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Caution on avian flu tests

This article was originally published in The Gray Sheet

Executive Summary

FDA cautions against relying on "rapid" diagnostic tests for influenza avian flu virus (H5N1) in humans in a document posted on the Office of In Vitro Diagnostic Devices Evaluation & Safety website Nov. 14. "None of the FDA-cleared rapid influenza A tests can differentiate influenza A virus subtypes or discriminate between those subtypes that commonly infect humans and those that typically infect birds," the notice says. Quidel announced Oct. 21 that study results for its QuickVue influenza A+B rapid test suggest it can detect H5N1 (1"The Gray Sheet" Nov. 14, 2005, p. 13). Applied BioSystems has a test designed for research and epidemiological use that reportedly can detect the subtype in less than two hours (2"The Gray Sheet" Nov. 14, 2005, p. 14). The World Health Organization has identified 130 confirmed human cases of avian influenza in Asia since 2003...

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