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What is the OraQuick® ADVANCE Rapid
HIV-1 / HIV-2 Antibody Test and how is it done?

The OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test is used to see if a sample of your oral fluid or blood contains HIV antibodies. If you decide to have an OraQuick® ADVANCE test, your healthcare provider will collect an oral fluid sample or take a small droplet of blood from your finger, or draw blood from your vein, run the test, and give the results to you during the same visit. The OraQuick® ADVANCE test is very accurate. However, additional testing is necessary to confirm a preliminary positive result. Complete information about the OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test device is available from your testing counselor or healthcare provider. You will get your results in 20 minutes and no blood has to be collected, only a swipe of your mouth to obtain oral fluid. Please do not eat or drink or take anything by mouth 1 hour prior to being tested. We have you do this to ensure test accuracy.

What The CDC Says About OraQuick ADVANCE:  Link

How well does the test work?

In the clinical studies by the manufacturer, OraQuick ADVANCE correctly identified 99.3% of people who were infected with HIV-1 (sensitivity) and 99.8% of people who were not infected with HIV-1 (specificity). FDA expects clinical laboratories to obtain similar results.

What are the limitations of the test?  
Does this test always give a correct result?

The limitations of this test are similar to the limitations of other HIV antibody tests, including:

• False Positives: Although very few were found in the clinical trial, a statistical analysis of the data indicates that a very small number of people who are not infected with HIV-1/2 will have reactive test results. As the test is used in broad outreach settings, it is expected that false positives may be seen and therefore, reactive results should not be considered definitive until confirmatory testing has been completed.

  False Negatives: A small number of people who are infected with HIV-1/2 will have negative test results. See the above “How well does test work?” It is very unlikely to give a false negative. Also see “Delayed detection of exposure”.

  Delayed detection of exposure: This test will not detect HIV-1/2 infection in people who were exposed within approximately three months prior to taking the test (since it can take that long for detectable HIV-1 antibodies to appear in the blood). Nearly everyone who is infected with HIV (99%) will have antibodies detected by 3 months after infection. At 3-6 weeks 85% will have a detectable amount of antibodies after 3 months more then 99% will.

  Follow-up testing: A reactive result is interpreted as preliminarily positive for HIV-1/2 infection. Individuals with reactive test results should have follow-up testing using another method to confirm the initial test result.

For these reasons, all individuals taking this test must receive counseling both before being tested and after receiving their test results. This counseling is included in our service and done by our licensed personnel.

What type of counseling is done for rapid HIV tests?

Counseling for rapid HIV tests includes:

• Information about the importance of HIV testing
• Ways to reduce the risk of becoming infected with HIV
• Next steps for people who have a reactive test result
• Need for additional testing in people who have had a recent exposure to HIV.

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