RAPID HIV I&II TEST

For the qualitative assessment of HIV I&II antibody in human serum, plasma and whole blood.

INTENDED USE:

Rapid HIV 1&II test is a single use, rapid device intended for qualitative detection of antibodies to Human   Immunodeficiency Viruses or HIV(1+2) in whole blood samples. It is intended for use in medical institution as the aid for the diagnosis of possible HIV infection and for the quick screening of blood donors and blood products.

SPECIFICATION:

1)        Specimen: whole blood/serum/plasma

2)        Format: strip/cassette

3)        Sensitivity: 99.6%

4)        Specificity: 99.9%

FEATURE:

1)        Simple: simply add specimen and dilution(if necessary) into sample well

2)        Rapid: results come out at 30 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING

1)        Strip: 100 tests/box

2)        Cassette: 25 tests/box, 50 tests/box

ASSAY PROCEDURE:

1)        Bring all materials and specimens to room temperature.

2)        Remove the test card from the sealed foil pouch.

3)        Use micropipetter to transfer 100 - 150 mL of sample, or place the transfer pipette supplied with the device in the specimen and depress the bulb to withdraw a sample.

4)        Hold the pipette in a vertical position over the sample well of the test card and deliver 2-3 drops(100-150 mL) of sample into the sample well.

5)        Read the result at 30 minutes.

PRINCIPLE:

This test employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 gp120, gp41 and HIV-2 gp-36 are dry-immobilized at the end of nitrocellulose membrane strip. HIV 1+2 antigens are bond at the Test Zone (T) and rabbit anti-HIV 1+2 monoclonal antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HIV 1/2 antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HIV 1+2 antigens generating a visible red line. If there are no HIV 1 or 2 antibodies in sample, no red line is formed in the Test Zone (T).The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1+2 antibodies aggregating in a red line, which indicates the validity of the test.