Waldheim Pharmazeutika (Austria) files Product License Application (PLA) for HIV-2 confirmatory test
This article was originally published in Clinica
Waldheim Pharmazeutika (Austria) has filed a Product License Application with the US FDA for Fluorognost HIV-2-IFA, its HIV-2 confirmatory test. Waldheim's managing director of diagnostics, Dr Hermann Mucke, says that trials of over 7,500 kits gave a sensitivity of 100% in West African and Indian HIV-2 seropositive donors and 99.63% in low-risk HIV-negative US blood donors. Specificity in HIV-negative West African disease ward attendants was 99.48% - significantly higher than Western blotting. Dr Mucke claims that indeterminate results, not false positives, were the reason the kit failed to reach 100% specificity.
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