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. 2011 May;52 Suppl 4(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

Christine C Ginocchio  1
Affiliations

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

Christine C Ginocchio. Clin Infect Dis. 2011 May.

Abstract

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.

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Figures

Figure 1.
Figure 1.
The xTAG Respiratory Virus Panel (RVP) is a multistep test that takes approximately 8–10 h to complete, depending on the number of samples to be tested. RT-PCR, reverse transcription polymerase chain reaction; TSPE, target-specific primer extension.
Figure 2.
Figure 2.
The Verigene System consists of 2 instruments (the fully automated Verigene Processor and the Verigene Reader) and single-use test cartridges.
See this image and copyright information in PMC

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