Dec 8, 1998
Dr. Why are bDNA (2.0) tests are not FDA approved and do you know, whether there are any cases, where people get false undetectable results with this bDNA test ? Are there any subtypes or strains which bDNA would not detect ? Thank you.
Response from Dr. Holodniy
Only the FDA knows the real answer. Although the test is widely used in clinical practice, it does not have the FDA seal of approval. Part of the reason has to do with the way the assay was put together and manufactured. The company has made improvements in the assay and now there is a 3.0 assay with a lower copy limit of 50 copies/ml. They have a few more clinical studies to perform before they go back to the FDA. bDNA should be able to detect all subtypes. MH
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