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Clin Infect Dis. 2011 May;52 Suppl 4:S312-25. doi: 10.1093/cid/cir046.

Strengths and weaknesses of FDA-approved/cleared diagnostic devices for the molecular detection of respiratory pathogens.

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Division of Infectious Disease Diagnostics, Department of Pathology and Laboratory Medicine, North Shore-LIJ Health System Laboratories, Hofstra North Shore-LIJ School of Medicine, Lake Success, New York 11041, USA.


The rapid, sensitive, and specific identification of the microbial etiological characteristics of respiratory tract infections enhances the appropriate use of both antibiotics and antiviral agents and reduces the risk of nosocomial transmission. This article reviews the current nucleic acid amplification tests approved by the U.S. Food and Drug Administration (FDA) for the detection of respiratory pathogens. In addition, Emergency Use Authorization tests for the detection of 2009 influenza A H1N1 are discussed. The advantages and limitations of the current FDA-approved/cleared tests are reviewed.

[Indexed for MEDLINE]

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