HIV (1&2) Rapid Human Oral Mucosal Transudate Test

Principle of Inspection

The HIV (1&2) Rapid Human Oral Mucosal Transudate Test is an immunochromatographic test for the antibodies to HIV- 1 and HIV-2. The test device is consisting of a Conjugate Pad containing HIV-1 and HIV-2 recombinant antigen-colloidal gold and rabbit IgG antibody-colloidal gold, and a nitrocellulose membrane with an immobilized mixture of recombinant HIV-1 and HIV-2 antigens in the Test Area, and Goat-anti-rabbit IgG antibody in the Control Area. The extracted specimen (oral mucosal transudate) is applied to the Sample Pad and migrated by capillary action through the Conjugate Pad and then through the nitrocellulose membrane.

If antibodies to HIV-1 and/or HIV-2 are present in the specimen, the antibodies bind to recombinant HIV-1 and/or HIV-2 antigen-colloidal gold conjugates from the Conjugate Pad. The complex migrates through the solid phase by capillary action until it is captured by immobilized HIV-1 and HIV-2 recombinant antigen at the Test Area (labeled “T”) and forms a single purplish/red “T” line. If antibodies to HIV-1 and HIV-2 are absent or are below the detection limit of the test, no purplish/red “T” line is formed.

To ensure assay validity, a procedural “Control” line (labeled “C”) containing Goat-anti-rabbit IgG antibody is incorporated in the nitrocellulose membrane. A purplish/red “C” line will always be presented regardless of whether antibodies to HIV-1 and/or HIV-2 are present in the specimen or not. It is the standard to determine whether there are enough samples and whether the chromatography process is normal. If the “C” line does not appear, indicating the test result is meaningless, this sample must be re-tested.

Specification packaging

1 Tests/Kit.