INTENDED USE

HIV (I+II) Antibody Rapid Test Kit is intended for use by healthcare professionals and qualified laboratory personnel. It is a single use, qualitative lateral flow immunoassay for in vitro detection of antibodies to Human Immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) in whole blood, serum or plasma. The test is intended for use as a screening test to diagnose HIV infection by professional healthcare practitioners. All specimen tested positive with the HIV (I+II) Antibody Rapid Test Kit must be confirmed with alternative testing method(s) such as ELISA or PCR.

SUMMARY

The human immunodeficiency virus type 1 and 2 (HIV 1+2) are enveloped single stranded RNA viruses that cause acquired immunodeficiency syndrome (AIDS). The HIV virus attacks the CD4 cells of the body which help the immune system to fight infections.
Presence of specific HIV-1 and/or HIV-2 virus antibodies in blood, serum, or plasma indicates exposure to the HIV-1 and/or HIV-2 virus, and is of great value in clinical diagnosis. The HIV (I+II) Antibody Rapid Test Kit is a simple, visual, qualitative test that detects these antibodies in whole blood, serum or plasma. Based on immunochromatographic principles the test is cost effective, easy to perform and provides test results within 15 minutes.

PRINCIPLE

HIV (I+II) Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of HIV-1 and HIV-2 specific antibodies. The nitrocellulose membrane is coated with recombinant HIV-1 capture antigens on test line “1” and with recombinant HIV-2 capture antigens on test line “2”. A control agent is immobilised at control line “C”. The test is initiated by adding the specimen (whole blood, serum or plasma) and the supplied buffer to the sample well. The recombinant HIV-1 and HIV-2 antigens conjugated with colloidal gold nanoparticles bind to the HIV-1 and HIV-2 antibodies in the test sample. The conjugated antibody-antigen complex migrates across the nitrocellulose membrane where it attaches to the corresponding HIV-1 and HIV-2 antigens on the test lines. The resultant red lines indicates a positive result. A red line on the control zone will appear on the test kit irrespective of a positive or negative result to indicate the correct performance of the reagents of the test kit.