NAME

HIV-1/2 Gold Rapid Screen Test - WB/S/P

INTENDED USE

The HIV-1/2 Rapid Screen Test (RST) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human serum/plasma and whole blood. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

PRECAUTION

1. For in vitro diagnostic uses only.
2. All patient samples should be treated as if capable of transmitting diseases.
3. Do not use test kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

SUMMARY AND EXPLANATION OF THE TEST

It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and HIV-2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high-risk persons for AIDS. HIV-1 and HIV-2 viruses delete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 Rapid Screen Test is designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in serum specimens.

PRINCIPLE

HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma and whole blood. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

MATERIALS SUPPLIED

1.     One pouched cassette with desiccant.

1. Blood diluents in a dropper bottle, stored at 4-30°C.
2. One piece of operating instruction.

MATERIALS NOT PROVIDED BUT REQUIRED

1. Specimen collection container, either plastic or class.
2. Timer.
3. Disposable gloves.