Abstract: Objective To evaluate the clinical diagnostic value of real-time FQ-PCR assay for the detection of Mycobacterium tuberculosis(MTB)/non-tuberculous mycobacteria (NTM). Methods 420 specimens were detected by real-time FQ-PCR, and the results were compared with those of AFB smear and culture.  Results The sensitivity of FQ-PCR was 48.5%, in which the sensitivity in bacterium-positive and bacterium-negative specimens were 95.8% and 14.5%, respectively. The specificity, positive predictive value and negative predictive value of FQ-PCR were 99.3%, 99.1% and 55.5%, respectively. 1 of 388 sputum specimens was NTM-positive by FQ-PCR, which was confirmed by DNA sequencing. 32 NTM isolates were confirmed by FQ-PCR and DNA sequencing. Their accuracy was 100%.  Conclusions The real-time FQ-PCR was a simple, rapid and specific assay for the detection ofMycobacterium tuberculosis /non-tuberculous mycobacteria in a sealed tube.

Key words: Mycobacterium tuberculosis, mycobacterum, nucleic acids, polymerase chain reaction