HIV screening test sensitivity to group O subtype to be required by FDA.
This article was originally published in The Gray Sheet
Executive Summary
HIV SCREENING TEST GROUP O DETECTION CAPABILITY TO BE REQUIRED BY FDA, agency staffers say. The agency is still in the early stages of developing its policy on screening for the rare group O subtype of the HIV virus, but says it plans to revise HIV test lot release requirements to include detection of group O as well as group M, the predominant strain of HIV. FDA has not yet set a timetable for implementing the requirements.