J.Mitra & Co. Pvt. Ltd

Okhla, Delhi

Diagnostic test kits, The HIV TRI-DOT test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgG) in human serum or plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for Anti HIV-1 and HIV-2 and is for in vitro diagnostic use only.Rapid visual test , based on Flow Through Technology.Differential detection of HIV-1 & HIV-2.Detection of group O & subtype C.Use of envelop antigens gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2.

The DIAGNOS HIV BI-DOT Test is a visual, rapid, sensitive and accurate immunoassay for the detection of HIV-1 & HIV-2 antibodies (IgG) in human serum or plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane.The test is a screening test for Anti HIV-1 and HIV-2 and is for in vitro diagnostic use only.

SALIENT FEATURES

• Rapid visual test , based on Flow Through Technology.
• Detection of group O & subtype C strain of HIV-1 prevalent in Asian subcontinent.
• Use of Envelope antigen; gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2.
• Shelf life 15 months at 2-8C.
• Results within 3 minutes.
• No instrument required.
• In built quality control dot.

HIV antigens are immobilized on a porous immunofiltration membrane. Sample and reagents pass through the membrane and are absorbed into the underlying absorbent. As the patient's sample passes through the membrane , HIV antibodies, if present, bind to the immoobilized antigens. Conjugate binds to the Fc portion of antibodies to give distinct pinkish purple DOT against a white background.

EVALUATIONS

• NARI PUNE:Performance of the test has been determined by National Aids Research Institute(NARI), Pune.The result are as follows:Sensitivity - 100 % and Specificity - 100 %
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

The HIV TRI-DOT test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgG) in human serum or plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for Anti HIV-1 and HIV-2 and is for in vitro diagnostic use only.

SALIENT FEATURES

• Rapid visual test , based on Flow Through Technology.
• Differential detection of HIV-1 & HIV-2.
• Detection of group O & subtype C.
• Use of envelop antigens gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2.
• 100% sensitivity & 100% specificity as per WHO Evaluation.
• Shelf life 15 months at 2-8C
• Available in convenient pack sizes-10 Tests, 50 Tests and 100 Tests.
• Results within 3 minutes.
• No instrument required.
• In built quality control dot.

HIV antigens are immobilized on a porous immunofiltration membrane. Sample and reagents pass through the membrane and are absorbed into the underlying absorbent. As the patients sample passes through the membrane, HIV antibodies, if present, bind to the immobilized antigens. Conjugate binds to the Fc portion of the HIV antibodies to give distinct pinkish purple DOT(s) against a white background.

EVALUATIONS

• WHO EVALUATION:Evaluation report from UNAIDS (WHO), CH-1211Geneva, Switzerland Aug 1999 the Sensitivity and Specificity of HIV TRI-DOT is 100 % .The panel used for evaluation of HIV TRI-DOT by Institute of Tropical Medicine, WHO Collaborating Centre in AIDS, Belgium also included HIV-O virus, which was found reactive with HIV TRI-DOT.
• NIMHANS BANGALORE:Evaluation report from National HIV Reference Laboratories of Government of India , claiming Sensitivity and Specificity of HIV TRI-DOT to be 100 %.
• CMC VELLORE:Evaluated by Department of Clinical Virology, Christian Medical College & Hospital, Vellore and published in JCM, vol. 38, Issue 2000, claiming 99.5% sensitivity and 99.9% specificity.
• NARI PUNE:Evaluation Report from National AIDS Research Institute(NARI-Pune) claiming sensitivity & Specificity to be 100 %.
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

The 4th Generation HCV TRI-DOT is a rapid, visual, sensitive and qualitative in vitro diagnostic test for the detection of antibodies to Hepatitis C virus in human serum or plasma.

It has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigen.

SALIENT FEATURES

• Based on Flow Through Technology, which is similar to Elisa technology because of involvement of washing steps at various levels to enhance the specificity.
• Use of highly purified HCV antigens for Core, NS3, NS4, NS5 immobilized on the device.
• Detection of all the subtypes of HCV.
• Results within 3 minutes.
• In built quality control dot which validates the test.
• 100% Sensitivity & 98.9% Specificity as per WHO evaluation.
• Shelf life : 15 months at 2-8C

HCV antigens are immobilized on a porous immunofiltration membrane. Sample and the reagents pass through the membrane and are absorbed into the underlying absorbent pad.

As the patient's sample passes through the membrane, HCV antibodies if present in serum/plasma, bind to the immobilized antigens. In the subsequent washing step, unbound serum/ plasma proteins are removed.

In the next step, the protein-A conjugate is added which binds to the Fc portion of the HCV antibodies to give distinct pinkish purple dot against a white background at the test region ("T1" &/or "T2"). At the control region ("C") a "Built-in Quality Control Dot" has been devised to confirm the proper functioning of the device, reagent and correct procedural application.

EVALUATIONS

• WHO EVALUATION:The kit has been evaluated by WHO Collaborating Centres by using various panels from Latin America , Asia, Europe &, African origin along with various sero -conversion panels from BBI including World wide performance panel and anti- HCV low titer performance panel. The Evaluation indicated the following results- Sensitivity 100% & Specificity 98.9%.
• PATH USA:Evaluated by PATH USA, (199 reference specimens from US, Indonesia & India) indicated Sensitivity of 100 % & Specificity of 99.2 %.
• AIIMS NEW DELHI:An evaluation by Department of Microbiology, All India Institute of Medical Sciences (AIIMS) New Delhi, INDIA (A national reference centre of Government of India) has indicated its Sensitivity 100% and Specificity 100%.
• CMC VELLORE:An Evaluation by CMC Vellore (on reference panel of 100 Samples indicated Sensitivity 100 % & Specificity 100 %.
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

The 4thGeneration HIV TRI-DOT + Ag test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 p24 antigen and HIV-1 & HIV-2 antibodies (IgG) in Human Serum or Plasma. The test is a screening test for p24 antigen (HIV-1), anti-HIV-1 & anti-HIV-2 and is for in vitro diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2 infection and for clinical diagnostic testing.

SALIENT FEATURES

• Rapid visual test , based on Flow Through Technology.
• Rapid test for simultaneous and differential detection of p24 Antigen & antibodies for HIV on the same device.
• Ideal for Blood screening: detects sero-negative HIV Cases.
• Use of gp-41, C terminus of gp120 for HIV-1 antibodies & gp-36 for HIV -2 antibodies.
• Detection of Group 0 & subtype C of HIV-1, which is most prevalent in India.
• Unique washing steps for clear Interpretation of Results.
• Evaluated by National Institute of Biologicals- 100 % Sensitivity & 100 % Specificity.

Advantage Typhi IgM & IgG Card is a rapid solid phase immuno-chromatographic test for the qualitative differential and simultaneous detection of salnonella typhi (S. typhi) IgM and IgG antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of typhoid infection and in the determination of recent and past infection.

SALIENT FEATURES

• Rapid qualitative test for differential detection of Salmonella typhi (S.typhi) IgM and IgG Antibodies in Human Serum / Plasma
• Determination of both recent and past infection
• Results within 20 minutes
• Bio-hazard free, fully covered, see-through Device
• Simple & Easy to use Test Procedure
• No Instruments required
• Long Shelf Life: 18 months at 2-30C
• Convenient Packsize: 10 Tests & 50 Tests

Advantage Typhi IgM & IgG Card is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibody (test line M) and anti-human IgG (test line G) immobilised on a nitrocellulose strip. The conjugate contains colloidal gold conjugated to S. typhi antigen. When a specimen followed by assay buffer is added to the sample well S. Typhi specific IgM &/or IgG antibodies if present, will bind to S. Typhi antigen gold conjugate making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anit-human IgG) the complex is trapped forming a purplish pink band which confirm a reactive test result. Absence of a coloured band in the test region indicates a non reactive test result. A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

PERFORMANCE CHARACTERISTICS

The kit has been evaluated with the known panel of fresh as well as frozen S. typhi IgM & IgG antibody positive and negative samples and results are compared with licensced commercially available test. The samples included cross-reacting samples; Rheumatoid factor, anti-nucleur antibodies etc. Following is the in-house evaluation:

Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serumplasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection.First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies.Diagnosis of both Primary & Secondary Infection.

Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection.

SALIENT FEATURES

• First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies.
• Diagnosis of both Primary & Secondary Infection.
• Detects all 4 serotypes of Dengue virus
• Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
• Highly Sensitive & Highly Specific
• Long shelf life: 24 months at 2-30C.
• Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.

Dengue Day 1 test kit consists of two devices: one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/IgG antibodies in Human serum/plasma. Dengue NS1 Antigen device contains two lines; 'C' (Control line) & "T" (Dengue NS1 Antigen test line). Test line is coated with anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at T as antibody-antigen-antibody gold colloid forms. Dengue IgM/IgG test device contains three lines; "C" (Control line), "M"(IgM test line) & "G"(IgG test line).IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG. When a sample is added to the device, IgG and IgM antibodies in the sample react with anti-human IgM or IgG antibodies coated on the membrane respectively. Colloidal gold complexes containing dengue 1-4 antigens is captured by the bound anti-dengue IgM or IgG on respective test bands located in the test window causing a pale to dark red band to form at the IgG or IgM region of the test device window. The intensity of the test bands in the respective device will vary depending upon the amount of antigen /antibody present in the sample. The appearance of any pink/ red colour in a specific test region should be considered as positive for that particular antigen and/or antibody type (IgG or IgM). A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

Advantage Leptospira IgM & IgG card is visual, rapid, sensitive and qualitative immunoassay for the detection of Leptospira specific IgM & IgG antibodies in human serum or plasma.

SALIENT FEATURES

• Rapid qualitative test for differential detection of Leptospira specific IgM and IgG Antibodies in Human serum/plasma.
• One step test procedure, add sample & read results
• Infection free see through device.
• Results with in 20 minutes.
• Shelf life of 18 months at 2-30C.
• Excellent Sensitivity- 99 % and Excellent Specificity- 99.5%

Advantage Leptospira IgM & IgG card test is based on Immunochromatographic assay principle. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the conjugate. If the sample contains Leptospira specific IgM and/or IgG antibodies, it forms a complex with the conjugate. The complex then migrates through the nitrocellulose membrane by capillary action. When the complex meets the immobilized antibodies (Test line M & G), it generates a red line, indicating that the sample is reactive. To serve as a procedural control, an additional control line C has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a red line at the control region upon contact with the conjugate.

Advantage Chikungunya IgM Card is a visual, rapid, sensitive, qualitative immunoassay for the detection of Chikungunya specific IgM antibodies in human serum or plasma.

SALIENT FEATURES

• Based on Sandwich Immunoassay principle.
• One step test procedure.
• Results within 15 minutes.
• Bio hazard free, fully covered, see through device.
• No Instruments required.
• Excellent Sensitivity & Specificity.
• Long Shelf life: 18 months at 2-30 C.
• Convenient pack size:10 Tests, 25 Tests & 30 Tests

Advantage Chikungunya IgM Card is a one step Immunochromatographic assay based on sandwich principle. The test sample is introduced which flows laterally through an absorbent pad where it mixes with the conjugate. If the sample contains Chikungunya specific IgM antibodies, it forms a complex with the conjugate. The complex then migrates through the nitrocellulose membrane by capillary action. When the complex meets the line of immobilized capture reagents (Test Line T), it generates a pink purple line, indicating that the sample is reactive .To serve as a procedural control, an additional control line C has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a pinkish-purple line at the control region upon contact with the conjugate.

Hiv test kit, 4TH GENERATION MICROLISA HIV Ag & Ab is an in- vitro qualitative enzyme immunoassay for the detection of antibodies to HIV-1 andor HIV-2 and HIV-1 p24 antigen in human serum or plasma. It is intended for screening of blood donors or other individuals at risk for HIV-1 andor HIV-2 infection and for clinical diagnostic testing.Use of Envelope Antigens gp41, C terminus of gp120 for HIV-1 and gp36 for HIV-2 & simultaneously detection of p24 antigen with p24 monoclonal antibodies

HEPACARD is visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human serum or plasma.The assay is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus(HBV).

SALIENT FEATURES

• Detects all the 11 subtype of HBsAg.
• Antigen Sensitivity- 0.5 ng/ml.
• No sample preparation required.
• See through Device for easy result interpretation.
• Shelf life-18 months at 2-8C.
• 100% Sensitivity & 99.4% Specificity by WHO Evaluation.

HEPACARD is a one step immunoassay based on the antigen capture, or "sandwich" principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line.The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the signal reagent.If the sample contains HBsAg, the collodial gold-antibody conjugate binds to the antigen, forming an antigen-antibody-collodial gold complex. The complex then migrates through the nitrocellulose strip by capillary action. When the complex meets the line of immobilized antibody(Test line) "T", the complex is trapped forming an antibody-antigen-antibody colldial gold complex. This forms a pink band indicating the sample is reactive for HBsAg. To serve as a procedural control, an additional line of anti-mouse antibody (Control line) "C", has been immobilized at a distance from the test line on the strip.If the test is performed correctly, this will result in the formation of a pink band upon contact with the conjugate.

EVALUATIONS

• WHO EVALUATION:Sensitivity 100% and Specificity 99.4% .
• PATH USA:Sensitivity 100% and Specificity 100% .
• DEPT. OF CLINICAL VIROLOGY, CMC VELLORE:In this evaluation of 90 samples the Sensitivity obtained was 100% and Specificity 100% .
• University of Madras:In this evaluation the Sensitivity obtained was 100% and Specificity 100% .
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

Advantage Dengue NS1 Ag card is a rapid solid phase Immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen in Human serum /Plasma.This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue Infection.

SALIENT FEATURES

• Rapid test based on lateral flow technique.
• Detection of Dengue in the seronegative stage i.e. from Day 1 of fever.
• Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
• Results with in 20 minutes
• Longer shelf life : 24 months at 2-30C.
• Convenient pack size : 25 tests
• Evaluated by Haffkines Institute Mumbai-
• Sensitivity-93% and Specificity- 99%

Advantage Dengue NS1 Ag card test is based on immunochromatographic test principle for the detection of Dengue NS1 antigen. When a sample is added to the device, Dengue NS1 Antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at T as antibody-antigen-antibody gold colloid forms.

The intensity of the test bands in the device will vary depending upon the amount of antigen present in the sample. The appreance of any pink. red colour in a specific test region should be considered as positive for that particular antigen. A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

ADVANTAGE MALARIA CARD is a visual, rapid and sensitive immunoassay for the qualitative differential detection of P.falciparum (HRP-2) and P.vivax (pLDH) malaria antigen in human blood only.Rapid, visual antigen based test for detecting infection with P.falciparum (HRP-2) & P.vivax (pLDH) malaria parasite in whole blood. See through Device for easy result interpretation.

ADVANTAGE MAL CARD is a visual, rapid and sensitive immunoassay for the qualitative diagnosis of P.falciparum and other Plasmodium Species (P.vivax/ P.malariae/ P.ovale/ P.falciparum) based on pLDH antigen in human whole blood.

SALIENT FEATURES

• Infection free- See through Device based on pLDH antigen Malaria parasite in whole blood
• Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
• Longer shelf life of 24 months at 4-30 C.
• Easy to interpret Colour Bands
• Results within 20 minutes.

ADVANTAGE MAL CARD is an immunoassay based on the Sandwich principle .The conjugate contains colloidal gold conjugated to monoclonal anti-pan specific pLDH (plasmodium lactate dehydrogenase) antibody. The test uses monoclonal anti-Pf pLDH antibody (test line F) & monoclonal anti-Pan specific pLDH antibody (test line P) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P.falciparum or P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the P.f specific pLDH/Pan specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

ADVANTAGE MALARIA CARD is a visual, rapid and sensitive immunoassay for the qualitative differential detection of P.falciparum (HRP-2) and P.vivax (pLDH) malaria antigen in human blood only.

SALIENT FEATURES

• Rapid, visual antigen based test for detecting infection with P.falciparum (HRP-2) & P.vivax (pLDH) malaria parasite in whole blood.
• Excellent Sensitivity & Specificity.
• See through Device for easy result interpretation.
• Longer shelf life of 24 months at 4-30 C.
• Easy to interpret colour bands
• Results within 20 minutes.

ADVANTAGE MALARIA CARD is an immunoassay based on the "Sandwich principle". Colloidal gold is conjugated to P.f. specific monoclonal anti-HRP-2 antibody and monoclonal anti-pan specific pLDH (plasmodium lactate dehydrogenase) antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) & monoclonal anti-P.v specific pLDH antibody (test line V) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P.falciparum or P.vivax or both, the colloidal gold conjugate complexes the HRP-2 / P.vivax specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

PRECISION:Within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative, a low positive and a strong positive. The C.V (%) of negative, low positive and strong positive values were within 10% of the time.

PERFORMANCE EVALUATION

All India Institute of Medical Sciences New Delhi.

AIIMS-New Delhi-As per evaluation at AIIMS with 200 fresh blood samples from random donors with known positive samples indicated 100 % sensitivity for both P.falciparum & P. vivax and 100 % specificity.

ADVANTAGE PAN MALARIA CARD is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of all four Plasmodium Species (P.falciparum/P.vivax/P.malariae/P.ovale) based on pLDH antigen in human whole blood only.

SALIENT FEATURES

• Detects infection with Plasmodium species(P.falciparum/P.vivax/P.malariae/P.ovale)
• Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
• See through Device for easy result interpretation.
• Longer shelf life -24 months, storage at 4-30 C.
• Results within 20 minutes.

ADVANTAGE PAN MALARIA CARD is an immunoassay based on the Sandwich principle. The method uses monoclonal anti-pan specific pLDH(plasmodium lactate dehydrogenase) antibody conjugated to colloidal gold and another monoclonal anti-pan specific pLDH antibody immobilized on a nitrocellulose strip in a thin line. The test sample is added in the sample well A, followed by addition of Assay buffer in Buffer well B. If the sample contains P.falciparum/P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the Pan specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result.Absence of a colored band in the test region indicates a non-reactive test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

PRECISION:Within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative. a low positive and a strong positive.The negative, low positive and strong positive results were correctly identified COV (%) of negative, low positive and strong positive values were with in 10 % of the time.

ADVANTAGE P.f MALARIA CARD is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of P.falciparum(P.f) specific Histidine-rich protein-(P.f. HRP-2) in human whole blood only.

SALIENT FEATURES

• Rapid visual antigen based test for detecting infection with P.falciparum (HRP-2) malaria parasite in whole blood.
• Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
• Sensitivity of 50 -100 parasites per l of blood.
• See through Device for easy result interpretation.
• Longer shelf life -24 months, storage at 4-30 C.
• Results within 20 minutes

ADVANTAGE P.f MALARIA CARD is an immunoassay based on the "Sandwich principle" . Colloidal gold is conjugated to monoclonal anti- Pf specific HRP-2 antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed.If the sample contains P.falciparum the colloidal gold conjugate complexes the Pf specific HRP-2 in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

PRECISION:Within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative. a low positive and a strong positive. The negative, low positive and strong positive results were correctly identified 100 % of the time.

ADVANTAGE MALARIA PAN +Pf CARD is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of infection with P.falciparum and other Plasmodium species (P.falciparum/P.vivax/P.malariae/P.ovale) in human whole blood only.

SALIENT FEATURES

• Detects P.f. (HRP-2) and PAN(pLDH)
• Individually pouched Single tests- Practical & Safe
• Infection free- See through Device
• Easy to perform test
• Easy to interpret Colour bands
• Results within 20 minutes
• Sensitivity of 100% & Specificity of 99.80%
• Longer shelf life -24 months, storage at 4-30 C

ADVANTAGE MALARIA PAN +Pf CARD is an immunoassay based on the "Sandwich principle. The conjugate contains colloidal gold conjugated to Pf specific monoclonal anti- HRP-2 antibody and monoclonal anti-pan specific pLDH antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) & monoclonal anti-pan specific pLDH antibody (test line P) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P.falciparum or P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the Pf specific HRP-2/ Pan specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

PRECISION:Within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative. a low positive and a strong positive. The C.V(%) of negative, low positive and strong positive values were within 100 % of the time.

Diagnos Dengue card is a rapid solid phase Immuno-chromatographic test for the qualitative differential detection of IgM and IgG antibodies to dengue virus in Human serum /Plasma. This test is for in vitro diagnostic use only and is intended as an aid in for presumptive diagnosis between primary and secondary dengue infection.

SALIENT FEATURES

• Rapid, visual and qualitative Immunoassay.
• Differential detection of IgM & IgG Antibodies.
• Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
• See through device for easy interpretation of results.
• Unique sample processing method ensures highest accuracy in results.
• Results with in 20 minutes.
• Longer shelf life : 24 months at 2-30C.
• Convenient pack size : 10 tests
• Evaluated by Haffkines Institute Mumbai-
• Sensitivity-91% and Specificity- 98%.

Diagnos Dengue card test is based on immunochromatographic test principle for the differential detection of Dengue IgM/IgG antibodies.

Dengue IgM/IgG test device contains three lines; C (Control line), M(IgM test line) & G(IgG test line).IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG.When a sample is added to the device, IgG and IgM antibodies in the sample react with red particles coated with Dengue proteins. As this sample/particle mixture migrates along the length of the test, the anti-dengue IgG or IgM antibody particle complex is captured by the relevant IgG and /or IgM test bands located in the test device window causing a pale to dark red band to form at the IgG or IgM Region of the test device window. The intensity of the test bands in the device will vary depending upon the amount of antigen /antibody present in the sample. The appreance of any pink/ red colour in a specific test region should be considered as positive for that particular antigen and/or antibody type (IgG or IgM). A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

Within-run(Intra assay) and between-run (Interassay) precisions have been determined by testing 10 replicates of five specimens: one negative. Two dengue IgM positive and Two Dengue IgG positive. The C.V (%) of all the five samples were within 10 % of the time.