title: Evaluation of the FluoroType MTB assay for the rapid and reliable detection of Mycobacterium tuberculosis in respiratory tract specimens.
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.
authors.affiliation: Limbach Laboratory, Heidelberg. Germany. ulrich.eigner@labor-limbach.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Eigner
authors.forename: Anke
authors.initials: A
authors.lastname: Veldenzer
authors.forename: M
authors.initials: M
authors.lastname: Holfelder
mesh_terms: D004269:DNA, Bacterial / Q000032:analysis; D006801:Humans; D008168:Lung / Q000382:microbiology*; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques; D015203:Reproducibility of Results; D012137:Respiratory System / Q000382:microbiology*; D012680:Sensitivity and Specificity
chemical_list: D004269:DNA, Bacterial