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

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


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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Antiviral Agents / therapeutic use
  • Cross Infection / prevention & control
  • Diagnostic Test Approval
  • Humans
  • Molecular Diagnostic Techniques / methods*
  • Reagent Kits, Diagnostic*
  • Respiratory Tract Infections / diagnosis*
  • Respiratory Tract Infections / microbiology
  • Respiratory Tract Infections / virology
  • Sensitivity and Specificity
  • United States
  • United States Food and Drug Administration


  • Anti-Bacterial Agents
  • Antiviral Agents
  • Reagent Kits, Diagnostic