New US tests must detect subtype-O
This article was originally published in Clinica
Executive Summary
The US FDA says any new kits submitted for approval will now be expected to detect subtype-O reliably, following the first CDC report of a case in the US. The infection was detected in a woman who had repeatedly tested negative for HIV-1 but who had symptoms of AIDS. It was identified after PCR with group-O primers. The patient, who has lived in the US since 1994, is believed to have acquired the infection in West Central Africa - like all but one or two of the handful of cases detected in Europe.