INTENDED USE

The HIV-1/2 Rapid Screen Test is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human 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.

PRINCIPLE

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.

 

HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human 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, a red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

STORAGE

The kits should be stored at temperature 4-28°C， the sealed pouch for the duration of the shelf life (24months).

SPECIMEN COLLECTION

Fingerstick Specimens(Whole Blood)

1. Clean the area to be lanced with an alcohol swab.

2. Squeeze the end of the fingertip and pierce it with a sterile lancet.

3. Wipe away the first drop of blood with sterile gauze or cotton.

4. Use micropipet to obtain about  100 ul fresh blood and add into sample well.

Plasma

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2. Separate the plasma by centrifugation.

3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2. Allow the blood to clot.

3. Separate the serum by centrifugation.

4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

PROCAUTION

1. FOR IN VITRO DIAGNOSTIC USES ONLY

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond

expiration date.

4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

 

REAGENTS AND MATERIALS PROVIDED

1.  One pouched cassette with desiccant.

2. Blood diluent in a dropper bottle, stored at 2-8°C.

3. One piece of operating instruction.

 

PROCEDURE

Add 20ul of serum/plasma and whole blood into sample well, after all blood completely absorbed., add 1 drop(50ul) of whole blood diluent. Observe the result in 5-30 minutes.

 

INTERPRETATION OF RESULTS

Negative: No apparent band in the test region (T), Only one red band appears in the control region (C). This indicates that no HIV1/2 antibodies have been detected.

Positive: In addition to one red band in the control region (C), a red band will appear in the test region (T). This indicates that the specimen contains HIV1/2 antibodies.

Invalid:No apparent band in the control region(C), this indicates a possible error in performing the test. The test should be repeated using a new device. 

LIMITATIONS

1. The test is to be used for the qualitative detection of antibodies to HIV.

2. A negative result does not rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quality to be detected at early stage of infection.

 

PERFORMANCE CHARACTERISTICS

 

A. Comparative Study

This RST was compared to another conventional ELISA for detection of antibodies to HIV. A total of 148 sera were tested by two procedures. The results are summarized in table 1 below:

 

Table1

Reference ELISA	RST for  HIV
	Positive	Negative
Positive	31	0
Negative	1	116

                 

Relative Sensitivity=100%;    Relative Specificity=99.2%

 

B. Cross Reactivity

10 specimens, which were IgG antibody positive to HBsAg; 15specimens which were antibody positive to HCV; 11 specimens which were RF positive; 9 specimens which were antibody positive to syphilis by conventional diagnostic kit, were tested negative by this RST.