Analytical performance determination and clinical validation of the novel Roche RealTime Ready Influenza A/H1N1 Detection Set.

ABSTRACT: The emergence of a novel pandemic human strain of influenza A (H1N1/09) virus in April 2009 has demonstrated the need for well-validated diagnostic tests that are broadly applicable, rapid, sensitive, and specific. The analytical performance and clinical validity of results generated with the novel Roche RealTime Ready Influenza A/H1N1 Detection Set using the LightCycler 2.0 instrument were characterized. Analytical performance was assessed by processing respiratory samples spiked with H1N1/09 and seasonal influenza A virus, a set of seasonal influenza A virus subtypes, and samples containing common viral and bacterial respiratory pathogens. The clinical validity of results was assessed in comparison to other assays by analyzing 359 specimens at three clinical sites and one reference labor

SUBMITTER: Wenzel JJ 

PROVIDER: S-EPMC2937696 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature