The HIV-1/2 Saliva Antibody Home Test kit is a manually performed, visually read, 20 minute immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 in human oral fluid. The HIV-1/2 Saliva Antibody Home Test kit is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer solution. Each component is sealed in separate compartments of a single pouch to form the test. The HIV-1/2 Saliva Antibody Home Test kit utilizes a proprietary lateral flow immunoassay procedure. The device plastic housing holds an assay test strip comprised of several materials that provide the matrix for the immunochromatography of the specimen and the platform for indication of the test results.

The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the HIV envelope region and a goat anti-human IgG procedural control immobilized onto a nitrocellulose membrane in the Test (T) zone and the Control (C) zone, respectively.An oral fluid specimen is collected using the flat pad on the test device, followed by the insertion of the test device into the vial of developer solution. As the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The intensity of the line color is not directly proportional to the amount of antibody present in the specimen.

Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies to HIV-1 and/or HIV-2 (refer to the Test Result and Interpretation of Test Result section below).

The test results are interpreted after 20 minutes but not more than 40 minutes after the introduction of the test device into the developer solution containing the test specimen. No precision pipeting, predilutions, or specialized instrumentation are required to perform the HIV-1/2 Saliva Antibody Home Test kit.