Dec 2, 2001
The insert that comes with a popular kit to run viral load warns:
"The Amplicor HIV-1 Monitor 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." (Roche 1999)
Then why is it used for these purposes? Aren't people making life decisions based on the results of this test? Why then the disclaimer?
| Response from Dr. Holodniy
The disclaimer is required by the FDA because in fact the test is not approved for diagnosis. I can't answer why people order, and labs are willing to perform the assay for this indication.
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