZOA OF MAN
MALARIAL PARASITES OF MAN
BLOOD FLAGELLATES OF MAN
COMMON INTESTINAL ROUNDWORMS OF MAN-PATHOLOGY
EXTRAINTESTINAL ROUNDWORM INFECTION OF MAN-LARVAL WORM PATHOLOGY
TISSUE ROUNDWORMS OF MAN, CHIEFLY FILARIAE
TAPEWORMS OF MAN
FLUKES OF MAN
RECAPITULATION
LABORATORY EXAMINATION FOR
Preservation and Shipment of Specimens to be Examined for Trophic and Encysted Protozoa
PVA (Polyvinyl Alcohol) Method of Brooke and Goldman
MIF (Merthiolate—Iodine-Formalin) Method of Sapero and Lawless
ROUTINE STOOL EXAMINATION AND CONCENTRATION METHODS HAVE BEEN DEALT WITH ELSEWHERE
Negative Stain Direct Faecal Smear Examination
Kato Cellophane Thick Smear Technique (Kato and Miura, 1954)
Materials
Procedure
Heidenhain's Iron Haematoxylin Staining Method for Intestinal Protozoa
Staining Solutions
Procedure
Gomori's Trichrome Stain
Staining Solution
Procedure
Cultivation of Intestinal Protozoa
Urine
Sputum
Spinal Fluid
Vaginal Secretions
Graham Cellulose Tape Technique for Diagnosis of Enterobiasis
BLOOD
Combined Thin and Thick Films
Making Films
Staining Films
Concentration of Microfilariae
Bone Marrow Smear
Serological Tests
Intradermal Tests
Casoni's Test
Muscle Biopsy for Trichinella spiralis
OVERVIEW OF MALARIA AND ITS DIAGNOSIS
Introduction
Historical Perspectives
Malaria Life Cycle
Malaria and Plasmodium Species
DISTRIBUTION OF MALARIAL DISEASE BY AGE AND SEX
South and East Asia and the Western Pacific
Eastern Mediterranean
North and South America
Africa
Clinical Malaria
Incubation Time
Typical Presentations
Cold Stage
Hot stage
Sweating
If the Infection is Left Untreated
Relapse
Recrudescence
COMPLICATIONS IN MALARIA
Severe Falciparum Malaria
Differentiating Features of the “Big Two” (P. vivax and P. falciparum malaria)
Drug-Resistant Malaria
Indian Scenario of Drug-Resistant Malaria
Clinical and Laboratory Diagnosis of Malaria
Clinical Diagnosis
Microscopic Diagnosis
Key Factors Affecting Diagnosis and Treatment of Malaria
Rapid Diagnostic Tests for Malaria
Isolation of Malaria Parasite Antigen
Antibodies to the Antigenic Markers of Malaria
First Generation Rapid Diagnostic Tests for Malaria
P. falciparum specific Histidine-Rich Protein-ll (Pf. HRP II)-based Assays
Principle of Pf. HRP-II Based Assays
Plasmodium Lactate Dehydrogenase (pLDH)
Principle of pLDH-Based Assays
1. HRP-II + pan pLDH Combination RDT
2. Pf. pLDH + pan pLDH Combination RDT
Limitations of First Generation Rapid Diagnostic Tests for Malaria
Experience with HRP-II and pLDH-Based Assays for the Detection of P. falciparum Malaria'
Assay Design Considerations for Second Generation Rapid Test for Malaria
Rapid Diagnostic Tests for Malaria: Formats—Pros and Cons
Management of Malaria
Management of Drug-resistant Malaria
General Prophylactic Drugs Used
CHAPTER 9:
Clinical Haematology
WAYS OF OBTAINING BLOOD
Capillary or Peripheral Blood
Venous Blood (Venipuncture)
Complications
Clinical Alert
ANTICOAGULANTS
Advantages of EDTA
Disadvantages of EDTA
Making EDTA Bulbs
Making Double Oxalate Bulbs
WHEREVER POSSIBLE, THE NECESSARY TESTS, INVESTIGATIONS AND PREPARATION OF BLOOD FILMS SHOULD BE DONE IMMEDIATELY
Anticoagulated Blood Storage and Blood Cell Morphology
EDTA Blood
Diagnostic Alerts
BLOOD COLLECTION SYSTEM
HAEMOGLOBIN (Hb)
HAEMOGLOBIN ESTIMATION
Sahli's method: (Sahli's haemoglobinometer) (Fig. 9.3):
Cyanmethaemoglobin Method
Drabkin's Reagent
Sheard-Sanford Oxyhaemoglobin Method
Other Methods
Chemical Methods
Sodium Lauryl Sulphate Method
Normal Haemoglobin Values
THE LOWER LIMIT OF ANAEMIA
Causes of Anaemia
POLYCYTHEMIA
Causes
HAEMATOCRIT/PACKED CELL VOLUME (PCV)
Definition
Methods
Wintrobe's Tube
Microhaematocrit
Interpretation
BLOOD CELL COUNTS
WBC
Counting Chamber
Methods
Calculation
RBCs
Diluting Fluid
Method
Interpretation
PLATELETS
Method
Rees-Ecker Method for Platelet Count
Diluting fluid
Procedure
Rough Estimation of Platelets Count from Stained thin Smear
Causes of Thrombocytopenia
Raised Platelet Count (Thrombocytosis)
ERYTHROCYTE INDICES
COMPLETE BLOOD COUNT (CBC), BLOOD
Normal Values
Complete Blood Count (CBC)
ERYTHROCYTE SEDIMENTATION RATE (ESR)
Methods
Westergren's Method
Wintrobe's Method
Microsedimentation (Landau) Method
Materials Required
Procedure
Normal Values
Sources of Error for any ESR method
Interpretation of ESR
BLOOD FILM EXAMINATION
Preparation of a Thin Blood Film
Making of Spreaders (Fig. 9.9)
Making Thick Smears
Fixing of Blood Films
Staining of Blood Films
Stain Preparation and Staining
Wright's Stain
Method
Leishman's Stain
Method
Giemsa's Stain
Method
Staining of Thick Films
Field's Stain
Method
Simeon's Modification of Boye's and Sterenal's Method
Method for Staining Thin Films
Procedure for Staining Thick Smears
Mounting and Preservation of Films
RAPID DIAGNOSTICS
Automation in Haematology
DEVELOPMENT OF BLOOD CELLS SITES OF BLOOD FORMATION
Normal Sites
Abnormal Sites
DEVELOPMENT OF BLOOD CELLS (Chart 9.1)
ERYTHROPOIESIS
LEUCOPOIESIS
The Myeloid Series
Development of a Mature Neutrophil
Lymphocytic Series
Monocytic Series
THROMBOPOIESIS
EXAMINATION OF A BLOOD FILM
Method
ALWAYS NOTE
Differential Leucocyte Count (DLC)
BONE MARROW EXAMINATION
BONE MARROW EXAMINATION AND REPORTING
Marrow Film Preparation
Imprints
Crush Preparation
Examination
BONE MARROW ASPIRATION ANALYSIS
DIFFERENTIAL CELL COUNT
Indications for Bone Marrow Aspiration
Absolute Indications
Diagnostic Importance
Confirmatory Importance
Contraindications
Morphological Types of Red Blood Cells
RBC MORPHOLOGY, BLOOD
Normal Values
CLASSIFICATION OF VARIATION FROM NORMAL
Usage
RETICULOCYTE COUNT
RED CELL FRAGILITY TEST
Red Blood Cell Abnormalities seen on stained Smear (In brief)
Quantitative Test
Reagents
Method
Interpretation
Clinical Implications
QUALITATIVE ASSESSMENT OF G6PD DEFICIENCY
Methaemoglobin Reduction Test
Reagents
Method
Interpretation
COMMERCIALLY AVAILABLE KIT FOR G6PD ASSESSMENT:G-SIX TEST FOR SCREENING AND QUANTITATION OF G6PD DEFICIENCY Courtesy: Tulip Group of Companies
Summary
Reagents
Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required
Screening Test Procedure
Quantitative Procedure
Interpretation of Results
Quantitative Test
Remarks
Clinical Implications
EXAMINATION OF FOETAL HAEMOGLOBIN
Qualitative Method
Interpretation
Quantitative Method
Normal Values
TESTS FOR SICKLING
QUANTITATIVE ESTIMATION OF G6PD G-SIX KIT (KINETIC METHOD) FOR THE DETERMINATION OF G6PDH ACTIVITY IN RBC's. (FOR IN VITRO DIAGNOSTIC USE ONLY) Courtesy: Tulip Group of Companies
Summary
Principle
Normal Reference Values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Notes
LABORATORY DIAGNOSIS OF DISORDERS RELATED TO RBCs
LABORATORY DIAGNOSIS OF IRON DEFICIENCY ANAEMIA
Peripheral Blood
Peripheral Smear
Bone Marrow
Serum Biochemistry
Normal Values for Iron Metabolism
Laboratory Findings in Iron Deficiency
Blood Count
Bone Marrow
Other
Causes of Iron Deficiency Anaemia
Blood Loss
Increased Requirements
Impaired Absorption
Inadequate Intake
LABORATORY DIAGNOSIS OF MEGALOBLASTIC MACROCYTIC ANAEMIAS
Peripheral Blood Findings in Vitamin B12 or Folic Acid Deficiency
Bone Marrow
Dyserythropoiesis
WBC Series
Megakaryocytes
Special Tests for Diagnosing Vitamin B12 Deficiency
Serum Vitamin B12 Assay
Radioactive Vitamin B12 Absorption Test
Schilling Test
Causes of Vitamin B12 Deficiency
Special Tests for Diagnosing Folate Deficiency
Serum Folate Assays
FIGLU Test
Radioactive Folic Acid Test-Like Schilling Test
Causes of Folic Acid Deficiency
Nutritional
Malabsorption
Increased Demand
Laboratory Findings in Megaloblastic Anaemias
Blood Counts
Bone Marrow
Blood Chemistry
Other Studies
Causes of Bone Marrow Megaloblastosis
LABORATORY DIAGNOSIS OF HAEMOLYTIC ANAEMIAS CAUSES AND CLASSIFICATION OF HAEMOLYTIC ANAEMIAS
Intracorpuscular Defects
Extracorpuscular Defects
Evidences of Haemolysis
Increased Breakdown of Haemoglobin
Compensatory Erythroid Hyperplasia
LABORATORY DIAGNOSIS OF HEREDITARY SPHEROCYTOSIS
Blood Picture
Peripheral Smear
Chemistry
LABORATORY DIAGNOSIS OF HEREDITARY ELLIPTOCYTOSIS
LABORATORY DIAGNOSIS OF ENZYME DEFICIENCY RELATED ANAEMIAS
G6PD Deficiency
Blood Picture
LABORATORY DIAGNOSIS OF AUTOIMMUNE HAEMYLOTIC ANAEMIA (AIHA)
Laboratory Diagnosis of Warm Antibody AIHA
Blood Picture
Immunology
Laboratory Diagnosis of Cold Antibody AIHA
CHAD
PCH
LABORATORY DIAGNOSIS OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA
LABORATORY DIAGNOSIS OF LEAD POISONING
LABORATORY DIAGNOSIS OF HAEMOGLOBIN STRUCTURE AND SYNTHESIS DISORDERS
SPECIAL TESTS
Autoscanning and Computing Densitometer 205
Features
Minimum System Configuration
System Configuration with ‘PC-:LINK 205’ Software
Technical Specifications
Optical
Mechanical
Electronics
Computing and Editing
Printed Records
Power
Optional Accessories
LABORATORY DIAGNOSIS OF SICKLE CELLS TRAIT
LABORATORY DIAGNOSIS OF SICKLE CELL ANAEMIA
COMMERCIALLY AVAILABLE KIT: SICKLEVUE SOLUBILITY TEST FOR DETECTION OF HAEMOGLOBIN S Courtesy: Tulip Group of Companies
Summary
Reagents
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Materials Provided with the Kit
Reagent Pack
Additional Material Required
Test Procedure
Screening Method
Differentiation Method
Interpretation of Results
Screening Method
Differentiation Method
Remarks
LABORATORY DIAGNOSIS OF UNSTABLE Hb HAEMOGLOBINOPATHY
THALASSAEMIAS (REDUCED SYNTHESIS RATE)
In β Thalassaemia
In α Thalassaemia
Laboratory Diagnosis of β Thalassaemia Minor
Blood Picture
Peripheral Smear Shows
Hb Electrophoresis
Laboratory Diagnosis of p Thalassaemia Major
Blood Picture
Bone Marrow
Hb Pattern on Electrophoresis
Laboratory Diagnosis of α Thalassaemia Hb-H Disease
Hb Bart's—Hydrops Foetalis
LABORATORY DIAGNOSIS OF APLASTIC ANAEMIA
Classification and Causes of Aplastic Anaemia
Drugs
Drugs which Regularly Cause Aplastic Anaemia
Drugs which Occasionally Cause Bone Marrow Depression
Chemicals
Physical Agents
PANCYTOPENIA
Blood Picture
Causes
NORMAL WHITE CELL VALUES AND PHYSIOLOGICAL VARIATIONS
Pathological Variations in White Cell Counts Neutrophilia
Eosinophilia
Lymphocytosis
Monocytosis
Basophilia
Morphologic Forms of Lymphocytes
Virocyte
Transformed Lymphocytes
Arneth Count
Arneth Index
Neutropenia and Agranulocytosis
Lymphopenia
Eosinopenia
Basophilopenia
LEUKAEMOID REACTIONS
Neutrophilic
Lymphocytic
Eosinophilic
BONE MARROW PLASMACYTOSIS
WHITE BLOOD CELLS
Neutropenia and Agranulocytosis
Blood Picture of Drug-Induced Neutropenia
Bone Marrow
Causes of Neutropenia
Drugs
OTHER CAUSES OF NEUTROPENIA
LABORATORY DIAGNOSIS OF INFECTIOUS MONONUCLEOSIS
Blood Picture
Paul Bunnel Test for Heterophile Antibody
LUPUS ERYTHEMATOSUS (LE) CELL/PHENOMENON
CLASSIFICATION OF ACUTE MYELOMONOCYTIC LEUKAEMIAS
LABORATORY DIAGNOSIS OF LEUKAEMIAS
Cytochemical Methods for Staining Leucocytes
Neutrophil Alkaline Phosphatase (Kaplow's Method)
Reagents
Procedure
Peroxidase (Myeloperoxidase, Kaplow's Method)
Reagents
Procedure
Interpretation
PERIODIC ACID-SCHIFF (PAS) REACTION
Sudan Black B Stain (Sheehan and Storey)
Reagents
Procedure
Interpretation
Nonspecific Esterase
Reagents
Procedure
Interpretation
ACUTE LEUKAEMIAS, LABORATORY DIAGNOSIS
Routine Haematologic Investigations
Blood Film Examination
Differentiation of ALL from AML
Other Investigations
CHRONIC MYELOID LEUKAEMIA
Laboratory Investigations
Diagnostic Features
Additional Features
CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)
Laboratory Findings
PARAPROTEINAEMIAS
Causes
MULTIPLE MYELOMA
Laboratory Diagnosis
Other Laboratory Findings
POLYCYTHAEMIA VERA
Laboratory Diagnosis
MYELOSCLEROSIS
Laboratory Diagnosis
HODGKIN'S DISEASE
Laboratory Findings in Hodgkin's Disease
CHAPTER 10:
Clinical Haematology Bleeding Disorders
PLATELETS, COAGULATION AND BLEEDING DISORDERS: LABORATORY INVESTIGATIONS
CAPILLARY FRAGILITY TEST OF HESS
Clinical Implications
Interfering Factors
BLEEDING TIME
Duke's Method
Requirements
Method
Precautions
Method
Interpretation
Clinical Implications
Interfering Factors
Patient Preparation
COAGULATION TIME
Capillary Tube Method of Wright
Lee and White's Method
Requirements
Method
Normal Values
Precautions and Errors
Clinical Implications
Interfering Factors
CLOT RETRACTION
Principle
Requirements
Method
Interpretation
Errors
HEPARIN THERAPY
Protocols and Blood Coagulation tests
QUALITY ASSURANCE FOR ROUTINE HAEMOSTASIS LABORATORY
Introduction
Preparation of Patients
Sample Collection Techniques (Phlebotomy)
Sample Preparation
Sample Processing and Storage
Buffered 3.2% Citrate Solution (Profact) Courtesy: Tulip Group of Companies
Summary
Reagent
Principle
Storage and Stability
Material Required But Not Provided
SAMPLE COLLECTION AND PREPARATION
For Coagulation assays
For ESR by Westergren Method
Precautions
Remarks
Calibration of instruments/equipments
Storage of Reagents
End Point Reading
Drug/Clinical Conditions Influencing Patient Results
Clinical Conditions
MNPT and INR
Quality Control Aspects
(PROTHROMBIN TIME) (QUICK ONE-STAGE METHOD) LIQUIPLASTIN® (Coutesy: Tulip Group of Companies)
Thromboplastin Reagent for Prothrombin Time (PT) Determination
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation of PPP
Additional Material Required for Manual and Calibration Curve Methods
TEST PROCEDURE
Manual Method
CALCULATION OF RESULTS
Manual Method
Expected Values
Remarks
SENSITIVE THROMBOPLASTIN REAGENT FOR PROTHROMBIN TIME (PT) DETERMINATION (ISI=1.0)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Additional Material Required
Sample Collection and Preparation of PPP
TEST PROCEDURE
Manual Method
CALCULATION OF RESULTS
Manual Method
Expected Values
Remarks
THROMBOPLASTIN REAGENT FOR PROTHROMBIN TIME (PT) DETERMINATION (Lyophilised reagent, ISI=1.0) Courtesy: Tulip Group of Companies
Summary
Reagent
Storage and Stability
Principle
Note
Additional Material Required
Reagent Preparation
Sample Collection and Preparation of PPP
TEST PROCEDURE
Manual Method
CALCULATION OF RESULTS
Manual Method
Expected Values
Remarks
Clinical Implications
Interfering Factors
Clinical Alert
MONITORING ORAL ANTICOAGULANT THERAPY
Introduction
Relevance and Use of the Prothrombin Time Test
Oral Anticoagulant Agents
Pharmacology of Oral Anticoagulants
PIVKA'S
The Role of PT Test in Monitoring Effects of Oral Anticoagulant Therapy
Problems in monitoring Oral Anticoagulant therapy
PT ratio (PTR)
Factors Influencing Anticoagulant Effects of Warfarin
Percent Activity
Standardization of Prothrombin Time Reagents and Reporting System
Basis of Calibration
The INR Method of Reporting Results
INR Conversion Table
Recommended therapeutic ranges for oral anticoagulant therapy
Other Factors Influencing The INR
MNPT
ISI value of PT used and Method of Clot Detection
Practical Considerations for Warfarin Therapy
Management of patients with high INR values with or without bleeding complications
Advantages of the INR system
Disadvantages of the INR system
PROTHROMBIN DETERMINATION (Two stage method)
Principle
Results
APTT/PTTK Cephaloplastin Reagent For Partial Thromboplastin Time (APTT) Determination Using Ellagic Acid As Activator
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
FNP Collection
Additional Material Required
TEST PROCEDURE
Manual Method
CALCULATION AND REPORTING OF RESULTS
Manual Method
Calibration Curve Method
Expected Values
Remarks
SOYABEAN CEPHALOPLASTIN REAGENT FOR PARTIAL THROMBOPLASTIN TIME (APTT) DETERMINATION USING ELLAGIC ACID, AS AN ACTIVATOR CELIN-SE. (Courtesy: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
FNP Collection
Additional Material Required
TEST PROCEDURE
Manual Method
CALCULATION AND REPORTING OF RESULTS
Manual Method
Calibration Curve Method
Expected Values
Remarks
Recalcification solution
CLINICAL IMPLICATIONS OF APTT
Circulating Anticoagulants
NORMAL AND ABNORMAL CONTROL PLASMAS FOR COAGULATION ASSAYS Plasmatrol H-I/II® (Courtesy: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Preparation of the Reagent
Test Procedure
Expected Values
Remarks
FIBROSCREEN THROMBIN TIME TEST FOR QUALITATIVE ESTIMATION OF FIBRINOGEN Courtesy: Tulip Group of Companies
Summary
Reagent
Storage and Stability
Principle
Note
Quality Control
Sample Collection and Preparation
Additional Material Required
Procedure
Manual method
Interpretation of Results
Expected Values
Remarks
Interpretation of first line tests:
FIBRINOGEN ESTIMATION-QUANTITATIVE
FIBROQUANT, REAGENT FOR QUANTITATIVE ESTIMATION OF FIBRINOGEN (Courtesy Tulip Group of Companies)
Summary
Reagent
Storage and Stability
Principle
Note
Quality Control
Sample Collection and Preparation
Additional Material Required
Procedure
A. Procedure for fibrinogen Calibration Curve Preparation
B. Test Procedure for Sample
Remarks
FIBRINOLYTIC ACTIVITY
EUGLOBULIN LYSIS TIME
Principle
Requirements
Method
Result
DILUTE BLOOD CLOT LYSIS TIME
Principle
Requirements
Method
Result
FDPs
A QUALITATIVE AND SEMIQUANTITATIVE LATEX SLIDE TEST FOR DETECTING CROSS LINKED FIBRIN DEGRADATION PRODUCTS IN HUMAN PLASMA. Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
KIT Composition
Additional Material Required
Test Procedure
Qualitative Method
Semi-quantitative Method
Interpretation of Results
Qualitative Method
Semi-quantitative Method
Remarks
SCREENING TESTS FOR DIAGNOSIS OF PROCOAGULANT DEFICIENCY
Requirements
Method
Results
LABORATORY DIAGNOSIS OF VASCULAR BLEEDING DISORDERS
LABORATORY DIAGNOSIS OF PLATELET DISORDERS
IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
DRUG INDUCED IMMUNE THROMBOCYTOPENIA
DISSEMINATED INTRAVASCULAR COAGULATION (DIC)
Causes of DIC
FUNCTIONAL PLATELET DISORDERS
Laboratory Diagnosis
Hereditary Disorders
Acquired Disorders
LABORATORY DIAGNOSIS OF COAGULATION DISORDERS
LABORATORY DIAGNOSIS OF HEMOPHILIA
Christmas Disease (Hemophilia B)
vON WILLEBRAND'S DISEASE
HEMORRHAGIC DISEASE OF NEWBORN
LUPUS ANTICOAGULANTS: BASIC CONCEPTS AND LABORATORY DIAGNOSIS
General Background
Anti-Phospholipid Antibody-Lupus Anticoagulants
APS (Anti-Phospholipid Syndrome)
Clinical findings with LA
Pathophysiological Mechanism of Thrombosis
LUPUS ANTICOAGULANTS AND BLEEDING COMPLICATIONS
Phospholipid Dependence of Lupus Anticoagulants
Laboratory Diagnosis of Lupus Anticoagulants
Immunological Assays
CLOT-BASED ASSAYS
APTT (Activated Partial Thromboplastin Time)
TTI (Tissue Thromboplastin Inhibition Test)
KCT (Kaolin Clotting Time)
PNP (Platelet Neutralization Procedure)
Hexagonal Phase Phospholipids
Recommendations and Criteria for the Diagnosis of Lupus Anticoagulants
Current Recommendations of the ISTH
Scientific Subcommittee Criteria for the Laboratory Diagnosis of Lupus Anticoagulants
dRVVT: The test of choice for screening and confirmation of LA
Principle of dRVVT for LA detection
Interpretation of results with dRVVT test
dRVVT as positive predictor of thrombotic events in APS
Therapeutic Measures for Patients with LA
dRVVT for Screening and Confirmation of Lupus Anticoagulants LADS, (Courtesy: Tulip Group of Companies)
Summary
Principle
Reagents Provided with the Kit
Note
Storage and Stability
Additional Material Required
Reagent Preparation
Sample Preparation
Test Procedure
Interpretation of Results
Remarks
LA REFERENCE PLASMA FOR LA TEST (Courtesy: Tulip Group of Companies)
Summary
Reagent
Principle
Reagent Storage and Stability
Note
Preparation of the Reagent
Test Procedure
Remarks
AUTOMATION IN COAGULATION ANALYSIS HEMOSTAR
Technical Features
HEMOSTAR XF
Technical Features
CoaLAB 6000
Compact
Versatile
User Friendly
Technical Specifications
CHAPTER 11:
Blood Banking (Immunohaematology)
BLOOD GROUP ANTIBODIES
Naturally Occurring Antibodies
GENETICS OF ABO SYSTEM
Biochemistry
SUBGROUPS OF A AND AB
Subgroups of B
Antibodies of ABO System
Anti-H
ABO TESTING PROCEDURES
ABO Antibody Reagents
Red Cells Reagents
Group O reagent Screen Cells
Preparation of Red Cell Suspensions
Method (for 2% suspension)
Blood grouping sera should meet the following requirements
ANTI-A, ANTI-B, ANTI-A, B
Blood Grouping Antisera for Slide and Tube Tests (FromTulip's Erybank Range)
Summary
Reagents
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Tube Test
INTERPRETATION OF RESULTS
Slide and tube tests
Remarks
NTI-A, ANTI-B, ANTI-A, B
Monoclonal Blood Grouping Antibodies for Slide and Tube Tests (From Tulip's Eryclone Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Tube Test
INTERPRETATION OF RESULTS
Slide and Tube tests
Remarks
ANTI-A1 LECTIN
Dolichos Biflorus Lectin for Slide and Tube Tests (From Tulips Erybank Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Tube Test
INTERPRETATION OF RESULTS
Slide and Tube Tests
Remarks
ANTI-H LECTIN
Ulex Europaeus Lectin for Slide and Tube Tests (From Tulip's Erybank Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
For recognition of H antigen on human red blood cells
For Assessing Secretor Status in Human Saliva
Additional Material Required for Slide and Tube Tests
Procedure
Slide Test
Tube Test
Tube Test (Secretor Status)
INTERPRETATION OF RESULTS
Slide and Tube Tests
Tube Test (Secretor Status)
Remarks
OTHER REQUIREMENTS
PHYSIOLOGICAL SALINE SOLUTION FOR SERO-LOGICAL APPLICATIONS (FROM TULIP'S ERYBANK RANGE) (SODIUM CHLORIDE 0.9% W/V)
Summary
Reagent
Principle
Note
Uses
BOVINE SERUM ALBUMIN 22% SOLUTION FOR SEROLOGICAL APPLICATIONS (From Tulip's Erybank Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Compatibility Testing
BROAD-SPECTRUM COMPATIBILITY TEST
Major Cross match Procedure
Initial Phase
Incubation Phase
Antiglobulin Phase
Antibody Titration Test
INTERPRETATION OF RESULTS
Compatibility Test
Antibody Titration Test
Remarks
CONCENTRATED ISO-OSMOTIC PHOSPHATE BUFFERED SALINE FOR SEROLOGICAL APPLICATIONS (Osmosol from Tulip)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Additional Material Required
Method of Preparation
Remarks
MEDIA FOR COLLECTION AND PRESERVATION OF REAGENT RED CELLS
Precautions
RED CELL PRESERVING SOLUTION FOR SEROLOGICAL APPLICATIONS (Erywell from Tulip)
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Procedure
Storage
Precautions
ABO GROUPING
Slide ABO Grouping Test
Six-tube Method (Fig. 11.3)
Interpretation
Solving Problems of Discrepancies
Repeat Preliminary Procedures
RH BLOOD GROUP SYSTEM
Clinical Importance of Rh
Present Status and Nomenclature
Rh Du Antigen
Rh antibodies
Reagents for Rh(D) Grouping
RH(D) GROUPING PROCEDURES
Slide Testing
Method
Tube Method
Interpretation
Testing for Du Method
Interpretation
ANTI-D (Rho)
Human (IgG) Polyclonal Blood Typing Antibodies for Slide and Modified Tube Tests (From Tulip's Erybank Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Additional Material Required for Slide and Tube Tests
TEST PROCEDURE
Slide Test
Tube Test
Du Test Procedure
INTERPRETATION OF RESULTS
Slide and Tube Tests
Du Test Procedure
Remarks
ANTI-D (Rho) (IgM)
Monoclonal Blood Typing Antibodies for Slide and Tube Tests (From Tulip's Eryclone Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Immediate Spin Tube Test
Du Test Procedure
INTERPRETATION OF RESULTS
Slide and Tube tests
Du Test Procedure
Remarks
ANTI-D (Rho) (IgG)
Monoclonal Blood Typing Antibodies for Slide and Modified Tube Tests (From Tulip's Eryclone Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Tube Test
Du Test Procedure
INTERPRETATION OF RESULTS
Slide and Tube tests
Du Test Procedure
Remarks
ANTI-D (Rho) (IgM + IgG)
Monoclonal Blood Typing Antibodies for Slide and Tube Tests (Rhofinal from Tulip)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required for Slide and Tube Tests
Test Procedure
Slide Test
Tube Test
Du Test procedure
INTERPRETATION OF RESULTS
Slide and Tube tests
Du Test Procedure
Remarks
BLOOD GROUP TESTING IN MICROPLATES
Procedure
ANTIHUMAN GLOBULIN TEST
Historical Perspective
Preliminary Notes: Antigen and antibody related to blood group serology
Antibody Nomenclature with Respect to Blood Group Serology
IgM Class Antibodies
IgG Class Antibodies
Role of Enhancement Medium
ENHANCEMENT TECHNIQUES
Albumin Additives
Enzymes
Positively Charged Molecules
Polyethylene Glycol (PEG)
LISS (Low Ionic Salt Solution) and LISS additives
COMPLEMENT
Immunoglobulin Requirements for Activation of Classical Pathway
Complement Binding Antibodies (Table 11.5)
Basic Concepts of Anti-human Globulin Testing
Anti-human Globulin Reagents
ICSH Recommendations for Polyspecific Anti-human Globulin Reagents
Monospecific Coomb's Reagent
DIRECT ANTI-HUMAN GLOBULIN TEST (DAT)
MAJOR APPLICATIONS OF DAT IN BLOOD GROUP SEROLOGY
Haemolytic Disease of the Newborn (HDN)
Transfusion Reactions
Other Immune Haemolytic Diseases
Classification of Autoimmune Haemolytic Anaemia
Drug-induced Haemolytic Anaemia
Importance of Serological Studies in DAT Positive Results (Table 11.6)
INDIRECT ANTI-HUMAN GLOBULIN TEST (IAT)
Applications of IAT
PROBABLE SOURCES OF ERROR IN ANTI-HUMAN GLOBULIN TESTING
False Negative Results
False Positive Results
Coomb's Control Cells/Complement Coated Cells
INDIRECT ANTI-HUMAN GLOBULIN TEST FOR THE DETECTION OF RED BLOOD CELL ANTIBODIES
Saline Phase Indirect Anti-human Globulin Test
ALBUMIN PHASE INDIRECT ANTI-HUMAN GLOBULIN TEST
LISS PHASE INDIRECT ANTI-HUMAN GLOBULIN TEST
PEG-ENHANCED INDIRECT ANTI-HUMAN GLOBULIN TEST
LIM (LOW IONIC MEDIUM-POLYBRENE) INDIRECT ANTI-HUMAN GLOBULIN TEST
Interpretation of Results for anti-human globulin Tests
Controls
Notes
PAPAIN—ONE-STAGE ENZYME TECHNIQUE / TWO-STAGE ENZYME TECHNIQUE
Procedure for One-stage Enzyme Technique
Procedure for Two-stage Enzyme Technique
ANTIBODY TITRATION STUDIES
Antibody Titration for Characterizing Type of Antibody in Serum
Procedure
Interpretation
Notes
Antibody Titration Studies for Early Detection of Haemolytic Disease of the Newborn
Materials
Quality Control
Procedure
Results
Notes
Use of Sulfhydryl Reagents to Distinguish between IgM and IgG Antibodies
Procedure
Notes
ELUTION TECHNIQUES
Citric Acid Elution Method
Procedure
Notes
COLDACID ELUTION
Procedure
Notes
Glycine-HCl/EDTA Elution
Procedure
Notes
Heat Elution
Procedure
Donath-Landsteiner Test
Procedure
Interpretation
Notes
Chequer Board Titration for Quality Control of Anti-IgG Potency in Polyspecific AHG Reagent and Evaluation of Complement Potency with Complement-coated Cells
Reagents and materials required for chequer board titration
Reagent Preparation Procedure
Dilutions of anti-D (IgG) reagent
CELL SENSITIZATION
Note
Dilutions of Anti-human Globulin Reagent
Preparation of Complement-Coated Cells
Preparation of 50% Cell Suspension of O Group Red Blood Cells
Collection of inert O group serum
Sensitization of O group red blood cells
Chequer Board Titration
Preparation of Coomb's Control Cells
Procedure
ANTI-HUMAN IgG MONOSPECIFIC COOMB'S REAGENT FOR DIRECT AND INDIRECT ANTI-GLOBULIN TEST (From Tulip's Erybank Range)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
For Direct Antiglobulin Test
For Indirect Antiglobulin Test
ADDITIONAL MATERIAL REQUIRED
For Direct Antiglobulin Test
For Indirect Antiglobulin Test
Procedure
Direct Antiglobulin Test
Indirect Antiglobulin Test for Antibody Identification
INTERPRETATION OF RESULTS
Direct Antiglobulin Test
Indirect Antiglobulin Test
Remarks
ANTIHUMAN GLOBULIN REAGENT
For Direct and Indirect Antiglobulin Tests (Eryclone® from Tulip)
Summary
Reagents
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Preparation of Coomb's Control Cells
Additional Material Required
Procedure
Direct Antiglobulin Test
INDIRECT ANTIGLOBULIN TEST
Major Cross-match Procedure
Initial Phase
Incubation Phase
Antiglobulin Phase
INTERPRETATION OF RESULTS
Direct Antiglobulin Phase
Indirect Antiglobulin Phase
Remarks
PREPARING COOMB'S CONTROL CELLS (AGTROL® FROM TULIP, STARTER PACK)
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Additional Collection and Storage
Procedure
Preparation and Validation of Coomb's Control Cells
Validation of prepared 5% Coomb's control cell suspension
Use of Coomb's Control cells
Interpretation and Results
Remarks
LOW IONIC SALT SOLUTION FOR SEROLOGI-CAL APPLICATIONS (TULISS FROM TULIP)
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Additional Material Required
Procedure
Indirect Antiglobulin Test for Cross Match
Initial phase
Incubation Phase
Antiglobulin Phase
For Antibody Detection
Initial Phase
Incubation Phase
Antiglobulin phase
INTERPRETATION OF RESULTS
Crossmatch
Antibody Detection
Remarks
STABILIZED, ACTIVATED PAPAIN ENZYME SOLUTION FOR SEROLOGICAL APPLICATIONS (Liquipap from Tulip)
Summary
Reagent
Reagent Storage
Principle
Note
Sample Collection and Preparation
Additional Material Required
Procedure
Two stage test
Interpretation of Results
Remarks
BLOOD TRANSFUSION
BLOOD DONORS
Donor Screening
Drawing of Blood
ADVERSE DONOR REACTIONS
Problems with Blood Flow
Haematoma
Accidental Puncture of the Artery
Mild, Moderate or Severe Reactions
Mild Donor Reactions
When Mild Donor Reactions Occur
Moderate Donor Reactions
When moderate donor reactions occur
Severe Donor Reactions
When Generalized Convulsions Occur
Hyperventilation
Accidents
COMPATIBILITY TESTING
The Cross-Match
Saline Cross-Match
The Open Slide Method
Saline Tube Method
Immediate-spin and Thermal Incubation Modification
Albumin Tube Method
Coomb's' Cross-Matching
Method of Cross-Matching Universal Donor Blood
Factors Leading to False Results
If Still an Unexpected Incompatibility is Obtained:
CHOICE OF MATERIAL FOR TRANSFUSION
BLOOD AND ITS PRODUCTS
Fresh Blood
Packed Cells
Plasma
BLOOD TRANSFUSION COMPLICATIONS
Complications Appearing Early
Complications Appearing Late
INVESTIGATIONS IN A CASE OF TRANSFUSION REACTION
Proceed as Mentioned Below
Interpretation of Results
LABORATORY DIAGNOSIS OF HEMOLYTIC DISEASE OF THE NEWBORN
CHAPTER 12:
Cerebrospinal and Other Body Fluids
CEREBROSPINAL FLUID
Normal Values for Lumbar CSF in Adults
Lumbar Puncture
Indications
Complications of Lumbar Puncture
CSF Rhinorrhoea and Otorrhoea
CSF Pressure
CSF
Gross Examination
Cell Counts
Diluting the Fluid
Count
Conditions that Elevate CSF Protein
Lange's Colloidal Gold Test
Glucose
Conditions that Effect the CSF Glucose
Enzymes
Bacteriologic Examination
Serologic Tests
SYNOVIAL FLUID (SF)
Microscopic Examination
Immunologic Studies
PLEURAL FLUID
Indications for Thoracentesis
Gross Examination
Microscopic Examination
Sometimes lymphocytic effusion may be seen in:
Eosinophilic pleural effusions may be seen in:
Immature blood cells may be seen in
Chemical Examination
Microbiologic Examination
PERICARDIAL FLUID (PF)
Normal
Gross Examination
Microscopic Examination
Microbiologic Examination
Chemical Examination
PERITONEAL FLUID
Gross Examination
Colour of Peritoneal Fluid
Microscopic Examination
Microbiologic Examination
Chemical Examination
AMNIOCENTESIS AND AMNIOTIC FLUID ANALYSIS, DIAGNOSTIC
Normal Value
Abnormalities that may be found upon Routine Analysis
Description
Risks
Contraindications
Preparation
Procedure
Postprocedure Care
Patient and Family Teaching
Factors that Affect Results
Other Data
CHAPTER 13:
Semen Analysis
SEMEN ANALYSIS
Collection
Gross Examination
Physical Characteristics
Microscopic Examination
Sperm Counts
Sperm Morphology (Fig. 13.1)
Chemical Examination of Semen
Reagent
Method
Reporting
Other Tests of Semen
Antibodies to Spermatozoa
CHAPTER 14:
Sputum Examination
SPUTUM EXAMINATION
Macroscopic Examination
Consistency and Appearance
Other Findings
Microscopic Examination
Sputum Culture
COMMON RESPIRATORY DISORDERS
Mycobacteria
Mycotic (Fungal) Disease
Pathological Fungi
Actinomyces israelii
Nocardia asteroides
Cryptococcus neoformans
Histoplasma capsulatum
Coccidiodes immitis
Blastomyces dermatidis
Candida albicans
Aspergillus fumigatus
Phycomycetes
Bronchial Asthma
Bronchiectasis
Chronic Bronchitis
Lung Abscess
Pneumonia
Pneumoconiosis
Pulmonary Embolism
Heart Disease
Viral Infections
Pulmonary Alveolar Proteinosis
Cytologic Examination in Malignancy
CHAPTER 15:
Pregnancy Tests
BIOASSAYS
Normal Values of hCG (Serum/Plasma)
Comments
IMMUNOLOGIC METHODS
Immunologic Tests for Pregnancy
SLIDE TEST FOR PREGNANCY (Foretel® from Tulip Group of Companies)
Latex Agglutination Inhibition Method
Summary
Reagents
Reagent Storage and Stability
Principle
Note
SAMPLE COLLECTION AND PREPARATION
Qualitative Method
Semi-quantitative Method
MATERIAL PROVIDED WITH THE KIT
Reagent Pack
Accessories Pack
Additional Material Required
Test Procedure
Qualitative Method
Semi-quantitative Method
INTERPRETATION OF RESULTS
Qualitative Method
Semi-quantitative Method
Remarks
SLIDE TEST FOR PREGNANCY (Foresight— from Tulip Group of Companies)
Direct Latax Agglutination Method
Summary
Reagent
Reagent Storage and Stability
Principle
Note
SPECIMEN COLLECTION AND PREPARATION
Qualitative Method
Semi-quantitative Method
Material Provided with the Kit
Additional Material Required
Test Procedure
Qualitative Method
Semi-quantitative Method
INTERPRETATION OF TEST RESULTS
Qualitative Method
Semi-quantitative Method
Remarks
ELISA PREGNANCY TEST (Vectra from Tulip Group of Companies)
Introduction
Summary
Principle
REAGENTS AND MATERIAL SUPPLIED
Storage and Stability
Note
Specimen Collection
Test Procedure
Interpretations of Results
Remarks
PERSPECTIVES ON MEMBRANE-BASED RAPID DIAGNOSTIC TESTS AND DETECTION OF hCG USING THESE TESTS
Index
How does the nitrocellulose membrane affect the sensitivity of Rapid Diagnostic Tests?
Pore size and capture reagent binding properties
Pore size and lateral flow rate
Why are colloidal gold sol particles commonly employed in the detector reagent in membrane-based Rapid Diagnostic Tests?
Colloidal gold sol particles as indicator
Effect of shape of colloidal gold sol particles on stability
Effect of shape of colloidal gold sol particles on sensitivity
Effect of size on colour of colloidal gold sol particles
Why are variations in band appearance commonly observed in membrane-based Rapid Diagnostic Tests employed for antigen detection?
What is the role of sample pad in membrane-based Rapid Diagnostic Tests
What is the role of soak pad in membrane-based Rapid Diagnostic Tests?
Why do “Faint Ghost Bands” appear at the test region if the device is left out on the work-table?
How do we interpret “Broken Bands” at the test/control region?
However, appearance of even a broken and at the test region indicates positive results.
What is pregnancy testing?
What is human Chorionic Gonadotrophin (hCG)?
What are the levels of hCG observed during normal pregnancy?
What is the effect of antibody pair used in the membrane-based Rapid Diagnostic Pregnancy Tests for detection of hCG?
What is the clinical significance of hCG?
What are the implications of sensitivity and specificity on membrane-based Rapid Diagnostic Tests for Pregnancy?
What is the ideal specimen to be employed for pregnancy testing?
Why are discrepant results observed during problem pregnancies?
Ectopic Pregnancy
Spontaneous abortions
Early Pregnancy Loss
Exogenous Administration of hCG
Trophoblastic tumors and non-trophoblastic tumors
Phantom hCG-like immuno-reactivity
After normal delivery
How do procedural errors affect Rapid Diagnostic Tests? Improper storage conditions
Procedural Errors
Dropper and Drop Size
Excess Sample Volume Dispensed
Damage in Packing
Reading results at the recommended time
DIPSTICK ICT PREGNANCY TEST (CLUE FROM ORCHID BIOMEDICAL SYSTEMS)
Summary
Principle
REAGENTS AND MATERIALS SUPPLIED
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure and Interpretation of Results
Limitation of the Test
PERFORMANCE CHARACTERISTICS
1. Sensitivity
2. Specificity
3. Accuracy
DEVICE ICT PREGNANCY TEST (CLUE, FROM ORCHID BIOMEDICAL SYSTEMS)
Introduction
Summary
Principle
REAGENTS AND MATERIALS SUPPLIED
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure and Interpretation of Results
Limitation of Tests
PERFORMANCE CHARACTERISTICS
1. Sensitivity
2. Specificity
3. Accuracy
ICT TECHNIQUES FOR URINE/SERUM SAMPLE
ADVANTAGES OF SERUM TESTING
DIPSTICK ICT, URINE/SERUM PREGNANCY TEST (GRAVI CHECK FROM ORCHID BIOMEDICAL SYSTEMS)
Introduction
Summary
Gravi Check
Principle
Reagents and Materials Supplied
Storage and Stability
Note
SPECIMEN COLLECTION AND PREPARATION
Urine as Sample
Serum as Sample
TEST PROCEDURE AND INTERPRETATION OF RESULTS
Limitations of the Test
PERFORMANCE CHARACTERISTICS
1. Sensitivity
2. Specificity
3. Accuracy
DEVICE ICT URINE/SERUM PREGNANCY TEST (GRAVI CHECK FROM ORCHID BIOMEDICAL SYSTEMS)
Introduction
Summary
Principle
Reagents and Materials Supplied
Storage and Stability
Note
SPECIMEN COLLECTION AND PREPARATION
Urine as Sample
Serum as Sample
Test procedure and Interpretation of Results
Limitation of the Test
PERFORMANCE CHARACTERISTICS
1. Sensitivity
2. Specificity
CHAPTER 16:
Examination of Gastrointestinal Contents
NORMAL SALIVA—CONSTITUENTS
Constituents
Gastric Constituents
Normal Gastric Constituents in Infants and Children
Abnormal Gastric Constituents
ROUTINE GASTRIC JUICE EXAMINATION
Gross Examination
Chemical Examination
Microscopic Examination
GASTRIC TEST MEALS
Procedures
Tubeless Gastric Analysis
Interpretation
Basal Gastric Secretion
Method
Interpretation
Augmented Histamine Test (AHT)
Method
Interpretation
Histamine Infusion Test
Advantages
Method
Interpretation
Histalog Test
Insulin Hypoglycaemia Test
Method
Interpretation
Gastrin Secretory Test
Miscellaneous Investigations
EXAMINATION OF DUODENAL CONTENTS
Duodenal Drainage
Indications
Method for Diagnostic Drainage
Examination for Diagnosis
Interpretation
COMPOSITION OF BILE
PANCREATIC FUNCTION TESTS
Composition of Pancreatic Juice
Gross and Chemical Characteristics of Pancreatic Juice
Digestive Enzymes
Proteolytic Enzymes
Peptidases
Nucleases
Amylolytic Enzymes
Lipolytic Enzymes
Acute Pancreatitis
Chronic Pancreatitis (Cirrhosis of Pancreas)
Carcinoma of Pancreas
LIPASE
SECRETIN TEST
OTHER LABORATORY TESTS IN ACUTE PANCREATITIS
MISCELLANEOUS TESTS FOR CHRONIC PANCREATITIS
SWEAT ELECTROLYTES PILOCARPINE IONTOPHORESIS
Diagnostic Application of Sweat Testing
CHAPTER 17:
The Endocrine System
INTRODUCTION
PITUITARY GLAND
Anterior Pituitary (Adenohypophysis)
Hormones Secreted by the Pituitary Gland
Causes of Hypopituitarism Resulting in Multiple or Single Deficiencies
Intrinsic Pituitary Disease
Extrinsic Pituitary Disorders
ANTERIOR LOBE
GROWTH HORMONE (GH)
Actions
Clinical Disorders
GROWTH HORMONE (GH) ELISA (FROM MONOBIND, Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Growth Hormone Calibrators —1.0 ml/vial
B. Enzyme (HRP)—Polyclonal antibody Conjugate and Biotinylated Monoclonal antibody—11 ml/vial
C. Streptavidin-coated Microplate—96 wells
D. Wash Solution Concentrate—20 ml
E. Substrate A ~7.0 ml/vial
F. Substrate B–7.0 ml/vial
G. Stop Solution – 6.0 ml/vial
FOR IN VITRO DIAGNOSTIC USE
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but not Provided
Reagent Preparation
Test Procedure
Quality Control
Results
Example 1
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Clinical Disorders
Interfering Factors
CORTICOTROPHIN (ACTH)
Actions
Methods of Evaluation
Clinical Disorders
OTHER ANTERIOR PITUITARY HORMONES TSH
FSH
LH
LH, FSH—Recommendations for Testing
PROLACTIN
Prolactin—Recommendations for Testing
INTERMEDIATE LOBE (PARS INTERMEDIA)
POSTERIOR PITUITARY (NEUROHYPOPHYSIS)
ADH
Clinical Disorders
Methods of Evaluation
Deficiency
Syndrome of Inappropriate ADH Secretion (SIADH)
FEEDBACK MECHANISM
Disorders of the Pituitary System
HYPOTHALAMUS
ADRENAL (SUPRARENAL) GLAND
Mineralocorticoids
Clinical Relevance
GLUCOCORTICOIDS
Cortisol Abnormalities
Adrenal Medulla
Clinical Disorders
THYROID
Role of Carrier Protein
Thyroxine-binding Globulin (TBG) Test
Free Hormones
Free T3 and Free T4 are the “Physiologically active hormones”
Feedback Mechanism
Neonatal Thyroxine
Anti-TPO (Thyroid Peroxidase Antibodies)
Clinical Application
Anti-Tg (Anti-Thyroglobulin Antibodies)
LATS (Long-Acting Thyroid Stimulator)
Clinical Significance
Disorders of the Gland
Clinical Manifestations
Tests for Thyroid Function
FT3, FT4—Recommendations for Testing
Free Thyroxine Index (FTI)
Thus: FT4 Index = T4 (total)× T3UR.
T3 Uptake Ratio (T3UR)
Clinical Significance
PARATHYROID
PANCREAS
Insulin
Functions of Insulin
Clinical relevance of C-peptide
Anti-Insulin Antibodies
TESTES
Androgen Abnormalities
Males
Females
Androgen Deficiency
OVARY
Synthesis
Oestrogen Abnormalities
Progesterone Abnormalities
PINEAL GLAND
HORMONES AND FERTILITY
MALE FERTILITY
Testicular Function
Post-testicular Function
Ejaculatory Disturbance, Impotence, and Sexual Problems
THE MALE HORMONE SYSTEM
The Hypothalamus and Pituitary Start the Action
Feedback Hormones from Testicles
Where Can Things Go Wrong?
An Overview of Hormonal Treatment
DIAGNOSING AND BEATING SPECIFIC HORMONAL PROBLEMS
Hyperprolactinaemia
Hypothyroidism
Congenital Adrenal Hyperplasia
Hypogonadotrophic Hypopituitarism
Panhypopituitarism
Kallmann's Syndrome
Delayed Puberty
Fertile Eunuch
FERTILITY FACTOR 2 TREATING UNRESPONSIVE TESTICLES
What Causes Testicular Failure?
Varicocoele
Cryptorchidism
Infection
Torsion
Klinefelter's Syndrome
Cushing's Syndrome
Germ Cell Aplasia (Sertoli Cell Only)
Testicular Enzyme Defects
FEMALE FERTILITY
The Five Female Fertility Factors
Fertility Factor—1: Ovulation
Fertility Factor—2: Sperm-Mucus Interaction
Fertility Factor—3: Fertilisation
Fertility Factor—4: Tubal Factor
Fertility Factor—5: Embryo Implantation
FEMALE HORMONE SYSTEM
What is Ovulation?
Cyclical Changes in the Menstrual Cycle
What makes One have a Period?
CLUES FROM THE MENSTRUAL HISTORY
The Three Types of Menstrual Patterns
The Regular Menstrual Period
Irregular Menstrual Periods or Amenorrhea for Six or More Months
Nonexistence of the Menstrual Period
CLUES FROM PHYSICAL EXAMINATION
The Physical Examination
Diagnostic Approaches for Irregular Menstrual Periods or Amenorrhea
Pregnancy Test
Progesterone Withdrawal Test
Positive Response to Progesterone Withdrawal
Negative Response to Progesterone Withdrawal
Positive Withdrawal to Oestrogen/Progesterone Stimulation
DETECTING OVARIAN FAILURE
DIAGNOSING ANOVULATION
Symptoms of Anovulation
Tests Used to Determine the Cause of Anovulation
Hormonal Tests for Diagnosing the Cause of Anovulation
Prolactin Pituitary Hormone
Thyroid Hormone
FSH and LH Pituitary Hormones
Adrenal Androgens (DHEAS and Testosterone)
Conditions that can Interfere with Ovulation and Menstruation
Practical Evaluation of Hormonal Status
ALGORITHM FOR EVALUATING AMENORRHOEA (Figs 17.10 to 17.15)
IMMUNOASSAYS FOR LH, FSH AND PRL
Detection Limits of Various Immunoassays
Normal Ranges
Sample Collection and Storage
CASE HISTORY-1
Investigations
Combined Glucagon, TRH and GnRH Stimulation Test:
Comment
CASE HISTORY-2
Investigations
Combined Pituitary Function Test
Oral Glucose Tolerance Test
Comment
CASE HISTORY-3
Investigations
Comment
CASE HISTORY-4
Investigations
Comment
CASE HISTORY-5
Investigations
Comment
CASE HISTORY-6
Investigations (woman)
Comment
CASE HISTORY-7
Investigations
Comment
THYROID FUNCTION TESTS
Introduction
Tests for Thyroid Function
Binding Proteins
Importance of Free T4 and Free T3
Increases in
Decreases in
The TSH-Free T4 Relationship
Problems in the Interpretation of Thyroid Function Tests
Common Causes of TSH/FT4/FT3 Discrepancies
Effects of Drugs on Thyroid Function
Drugs that Affect Results of Thyroid Function Tests
Relationship Between Serum Total T4 and Total T3 Concentrations in Various Disorders
Serum T3 Concentration
Free T4 and Free T3 in Various Disease Conditions
Assay Choice Application
Screening and Case Finding
Untreated Patients
Assessment of the Response to Treatment
Difficult Diagnostic Situations
Thyroid Diagnosis and Treatment
Recommendations for Thyroid Testing
Diagnostic Approach to Anomalous Serum T3, T4, and TSH Values
Typical Reference Ranges for Serum Thyroid Hormones and TSH in Humans*
CASE HISTORY 1
Investigations
Comment
CASE HISTORY 2
Investigations
Comment
CASE HISTORTY 3
Investigations
Comment
CASE HISTORY 4
Investigations
Comment
CASE HISTORY 5
Investigations
Comment
CALCITONIN
Clinical Relevance
Procedure
Interfering Factors
PARATHYROID
Actions
Clinical Disorders
Methods of Evaluation
Serum Calcium
Tubular Reabsorption of Phosphate (TRP)
Calcium Infusion Test
Ellsworth-Howard Test
Serum Parathyroid Hormone
Parathyroid Hormone Assay; Parathyrin; Parathormone (PTH-C Terminal)
Test Significance
Clinical Relevance
Interfering Factors
ADRENAL CORTEX
Actions
Clinical Disorders of Adrenal Steroids
Methods of Evaluation of Glucocorticoids and Androgens
Urinary 17-Hydroxycorticosteroids, 17-Ketosteroid Excretion, Ketogenic Steroids, or Free Cortisol
ALDOSTERONE
Aldosterone, Serum and Urine
Normal values
Method
Test Significance
Clinical Relevance
Interfering Factors
CLINICAL DISORDERS OF MINERALOCORTICOIDS
Primary Hyperaldosteronism
Secondary Hyperaldosteronism
Islolated Hypoaldosteronism
ADRENAL MEDULLA
Catecholamines, Plasma
Catecholamines, Urine
Actions
Clinical Disorders
Method of Evaluation
Histamine Provocative Test
Phentolamine Blocking Test
TESTES
ACTIONS
CLINICAL DISORDERS
METHODS OF EVALUATION
TESTOSTERONE, FREE, BLOOD
TESTOSTERONE, TOTAL, BLOOD
Description
Interfering Factors
TESTOSTERONE DIRECT IMMUNOENZYMATIC DETERMINATION OF TESTOSTERONE ON SERUM OR PLASMA: (Courtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENT, MATERIAL AND INSTRUMENTATION
2.1 Reagent and Material Supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. PROCEDURE
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
ESTRIOL
Direct Immunoenzymatic Determination of Unconjugated Oestriol of Serum Plasma (Courtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENT, MATERIAL AND INSTRUMENTATION
2.1 Reagent and Material supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. Procedure
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
6. REFERENCE VALUES
Estriol Values are Increased in
Estriol Values are Decreased in
17-β-ESTRADIOL
Direct Immunoenzymatic Determination of 17-β-Estradiol in Serum, Plasma (Courtesy: Lilac Medicare)
Principle
2. REAGENTS, MATERIAL AND INSTRUMENTATION
2.1 Reagents and Material Supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
Procedure
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
Note
6. REFERENCE VALUES
Estradiol is Increased in
Estradiol is Decreased in
DHEA-S (DEHYDROEPIANDROSTERONE SULFATE)
Direct Immunoenzymatic Determination of Dehydroepiandrosterone Sulfate of Serum Plasma Courtesy: Lilac Medicare
1. PRINCIPLE
2. REAGENT, MATERIAL AND INSTRUMENTATION
2.1 Reagent and Material Supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
Sample Dilution
3.1 Precaution
4. PROCEDURE
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
6. Reference Values
Values are Increased in
Values are Decreased in
Δ4-ANDROSTENEDIONE
Direct Immunoenzymatic Determination of A 4-Androstenedione of Serum, Plasma (Curtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENT, MATERIAL AND INSTRUMENTATION
2.1 Reagent and Material supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. Procedure
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
6. REFERENCE VALUES
PROGESTERONE
Direct Immunoenzymatic Determination of Progesterone in Serum, Plasma (Courtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENTS, MATERIAL AND INSTRUMENTATION
2.1 Reagents and Material Supplied in the Kit
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
12.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. Procedure
5. STANDARD CURVE: CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
Normal Values (Units- ng/ml)
Values are Increased in
Values are Decreased in
17αOH PROGESTERONE
Direct Immunoenzymatic Determination of 17α OH Progesterone of Serum, Plasma (Courtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENT, MATERIAL AND INSTRUMENTATION
2.1 Reagent and Material Supplied in the Kit
17αOH progesterone standards having the following concentrations
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of Reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. PROCEDURE
5. STANDARD CURVE: CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
6. REFERENCE VALUES
CORTISOL
Direct Immunoenzymatic Determination of Cortisol in Serum, Plasma (Courtesy: Lilac Medicare)
1. PRINCIPLE
2. REAGENTS, MATERIAL AND INSTRUMENTATION
2.1 Reagents and Material Supplied in the Kit
Cortisol standards having the following concentration:
2.2 Notes
2.3 Reagents Necessary which are not Supplied with the Kit
2.4 Auxiliary Materials and Instrumentation
2.5 Preparation of reagents
3. PREPARATION OF THE SAMPLE
3.1 Precaution
4. PROCEDURE
5. STANDARD CURVE-CALCULATION OF RESULTS
5.1 Mean Absorbance and Relative Percentage
5.2 Standard Curve
5.3 Calculation of Results
CORTISOL
Plasma Cortisol
Normal Values
Cortisol Levels are Increased in
Cortisol Levels are Decreased in
Interfering Factors
CORTISOL SUPPRESSION (DEXAMETHASONE SUPPRESSION)
Test Significance
Method
Clinical Relevance
CORTISOL STIMULATION (CORTROSYN STIMULATION)
Test Significance
Method
Clinical Relevance
WATER EXCRETION TEST (SOFFER)
Interpretation
Corticotrophin (ACTH) Response test (Thorn test)
Method
Interpretation
ADRENOCORTICAL INHIBITION TEST
TOTAL TRIIODOTHYRONINE (T3)
SUMMARY AND EXPLANATION OF THE TEST
PRINCIPLE
Competitive Enzyme Immunoassay
REAGENTS FOR 96-Well MICROPLATE
A. Human Serum References-1.0 ml/vial
B. Enzyme-antigen Conjugate-10 ml/vial
C. Enzyme-antigen Conjugate Buffer-11 ml
D. Antibody-Coated Microplate-96 Wells
E. Wash Solution Concentrate-20 ml
F. Substrate A-7.0 ml/vial
G. Substrate B-7.0 ml/vial
H. Stop Solution-6.0 ml/vial
PRECAUTIONS
For in vitro Diagnostic Use Not for Internal or External Use in Humans or Animals
SPECIMEN COLLECTION AND PREPARATION
MATERIALS
Provided
Required but not Provided
REAGENT PREPARATION
1. Working R eagent 1-T3-enzyme Conjugate Solution
General Formula
2. Wash Buffer
3. Working Substrate Solution-Prepare Imme diately Before Use
TEST PROCEDURE
QUALITY CONTROL
RESULTS
Example
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Expected values for the T3 EIA Test System
Interpretation of Total T3 in ng/ml
FREE TRIIODOTHYRONINE (FT3) (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Competitive Enzyme Immunoassay-Analog Method for Free T3
REAGENT FOR 96-WELL MICROPLATE
A. Human Serum References-1.0 ml/vial
B. Enzyme-antigen Conjugate-1.0 ml/vial
C. Enzyme-antigen Conjugate Buffer-11 ml
D. Antibody-Coated Microplate-96 Wells
E. Wash Solution Concentrate-20 ml
F. Substrate A −7.0 ml/vial
G. Substrate B-7.0 ml/vial
H. Stop Solution-6.0 ml/vial
Precautions
Not for Internal or External Use in Humans or Animals
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1-Triiodothyronine-enzyme Conjugate Solution
General Formula
2. Wash Buffer
3. Working Substrate Solution-Prepare Immediately before Use
Test Procedure
Quality Control
Results
Example 2
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
UPTAKE (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Competitive Enzyme Immunoassay
REAGENT FOR 96-WELL MICROPLATE
A. Human Serum References −1.0 ml/vial
B. Enzyme-antigen Conjugate −1.0 ml/vial
C. Enzyme-antigen Conjugate Buffer-11 ml
D. Antibody-Coated Microplate-96 wells
E. Wash Solution Concentrate-20 ml
F. Substrate A-7.0 ml/vial
G. Substrate B-7.0 ml/vial
H. Stop Solution-6.0 ml/vial
Precautions
Use Not for Internal or External Use in Humans or Animals
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1-T4-Enzyme Solution-Prepare Monthly
2. Wash Buffer
3. Working Substrate Solution-Prepare Daily
Test Procedure
Quality Control
QC Parameters
Results
Example 1
27.3 per cent U/Example 23.0 per cent = 0.910.
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
TOTAL THYROXINE (T4) (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Competitive Enzyme Immunoassay
REAGENTS FOR 96-WELL MICROPLATE
A. Human Serum References-1.0 ml/vial
B. Enzyme-antigen Conjugate-1.0 ml/vial
C. Enzyme-antigen Conjugate Buffer-11 ml
D. Antibody-Coated Microplate-96 Wells
E. Wash Solution Concentrate-20 ml
F. Substrate A ~7.0 ml/vial
G. Substrate B-7.0 ml/vial
H. Stop Solution-6.0 ml/vial
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1-Thyroxine-enzyme Conjugate Solution
2. Wash Buffer
3. Working Substrate Solution-Prepare immediately before use
Test Procedure
Quality Control
Results
Example 4
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
Normal Values (μg/dl)
FREE THYROXINE (FT4) (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Competitive Enzyme Immunoassay-Analog Method for Free T4
REAGENTS FOR 96-WELL MICROPLATE
A. Human Serum References-1.0 ml/vial
B. Enzyme-antigen Conjugate-1.0 ml/vial
C. Enzyme-antigen Conjugate Buffer-11 ml
D. Antibody-Coated Microplate-96 wells
E. Wash Solution Concentrate-20 ml
F. Substrate A-7.0 ml/vial
G. Substrate B-7.0 ml/vial
H. Stop Solution-6.0 ml/vial
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1-Thyroxine-enzyme
Conjugate Solution
2. Wash Buffer
3. Working Substrate Solution-Prepare immedia tely before use
Test Procedure
Quality Control
Results
Example 5
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
THYROTROPIN (TSH) Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Thyrotrophin Calibrators-1.0 ml/vial
B. Enzyme-Polyclonal Conjugate and Biotinylated Monoclonal Antibody—11 ml/vial
C. Streptavidin-Coated Microplate-96 Wells
D. Wash Solution Concentrate-20 ml
E. Substrate A—7.0 ml/vial
F. Substrate B-7.0 ml/vial
G. Stop Solution-6.0 ml/vial
FOR IN VITRO DIAGNOSTIC USE NOT FOR INTERNAL OR EXTERNAL USE IN HUMANS OR ANIMALS
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1-Wash Buffer
2. Working Reagent 2-Substrate Solution-Prepare before Use
Test Procedure
Quality Control
Results
Example 6
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Normal Values (μIU/ml)
THYROGLOBULIN ANTIBODIES (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
A Sequential ELISA Method
REAGENTS FOR 96-WELL MICROPLATE
A. Anti-Thyroglobulin Calibrators-1.0 ml/vial
B. Thyroglobulin Biotin Conjugate-11 ml/vial
C. Enzyme-antigen Conjugate-11 ml/vial
D. Streptavidin-Coated Microplate—96 Wells
E. Serum Diluent Concentrate-20 ml
F. Wash Solution Concentrate-20 ml Icon
G. Substrate A ~7.0 ml/vial
H. Substrate B-7.0 ml/vial
I. Stop Solution-6.0 ml/vial
PRECAUTIONS
For In Vitro Diagnostic Use Not for Internal or External Use in Humans or Animals
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Serum Diluent
2. Wash Buffer
3. Patient Sample Dilution (1/100)
4. Working Substrate Solution-Prepare Immediately before Use
Test Procedure
Quality Control
Results
Example 7
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
THYROID PEROXIDASE ANTIBODIES (Courtesy; Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
A Sequential ELISA Method
REAGENTS FOR 96-WELL MICROPLATE
A. Anti-TPO Calibrators-1.0 ml/vial
B. Thyroid Peroxidase Biotin Conjugate-11 ml/vial
C. Enzyme-antigen Conjugate-11 ml/vial
D. Streptavidin-Coated Microplate-96 Wells
E. Serum Diluent Concentrate—20 ml
F. Wash Solution Concentrate-20 ml
G. Substrate A-7.0 ml/vial
H. Substrate B-7.0 ml/vial
I. Stop Solution-6.0 ml/vial
Precautions
Not for Internal or External Use in Humans or Animals
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Serum Diluent
2. Wash Buffer
3. Patient Sample Dilution (1/100)
4. Working Substrate Solution-Prepare Immediately before use
Test Procedure
Quality Control
Results
Example 8
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
LUTEINISING HORMONE (LH) Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Luteinising Hormone Calibrators—1.0 ml/vial
B. Enzyme-Polyclonal Conjugate and Biotinylated Monoclonal Antibody—11 ml/vial
C. Streptavidin-Coated Microplate – 96 Wells
D. Wash Solution Concentrate – 20 ml
E. Substrate A −7.0 ml/vial
F. Substrate B – 7.0 ml/vial
G. Stop Solution – 6.0 ml/vial
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1 - Wash Buffer
2. Working Reagent 2-Substrate Solution - Prepare before Use
Test Procedure
Quality Control
Results
Example 9
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
Values are Increased in
Values are Decreased in
FOLLICLE STIMULATING HORMONE (FSH)
Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. FSH Calibrators −1.0 ml/vial
B. Enzyme-Polyclonal Conjugate and Biotinylated Monoclonal antibody—11 ml/vial
C. Streptavidin-Coated Microplate-96 Wells
D. Wash Solution Concentrate – 20 ml
E. Substrate A ~7.0 ml/vial
F. Substrate B – 7.0 ml/vial
G. Stop Solution ~ 6.0 ml/vial
For In Vitro Diagnostic Use Not for Internal or External Use in Humans or Animals
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1 - Wash buffer
2. Working Reagent 2-Substrate Solution-Prepare before Use
Test Procedure
Quality Control
Results
Example 10
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Normal Values in MIU/ml
Values are Increased in
Values are Decreased in
PROLACTIN HORMONE (PRL) Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Prolactin Hormone Calibrators −1.0 ml/vial
B. Enzyme-Poiyclonal Conjugate and Biotinylated Monoclonal antibody—11 ml/vial
C. Streptavidin Coated Microplate – 96 wells
D. Wash Solution Concentrate – 20 ml
E. Substrate A ~7.0 ml/vial
F. Substrate B – 7.0 ml/vial
G. Stop Solution— 6.0 ml/vial
For In Vitro Diagnostic Use Not for Internal or External Use in Humans or Animals
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided
REAGENT PREPARATION
1. Working Reagent 1—Wash Buffer
2. Working Reagent 2—Substrate Solution - Prepare before use
Test Procedure
Quality Control
Results
Example 11
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
Normal range of HPRL in ng/ml)
HPRL Levels are Increased in
HPRL Levels are Decreased in
CHORIONIC GONADOTROPHIN (HCG)
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Chorionic Gonadotrophin Calibrators −1.0 ml/vial
B. Enzyme-Polyclonal Conjugate and Biotinylated Monoclonal Antibody—11 ml/vial
C. Streptavidin-Coated Microplate— 96 Wells
D. Wash Solution Concentrate – 20 ml
E. Substrate A ~7.0 ml/vial
F. Substrate B— 7.0 ml/vial
G. Stop Solution – 6.0 ml/vial
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required but Not Provided:
REAGENT PREPARATION
1. Working Reagent 1— Wash Buffer
2. Working Reagent 2—Substrate Solution - Prepare before Use
Test Procedure
Quality Control
Results
Example 12
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Range of Values
Normal Values
Values are Increased in
Values are Decreased in Abortion and Ectopic Pregnancy
Factors that Affect Results
Other Data
INSULIN Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
Precautions
Specimen Collection and Preparation
REAGENTS AND MATERIALS PROVIDED
1. Insulin Calibrators – 2.0 ml/vial (Dried)
2. Enzyme-Insulin Antibody Conjugate and Biotinylated Monoclonal Antibody —13 ml/vial
3. Streptavidin-Coated Microplate—96 Wells
4. Wash Solution Concentrate—20 ml
5. Substrate A —7.0 ml/vial
6. Substrate B — 7.0 ml/vial
7. Stop Solution—8.0 ml/vial
8. Instructions
Required but Not Provided
REAGENT PREPARATION AND STORAGE
1. Wash Buffer
2. Working Substrate Solution
Test Procedure
Quality Control
Calculation Control
Example 13
Quality Control
Limitations of Procedure
Expected Values
C-PEPTIDE (Courtesy: Lilac Medicare)
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
PRECAUTIONS
For In Vitro Diagnostic Use Not for Internal or External Use in Humans or Animals
Specimen Collection and Preparation
Reagents and Materials Provided
Required but Not Provided
REAGENT PREPARATION
1. Wash Buffer
2. Working Substrate Solution
Test Procedure
Quality Control
Calculation of Results
Example 14
Quality Control
Limitations of Procedure
Expected Values
ANTI-INSULIN (Courtesy: Lilac Medicare)
Warnings and Precautions
Material Supplied
Controls
Technical Data
Principle of the Procedure
Reaction Phases
Phase 1
Phase 2
Phase 3
Clinical Relevance
Indications
Normal Values
Specificity
Calibration
IMMUNOASSAY PROCEDURE
Materials Required
Equipment
Preparation of Reagents
Optional
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
Recommended Lin-Log Plot
Calculation Example
Calibrators
ASSAY CHARACTERISTICS
Sensitivity
CHAPTER 18:
Diabetes Mellitus Laboratory Diagnosis
DIABETES MELLITUS
Classification and Causes of Diabetes
SCREENING TESTS
Urine Glucose (Methods mentioned elsewhere)
Fasting Blood Sugar
Two-hour Postprandial Blood Glucose
Criteria for the Diagnosis of Diabetes Mellitus and Impaired Glucose Homeostasis
DIAGNOSTIC TESTS
Oral Glucose Tolerance Test (OGTT)
Patient Preparation
Interpretation
Interfering Factors
I/V GTT
RAPID I/V GTT
CORTISONE GLUCOSE TOLERANCE TEST
PARENTERAL ADMINISTRATION OF GLUCAGON OR EPINEPHRINE
I/V TOLBUTAMIDE TEST
I/V INSULIN TOLERANCE TEST
GLYCOSYLATED HAEMOGLOBIN (HBA1C); GLYCO-HAEMOGLOBIN (G-HB); DIABETIC CONTROL INDEX
Factors that Affect Results
Other Data
Test Significance
Clinical Relevance
Interfering Factors
GLYCOSYLATED HEMOGLOBIN KIT (Ion Exchange Resin method) For the quantitative determination of Glycohemoglobin in Blood (For in vitro Diagnostic use only)
Summary
Principle
Normal Reference Values
Storage/Stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Notes
INSULIN
C-PEPTIDE
GLUCAGON
Other Important Tests in Diabetics
HYPOGLYCAEMIA
Causes of Hypoglycaemia
Spontaneous (fasting) Hypoglycaemia
Induced Hypoglycaemia
RAPID DIAGNOSTICS
CHAPTER 19:
Liver Function Tests
TESTS OF EXCRETION BY THE LIVER
Bile Pigment
Types of bilirubin
CLASSIFICATION OF THE CAUSES OF JAUNDICE
EVALUATION OF SYNTHESIS IN LIVER
Serum Proteins (albumin especially)
Prothrombin Concentration
Low Prothrombin in Presence of Jaundice
Low Prothrombin in the Absence of Jaundice
Cholesterol and its Esters
Decrease of Both Substances
Increase of Total but Decrease of Esters
DETOXIFICATION
Serum Protein changes in Selected Diseases
Hippuric Acid Test
EVALUATION OF ENZYME ACTIVITY
Serum Transaminases
Serum Alkaline Phosphatase
SUGGESTED LIVER FUNCTION TESTS
Rapid Diagnostics
LIVER BATTERY (PROFILE), SERUM
Normal Values are Dependent Upon Methods Used
Description
CHAPTER 20:
Clinical Chemistry
COLORIMETRY
Calculation of Absorbance (A):
PHOTOMETER
A. Light source
B. Wavelength selectors
C. Cuvettes and flow-through cells
D. Photoelectric cell
E. Galvanometer
Requirements of Colorimetric Analysis
Sources of error in photometry
Inherent Properties of the Solution
Instrument
Operator Errors
CLINICAL CHEMISTRY
Specimen Collection and Processing
Proper Specimen Collection
Specimen Collection
Processing
Centrifuge
Difficulties
Blood Collection, Precautions and Errors
Clinical Chemistry and Drug Interference (See Appendix II)
CONTROLSERA
NORMAL VALUES DIFFER WITH DIFFERENT KITS AND MANUFACTURES. ALWAYS CONSULT THE PRODUCT INSERT FOR EXACT METHOD FOR A PARTICULAR KIT, FOLLOW THE MANUFACTURES INSTRUCTIONS STRICTLY.
BLOOD UREA NITROGEN (BUN)
UREA (DAM METHOD)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
UREA (MOD. BERTHELOT METHOD) (COURTESY: TULIP GROUP OF COMPANIES)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Note
UREA (GLDH Kinetic method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Substrate Start Assay
Sample Start Assay
Calculations
Linearity
Note
NORMAL VALUES (GENERAL REFERENCE)
CLINICAL RELEVANCE
Interfering Factors
Comments
PLASMA OR SERUM CREATININE (Courtesy: Tulip Group of Companies)
Normal Values
CREATININE (Alkaline Picrate method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Reference values
Storage/stability
Reagent Preparation
Sample Material
Serum or Urine
Procedure
Deproteinization of specimen
Colour development
Calculations
Linearity
Note
CREATININE (Mod Jaffa's Kinetic method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Reference values
Storage/stability
Reagent Preparation
Sample Material
Serum or Urine
Procedure
Calculations
Linearity
Note
CLINICAL RELEVANCE
Interfering Factors
SERUM BILIRUBIN
Normal Values
BILIRUBIN (Mod Jendrassik and Grof's method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/Stability
Reagent Preparation
Sample material
Procedure
Direct Bilirubin Assay
Total Bilirubin Assay
Calculations
Linearity
Note
CAUSES OF HYPERBILIRUBINEMIA
Unconjugated (Indirect) Hyperbilirubinemia
CONJUGATED (DIRECT) HYPERBILIRUBINEMIA
Interfering Factors
Comments
ICTERUS INDEX
Reagents
Method
Calibration Curve
TOTAL PROTEIN
TOTAL PROTEIN (Biuret method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent preparation
Sample material
Procedure
Calculations
Linearity
Note
SERUM ALBUMIN
DETERMINATION OF SERUM ALBUMIN (BCG method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
NORMAL VALUES
Specimen Collection and storage
CLINICAL RELEVANCE
Causes of Hypoalbuminemia
Reduced Synthesis
Increased Loss
Increased Catabolism
Multifactorial
Disorders Associated with Polyclonal Gammopathies
Chronic Liver Disease
Collagen Diseases
Chronic Infections
Miscellaneous
Causes of Monoclonal Gammopathies
Interfering Factors
SERUM CHOLESTEROL
CHOLESTEROL (CHOD/PAP method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
Normal Values
Clinical Relevance
Interfering Factors
Patient Preparation
HDL CHOLESTEROL
HDL CHOLESTEROL KIT (PEG/CHOD-PAP method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Precipitation of VLDL & LDL:
Cholesterol Assay
Calculations
Calculation of LDL Cholesterol (mg/dl)
Linearity
Note
RISK FACTOR
HDL CHOLESTEROL PPT SET (PEG Precipitation Method) (Courtesy: Tulip group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Procedure for the cholesterol assay
Calculations
Linearity
Note
CLINICAL RELEVANCE
Interfering Factors
Patient Preparation
Patient Aftercare
CHOLESTEROL: LDL AND VLDL
Normal Values
LDL-CHOLESTEROL FULLY ENZYMATIC, COLORIMETRIC TEST, Courtesy: Randox
Principle
Sample
Reagents
Preparation of Reagents
Procedure
Calculation
Using a Standard
Calculation of the LDL-cholesterol
Using a Factor
Calculation the LDL-Cholesterol
Clinical Interpretation
Note
Test Significance
SERUM TRIGLYCERIDES
Classification of Triglyceride Levels
TRIGLYCERIDES (GPO/PAP method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Note
CLINICAL IMPLICATIONS
BLOOD GLUCOSE
GLUCOSE (GOD/POD method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
BODY FLUID, GLUCOSE, SPECIMEN
CAUSES OF ABNORMAL GLUCOSE LEVELS
URIC ACID
URIC ACID (Uricase/PAP method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Normal Values
CLINICAL RELEVANCE
Factors Affecting Serum Uric Acid levels
Increased Production, Raised Serum Levels
Decreased Excretion, Raised Serum Levels
Increased Excretion, Lowered Serum Levels
Decreased Production, Lowered Serum Levels
CALCIUM
CALCIUM (OCPC method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
CALCIUM (Arsenazo III method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Linearity
Note
NORMAL VALUES
Specimen Collection and Storage
CLINICAL RELEVANCE
Be Careful
Interfering Factors
PHOSPHORUS
PHOSPHORUS (Molybdate UV method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Note
PHOSPHORUS (Mod Gomorri's method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Notes
NORMAL VALUES
CLINICAL RELEVANCE
Hypophosphatemia (Decreased phosphorus levels)
Interfering Factors
CHLORIDE
CHLORIDE (Thiocyanate Method) Courtesy: Tulip Group of Companies
Principle
Normal reference values
Chloride Kit
Storage/stability
Reagent Preparation
Procedure
Chloride Assay
Linearity
Notes
Calculation
Normal Values
CLINICAL RELEVANCE
Interfering Factors
Be Careful
SERUM IRON AND TIBC
IRON AND TIBC (Ferrozine method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Iron assay
TIBC assay
Calculations
Linearity
Notes
CLINICAL RELEVANCE
Interfering Factors
TRACE ELEMENTS
ZINC
ZINC (Colorimetric Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Notes
NORMAL VALUES
Toxic level symptoms
Deficiency Symptoms
Values are increased in
Values are decreased in
COPPER
COPPER (Colorimetric Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Working reagent
Sample material
Procedure
calculations
Linearity
Notes
Toxic level symptoms
Deficiency symptoms
Values are Increased in
COPPER URINE
Normal Values
Values are increased in
Values are decreased in
MAGNESIUM
MAGNESIUM (Calmagite Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Notes
NORMAL VALUES
Toxic Level Symptoms
Deficiency Symptoms
Values are increased in
Values are decreased in
MAGNESIUM URINE
AUTOMATION IN CLINICAL CHEMISTRY
INSTRUMENTATION
PRESENTSTATUS
BENEFITS OF A SEMIAUTOMATIC ANALYSER
Economy
Wide Spectrum of Tests
Speed
Accuracy and Reliability
Convenience
Non-dependence on Technicians
Business Growth
WHICH LAB NEEDS AUTOMATION?
SELECTION OF A MODEL
ANALYSER CLASSIFICATION
Semiauto Analysers
Batch Analysers
Random Access Auto Analyser
CLIN CHECK PLUS (Courtesy: Tulip Group of Companies)
EP/KIN/FXT/MSD AND ABS MODE
Features
Technical features CCP
SCREEN MASTER 3000 (Courtesy: Tulip Group of Companies)
Features
Technical Features of Screenmaster 3000
MAP LAB PLUS
Features
Technical Features of Maplab Plus
FULLY
System Overview
Modern
Compact
Software
Technical Specifications of Fully Measuring System
CHAPTER 21:
Enzymology
α AMYLASE
SERUM AND URINE (Direct Substrate Method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
For Urine as Sample
Calculations
Linearity
Note
Normal Values
CLINICAL RELEVANCE
Increased levels are found in
Decreased Levels are found in
LIPASE
Lipase, Serum
Normal Value
Description
PHOSPHATASES
Units For Reporting Phosphatase Activity
Specimen
ALKALINE PHOSPHATASE (ALP)
Clinical Significance
ALKALINE PHOSPHATASE, SERUM
ALKALINE PHOSPHATASE (Mod. Kind and King's Method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Calculations
Linearity
Note
ALKALINE PHOSPHATASE (DEA) (pNPP Kinetic Method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
Clinical Relevance
Elevated Levels
Reduced Levels
Interfering Factors
ALKALINE PHOSPHATASE ISOENZYMES
Clinical Relevance
ACID PHOSPHATASE
Clinical Significance
Normal Values
Specimen
ACID PHOSPHATASE (Mod. King's Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Assay
Calculations
Linearity
Notes
ACID PHOSPHATASE (α Naphthylphosphate Kinetic Method) (Courtesy: Tulip Group of Companies)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Total ACP Assay
Non Prostatic ACP Assay: (Tartrate Inhibited)
Calculations
Linearity
Notes
CLINICAL RELEVANCE
Interfering Factors
Serum Alkaline Phosphatase and Acid Phosphatase
TRANSAMINASES
Clinical Significance
Evaluation of Methods
Specimen
SGOT (AST) (Reitman and Frankel's Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample Material
Procedure
Assay
Note
SGOT (AST) (Mod. IFCC Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Substrate Start Assay
Calculations
Linearity
Note
SGPT (ALT) (Reitman and Frankel's Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Plotting of the Calibration curve
Assay
Note
SGPT (ALT) (Mod. IFCC Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Substrate Start Assay
Sample Start Assay
Calculations
Linearity
Note
CLINICAL RELEVANCE OF SGPT ESTIMATION
CLINICAL RELEVANCE OF SGOT ESTIMATION
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGTP) BLOOD
Normal Values
GLUTAMYL TRANSFERASE (Carboxy Substrate Method)
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Calculations
Linearity
Note
CLINICAL RELEVANCE
LACTIC DEHYDROGENASE
Clinical Significance
Normal Values
LDH (P-L) (Mod. IFCC Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Substrate Start Assay
Sample Start Assay
Calculations
Linearity
Note
CLINICAL RELEVANCE
Interfering Factors
Electrophoresis of LDH Isoenzymes
Normal values
Test Significance
Clinical Relevance
CK (NAC ACT) (Mod. IFCC Method) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Substrate Start Assay:
Sample Start Assay
Calculations
Linearity
Note
CK MB (NAC ACT)(IMMUNOINHIBITION/MOD. IFCC METHOD) Courtesy: Tulip Group of Companies
Summary
Principle
Normal reference values
Storage/stability
Reagent Preparation
Sample material
Procedure
Substrate Start Assay
Substrate Start Assay
Calculations
Linearity
Note
CREATINE KINASE (CK)
Clinical Relevance
C K Isoenzymes
Normal Values (at 37°C) CK
Diagnostic Alert
6% Rule
Interfering Factors
ENZYMOLOGY IN RELATION TO HEART DISEASE
Introduction
CLINICAL PRESENTATION
DIAGNOSIS OF MI
Electrocardiogram (ECG)
Imaging
Biochemical Markers of Myocardial Necrosis
CK and its Isoenzymes—The Time-tested Biomarker
Diagnostic Applications of CK and its Isoenzymes
Special Findings
Isoforms of CK
Biochemistry and Physiology
CK ACTIVITY—SKELETAL MUSCLE DISEASE
CK activity—HEART DISEASE
CLINICAL ENZYMOLOGY IN MI— A BRIEF ANALYSIS
METHOD OF DETERMINATION—TOTAL CK
METHOD OF DETERMINATION—CK ISOENZYMES
Immunoinhibition method
Isoenzyme electrophoresis method
Immunoassay for Determination of CK-MB Mass (Concentration)
Interferences have been described in these assays too
CRITICAL DETERMINANTS OF CK AND CK-MB REAGENT SYSTEM DESIGN
Appropriate activator
Adenylate Kinase (AK) Interference
Cation Inhibitor
Anti CK-M Antibody used in Immunoinhibition Method
Liquid Reagent System
OTHER BIOMARKERS OF MI
Myoglobin
Cardiac Troponin-l (cTnl)
IMPORTANT TERMS
Angina pectoris
Angiography
Aortic stenosis
Arterial embolism
Atheroma
Atria
Defibrillation
Delirium Tremens
Diaphoresis
Dyspnoea
Endocarditis
Endocardium
Epicardium
Epigastrium
Glycogenosis Type V
Malignant Hyperthermia
Marantic Endocarditis
Muscular Dystrophy
Myasthenia Gravis
Myocarditis
Myocardium
Myocytes
Myositis
Myotonia Congenita
Ocular Myositis
Parkinson's Disease
Pericarditis
Polymyositis
Regurgitation
Resuscitation
Rhabdomyolysis
Spinal Muscular Atrophy
Status Asthmaticus
Syncope
Tachycardia
Tetany
Thrombogenesis
Transmural
Triage
Viral Myositis
LIVER DISEASE (SERUM ENZYME PATTERNS) VALUES ARE X TIMES THE UPPER NORMAL LIMITS
AUTOMATION IN CLINICAL CHEMISTRY RANDOM ACCESS AUTO ANALYSER
Design
Support
Cost
MARS (Courtesy: Lilac Medicare)
MARS- TECHNICAL SPECIFICATIONS
System
Sample
Reagent
Pipetting System
Photometry
Cuvette System
Incubation
Water Requirement
Waste
CHAPTER 22:
Blood Gases and Electrolytes
BLOOD GASES
Introduction
Procedure for Obtaining Arterial Blood Sample
Clinical Alert
Blood Gas Symbols
Combination of Symbols
Blood Gases, Arterial (ABG), Blood
Blood Gases, Capillary, Blood
Normal Values
Blood Gases, Venous, Blood
Normal Values
PARTIAL PRESSURE OF CARBON DIOXIDE (PCO)
Normal Values
Explanation of Test
Procedure
Clinical Implications
Clinical Alert
OXYGEN SATURATION (SO2)
Normal Values
Explanation of Test
Procedure
OXYGEN (O2) CONTENT
Normal Values
Explanation of Test
Procedure
Clinical Implications
PARTIAL PRESSURE OF OXYGEN (PO)
Normal Values
Background
Explanation of Test
Procedure
Clinical Implications
CARBON DIOXIDE (CO2) CONTENT OR TOTAL CARBON DIOXIDE (TCO)
Normal Values
Background
Explanation of Test
Procedure
Clinical Implications
Clinical Alert
Interfering Factors
BLOOD pH
Normal Values
Background
Explanation of Test
Procedure
Clinical Implications
Clinical Alert
Interfering Factors
BASE EXCESS/DEFICIT
Normal Values (± 3 mEq/litre)
Explanation of Test
Procedure
Clinical Implications
AUTOMATION IN BLOOD GAS ANALYSIS BLOOD GAS ANALYSERS (FROM AVL)
Measured Parameters
Calculated Parameters
ELECTROLYTE ANALYSIS BY FLAMEPHOTOMETER
FLAME PHOTOMETER 129 (FROM SYSTRONICS)
Microprocessor-Based Automation
Salient Features
Easy Menu Driven Operation
Technical Specifications
Range of Operation
Standard Solutions
Normal Values
Alterations of Sodium and Extracellular Fluid (ECF)
Hyponatraemia (serum sodium concentration lower than normal)
Hypernatraemia (serum sodium concentration higher than normal)
Abnormalities of Serum and Whole Body Potassium
Hyperkalaemia (serum potassium concentration more than normal)
Hypokalemia (serum potassium concentration lower than normal)
RAPID DIAGNOSTICS IN ELECTROLYTE ANALYSIS
Easylyte Systems from Medica
Easylyte Sodium Potassium Analyser
Customer Support
Ease of Operation
Economy
Print Outs
Easylyte Lithium (Sodium, Potassium, Lithium Analyser)
Economy
Easy Operation
Easy Maintenance
Reliability
Easylyte Plus (Sodium, Potassium and Chloride Analyser)
CHAPTER 23:
Serology/Immunology
TECHNOLOGIES RAPID IMMUNOCHROMATOGRAPHIC TECHNIQUES
Perspective on Membrane-based Rapid Diagnostic Tests and Detection of hCG Using these Tests
What are the Principles of Membrane-based Rapid Diagnostic Tests?
What are the Components of Membrane-based Rapid Diagnostic Tests and how are they Constructed?
What are the Limitations and Effects of Various Components on the Performance of Membrane Rapid Diagnostic Tests?
How does the Nitrocellulose Membrane affect the Sensitivity of Rapid Diagnostic Tests?
Pore Size and Capture Reagent Binding Properties
Pore Size and Lateral Flow Rate
Why are Colloidal Gold Sol Particles commonly employed in the Detector Reagent in Membrane-based Rapid Diagnostic Tests?
Colloidal Gold Sol Particles as Indicator
Effect of Shape of Colloidal Gold Sol Particles on Stability
Effect of Shape of Colloidal Gold Sol Particles on Sensitivity
Effect of Size on Colour of Colloidal Gold Sol Particles
Why are Variations in Band Appearance Commonly Observed in Membrane-based Rapid Diagnostic Tests Employed for Antigen Detection?
What is the Role of Sample Pad in Membrane-based Rapid Diagnostic Tests?
What is the Role of Soak Pad in Membrane-based Rapid Diagnostic Test?
Why do “Faint Ghost Bands” Appear at the Test Region if the Device is left out on the Worktable?
How do we Interpret “Broken Bands” at the Test/ Control Region?
Excess Sample Volume Dispensed
ENZYME IMMUNOASSAY
Introduction
CLASSIFICATION OF ELISA
1. Direct ELISA
2. Indirect ELISA
3. Capture ELISA
a. Antigen Capture
b. Antibody Capture
4. Competitive ELISA
a. Direct Antibody Competition
b. Direct Antigen Competition
5. Streptavidin-Biotin ELISA
Avidin-Biotin relation of Ag-Ab binding
Advantages of Streptavidin
Significance of Coating Streptavidin as Solid Phase
6. Immunocapture ELISA
7. Interference Corrected ELISA
Homogeneous ELISA
Latex Particle Agglutination Immunoassay (LPAIA)
Enzyme-Multiplied Immunoassay Technique (EMIT)
Apoenzyme Reconstitution Immunoassay System (ARIS)
Fluorophore-Labelled Homogeneous Immunoassay (FLHIA)
Homogeneous Fluorescence Polarisation Immunoassay (FPIA)
Microparticle Enzyme Immunoassay (MEIA)
Heterogeneous ELISA
Quantitative ELISA
Semi-quantitative ELISA
Qualitative ELISA
ELISA: PRACTICAL ASPECTS
References
STEPS IN ELISA
INTERFERENCES IN IMMUNOASSAYS
PREANALYTICAL VARIABLES
Hemolysis and Hyperbilirubinaemia
ANALYTICAL VARIABLES
POSTANALYTICAL VARIABLES
Use of Wrong Reference Values
Use of Wrong Units
ELISA TROUBLESHOOTING
PRACTICAL TIPS ON ELISA
Strip/Plate Washers
Washing Tips
Pipetting Tips
Microplates
Substrate Preparation
Conjugates
General tips
MATRIX EFFECTS
1. The Effect of Reagents
2. Effect of Proteins
MECHANICAL INTERFERENCE
NONSPECIFIC INTERFERENCE
HOOK EFFECT
Reduction of Hook Effect
EDGE EFFECT
ASSAY SPECIFICITY
ASSAY SENSITIVITY
CHEMILUMINESCENCE: THE TECHNOLOGY
Introduction
COMPONENTS OF CHEMILUMINESCENT SYSTEM
The Signal
Signal Quantity
Signal Duration
Instrumentation
Comparison with Other Technologies
Drawbacks of Other Technologies
Radio Immunoassay
Enzyme Immunoassay
Fluorescence Immunoassay
References
Advantages of Chemiluminescence Technology
Advantages
Advantages
POLYMERASE CHAIN REACTION
Denaturation by Heat
Annealing Primer Binding to Target
Extension
Limitations/Difficulties
Types of PCR
RIA
Measurement of Radioactivity
TEST FOR SYPHILIS
VDRL TEST
CONVENTIONAL VDRL TEST
Principle
Equipment Required
Precautions
Sample
Preparation of Patient's Serum (Inactivation)
Reagents Usually Supplied
Preparation of Working Solutions
Working Antigen Suspension
Note
Preliminary Testing of the Working Antigen Suspension
Storage and Stability
Procedure
Qualitative Test
Quantitative Test
Note
Interpretation of Test Results
Notes
Limitation of the Test
MODIFIED VDRL REAGENT (TREPOLIPIN®, Courtesy: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Additional Material Required
Test Procedure
Qualitative Method
Quantitative Method
INTERPRETATION OF RESULTS
Qualitative Method
Quantitative Method
Remarks
TOLUIDINE RED UNHEATED SERUM TEST FO RAPID SERODIAGNOSIS OF SYPHILIS (REDGEN, Courtesy: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Additional Material Required
Test Procedure
Qualitative Method
Quantitative Method
INTERPRETATION OF TEST RESULTS
Qualitative Method
Quantitative Method
Remarks
LATEX SLIDE TEST FOR VDRL (SYPHFINAL, MFD: Tulip Group of Companies)
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Additional Material Required
Test Procedure
Qualitative Method
Quantitative Method
INTERPRETATION OF TEST RESULT
Qualitative Method
Quantitative Method
Performance Characteristics
Remarks
RAPID PLASMA REAGIN (RPR) CARD TEST/ CARBON ANTIGEN FOR SYPHILIS TESTING (CARBOGEN), Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the RPR Kit
Additional Material Required
Test Procedure
Qualitative Method
Quantitative Method
INTERPRETATION OF TEST RESULTS
Qualitative Method
Quantitative Method
Remarks
ONE-STEP TEST FOR SYPHILIS: DIPSTICK (Syphicheck®, Mfd: Tulip Group of Companies)
Introduction
Summary
Principle
Reagents and Materials Supplied
Additional Material Required
Storage and Stability
Note
Specimen Collection and Preparation
Testing Procedure and Interpretation of Results
Performance Characteristics
ONE-STEP TEST FOR SYPHILIS (DEVICE) SYPHICHECK, Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Materials Supplied
Storage and Stability
Specimen Collection and Preparation
Testing Procedure and Interpretation of Results
Remarks
WIDAL ANTIGEN SET/ANTIGENS FOR TUBE TESTS (TYPHOCHEK) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
MATERIAL PROVIDED WITH THE KIT
Reagent Pack
Additional Material Required
Procedure
a. Standard Tube Test Method
Interpretation of Results
Remarks
WIDAL ANTIGEN SET/ANTIGENS FOR SLIDE AND TUBE TESTS (TYDAL) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
MATERIAL PROVIDED WITH THE KIT
Reagent Pack
Additional Material Required
Quantitative Method
Procedure
Slide Screen Method
Slide Semiquantitative Method
Quantitative Method
Tube Test Procedure
Interpretation of Results
Slide Screen Method
Slide Semiquantitative Method
Quantitative Method
Remarks
REDUCED WIDAL ANTIGEN SET: O AND H FOR TUBE TESTS (VITAL WIDAL) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Additional Material Required
1. Procedure
Tube Test Method
Interpretation of Results
Remarks
POSITIVE CONTROL FOR WIDAL TEST
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Additional Material Required
Procedure
Slide test Method
Interpretation of Results Slide Test Method
SLIDE AND TUBE TEST FOR DETECTION OF ANTIBODIES TO BRUCELLA ABORTUS/ MELITENSIS BRUCEL A/M®, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Quantitative Method
PROCEDURE
Slide Test Method
Qualitative Method
Semiquantitative Method
Tube Test Method
INTERPRETATION OF RESULTS
Slide Test Method
Qualitative Method
Semiquatitative Method
Tube Test Method
Remarks
SLIDE SCREENING TEST FOR BRUCELLA Antibodies (Brucel-RB) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Additional Material Required
PROCEDURE
Slide Test Method
Qualitative Method
Semiquantitative Method
INTERPRETATION OF RESULTS
Qualitative Method
Semiqualitative Method
Remarks
BRUCELLOSIS POSITIVE CONTROL Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Additional Material Required
Procedure
Slide Test Method
INTERPRETATION OF RESULTS
Slide Test Method
RAPID TEST FOR IgM AND IgG ANTIBODIES TO DENGUE VIRUS:DENGUE FEVER (Denguecheck-WB) (Device) (Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Materials Supplied
Storage and Stability
Note
Specimen Collection and Preparation
Testing Procedure and Interpretation of Results
INTERPRETATION OF RESULTS
Negative Test Result
Positive Test Result
Remarks
TEST FOR INFECTIOUS MONONUCLEOSIS (IMMUTEX®), Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Materials Provided with the Kit
Reagent
Accessories
Additional Material Required
TEST PROCEDURE
Qualitative Method
INTERPRETATION OF RESULTS
Remarks
RAPID TEST FOR IgM ANTIBODIES TO LEPTOSPIRA: LEPTOSPIROSIS (LEPTOCHEK WB) (DEVICE), Courtesy: Tulip Group of Companies
Introduction
Summary
PRINCIPLE
Reagents and Material Supplied
Storage and Stability
Note
Specimen Collection and Preparation
Testing Procedure and Interpretation of Results
Negative Test Result
Positive Test Result
Performance Characteristics
Remarks
RAPID TEST FOR P. FALCIPARUM MALARIA (PARACHECK Pf) (DEVICE), Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Materials Supplied
Paracheck Pf Kit contains
Optional Material Required
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure
Limitations of the Test
RAPID TEST FOR MALARIA (Parascreen) Pan/P (Device), Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Material Supplied
Optional Material Required
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure
Negative for Malaria
Positive for Malaria
Limitations of the Test
RAPID TEST FOR MALARIA PAN/PV/PF (PARAMAX-3) (DEVICE), Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Material Supplied
Optional Material Required
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure
Negative for Malaria
Positive for Malaria
Limitation of the Test
SLIDE TEST FOR C-REACTIVE PROTEIN (Rhelax CRP), Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Material Provided with the Kit
Reagent
Accessories
Additional Material Required
Test Procedure
Qualitative Method
Semiquantitative Method
Interpretation of Test Results Qualitative Method
Semiquantitative Method
Remarks
SLIDE TEST FOR ANTI STREPTOLYSIN O (Rhelax ASO), Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Material Provided with the Kit
Reagent
Accessories
Additional Material Required
Test Procedure
Qualitative Method
Semiquantitative Method
INTERPRETATION OF TEST RESULTS
Qualitative Method
Semiquantitative Method
Remarks
SLIDE TEST FOR RHEUMATOID FACTORS (Rhelax RF), Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Material Provided with the Kit
Reagent
Accessories
Additonal Material Required
Test Procedure
Qualitative Method
Semiquantitative Method
INTERPRETATION OF TEST RESULTS
Qualitative Method
Semiquantitative Method
Remarks
SLIDE TEST FOR ANTI DEOXYRIBONUCLEOPROTEIN (Rhelax SLE) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Preparation
Material Provided with the Kit
Reagent Pack
Accessories Pack
Additional Material Required
TEST PROCEDURE
Qualitative Method
Semiquantitative Method
INTERPRETATION OF RESULTS
Qualitative Method
Semiquantitative Method
Remarks
AUTOIMMUNE DISORDERS AND ANA
Introduction
How does the Immune System Work?
Components of the Immune System
Helper T-Cell: Commander-in-chief of the immune system
Killer T Cell: Recruited and activated by helper T cells
Suppressor T Cell: Keeping in control
B Cell: Biologic arms factory
Antibody: Ammunition of the immune system
Autoantibodies
Memory Cell: Watchdogs of the immune system
Antigen Presenting Cells
Immune Complexes and the Complement System
What Happens During an Immune Response
Classification of Autoimmune Disorders
Factors Influencing Autoimmunity
SYSTEMIC LUPUS ERYTHEMATOSUS-SLE (LUPUS)
What Causes Lupus
Symptoms of Lupus
Common Symptoms of Lupus
Diagnosing Lupus
Treating Lupus
SCLERODERMA
Causes
Symptoms of Scleroderma
Diagnosis
Treatment
SJÖGREN'S SYNDROME
Symptoms
Physical
Lab Studies
Treatment
MIXED CONNECTIVE TISSUE DISEASE (MCTD)
Causes
Symptoms
Diagnosis
Treatment
POLYMYOSITIS AND DERMATOMYOSITIS
ANTINUCLEAR ANTIBODIES
Autoantibodies to DNA
Single-Stranded DNA (ssDNA)
Autoantibodies to Histones
Autoantibodies to snRNPs
Anti-Scl Antibodies
Anti-Jo-1 Antibodies
Antibodies to Poly-Nucleosomes and Mono-Nucleosomes
Centromere B
Other Autoantibodies
DIAGNOSTIC METHODS FOR DETECTING ANTINUCLEAR ANTIBODIES
ANA Immunoflourescence (FANA)
1. ANA Titre
2. ANA Pattern
Disadvantages
First and Second Generation EIA
Disadvantages
Third Generation EIAs
ANA TESTING (MFD: Orgentec, Courtesy: Lilac Medicare)
Warnings and Precautions
Material Supplied
Technical Data
Principle of the Procedure
Reaction Phase
Phase 1
Phase 2
Phase 3
Specificity
Calibration
Clinical Relevance
IMMUNOASSAY PROCEDURE
Materials Required
Equipment
Preparation of reagents
Optional
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
CALCULATION OF RESULTS
Semiquantitative Results
Qualitative Results
Calculation Example
Incubation Scheme
ANA: Description
ANA/ANF is positive in
ANTI-dsDNA (MFD: Orgentec, Courtesy: Lilac Medicare)
Warnings and Precautions
Materials Supplied
Controls
Technical Data
Principle of the Procedure
Reaction Phases
Phase 1
Phase 2
Phase 3
Clinical Relevance
Normal Values
Specificity
Calibration
Materials Required
Equipment
Preparation of Reagents
Optional
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Assay Characteristics
Sensitivity
Parallelism
Precision
Immunoassay Procedure
Calculation of Results
Recommended Lin-Log Plot
Calculation Example
Incubation Scheme
Anti-dsDNA Ab Interpretaton
ANACOMBI (ANA PROFILE TESTING) IMMUNOMETRIC ENZYME IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF ANA-AUTOANTIBODIES (MFD: Orgentec, Courtesy: Lilac Medicare)
Warnings and Precautions
Materials Supplied
Technical Data
Principle of the Procedure
Reaction Phases
Phase 1
Phase 2
Phase 3
Clinical Relevance
Specificity
Calibration
Materials Required
Equipment
Preparation of Reagents
Optional
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
NOTES ON TECHNIQUE
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
OD Quotient Calculation
Alternative Calculation
Calculation Example
Incubation Scheme
ANA PROFILE
ANA Profile Positivities
SS-A/Ro Interpretation
SS-B/La Interpretation
Sm Interpretation
SmRNP Interpretation
Scl-70 Interpretation
Jo-1 Interpretation
ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES ANCA PROFILE ANCAcombi MFD: Orgenetec, Courtesy: Lilac Medicare
Warnings and Precautions
Materials Supplied
Controls
Technical Data
Principle of the Procedure
Phase 1
Phase 2
Phase 3
Clinical Relevance
Proteinase 3
Myeloperoxidase
BPI
Elastase
Cathepsin G
Lysozyme
Lactoferrin
Specificity
Calibration
IMMUNOASSAY PROCEDURE
Materials Required
Equipment
Preparation of reagents
Optional
Specimen Collection and Preparation
Preparation and Storage or Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
Calculation Example
Incubation Scheme
ANTIPHOSPHOLIPID SYNDROME
Introduction
History of APLS
What is a Phospholipid?
What are Antiphospholipid Antibodies (APLs)?
β2-Gycoprotein and its Relationship to APLS?
Mechanism of Action of APLs
Antiphospholipid Antibodies and Pregnancy
Other Clinical Features Associated with Antiphospholipid Antibodies
Deep Vein Thrombosis
Arteries can also Clot
Blotchy Skin
Headaches and Migraines
Memory Loss
Who should be Tested for Antiphospholipid Antibodies?
LABORATORY DIAGNOSIS FOR APLS
1. Venereal Disease Research Laboratory (VDRL)
2. Coagulation-based Tests
2a. Lupus Anticoagulant (LA)
2b. APTT
2c. Dilute Rusell Viper Venom Time (dRVVT)
2d. Kaolin Clotting Time
2e. Platelet Neutralisation Test
2f. Hexagonal Phospholipid Neutralisation
3. Anticardiolipin Test (aCl)
4. Antiphosphatidyl Serine Test (aPS)
APPROACH TO THE PATIENTS SUSPECTED OF HAVING APLAs
Relationship of LA, aCL and aPS
Differential Diagnosis
Commercial Kits Used for Antiphospholipid Antibodies
Specimen Requirement for Antiphospholipid Testing
TREATMENT
What is the Treatment for a Person who has Antiphospholipid Antibodies?
If a woman has Antiphospholipid Antibodies and is Pregnant, how is it Treated?
ANTI-CARDIOLIPIN IgM/IgG WITH HUMAN β2-GLYCOPROTEIN I AS COFACTOR MFD: Orgentec, Courtesy: Lilac Medicare
Warnings and Precautions
Material Supplied
Controls
Technical Data
Principle of the Procedure
Phase 1
Phase 2
Phase 3
Clinical Relevance
Normal Values
Specificity
Calibration
IMMUNOASSAY PROCEDURE
Preparation of reagents
Optional
Specimen Collection and Preparation
Preparation and Collection of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
Recommended Lin-Log Plot
Calculation Example
ASSAY CHARACTERISTICS
Parallelism
Precision
Incubation Scheme
ANTICARDIOLIPIN IgA WITH HUMAN β2-GLYCOPROTEIN I AS COFACTOR Mfd: Orgentec, Courtesy: Lilac Medicare
Warnings and Precautions
Material Supplied
Controls
Technical Data
Principle of the Procedure
Phase 1
Phase 2
Phase 3
Clinical Relevance
Specificity
Normal Values
Calibration
IMMUNOASSAY PROCEDURE
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
Recommended Lin-Log Plot
Calculation Example
Assay Characteristics
Sensitivity
Parallelism
Precision
Incubation Scheme
ANTIPHOSPHOLIPID SCREEN (IgG/IgM) WITH HUMAN β2-GLYCOPROTEIN I AS COFACTOR Mfd: Orgentec. Courtesy: Lilac Medicare
Warnings and Precautions
Material Supplied
Controls
Technical Data
Principle of the Procedure
Phase 1
Phase 2
Phase 3
Clinical Relevance
Normal Values
Specificity
Calibration
IMMUNOASSAY PROCEDURE
Preparation of reagents
Specimen Collection and Preparation
Preparation and Storage of Reagents
Preparation of Sample Buffer
Preparation of Buffered Wash Solution
Notes on Technique
Pipetting and Sample Handling
Immunoassay Procedure
Calculation of Results
Recommended Lin-Log Plot
Calculation Example
HEPATITIS MARKERS
AUSTRALIA ANTIGEN HBSAG (VIRUTEX HBsAG) Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Sample Collection and Storage
Material Provided with the Kit
Reagent Pack
Accessories Pack
Additional Material Required
Procedure
Interpretation of Results
Remarks
ONE STEP TEST FOR HBsAG VIRUCHECK® DIPSTICK, Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Materials Supplied
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure
Limitations of the Test
ONE-STEP TEST FOR HBsAG VIRUCHECK® DEVICE, Courtesy: Tulip Group of Companies
Introduction
Principle
Regents and Materials Supplied
Storage and Stability
Note
Specimen Collection and Preparation
Testing Procedure and Interpretation of Results
Limitation of the Test
HCV FLAVICHECK® DEVICE, Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
Reagents and Materials Supplied
Kit Components
Storage and Stability
Note
Specimen Collection and Preparation
Test Procedure and Interpretation of Results
Remarks
ELISA-BASED TESTS HAV AB, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Validity of the Assay
Calculation of Results
Example of Calculation
Assay Performances
HAV IgM, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Example of Calculation
Assay Performance
HBc Ab, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
Content of the Kit
Storage and Stability
Materials not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure
Important Notes
Validity of the Assay
Calculation of Results
Assay Performances
HBc IgM, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Assay Performances
Example of Calculation
HBeAb, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Characteristics of the Assay
Example of Calculation
HBeAG, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Example of Calculation
Characteristics of the Assay
HBe Ag/Ab, Courtesy: Lilac Medicare
Introduction
Principle of the Assay HBeAg
HBeAb
Test Conditions and Notices
Content of the Kit
Storage and Stability
Materials not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure
Important notes
HBeAg Test
HBeAb Test
Validity of the Assay
HBeAg Test
HBeAb Test
Calculation of Results
HBeAg Test
HBeAb Test
Example of calculation
Assay Performances
HBeAg Test
HBeAb Test
HBs Ab, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
Content of the Kit
Storage and Stability
Materials not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure
Important Notes
Validity of the Assay
Calculation of Results
Quantitative Assay
Example of Standard Curve
Qualitative Assay
Assay Performances
HBsAG ONE STEP Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Important Notes
Assay Scheme
Validity of the Assay
Calculation of Results
Example of Calculation
CHARACTERISTICS OF THE ASSAY
Sensitivity
Specificity
Reproducibility
HBsAg, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Notices and Warnings
CONTENT OF THE KIT
Storage and Stability
Material not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure
Important Notes
Operative Instructions
Validity of the Assay
Important Note
Calculation of Results
Example of Calculation
ASSAY PERFORMANCES
Sensitivity
Specificity
Reproducibility
Assay Scheme
HBsAg CONFIRMATORY TEST Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
ASSAY PROCEDURE
Important notes
Positive Samples with OD 450 nm higher than 2 to 3
Positive samples with OD 450 nm lower than 2 to 3
Calculation of Results
Example
Test Performances
MICRO ELISA HCV Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
CONTENT OF THE KIT
Storage and Stability
Material not Provided
Samples
Preparation of Reagents
Washing Instructions
ASSAY PROCEDURE
Important Notes
Automated Assay
Standard Manual Procedure
Validity of the Assay
Calculation of Results
Example of Calculation
Assay Performances
HCV IgM, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
Content of the Kit
Storage and Stability
Materials not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure Important Notes
Validity of the Assay
Calculation of Results
Assay Performances
HCV-Ab CONFIRMATORY TEST Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
CONTENT OF THE KIT
Storage and Stability
Material not Provided
Samples
Preparation of Reagents
Washing Instructions
ASSAY PROCEDURE
Important Notes
Validity of the Assay
Interpretation of Results
HDV Ab, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
CONTENT OF THE KIT
Storage and Stability
Material not Provided
Samples
Preparation of Reagents
Washing Instructions
ASSAY PROCEDURE
Important Notes
Validity of the Assay
Calculation of Results
Example of Calculation
Assay Performances
HDV Ag, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Assay Performances
HDV IgG, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Assay Performances
HDV IgM, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Important Notes
Assay Procedure
Validity of the Test
Results
Assay Performances
HEV Ab, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Example of Calculation
Assay Performances
HEV IgG, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Content of the Kit and Reagents Preparation
Conditions and Notices
Storage and Stability of the Kit
Materials not Provided in the Kit
Samples
Reagents Preparation
Washing Instruction
Assay Procedure
Assay Scheme
Validity of the Assay
Calculation of Results
Assay Performances
HEV IGM, Courtesy: Lilac Medicare
Introduction
Principle of the Assay
Test Conditions and Notices
Content of the Kit
Storage and Stability
Materials not Provided
Samples
Preparation of Reagents
Washing Instructions
Assay Procedure
Validity of the Assay
Calculation of Results
Assay Performances
TORCH INFECTIONS Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Storage
MATERIAL PROVIDED WITH THE KIT
Reagent Pack
Accessories Pack
Additional Material Required
Test Procedure
Qualitative Method
Semi Quantitative Method
INTERPRETATIONS OF RESULTS
Qualitative Method
Semi Quantitative Method
Differentiation IgG - IgM
Significance of Test Results
Remarks
TORCH INFECTIONS—INTRODUCTION
Toxoplasma Infection
Rubella Infection
Cytomegalovirus Infection
Herpes Simplex Virus (1 + 2) Infections
TORCH SCREEN EIA KIT Courtesy: Lilac Medicare
Introduction
Principle of the EIA Test
Components
Material Required but not Provided
Precautions
Specimen Preparation
Assay Procedure
Quality Control
Results
Calculation
Reporting Results
Interpretation of Results
Performance Characteristics
TORCH SCREEN IgG EIA KIT Courtesy: Lilac Medicare
Intended Use
Introduction
Principle of the EIA Test
Components
Material Required but not Provided
Precautions
Specimen Preparation
Assay Procedure
Quality Control
Results
Calculation
Reporting Results
Interpretation of Results
PERFORMANCE CHARACTERISTICS
Linearity
Linerity Dilution Test
HUMAN IMMUNODEFICIECNY VIRUS
HIV Virus
Origin of HIV
The HIV Virion
HIV Types and Variants
Life Cycle of the HIV
Integration of Viral DNA
Transcription: Back to RNA
Translation: RNA > Proteins
Clinically Apparent Disease
HIV Specific Prognostic Markers
Non Specific Markers of HIV Progression
HIV Diagnostic Testing Techniques
Enzyme Immunoassays (EIA)
Generation of Assays
EIA ASSAY FORMATS
Type 1: Indirect or Antiglobulin
Type 2: Competitive Assay
Type 3: Class Specific Antibody Capture Assay
Type 4: Double Antigen Sandwich or Immunometric Assay
HIV Antigen EIA's
Confirmatory/Supplementary Assays
Virus Detection Methods
p24 Antigen and Nucleic Acid Technologies
Rapid Tests for the Detection of Anti-HIV Antibodies
Flow Through v/s Lateral Flow Technology
Application of HIV Testing
Screening
Diagnosis
Approach to Confirmatory Supplementary Tests
Western Blot (WB)
NAT-PCR Based Methods
Alternative Approach to Confirmatory Testing
WHO/UNAIDS Strategies for HIV Antibody Screening
Discrimination Between HIV-1 and HIV-2 Infection
Paediatric HIV Infection
Transmission of HIV from Mother to Infants
Diagnostic Challenges: Child Born to a HIV Infected Mother
Anti Retroviral Therapy
Use of Highly Active Anti Retroviral Therapy (HAART)
Vaccines for HIV Infection
RAPID IMMUNOCONCENTRATION TEST FOR HIV I AND HIV 2 ANTIBODIES. FLOW THROUGH METHOD RETROQUICK-HIV, Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
REAGENTS AND MATERIALS SUPPLIED
Kit components
Storage and Stability
Specimen Collection and Preparations
Test Procedure
INTERPRETATION OF RESULTS
Negative Test result
Positive Test results
Invalid Test result
Performance Characteristics
Remarks
RAPID IMMUNOCHROMATOGRAPHIC TEST FOR HIV 1/2 ANTIBODIES LATERAL FLOW METHOD
RETROCHECK HIV, Courtesy: Tulip Group of Companies
Introduction
Summary
Principle
REAGENTS AND MATERIAL SUPPLIED
Kit Components
Storage and Stability
Specimen Collection and Preparation
Test Procedure and Interpretation of Results
Performance Characteristics
Remarks
TUBERCULOSIS
TB IgG, IgA, IgM Ab, Mfd. ANDA Courtesy: Lilac Medicare
Serodiagnosis of Mycobacterial Infections
Principle of the Method
Reagents
A. For IgA tests
B. For IgG tests
C. For IgM tests
Material Required but not Provided
Specimen Collection and Preparation
Precautions of Use
Preparation of the Reagents
a. Washing solution
b. TMB work solution
Preparation of Diluted TMB solution
Test Procedure
A. For the IgA tests
B. For the IgG Tests
C. For the IgM tests
Summary of the Procedure
Incubate 1 hour at 37°C
Incubate 30 Minutes at 37°C
Incubate 15–25 minutes at 37°C for IgM
Determination of Results
A. IgA and IgG tests
B. IgM Tests
C. Limits of the Methods
D. Specificity
E. Sensitivity
‘Interpretation of the Results
A. Cut off
IgM
B. Healthy People
C. Tuberculous States
D. HIV Cases
E. IgA Antibodies
F. Interpretations of Serological Results
TUMOUR MARKERS
ALPHA-FETOPROTEIN (AFP) ELISA Courtesy: Lilac medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
Reagents for 96-Well Microplate
FOR IN VITRO DIAGNOSTIC USE NOT FOR INTERNAL OR EXTERNAL USE IN HUMANS OR ANIMALS
Precautions
Specimen Collection and Preparation
Materials Provided
Required But Not Provided
Reagent Preparation
Test Procedure
Quality Control
Results
Example 1
QC Parameters
Limitations of Procedure
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Increased
Decreased
CA 15–3 (CARCINOGENIC ANTIGEN 15–3) Courtesy: Lilac Medicare
Summary and Explanation of the Assay
Principles of the CA15–3 EIA
Kit Contents
Materials Required but not Supplied with the Kit
Specimen Collection and Handling
Warnings and Precautions
Procedural Notes
Assay Procedure
Sample Preparation
Option
Calculation of Results
Calculation of Results with Diluted Samples
Quality Controls
Limitation of the Procedure
Expected Values
Performance Characteristics
Precision
Detection Limit
Recovery
Linearity
Hook Effect
Ca 15–3 (Carcinogenic Antigen 15–3), Serum
Norm <22 U/ ml
Increased
Decreased
CA 19–9 (CARBOHYDRATE AG 19–9, GICAM GASTROINTESTINAL CANCER ANTIGEN) BLOOD Mfd: Can Ag, Courtesy: Lilac Medicare
Summary and Explanation of the Assay
Principles of the CanAg CA19–9 EIA
Kit Contents
Protocol Sheet
Materials Required but not Supplied with the Kit
Specimen Collection and Handling
Warnings and Precautions
Procedural Notes
CANAG CA19–9 EIA PROD. NO. 120–10
Protocol Sheet September 1998
Calculation of Results
Calculation of Results with Diluted Samples
Quality Controls
Limitation of the Procedure
Expected Values
Performance Characteristics
Dose-response and precision profile
Precision
Detection Limit
Recovery
Linearity
Hook Effect
Usage
Increased
CA242 Mfd: Can Ag, Courtesy: Lilac Medicare
Summary and Explanation of the Assay
Principles of the CA242 EIA
Kit Contents
Materials Required but not Supplied with the Kit
Specimen Collection and Handling
Warnings and Precautions
Procedural Notes
Assay Procedure
Protocol Sheet September 1998
Calculation of Results
Calculation of Results with Diluted Samples
Quality Controls
Limitations of the Procedure
Reference Value
PERFORMANCE OF THE CHARACTERISTICS
Dose-response and Precision Profile
CA242 U/ml
Precision
Detection Limit
Recovery
Hook Effect
Linearity
CA 50 (CARBOHYDRATE ANTIGEN 50), BLOOD
Increased
Decreased
CA 125 (CANCER ANTIGEN 125) Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS MATERIALS PROVIDED
A. Cancer Antigen 125 (CA-125) 1 ml/vial
B. Enzyme-Antibody-Conjugate and Biotinylated Monoclonal antibody—13ml/vial
C. Streptavidin Coated Microplate—96 wells
D. Wash Solution Concentrate – 20 ml
E. Substrate A -7ml/vial
F. Substrate B—7ml/vial
G. Stop Solution-8ml/vial
Product Instructions
Required But Not Provided
Precautions
Specimen Collection and Preparation
Reagent Preparation
Test Procedure
Quality Control
Results
QC Parameters
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
CARCINOEMBRYONIC ANTIGEN (CEA) Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
REAGENTS FOR 96-WELL MICROPLATE
A. Carcinoembryonic antigen (CEA) −1.0 ml/vial
B. Enzyme-Polyclonal Conjugate and Biotinylated Monoclonal antibody—11 ml/vial
C. Streptavidin Coated Microplate - 96 wells
D. Wash Solution Concentrate - 20 ml
E. Substrate A -7.0 ml/vial
F. Substrate B - 7.0 ml/vial
G. Stop Solution—6.0 ml/vial
For In Vitro Diagnostic Use
Precautions
Specimen Collection and Preparation
MATERIALS
Provided
Required But Not Provided
Reagent Preparation
Test Procedure
Quality Control
Results
Example 1
LIMITATIONS OF PROCEDURE
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Increased
Decreased
PROSTATE-SPECIFIC ANTIGEN (PSA)
TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ELISA, Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
Immunoenzymometric Assay
MATERIAL PROVIDED
A. Prostrate Specific antigen (PSA) 1.0 ml/vial
B. Enzyme-Conjugate/Biotinylated Monoclonal antibody —6.0 ml/vial
C. Streptavidin Coated Tubes
D. Wash Solution Concentrate - 20 ml
E. Substrate A -7.0 ml/vial
F. Substrate B - 7.0 ml/vial
G. Stop Solution - 8.0 ml/vial
H. Product Insert
For in Vitro Diagnostic Use
Precautions
Specimen Collection and Preparation
Materials Required but not Provided
Reagent Preparation
Stop solution dilution
Test Procedure
Quality Control
Results
Example 1
Limitations of Procedure
A. Assay Performance
B. Interpretation
Expected Ranges of Values
Usage
Increased
Description
PROSTATIC ACID PHOSPHATES (PAP), BLOOD
Increased
Decreased
Description
MISCELLANEOUS ELISA-BASED INVESTIGATIONS ANTI-H PYLORI IgG ANTI-H PYLORI IgM, ANTI-H PYLORI IgA, Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
PRINCIPLE
A Sequential ELISA Method
Reagents for 96-Well Microplate
A. Anti-H. pylori Calibrators—1.0 ml/vial
B. H. Pylori Biotin Conjugate- 11 ml/vial
C. Enzyme-antigen Conjugate - 11 ml/vial
D. Streptavidin-Coated Microplate - 96 wells
E. Serum Diluent Concentrate— 20 ml
F. Wash Solution Concentrate—20 ml
G. Substrate A ~7.0 ml/vial
H. Substrate B - 7.0 ml/vial
I. Stop Solution - 6.0 ml/vial
Precautions
Specimen Collection and Preparation
Materials
Provided
Required but not Provided
Reagent Preparation
1. Serum Diluent
2. Wash Buffer
3. Patient Sample Dilution (1/100)
4. Working Substrate Solution -Prepare Immediately Before Use
Test Procedure
Quality Control
Results
QC Parameters
Limitations of Procedure
A. Assay Performance
B. Interpretation
FERRITIN, Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
Principle
Immunoenzymometric Sequential Assay
Quality Control
Results
QC Parameters
Limitations of Procedure
A. Assay Performance
Reagents
Provided
Required but not Provided
Precautions
Specimen Collection and Preparation
Reagent Preparation
Test Procedure
B. Interpretation
IMMUNOGLOBULIN E (IgE) Mfd: Monobind, Courtesy: Lilac Medicare
Summary and Explanation of the Test
Principle
Immunoenzymometric Sequential Assay
Reagents Provided
A. Human Serum References-1.0 ml/viat
B. IgE Biotin Conjugate-13 ml/vial
C. IgE Enzyme Conjugate-13 ml/vial
D. Streptavidin Microplate - 96 wells
E. Wash Solution Concentrate—20 ml
F. Substrate A - 7.0 ml/via
G. Substrate B - 7.0 ml/vial
H. Stop Solution-8.0 ml/vial
I. Product Insert
Required but not Provided
Precautions
Specimen Collection and Preparation
Reagents Preparation
Test Procedure
Quality Control
Results
Example 1
QC Parameters
Limitations of Procedure
Expected Ranges of Values
Performance Characteristics
A. Precision
Inter-Assay Precision
Intra-assay precision
B. Accuracy
C. Parallelism
D. Sensitivity
E. Specificity
F. Linearity
CHAPTER 24:
Histopathology
PREPARATION OF TISSUES
Fixation
Decalcification
Nitric Acid Method
Formic Acid Sodium Citrate Method
Electrolytic Method
Processing of Tissues
Method I
Method II
Method III
Preparation of Sections
Cutting Sections
Attaching Sections to Slides
Technique for Frozen Sections
Staining
Mounting
REMOVAL OF PIGMENTS AND PRECIPITATES
Mercury Precipitate
Formalin Produced Precipitate
Method I
Note
Method II
Melanin Pigment
Malarial Pigment
Method I
Method II
Method III
ROUTINE STAINING PROCEDURES
COMMONLY EMPLOYED HAEMATOXYLINS
Harris's Alum Haematoxylin
Mayer's Haematoxylin
Counterstains for Haematoxylin Stains
Stock 1% Aqueous Eosin Solution
Stock 1% Alcoholic Eosin Solution
Working Eosin Solution
Routine Haematoxylin and Eosin Stain
Solution
Staining Procedure
SPECIAL STAINS
Stains for Connective Tissue
Stains for Cytoplasmic Granules
Stains for Fats and Lipoids
Stains for Carbohydrates and Mucoproteins
Stains for Pigments and Minerals
Stains for Bacteria, Fungi and Inclusion Bodies
SOME STAINING TECHNIQUES IN DETAIL
Mallory's Phosphotungstic Acid Haematoxylin Stain
PTAH
Staining Procedure
Results
van Gieson's Stain for Collagen Fibres
Solution
Staining Procedure
Results
Masson's Trichrome Stain
Solutions
Staining Procedure
Results
Verhoff's Elastic Stain
Solutions
Sodium Thiosulphate (Hypo) Solution
Staining Procedure
Results
Wilder's Reticulin Stain
Solutions
Staining Procedure
Results
Fontana-Masson Stain for Argentaffin Granules
Solutions
Staining Procedure
Results
Oil Red O Fat Stain
Solutions
Staining Procedure
Results
Best's Carmine Stain for Glycogen
Solutions
Staining Procedure
Results
Periodic Acid-Schiff (PAS) Reaction
Solutions
OR
Staining Procedure
Results
Mayer's Mucicarmine Stain
Solutions
Staining Procedure
Results
Crystal Violet Amyloid Stain
Solutions
Staining Procedure
Results
von Kossa's Method for Demonstrating Calcium
Solutions
Staining Procedure
Results
Ziehl-Neelsen Stain for Acid-Fast Bacteria
Solutions
OR
AUTOMATION IN HISTOPATHOLOGY
Hypercentre (Shandon)
Histocentre (Shandon)
2 LE (Shandon)
Duplex (Shandon)
Hypercut (Shandon)
Autosharp 5 (Shandon)
Linistain GLX (Shandon)
Varistain 24 (Shandon)
Varistain 12 (Shandon)
Autoslip (Shandon)
CHAPTER 25:
Cytology
FNAC
Fine-Needle Aspiration Cytology Transcutaneous Aspiration of Palpable Lesions
ASPIRATION OF INTRATHORACIC MASSES
Lung
Liver
Advantages of the Procedure
Limitation
ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION CYTOLOGY
B-Scanning
Advantages
Disadvantages
Application
Smearing Techniques
One-Step Smearing Technique
Two-Step Particle Concentration and Smearing Technique
REQUIREMENTS FOR LABORATORY SET UP
Equipment
Glassware
May-Grünwald-Giemsa (MGG) Stain
Reagents
Preparation of Stains
Staining Techniques
Papanicolaou's Stain
Harris's Haematoxylin
Orange G-6
Eosin Azure-36 (EA-36)
Automatic Staining
Staining Method
Results
Combined Alcian Blue—PAS Technique for Acid and Neutral Mucins
Preparation of Stains
Method
Results
Naphthol ASBI Phosphate Method for Acid Phosphatase
Preparation of Solutions
Method
Results
Alkaline Phosphatase: Azo Dye Coupling Method Using Alpha Naphthyl Phosphate
Fixation
Preparation of incubating medium
Method
Results
α-Naphthyl Acetate Method for Nonspecific Esterase
Preparation of Solutions
Method
Results
Diaminobenzidine Method for Peroxidase
Method
Result
Peroxidase Stain
Preparation of Solutions
Method
Results
Oil Red O Method for Lipids
Preparation of Solution
Method
Results
Immunoperoxidase Staining
Introduction
Material
Immunofluorescence
Method
AUTOMATION IN CYTOLOGY
CHAPTER 26:
Microbiology and Bacteriology
CLASSIFICATION
Protophyta
Schizomycetes (Bacteria and related forms)
Microtatobiotes (The smallest living things)
Thallophyta
BACTERIAL CELL CONSTITUENTS
Shape of Bacteria
Products of Bacterial Growth
KOCH'S POSTULATES
MORPHOLOGY AND STAINING REACTIONS
Gram's Stain
Method
Results
Reagents
Ziehl-Neelsen Stain
Method
Results
Modified Ziehl-Neelsen's Stain
RAPID TWO STEP COLD AFB STAIN (Courtesy: Tulip Group of Companies)
Novachrom
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Specimen Collection and Preparation
Specimen Preparation
Test Procedure
Interpretation of Results
Grading of results
Remarks
SPECIAL STAINS
Stains for Diphtheria Bacillus
Ponder's Stain
Albert's Stain
Modified Neisser's Method
Staining of Capsules
Hiss's Method
India Ink Method
Staining of Spores
Modified Ziehl-Neelsen's Method
Result
Staining of Spirochaetes
Fontana's Method
Method
Result
Staining of Fungi
Lactophenol Cotton Blue
Staining of Flagella
Loeffler's Method
Method
Result
Negative Staining
India Ink method
MOTILITY OF BACTERIA
Hanging Drop Method
CULTURE
Media
Temperature
Atmosphere
Cultural Characteristics
Biochemical Reactions
Serology
PREPARATION OF CULTURE MEDIA
Peptone Water
Nutrient Broth
Nutrient Agar
Blood Agar
Chocolate Agar
Sugar Media
Preparation of Andrade's Indicator
Hiss's Serum Water Sugars
Loeffler's Serum Slopes
Media for Identification of Fungi
Sabouraud's Glucose Agar
READY TO POUR, STERILISED POUCHED MEDIA FOR MICROBIOLOGICAL APPLICATIONS (Courtesy: Tulip Group of Companies
Instaprep
Summary
Reagent
Nutrient Agar
MacConkey Agar
CLED Agar with Andrade's Indicator
Sabouraud Dextrose Agar
Mueller Hinton Agar
Principle
Storage and Stability
Additional Material Required
Procedure
Interpretation of Results
Remarks
MEDIA FOR GROWTH OF ANAEROBES
LOWENSTEIN JENSEN MEDIUM
METHOD OF INOCULATION
Streak Plate Method
PRECAUTIONARY MEASURES TO BE UNDERTAKEN IN A MICROBIOLOGY LABORATORY
SPECIMEN COLLECTION
URINE
EASYBACT Courtesy: Tulip Group of Companies
Summary
Reagent
Principle
Storage and Stability
Additional Materials Required
Specimen Collection and Preparation
TEST Procedure
Interpretation of Results
Identification of Bacteria
Remarks
Notes
FECES
SPUTUM
THROAT AND NASAL SMEARS
PUS SWABS
BLOOD CULTURES
CSF, PLEURAL FLUID AND OTHER BODY FLUIDS
EAR DISCHARGE CULTURES
EYE CULTURES
GRAM-POSITIVE COCCI
Staphylococci
Morphology
Culture
Pathogenicity
Streptococci
Morphology
Culture
Pathogenicity
Pneumococci
Morphology
Culture
Pathogenicity
GRAM-NEGATIVE COCCI
Neisseria
N. catarrhalis
Morphology
Culture
N. Meningitidis
Morphology
Culture
N. Gonorrhoea
Morphology
Culture
Comparison of meningococci and gonococci
Veilonella
ANAEROBIC SPORE BEARING BACILLI
Clostridia
Pathogenic clostridia
Clostridium tetani
Morphology
Culture
Laboratory Diagnosis
Toxin produced
Gas Gangrene Causing Organisms
Clostridium welchii (or C. perfringens)
Morphology
Culture
Toxins produced
Clostridium septicum
Morphology
Culture
Clostridium novyi
Morphology
Culture
Diagnosis of Gangrene
Microscopy
Culture
Clostridium botulinum
Morphology
Culture
Laboratory Diagnosis
AEROBIC SPORE FORMING BACILLI
GRAM-POSITIVE BACILLI
Corynebacteria
Morphology
Culture
Diseases Caused
Laboratory Diagnosis
Diphtherioid bacilli
Corynebacterium hoffmanni
Corynebacterium xerosis
Corynebacterium acne
MYCOBACTERIUM
Other Pathogenic Mycobacteria
M. lepraemurium
Non-Pathogenic Species
M. smegmatis
M. butyricum
Anonymous Strains
Animal Inoculation
OVERVIEW OF M. TUBERCULOSIS DIAGNOSTIC APPROACH AFB STAINING, CULTURE AND SENSITIVITY
INTRODUCTION
BRIEF MICROBIOLOGY
DIAGNOSIS OF MYCOBACTERIUM TUBERCULOSIS INFECTION
SPECIMEN SELECTION
SAMPLE CONCENTRATION AND DECONTAMINATION
MUCOLYTIC, DISINFECTANT, SPECIMEN PRETREATMENT AND BUFFERING SYSTEM FOR AFB STAINING AND CULTURE (Courtesy: Tulip Group of Companies)
Lyfectol
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Specimen Collection
Procedure
Preparation of Mucolytic Reagent
Processing of Specimen
Remarks
EFFECT OF CENTRIFUGAL FORCE ON POSITIVE SMEARS/CULTURES FOR MYCOBACTERIA
THE AFB SMEAR
RAPID TWO STEP COLD AFB STAIN (Courtesy: Tulip Group of Companies)
Novachrom
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Specimen Collection and Preparation
Specimen Preparation
Test Procedure
Interpretation of Results
Grading of Results
Remarks
Quantitation Scale for Acid-Fast Bacillus Smears according to stain used
FACTORS INFLUENCING SENSITIVITY AND SPECIFICITY OF AFB SMEARS
FALSE POSITIVE RESULTS
FALSE NEGATIVE RESULTS
AFB CULTURE AND ISOLATION
READY TO USE LJ SOLID MEDIUM FOR MYCOBACTERIUM TUBERCULOSIS ISOLATION (Courtesy: Tulip Group of Companies)
Mycocult
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Specimen Collection and Preparation
Specimen Preparation
Test Procedure
Interpretation of Results
Remarks
COMBIPACK OF SOLID AND LIQUID MEDIUM FOR MYCOBACTERIUM TUBERCULOSIS ISOLATION (Courtesy: Tulip Group of Companies)
Combicult
Summary
Reagent
Principle
Storage and Stability
Additional Material Required
Specimen Collection and Preparation
Specimen Preparation
Preparation of Kirchner Medium
Test Procedure Kirchner medium
Lowenstein-Jensen slant
Interpretation of Results
Remarks
SUSCEPTIBILITY TESTING OF MYCOBACTERIUM TUBERCULOSIS
Pattern of Drug Resistance for Mycobacterium tuberculosis
Susceptibility Testing Methodology
SUSCEPTIBILITY TESTING OF MYCOBACTERIA
Drug Concentrations for Proportion Method Susceptibility Testing using various culture media*
Drug Concentration (μg/ml)
PRIMARY/SECONDARY DRUG CONTAINING LOWENSTEIN-JENSEN MEDIA PANEL MTB SENSITIVITY TESTS Courtesy: Tulip Group of Companies
Sensicult
Summary
Reagent
Contents
Principle
Storage and Stability
Additional Material Required
Inoculum Preparation for Sensitivity Testing
Test Procedure
Interpretation of Results
Remarks
OTHER MARKERS
IN DETERMINATION OF ADENOSINE DEAMINASE ACTIVITY IN SERUM, PLASMA AND BIOLOGICAL FLUIDS ADA-MTB® (Courtesy: Tulip Group of Companies)
ADA-MTB®
Summary
Reagent
Principle
Reference Values
Storage and Stability
Note
Additional Material Required
Reagent Preparation
Specimen Collection and Preparation
Test Procedure
Calculations
Linearity
Remarks
GRAM-NEGATIVE BACILLI
ACHROMOBACTERIACEA
Alcaligens fecalis
ENTEROBACTERIACEAE
Paracolon Bacilli
ENTERIC FEVER BACILLI-TYPHOID AND PARATYPHOID
Salmonella paratyphi A and Salmonella paratyphi B
Pathogenicity
Diagnosis of Enteric Infections
Blood Culture
Feces Culture
Urine Culture
Widal Reaction
ORGANISMS OF BACTERIAL ENTERITIDIS OF FOOD POISONING
GROUP OF DYSENTERY BACILLI
BRUCELLACEAE
Pasturella Pestis
Morphology
Culture
Pasturella Tularensis
Morphology
Culture
Bordetella pertussis
Morphology
Culture
Brucella
Laboratory Diagnosis
HAEMOPHILUS
PSEUDOMONADACEAE
BACTERIACEAE
SPIROCHAETES
Leptospira Icterohemorrhagiae
Laboratory Diagnosis
Cultivation
Borrelia
Borrelia vincenti
Borrelia recurrentis
Borrelia duttonii
Laboratory Diagnosis of Relapsing Fevers
Spirillum minus
GRAM STAINER
CHAPTER 27:
Mycology
SUPERFICIAL MYCOSES AND DERMATOPHYTES
Laboratory Diagnosis
INTERMEDIATE SUPERFICIAL DEEP MYCOSES
DEEP OR SYSTEMIC MYCOSES
FUNGI USUALLY PRESENT AS CONTAMINANTS BUT WHICH RARELY CAUSE DISEASE— USUALLY IN PATIENTS CHRONICALLY ILL FROM OTHER DISEASES
MYCOLOGICAL METHODS
Collection and Despatch of Specimens
Microscopic Examination
Cultural Examination
CHAPTER 28:
Diagnostic Skin Tests
TECHNIQUE OF SKIN TESTS
Intracutaneous Injection
Transcutaneous Administration
Patch Tests
IMMUNOLOGIC BASIC FOR SKIN TESTS
Toxin—Antitoxin Neutralisation
Anaphylatic Type of Hypersensitivity (Immediate Reactions)
Tuberculin Type of Hypersensitivity (Delayed Reactions)
COMMON SKIN TESTS
Toxin—Antitoxin Neutralisation Tests
Schick Test
Dick Test
Schültz-Charlton Reaction
Immediate Reaction Type of Skin Tests
Test for Sensitivity to Horse Serum
Direct Skin Tests for Allergens (Respiratory, contact, drug, or food)
Prausnitz-Kustner Reactions
Penicillin Hypersensitivity
Foshay's Test
Extracts of Parasitic Worms (e.g. Trichinella)
Delayed Reaction Type of Skin Tests
Tuberculin test (Mantoux test, Pirquet Reaction)
Candida
Filariasis
Ducrey Test (Ito-Reenstierna test, chancroid skin test, dmelcos test; for the diagnosis of chancroid)
Brucellergen Test (For the diagnosis of brucellosis)
Tularaemia Skin Test
Frei Test (For the diagnosis of lymphogranuloma venereum)
Mumps and Herpes Simplex Tests
Echinococcus Skin Test (Casoni reaction; for the diagnosis of hydatid disease)
Trichinella Skin Test (For the diagnosis for trichinosis)
Coccidioidin Test (For diagnosis of past infection with Coccidioides immitus)
Histoplasmin Test (For the diagnosis of past infection with Histoplasma capsulatum)
Blastomycin Test (For the diagnosis of past infection with Blastomyces)
Kveim-Siltzbach Test (For the diagnosis of sarcoidosis)
Toxoplasma Skin Test
Nonbacterial Regional Lymphadenitis (“Cat Scratch Fever”) Test
CHAPTER 29:
Diagnostic Immunology (Immunodiffusion, Electrophrosis and Turbidimetry)
QUALITATIVE DETERMINATION OF PLASMA PROTEINS BY IMMUNOPRECIPITATION
Immunodiffusion Method of Oudin
Double Diffusion Method of Ouchterlony
Grabar and Williams's Method of Immunoelectrophoresis
METHODOLOGY
Double Diffusion of Ouchterlony
Macrotechnique
Reagents
Preparation of Agar Gel Slides
Gel Diffusion Procedure
Microtechnique
Recording of Results
Possible Sources of Error
IMMUNOELECTROPHORESIS
Reagents and Equipment
Agar
Buffer
Antisera
Immunoelectrophoresis Equipment
Preparation of Agar Gel Slides
Application of Antigens
Electrophoresis
Application of Antiserum
Fixation of Precipitin Patterns
Protein Stains
Lipoprotein Stains
Peroxidase Reaction (for haptoglobin and haemopexin)
Ceruloplasmin Stain
Cholinesterase Stain
Lipid-Protein Double Staining
Identification and Interpretation of Precipitin Lines
PRACTICAL APPLICATION OF IMMUNOELECTROPHORESIS
QUANTITATIVE DETERMINATION OF PLASMA PROTEINS BY IMMUNOPRECIPITATION
FUNDAMENTAL QUANTITATIVE CONSIDERATIONS
Single Radial Immunodiffusion
Equipment
Procedure
TUBIDIMETRY
Introduction
Immunoassays
Qualitative Immunoassays
Quantitative Immunoassays
SPECTROPHOTOMETRY
Measuring Principles in Biochemistry
Criteria for Wavelength Selection
Reading Methods
Standarisation of Time Interval for Rate Reactions
Measurement of Immune Complexes by Spectrophotometry
Selection of Wavelength for Measuring Immune Complexes
Turbidimetry vs Nephelometry
CONSIDERATIONS FOR MEASUREMENTS OF TURBIDIMETRIC IMMUNOASSAYS (TIA)
The Antibody Excess Zone
Zone of Equivalence
The Antigen Excess Zone
Optimisation, Standardisation and Quality Control of Turbidimetric Assays
Reading Principles in Turbidimetry
Real Sample Blanking
lmmediate Mixed Blanking
Reaction Kinetics and its Effect on Blanking
CONCEPTS OF ASSAY OPTIMISATION
Detection Limit
Measuring Range
Security Range
Reagent Optimisation
Standard Curve
INSTRUMENTATION FOR TURBIDIMETRY
Aspiration Mode
Cuvette Mode
Classification of Analysers
Semiautomated Analysers
Automated Analysers
Centrifugal Analysers
Static Instruments
TURBIDIMETRIC IMMUNOASSAY FOR DETERMINATION OF RHEUMATOID FACTORS
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of RF Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR DETERMINATION OF C-REACTIVE PROTEIN, QUNATIA CRP®, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of CRP Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test procedure for specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY'FOR ULTRASENSITIVE DETERMINATION OF C-REACTIVE PROTEIN
Quantia CRP-US, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of CRP US Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Males
Females
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR DETERMINATION OF ANTISTREPTOLYSIN ‘O’ IN HUMAN SERUM
Quantia CRP-US, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of ASO Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR DETERMINATION OF MICROALBUMINURIA
Quantia MA®, Courtesy: Tulip Group of Companies
Summary
Reagents
Storage and Stability
Principle
Note
Sample Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of MA Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF IMMUNOGLOBULIN IgA IN HUMAN SERUM
Quantia IgA, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of IgA Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF IMMUNOGLOBULIN IgG IN HUMAN SERUM
Quantia IgG, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of IgG Calibration Curve
Test Procedure for Preparation of Calibration Cvurve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF IMMUNOGLOBULIN IgM IN HUMAN SERUM
Quantia IgM, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of IgM Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF COMPLEMENT C3 IN HUMAN SERUM
Quantia C3, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of C3 Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF COMPLEMENT C4 IN HUMAN SERUM
Quantia C4, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of C4 Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
TURBIDIMETRIC IMMUNOASSAY FOR ESTIMATION OF ANTITHROMBIN III IN HUMAN SERUM
Quantia AT III, Courtesy: Tulip Group of Companies
Summary
Reagent
Reagent Storage and Stability
Principle
Note
Specimen Collection and Preparation
Additional Material Required
Test Procedure
Assay Conditions
Method for Preparation of AT III Calibration Curve
Test Procedure for Preparation of Calibration Curve
Test Procedure for Specimen
Validation Criteria
Calculations
Specific Performance Characteristics
Measuring Range
Detection Limit/Analytical Sensitivity
Prozone Limit
Precision
Interference
Reference Values
Remarks
AUTOMATION IN TURBIDIMETRY
Quantimate Turbidimetry Analyser
Optimised Measuring System
Instrument specifications
CHAPTER 30:
Cytogenetics
INTRODUCTION
Cell Division
BLOOD LYMPHOCYTE CULTURE
Chromosome Preparation from Bone Marrow
Chromosome Preparation from Whole Blood Culture
Harvesting of Cultures
Preparation of Chromosome Slide
Cleaning and Preparation of Slides
Procedure of Giemsa Staining
Preparation of Phosphate Buffer Solution
KARYOTYPING
G AND Q BANDINGS
G Banding
Q Banding (Quinacrine Banding Technique)
C Banding Technique
Importance of Chromosomal Studies
Variations in the Chromosome Number
Polyploidy
Aneuploidy
Barr Body Analysis Buccal Smear for Staining Sex Chromatin Mass
Preparation
Procedure
Postprocedure Care
Client and Family Teaching
Factors that Affect Results
Other Data
APPENDICES:
Appendix I Drug Affecting Laboratory Tests Values
DRUGS AFFECTING RESULTS OF BLOOD STUDIES, ELECTROLYTES, BLOOD GAS ANALYSES, AND ISOTOPE STUDIES
DRUGS AFFECTING RESULTS OF MURINE STUDIES
DRUGS THAT MAY AFFECT COLOUR OF URINE
DRUGS AFFECTING RESULTS OF FECAL STUDIES
DRUGS AFFECTING RESULTS OF HAEMATOLOGIC AND SEROLOGIC STUDIES
DRUGS AFFECTING CEREBROSPINAL FLUID STUDIES
APPENDICES:
Appendix II
APPENDICES:
Appendix III
IMMUNOHAEMATOLOGY
Reagents for Forward/Subgrouping
HAEMATOLOGY
Haematology Reagents
IMMUNOLOGY
Infectious Diseases Reagents
Fertility Reagents
Rheumatology Reagents
Other Markers
IMMUNOTURBIDIMETRY
Quantia Range
HAEMOSTASIS
Reagents for Routine Screening
MICROBIOLOGY
Pouched Media for Essential Microbiology
Culture Systems
Mycobacteriology Reagents
RAPID TESTS
Fertility
Infectious Disease
Infectious Disease
Cancer Markers
Cardiac Marker
BIOCHEMISTRY
Enzymes
Substrates
Other Metabolities
Metals and Ions
ELISA
Infectious Disease
Fertility
INSTRUMENTATION
Haemostasis
Clinical Chemistry
Immunoturbidimetry
BIOCHEMISTRY
Haemoglobin Estimation
Controls and Calibrators
OTHERS
Microkrom Microscopy Stains
Special Tests
RAPID TESTS
In Pipeline
IMMUNOTURBIDIMETRY
In Pipeline
BIOCHEMISTRY
In Pipeline
MANUFACTURING LOCATIONS
THYROID IMMUNOASSAYS
Thyroid Microwell ELISA
Thyroid Microwell Elisa
Thyroid Coated Tube Assay
FERTILITY IMMUNOASSAYS
Pituitary Hormone Microwell Elisa
PITUITARY HORMONE COATED TUBE ASSAY
STEROID HORMONE MICROWELL ELISA
ONCO IMMUNOASSAYS
Tumour Markers Coated Tube Assay
Tumour Markers Coated Tube Assay
TORCH IMMUNOASSAYS
TORCH Panel Microwell ELISA
TORCH Combination ELISA
HEPATITIS MARKER IMMUNOASSAYS
Hepatitis Marker Microwell ELISA
AUTOIMMUNE IMMUNOASSAYS
Autoimmune ELISA Kits
OTHER IMMUNOASSAYS
Other ELISA
LIQUITECH QUALITY CONTROL PACKAGES
Referral/Accuracy Control
Referral/Accuracy Control (Ex. QC)
Precision Control (In. QC)
LIQUITECH VARIFIX
CAPP Varifix Single Channel Standard Micropipette
CAPP Varifix Single Channel Short Micropipette
CAPP Varifix Single Channel Colourline Micropipette
CAPP Varifix Multichannel Micropipette
CAPP VARIFIX-HLA TERASAKI PIPETTE
TRANSPLANTATION DIAGNOSTICS
Pre-Dropped HLA Typing Sera
HLA-SSO/SSP TYPING SYSTEMS
Lyophilised Sera for HLA Typing, HLS Control Sera and Accessories
IMMUNOASSAY AUTOMATION
Triturus: Fully Automated Walkaway Enzyme Immunoassay Automation
Triturus
ALPHA PRIME: MULTIPARAMETRIC IMMUNOASSAY SYSTEM
INDEX
TOC
Index
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