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FDA-APPROVED TEST KITS' RELIABILITY FOR CADAVERIC SPECIMENS

This article was originally published in The Gray Sheet

Executive Summary

FDA-APPROVED TEST KITS' RELIABILITY FOR CADAVERIC SPECIMENS questioned by the American Association of Blood Banks in March 14 comments on FDA's interim final rule for banked human tissue used in transplantation. Under the interim rule, which was published and became effective in December, FDA mandated that tissue donor blood samples be tested for HIV-1, HIV-2, hepatitis B surface antigen, and hepatitis C by a lab certified under the Clinical Laboratory Improvement Amendments of 1988 using FDA-approved assays ("The Gray Sheet" Dec. 13, 1993, p. 18).
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