The Amplicor HIV-1 Monitor Test
Jul 15, 2001
Why does Roche Diagnostic Systems, the designer of the Viral Load Test Kit, have the following disclaimer on their product?: "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." Aren't treatment decisions largely based on viral load numbers?
Response from Dr. Holodniy
The key to your question is "treatment decisions". This implies people are HIV antibody positive, with detectable viral loads, and require treatment for their HIV infection. That is what Roche has US FDA approval for, not diagnosis of HIV infection.
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