Clinical diagnostic performance of the simultaneous amplification and testing methods for

Clinical diagnostic performance of the simultaneous amplification and testing methods for detection of the Mycobacterium tuberculosis complex for smear-negative or sputum-scarce

pulmonary tuberculosis in China

Fan Lin;Zhang Qing;Cheng Liping;Liu Zhibing;Ji Xiaobing;Cui Zhenling;Ju Jingliang

【期刊名称】《中华医学杂志（英文版）》 【年(卷),期】2014(127)010

【摘要】Background Early detection of pulmonary tuberculosis (PTB) is a big challenge in smear negative and sputum scarce patients in China.Simultaneous amplification and testing methods for detection of the Mycobactedum tuberculosis (MTB) complex (SAT-TB assay) is a novel molecular technique established in our hospital.This method has a high sensitivity and specificity in the lab.In this study,the clinical diagnostic performance of this method in smear-negative or sputum-scarce PTB suspects was investigated and evaluated.Methods Two hundred smear negative and 80 sputum-scarce patients were recruited in this study.Samples that included sputum or bronchial washing fluid were collected and sent for both bacteria culture and SAT-TB assay.Diagnosis for these patients was based on the comprehensive evaluation of chestX-ray/CT study,histology examination,lab results,and treatment response.Sensitivity,specificity,positive predictive value (PPV)