Beijing Marr Bio-pharmaceutical Co., Ltd

NAME AND INTENDED USE

The Aware™ HIV-1/2 OMT test is a single-use, qualitative, visually read, in vitro immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human oral mucosal transudate specimens. It is intended for use as a point-of-care aid in the clinical diagnosis of HIV infection. This test may be used as a component of a multi-test rapid algorithm in conjunction with other approved HIV antibody assays.

SUMMARY AND EXPLANATION OF THE TEST

Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex (ARC), and pre-AIDS are thought to be caused by the Human Immunodeficiency Viruses (HIV) Type 1 and Type 2^1-4. Individuals infected with HIV produce antibodies against the HIV viral proteins. Testing for the presence of these antibodies in bodily fluids (e.g., blood, oral fluid, urine) is an accurate aid in the diagnosis of HIV infection^5-10. The Aware™ HIV-1/2 OMT test is a point-of-care test to aid in the diagnosis of infection with HIV-1 or HIV-2.

BIOLOGICAL PRINCIPLES OF THE TEST

The Aware™ HIV-1/2 OMT test is composed of a single-use test device, an oral fluid specimen collection swab, and a tube of Oral Fluid Sample Buffer. The test utilizes a proprietary lateral flow immunoassay procedure. The assay test strip is 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 contains recombinant proteins repre­senting the immunodominant regions of the HIV-1 gp41 and HIV-2 gp36 transmembrane proteins and a goat anti-human IgG F(ab’)₂ fragment antibody- capture procedural control immobilized onto the nitrocellulose membrane in the Test Zone and the Control Zone, respectively.

To perform the assay, an oral fluid specimen collection swab is wiped across the upper and lower gums of the patient, and this swab is then placed in the tube of Oral Fluid Sample Buffer and mixed. The liquid in the swab is expressed out and the used swab is discarded. The assay test strip is then placed vertically into the test tube containing the specimen/buffer mixture. As the diluted specimen migrates up the assay test strip, it rehydrates a reddish Protein A/colloidal gold reagent (“conjugate”) on the strip and IgG in the specimen becomes bound to the Protein A/colloidal gold particles (“IgG/conjugate complex”). The specimen/conjugate mixture continues to migrate up the strip, and first encounters the Test Zone of the assay test strip containing the HIV antigens. If the specimen contains antibodies to HIV, the IgG/conjugate complex binds to the antigen and becomes immobilized at the antigen line in the Test Zone and a reddish colored line

appears. In a validly performed test, this indicates a reactive result. The intensity of the line is not propor­tional to the amount of antibody present in the speci­men. In a validly performed test, the absence of a colored line in the Test Zone indicates that the speci­men does not contain anti-HIV antibodies. The specimen/conjugate mixture continues to migrate up the assay test strip until it encounters the Control Zone. The Control Zone contains goat anti-human IgG F(ab’)₂ fragments immobilized in a line on the assay test strip. The remaining IgG/conjugate complexes become bound to the immobilized F(ab’)₂ fragments and a reddish colored line appears. The appearance of the control line is evidence that the test functioned properly and the sample contained human IgG. A reddish-purple control line will appear in the Control Zone during the performance of all valid tests, whether or not the sample is reactive or negative for antibodies to HIV-1 or 2. The specimen continues to migrate past the Control Zone into the final absorbent pad, which helps draw the specimen/conjugate mixture through the strip and clear any background color.

The test results are interpreted after 20 minutes but not more than 45 minutes after the introduction of the assay test strip to the diluted specimen.

MATERIALS PROVIDED

Each Aware™ HIV-1/2 OMT Test (1 test kit) contains:

1)      One package insert (this document)

2)      1 plastic pouches (test sets) each containing:

•        One (1) foil pouch containing one Oral Fluid Test Strip and one desiccant

•        One (1) capped test tube containing Oral Fluid Sample Buffer (1 mL)

•        One (1) Oral Fluid Sample Collection Swab

Also available separately is the Aware™ HIV-1/2 OMT Control Kit, Cat.

MATERIALS REQUIRED BUT NOT PROVIDED

•        20-45 minute timer or watch

•        Disposable gloves

•        Disposal container

WARNINGS AND PRECAUTIONS

For in vitro diagnostic use. Read the package insert completely before using the product. Follow the instructions carefully. Failure to follow instructions may result in inaccurate test results.