HCV and HBsAg and HIV 3 in 1 Rapid Test

Intended Use

HCV and HBsAg and HIV 3 in 1 Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of anti-HCV antibodies, HBsAg, and anti-HIV antibodies in human whole blood, serum or plasma specimens. HCV and HBsAg and HIV 3 in 1 Rapid Test is intended for use as an aid in the diagnosis of HCV, HBV and HIV infections.

Principle

The HCV-HBsAg-HIV 3 in 1 Rapid Test Device detects anti-HCV antibodies, HBsAg, and anti-HIV antibodies through visual interpretation of color development on the internal strip. Recombinant HCV antigen, anti-HBsAg antibody, and recombinant HIV antigen are immobilized in the test region of HCV, HBsAg and HIV respectively on the membrane.

During testing, the specimen and then buffer reacts with mixture of recombinant HCV antigen conjugate, anti-HBsAg antibody conjugate and recombinant HIV antigen conjugate precoated onto the sample pad of the assay. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough target antigen or antibody in the specimen, a colored band will form at the each test region on the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Precautions

● This test has been authorized only for the presence of HBsAg and antibodies against HCV or HIV, and not for any other viruses or pathogens.

● Store the HCV/HBsAg/HIV 3 in 1 Rapid Test Device at 2-30℃ when not in use.

● Kit contents are stable until the expiration dates marked on their outer packaging and containers.

● Only clear, non-hemolyzed specimens are recommended for use with this test.  Serum or plasma should be separated as soon as possible to avoid hemolysis.

Test Procedure

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