Abstract: Objective To investigate the clinical significance of using the simultaneous amplification and testing method (SAT) in the early diagnosis of suspected pulmonary tuberculosis. Methods Three hundred and thirty-eight cases with respiratory disease (including 242 cases with suspected pulmonary tuberculosis and 96 cases with non-tubercular and other lung diseases) admitted in Guangzhou Chest Hospital from July to December 2015 were recruited in the study. Sputum samples were submitted for testing for SAT, smear, culture and strain identification. The number of cases of infection with Mycobacterium tuberculosis, and non-tuberculosis mycobacteria were determined. The coincidence rate of SAT and MTB culture, SAT and strain identification were calculated, and the sensitivity and specificity of SAT in the detection of suspected pulmonary tuberculosis was determined. Results Of the 242 cases with suspected pulmonary tuberculosis, 233 cases were sputum culture positive, 222 cases were infected with Mycobacterium tuberculosis, and 11 cases with non-tubercular mycobacteria, 96 cases with non-tubercular and other lung diseases were sputum culture negative. In the MTB group, 192 cases were SAT positive, and the coincidence rate of SAT and strain identification was 86.5% (192/222). In the NTM group, no case (0/11) were SAT positive, and the coincidence rate of SAT and strain identification was 100.0% (11/11). Of the 96 cases with non-tubercular and other lung diseases, 2 cases were SAT positive (2.1%, 2/96), and the coincidence rate of SAT with MTB culture and strain identification was 97.9% (94/96). The sensitivity of SAT in the diagnosis of suspected pulmonary tuberculosis was 86.5% (192/222), and the specificity was 97.9% (94/96). Conclusion The use of the SAT assay has important clinical significance for the early diagnosis of suspected pulmonary tuberculosis.

Key words: Tuberculosis, pulmonary, Nucleic acid amplification techniques, Early diagnosis, Mycobacterium infections, atypical, Respiratory tract diseases