INTRODUCTION

One Step Anti-HIV 1+2 Test is a rapid direct binding screening test for the presence of antibodies to HIV 1 and HIV 2 viruses. The test is based on the principle of double antigen sandwich immunoassay for detection of Anti-HIV in serum and/or whole blood Purified recombinant antigens are employed to identify Anti-HIV specifically. This one step test is very sensitive and only takes about 10-15 minutes. Test results are read visually without any instrumentation.

SPECIMEN COLLECTION AND STORAGE

For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

For whole blood specimen, collect fresh blood specimen just prior to using the assay. Specimens must be fresh. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

TEST PROCEDURE

1. Do not open foil pouch until ready to begin testing. Refrigerated test devices should be allowed to come to room temperature (15°-28°C) before opening the pouch.

2. Remove the device from the protective pouch and label the device with specimen identification.

3. Add 50 ul( two drops) of fresh blood or 80-100 ul (four drops)of serum to the Sample Well (for Card) or Sample Pad (for Dipstick). For whole blood testing, then add 2 drops (50 ul) of test running buffer into the sample well or sample pad.

4. Read the result within 10-15 minutes. Do not read results after 30 minutes. Observe the colored band developed over the control region indicating the assay is complete.

INTERPRETATION OF RESULTS

Positive: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.

Negative: In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.

Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has deteriorated.

STORAGE AND STABILITY

The test kit can be stored at room temperature (18 to 30°C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use test kit beyond expiry date.

3. The test device should not be reused