Abstract: Objective  To evaluate the clinical application value of detecting the Mycobacterium tuberculosis and non-tuberculous mycobacteria (NTM) by PCR-fluorescent probe.  Methods  1015 sputum specimens and 56 clinical isolates were studied using PCR-fluorescent probe of Capital Bio Corporation. And the results were compared with that of Mycobacterium tuberculosis detection kit of Daan Company.  Results  The sensitivity and specificity of detecting Mycobacteria in the sputum specimens by PCR-fluorescent probe were 50.3% (373/741) and 98.9% (271/274) respectively, in which the sensitivities for smear-positive and smear-negative pulmonary tuberculosis were 97.0%（257/265） and 24.4%（116/476） respectively. Of 1015 sputum specimens, 11（1.1%）were detected as NTM, Using 16S rDNA sequencing as control, the accuracy rate was 100.0%. 138 sputum specimens were detected repeatedly, the coincidence rate was 100.0%. Of 56 clinical isolates, 1 strain was detected as Mycobacterium tuberculosis and 55 were detected as NTM, the accuracy rate was also 100.0%. The total coincidence rate of 226 sputum specimens was 95.1% (215/226) compared with Mycobacterium tuberculosis detection kit of Daan Company. There were no significant difference between two methods (χ²=2.98, P=0.226). Conclusion  PCR-fluorescent probe can rapidly detect and differentiate Mycobacterium tuberculosis and NTM, have the value of clinical application.

Key words: Mycobacterium tuberculosis, Mycobacterium, Polymerase chain reaction, Fluorescent dyes, Sputum