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immunoassayReagents

INTENDED USE The Finecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative and semi-quantitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen. The 2019-nCoV RBD antibodies are protective antibody produced by the human body after inoculation with 2019-nCoV vaccine or infection with 2019-nCoV. The test is intended as an aid to assess the adaptive humoral immune response to the 2019-nCoV RBD protein. STORAGE AND STABILITY 1. Store at 4~30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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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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