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Biotech / Medical : Calypte Biomedical Corporation (CALY) -- Ignore unavailable to you. Want to Upgrade?


To: dowman who wrote (200)11/8/1997 8:54:00 PM
From: JanyBlueEyes  Read Replies (1) | Respond to of 381
 
....this product can not be used in this manner without FDA approval. They may have to go thru another round of clinicals to obtain such an approval...

This was specifically stated in the Pacific Growth Equities post:
siliconinvestor.com

"All of this suggests that a combination of urine and blood testing should be used for 100% sensitivity. So, for areas that require a zero tolerance, i.e. the blood supply, for HIV-1, combination testing would be a significant improvement. We believe that these findings will result in additional clinical studies, and that the basis for urine based testing (or combined testing) will be established.

The potential implication is that blood donors may ultimately have to be screened with urine HIV tests. The FDA has required the blood supply to be screened for HIV subtype O, with only 2 confirmed cases having been known to be missed with existing blood tests. With these studies, strong evidence exists that combination testing would be more accurate. Currently, in the U.S. there are 45-50 million blood bank screening tests performed annually."