Evaluation of the FluoroType MTB assay for the rapid and reliable detection of Mycobacterium tuberculosis in respiratory tract specimens

Clin Lab. 2013;59(9-10):1179-81. doi: 10.7754/clin.lab.2013.121209.

Abstract

We performed the first evaluation study of the new FluoroType MTB assay, a HyBeacon based nucleic acid amplification test for the direct detection of Mycobacterium tuberculosis in respiratory tract specimens. Using mycobacterial culture as a reference, 661 specimens were tested. Sensitivity and specificity were 95.1% and 96.4% for all specimens, sensitivity was 100% for smear-positive and 84.6% for smear negative specimens, respectively. The FluoroType MTB assay showed fast and accurate results within 3 hours, including DNA extraction.

Publication types

  • Evaluation Study

MeSH terms

  • DNA, Bacterial / analysis
  • Humans
  • Lung / microbiology*
  • Mycobacterium tuberculosis / genetics
  • Mycobacterium tuberculosis / isolation & purification*
  • Nucleic Acid Amplification Techniques*
  • Reproducibility of Results
  • Respiratory System / microbiology*
  • Sensitivity and Specificity

Substances

  • DNA, Bacterial