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Items tagged with 'result interpretation'

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Rapid Test

Intended Use 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 : 30 months at 2-30°C. Convenient pack size : 10 tests Sensitivity-95% and Specificity- 97%. Principle

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Rapid Test

Intended Use 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-30 months at 2-30°C. WHO Evaluated with 100% Sensitivity.

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Rapid Test

Intended Use The 4th Generation 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 (IgM,IgG & IgA) 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 enzyme immuno assay & 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. Long Shelf life: 15 months at 2-8° C.

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Rapid Test

Intended Use Scrub Typhus (Tsutsugamushi) IgM & IgG Card is a rapid solid phase immuno-chromatographic assay for the qualitative and differential detection of IgM and IgG antibodies to Scrub Typhus antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Rapid ,visual and qualitative Immunoassay. Differential detection of IgM & IgG antiobodies to Scrub Typhus (Tsutsugamushi) in Human Serum / Plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results with in 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 20T & 50T. Sensitivity & Specificity: 100% (In house Evaluation)

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Rapid Test

Intended Use 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 30 months at 4-30° C. Easy to interpret colour bands Results within 20 minutes.

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Rapid Test

Intended Use 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 -30 months, storage at 4-30° C. Results within 20 minutes.

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Rapid Test

Intended Use 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 -30 months, storage at 4-30° C. Results within 20 minutes.

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Rapid Test

Intended Use Scrub Typhus IgM/IgG/IgA Card is a rapid solid phase immuno-chromatographic assay for the qualitative detection of IgM, IgG& IgA antibodies to Scrub Typhus in human serum / plasma / whole blood. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Finger prick, rapid, visual and qualitative Immunoassay. Detection of all antibodies (IgM, IgG, IgA) to Scrub Typhus (Tsutsugamushi) in Whole blood/serum / plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results within 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 25 T. Sensitivity & Specificity: 100%

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Rapid Test

Intended Use HIV Ag & Ab Card (4th Generation) is a visual, rapid qualitative and sensitive solid phase immunochromatographic assay for the differential detection of HIV-1 p24 Antigen and Antibodies (IgM, IgG & IgA) to HIV-1& HIV-2 in Human Serum/ Plasma/ Whole blood (collected by venipuncture or Fingerprick). The test is a screening test for p24 antigen (HIV-1) and HIV antibodies (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. It is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2). The test is for in vitro diagnostic use only and is intended for screening of blood donors or others individuals at risk for HIV-1 and/or HIV-2 infection and for clinical diagnostic testing. Salient Features • Finger prick, rapid, visual and qualitative Immunoassay. • 4TH Generation Rapid test for differential detection of p24 Antigen & antibodies for HIV in serum/plasma /whole blood. • Ideal for Blood screening, detects sero-negative HIV Cases. • Use of gp-41, C terminus of gp120 for HIV-1 , gp-36 for HIV -2 antibodies and Anti-p24 for HIV p24 Ag detection. • Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India. • Based on Immunochromatography Technique. • See through device for easy interpretation of results. • Sensitivity : 100 % & Specificity: 100% • Analytical Sensitivity of HIV p24 Ag : 100 IU/ml (traceable to p24 Antigen NIBSC Standard, U.K. Code No. 90/636) • Long Shelf life 30 months at 2-30°C • Convenient pack size: 25 T.

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