Serology products

RF Latex 

Intended Use:

Test for qualitative determination of Rheumatoid Factors (RF) by immune agglutination method.

Introduction:

Rheumatoid factors are a group of antibodies directed to determinants in the Fc portion of the immunoglobulin G molecule. Although rheumatoid factors are found in a number of rheumatoid disorders, such as systemic lupus erythematosus (SLE) and Sjogren’s syndrome, as well as in nonrheumatic conditions, its central role in clinic lies its utility as an aid in the diagnosis of rheumatoid arthritis (RA). A study of the ‘American College of Rheumatology’, shows that the 80.4% RA patients were RF positive.

 

Principle:

The RF-Latex is a slide agglutination test for the qualitative and semi-quantitative detection of RF in human serum. Latex particles coated with human gammaglobulin are agglutinated when mixed with samples containing RF.

Kit Components

Latex Reagent – 1 Bottle.
Positive Control – 1 Bottle.
Negative Control – 1 Bottle.
Mixing Sticks.
Sample Droppers.
Glass Slide.
Instructions for Use.

Specification

ProcedureQualitative only (Slide Test) and Semi-quatitative method (Slide Test)
Procedure Time2 minutes for Qualitative as well as Semi-Quantitative Method
Analytical Sensitivity6 IU/mL
Sample TypeFresh Serum
Prozone EffectNot detected upto 800 IU/mL.
Pack Sizes25 Test
50 Test
100 Test.
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions25 test – 85x105x145 mm.
50 test – 85x105x145 mm.
100 test – 85x105x145 mm.
Approx. weight of kit25 test – 64 gms.
50 test- 86 gms.
100 test – 96 gms.
Supply Capacity600 mn ml per annum

Intended Use:

Test for determination of C-Reactive Protein (CRP) by Immuno Agglutination method.

Introduction:

CRP is an acute-phase protein present in normal serum, which increases significantly after most forms of tissue injuries, bacterial and virus infections, inflammation and malignant neoplasia. During tissue necrosis and inflammation resulting from microbial infections, the CRP concentration can rise up to 300 mg/L in 12-24 hours.

Principle:

The CRP-Latex is a slide agglutination test for the qualitative and semi-quantitative detection of C – Reactive Proteins (CRP) in human serum. Latex particles coated with goat IgG anti-human CRP are agglutinated when mixed with samples containing CRP.

Kit Components

Latex Reagent – 1 Bottle.
Positive Control – 1 Bottle.
Negative Control – 1 Bottle.
Mixing Sticks.
Sample Droppers.
Glass Slide.
Instructions for Use.

Specification

ProcedureQualitative only (Slide Test) and Semi-quatitative method (Slide Test)
Procedure Time2 minutes for Qualitative as well as Semi-Quantitative Method
Analytical Sensitivity5 mg/L
Sample TypeFresh Serum
Prozone EffectNot detected upto 1600 mg/L
Pack Sizes25 Test
50 Test
100 Test.
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions25 test – 85x105x145 mm.
50 test – 85x105x145 mm.
100 test – 85x105x145 mm.
Approx. weight of kit25 test – 64 gms.
50 test- 86 gms.
100 test – 96 gms.
Supply Capacity600 mn ml per annum

CRP Latex

Blood Grouping(3x10 ml)(4x10 ml)(10x10 ml )

Blood Grouping Anti ABD (3x10 ml)

Kit Component (3×10 ml)

Anti ‘A’ Monoclonal- 1 bottle of 10 ml.
Anti ‘B’ Monoclonal- 1 bottle of 10 ml.
Anti ‘D’ Monoclonal (IgG+IgM)- 1 bottle of 10 ml.

Blood Grouping Anti ABD AB (4x10 ml)

Kit Component (4×10 ml )

Anti ‘A’ Monoclonal – 1 bottle of 10 ml.
Anti ‘B’ Monoclonal – 1 bottle of 10 ml.
Anti ‘D’ Monoclonal (IgG+IgM) – 1 bottle of 10 ml.
Anti ‘AB’ Monoclonal – 1 bottle of 10 ml.

Blood Grouping Anti A (10x10 ml )

Kit Component (10×10 ml)

Anti ‘A’ Monoclonal Antibody- 1 bottle of 10 ml for 1×10 ml pack size.
Anti ‘A’ Monoclonal Antibody- 10 bottles of 10 ml for 10×10 ml pack size.
Instructions for Use.

Intended Use:

Test for qualitative detection of ABO antigens on human RBCs by immunoagglutination method.

Introduction:

The mouse monoclonal IgM Anti-A, Anti-B and Anti-AB antibodies are produced “in-vitro” as culture supernatant of selected hybridoma, obtained by the fusion of mouse antibody producing B-lymphocytes with mouse myeloma cells. Monoclonal sera ANTI-A, ANTI-B and ANTI-AB are specific IgM immunoglobulin which are directed against the human red blood cell antigens A, B and AB respectively. Monoclonal sera immunoglobulins are produced from individual cell line hence they are identical in their chemical structure and biological activity. The Rho (D) antigen is found on erythrocytes of approximately 95% of the Indian population. The terms “Rh” positive or “Rh” negative are understood to refer solely to the presence or absence of this antigen accordingly. Anti D (Rho) monoclonal IgM is used for the detection of the presence of Rho antigen on the red blood cells.

 

Specification

ProcedureQualitative only (Slide Test), Semi-quantitative method (Slide Test) as well as Quantitative method (Tube Test)
Procedure Time1 min for qualitative and semi-quantitative method
Sample TypeSerum only
SensitivityUp to 1:320 dilutions in Semi-quantitative and Quantitative test method
Pack Size10×10 ml
3×10 ml
4×10 ml
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions10×10 ml – 160x210x40 mm.
3×10 ml – 85x105x45 mm
4×10 ml – 85x105x45 mm
Supply Capacity600 mn ml per annum

WIDAL ANTIGENS

Widal 2 Antigen (2+2x5 ML)

Kit Components 2+2x5ml

  1. S. typhi ‘O’ Antigen – 2 bottle of 5 ml.
  2. S. typhi ‘H’ Antigen – 2 bottle of 5 ml.
  3. Positive Control – 1 bottle
  4. Glass Slide – 1 Nos
  5. Instructions for Use.

Widal 4 Antigen (4x5 ML)

Kit Components 4x5ml

  1. S. typhi ‘O’ Antigen – 1 bottle of 5 ml.
  2. S. typhi ‘H’ Antigen – 1 bottle of 5 ml.
  3. S. paratyphi ‘AH’ Antigen – 1 bottle of 5 ml.
  4. paratyphi ‘BH’ Antigen – 1 bottle of 5 ml.
  5. Positive Control – 1 bottle
  6. Negative Control – 1 bottle
  7. Glass Slide – 1 Nos
  8. Instructions for Use.

Widal 8 Antigen (8x5 ML)

Kit Components 8x5ml

  1. typhi ‘O’ Antigen – 1 bottle of 5 ml.
  2. typhi ‘H’ Antigen – 1 bottle of 5 ml.
  3. paratyphi ‘AH’ Antigen – 1 bottle of 5 ml.
  4. paratyphi ‘BH’ Antigen – 1 bottle of 5 ml.
  5. paratyphi ‘CH’ Antigen – 1 bottle of 5 ml.
  6. paratyphi ‘AO’ Antigen – 1 bottle of 5 ml.
  7. paratyphi ‘BO’ Antigen – 1 bottle of 5 ml.
  8. paratyphi ‘CO’ Antigen – 1 bottle of 5 ml.

Intended Use:

Test for determination of antibodies against Salmonella antigens by Slide & Tube Test method.

Introduction:

Salmonella typhi & Salmonella paratyphi are the causative agents of “Enteric Fever”. The antigens of typhoid and paratyphoid consist of 2 distinct fractions – the stable somatic ‘O’ antigen and the labile flagellar ‘H’ antigen. The paratyphoid antigens are further classified into ‘A’ and ‘B’ species. In typhoid and paratyphoid, the ‘H’ antigen is type specific whereas the ‘O’ antigen is group specific.

Specification

ProcedureQualitative only (Slide Test), Semi-quantitative method (Slide Test) as well as Quantitative method (Tube Test)
Procedure Time1 min for qualitative and semi-quantitative method
Sample TypeSerum only
SensitivityUp to 1:320 dilutions in Semi-quantitative and Quantitative test method
Pack Sizes2+2×5 ML.
4×5 ML
8×5 ML
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions2+2×5 ml – 85x105x45 mm
4×5 ml – 85x105x45 mm
8x5ml – 85x135x60 mm
Approx. weight of kit2+2×5 ml – 77 gms.
4x5ml- 85x105x45 mm
8x5ml – 192 gms
Supply Capacity600 mn ml per annum

Brucella A+M

Intended Use:

Test for qualitative determination of antibodies against Brucella pathogen in human sera.

Introduction:

Human Brucellosis (Diurnal or undulant fever) is a common febrile illness caused by infection with bacteria of some of the Brucella species (Abortus, Melitensis). This undulant fever is associated with symptoms, which are often variable and non-specific with chills, fever, sweats and anorexia. On exposure the body responds to this antigenic stimulation by producing specific antibodies whose titres rise slowly at early stages and then increases. Specific antibodies to the Brucella species are detectable a few weeks after exposure and are of considerable importance in the diagnosis of Brucellosis. Information regarding the titre of antibodies can be obtained by using specific antigen suspensions.

Method Principle:

The smooth, attenuated stained antigen suspensions are mixed with the patient’s serum. Specific antibodies to Brucella antigens if present in the patient serum will react with the antigen suspension to produce an agglutination reaction. No agglutination indicates the absence of specific antibodies to Brucella antigens.

Kit Components

Brucella Abortus Antigen – 1 bottle of 5 ml.
Brucella Melitensis Antigen – 1 bottle of 5 ml.
Instructions for Use.

Specification

ProcedureQualitative only (Slide Test), Semi-quatitative method (Slide Test) as well as Quantitative method (Tube Test).
Procedur Time1 min for qualitative and semi-quantitative method.
Sample TypeSerum Only
SensitivityUpto 1:320 dilution in Semi-quantitative and Quantitative test method.
Pack Sizes2×5 ml
Storage Temperature2- 80C
Shelf life24 months
Kit dimensions2×5 ml – 85x105x45 mm.
Approx. weight of kit2×5 ml – 77 gms.
Supply Capacity600 mn ml per annum

RPR Carbon Antigen

Intended Use:

Test for determination of RPR (Rapid Plasma Reagins) in human serum by Slide Test method.

Introduction:

Reagins are a group of antibodies against some components of the damage tissues from patients infected by Treponema pallidum, the agent which causes the syphilis. This microorganism produces some damage to the liver and heart, releasing some tissue fragments. Immunological patient system reacts producing reagins, antibodies against these fragments.

Method Principle:

The RPR Syphilis screening test is a macroscopic non-treponemal flocculation card test for detection and to quantify reagin, an antibody like substrate present in serum or plasma and spinal fluid from syphilitic persons.

Kit Components

1 bottle Carbon antigen reagent.
1 bottle Positive Control.
1bottle Negative Control
Mixing sticks.
Sample Dopper.
Sildes.
Instructions for Use.

Specification

ProcedureQualitative (Slide method) and Quantitative (Slide method – Serial Dilution)
Procedur TimeQualitative- 8 mins.
Quantitative- 8 mins
Sample TypeSerum and Plasma
SensitivityUpto 1:256 dilution in quantitative test method
Pack Sizes25 TEST
50 TEST
100 TEST
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions25 test – 85x105x145 mm
50 test – 85x105x145 mm
100 test – 85x105x145 mm
Approx. weight of kit25 test – 9 kgs
50 test – 11 kgs
100 test – 12 kgs
Supply Capacity600 mn ml per annum

ASO Latex

Intended Use:

Test for determination of antibodies against Streptolysin “O” by Immuno Agglutination method.

Introduction:

Streptolysin “O” is a toxic immunogenic exoenzyme produced by haemolytic Streptococci of groups A, C and G. Measuring the ASO antibodies are useful for the diagnostic of rheumatoid fever, acute glomerulonephritis and streptococcal infection. Rheumatic fever is an inflammatory disease affecting connective tissue from several parts of human body as skin, heart, joints etc. and acute glomerulonephritis is a renal infection that affects mainly to renal glomerulus.

Features:

The ASO-Latex is a slide agglutination test for the qualitative and semi-quantitative detection of anti-steptolysin “O” (ASO) antibodies. Latex particles coated with steptolysin “O” are agglutinated when mixed with samples containing ASO.

Kit Components

Latex Reagent – 1 Bottle.
Positive Control – 1 Bottle.
Negative Control – 1 Bottle.
Mixing Sticks.
Sample Droppers.
Glass Slide.
Instructions for Use.

Specification

ProcedureQualitative only (Slide Test) and Semi-quatitative method (Slide Test)
Procedure Time2 minutes for Qualitative as well as Semi-Quantitative Method
Analytical Sensitivity200 IU/mL
Sample TypeFresh Serum
Prozone EffectNot detected upto 1500 IU/mL
Pack Sizes25 Test
50 Test
100 Test.
Kit components1 bottle each for NAP and TAP Diluent.
Substrate vial.
Instructions for Use.
Storage Temperature2- 80C
Shelf life18 months
Kit dimensions25 test – 85x105x145 mm.
50 test – 85x105x145 mm.
100 test – 85x105x145 mm.
Approx. weight of kit12 ml – 66 gms
50 ml – 99 gms
Supply Capacity600 mn ml per annum