检索历史 清除

摘要Background Early diagnosis of smear-negative tuberculosis (TB) remains a great challenge for TB control and treatment.Real-Time Simultaneous amplication and testing method of Mycobacterium tuberculosis complex (SAT-TB assay) is a novel diagnostic tool, its value for fast diagnosis of TB needs to be further evaluated.Methods A prospective, consecutive study was conducted at Shanghai Pulmonary Hospital to evaluate the diagnostic value of SAT-TB assay for smear-negative or sputum scarce pulmonary tuberculosis (PTB).Patients were examined by SAT-TB assay on sputum or Bronchoalveolar lavage fluid (BALF) if patients were sputum scarce using conventional culture methods as standard reference.Results 0f 216 patients who were sputum smear negative or sputum scarce but suspected of PTB, 40 patients were confirmed as PTB by culture, 117 patients were diagnosed as probable PTB, 59 patients as non-PTB.The sensitivity, specificity, PPV, NPV, LR+, and LR-of SAT-TB assay on both sputum and BALF were 39% (95%CI, 31-47) , 100% (95%CI, 94-100) , 100%(95%CI, 94-100), 38%(95%CI, 30-46), 46.71 (95%CI, 2.94-743.28) and 0.62 (95%CI, 0.54-0.70) , respectively.There were 37 patients with SAT-TB positive but cultures negative from 117 PTB cases.The sensitivity of SAT-TB (42%) on BALF was higher than that of SAT-TB on sputum (35%).Conclusions SAT-TB assay is a promising valuable method for early diagnosis of smear-negative or sputum scarce PTB by advantages of high specificity and inexpensiveness.