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Can you explain why?

May 11, 2007

Why are there disclaimers on all HIV test kits? Can you explain?

"The AMPLICOR HIV-1 MONITOR [Viral Load] test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection,"

"Do not use this kit as the sole basis of diagnosis of HIV-1 infection" (Abbott Laboratories HIV Test, Roche Viral Load Test and Epitope, Inc. Western Blot Test,

Positive test results can occur due to "prior pregnancy, blood transfusions...and other potential nonspecific reactions" (Vironostika HIV Test, 2003).

Response from Dr. Frascino


There are disclaimers on HIV test kits because these tests have limitations. I'll quickly run through the ones you list.

1. The Amplicor HIV-1 Monitor is a viral load test. As I have frequently noted in this forum, viral load tests are not recommended for HIV diagnostic screening because of the rate of false-positive results. The disclaimer just corroborates this recommendation. Viral load tests are not diagnostic tests to confirm or rule out the presence of HIV infection!

2. The Abbott HIV test is an antibody test. It should not "solely" be used to diagnose HIV infection because all screening antibody tests require a confirmatory, more sensitive test, such as a Western Blot before a diagnosis of HIV positive can be made.

3. The Roche viral load test. See #1 above.

4. The Western Blot test should not be used as the sole basis for diagnosis of HIV-1 infection because it is used only as a confirmatory test and requires an initial positive HIV ELISA test.

5. The Vironostika HIV test, like all HIV antibody tests, can have false-positive results due to a variety of causes, including the ones listed.

You can read more about HIV tests and their limitations in the archives. The disclaimers as stated are accurate.

Dr. Bob

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