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FDA gives special clearance for H1N1 claims from Quidel and Meridian

This article was originally published in Clinica

Executive Summary

Two more rapid flu tests can be used to detect the H1N1 pandemic virus, adding to the recent glut of approvals for similar diagnostics. The US FDA has granted special 510(k) clearance for updated labelling claims for Quidel's QuickVue Influenza A+B test and Meridian Bioscience's Tru Flu, highlighting their sensitivity to H1N1. Meridian (River Hills Drive, Cincinnati) will update the Tru Flu package insert to say that it has shown "analytical activity" to two H1N1 flu strains, while Quidel (San Diego, California) will update the QuickVue label to include "reactivity with culture isolates of the 2009 H1N1 influenza A virus". Neither test's performance with clinical specimens has been proven. QuickVue and Tru Flu provide results in 10 minutes and 15 minutes, respectively.

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