Journal Article

Strengths and Weaknesses of FDA-Approved/Cleared Diagnostic Devices for the Molecular Detection of Respiratory Pathogens

Christine C. Ginocchio

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue suppl_4, pages S312-S325
Published in print May 2011 | ISSN: 1058-4838
Published online May 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/cir046
Strengths and Weaknesses of FDA-Approved/Cleared Diagnostic Devices for the Molecular Detection of Respiratory Pathogens

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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.

Journal Article.  9234 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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