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  

作　　者：Fan Lin Zhang Qing Cheng Liping Liu Zhibing Ji Xiaobing Cui Zhenling Ju Jingliang Xiao Heping 

机构地区：[1]Tuberculosis Center for Diagnosis and Treatment Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China [2]Shanghai Key Laboratory of Tuberculosis Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China [3]Shanghai Rendu Biotechnology Co., Ltd., Shanghai 201201, China

出　　处：《Chinese Medical Journal》2014年第10期1863-1867,共5页中华医学杂志（英文版）

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） and negative predictive value （NPV） for each diagnostic test were investigated and calculated using confirmed tuberculosis （TB） and non-TB cases.The time required for detection of MTB was also measured for each method.Results Ninety-two patients （33％） were diagnosed as definitive TB,112 patients （40％） were probable PTB,and 76 （27％） were non-TB.The sensitivity,specificity,PPV,and NPV of SAT-TB in smear-negative PTB suspects were 93％ （95％ CI,84％-98％）,98％ （95％ CI,90％-100％）,98％ （95％ Cl,91％-100％）,and 93％ （95％ CI,83％-98％）.In sputum scarce PTB suspects,the sensitivity,specificity,PPV,and NPV of the SAT-TB assay on bronchial washing fiuids were 90％ （95％Cl,74％-98％）,100％ （95％ Cl,85％-100％）,100％ （95％ Cl,88％-100％）,and 88％ （95％ CI,69％-97％）.The accuracy of the SAT-TB assay is consistent with the bacteria culture assay.The median time required for detecting MTB in the SAT-TB assay was 0.5 day,which was much faster than bacteria culture （28 days）.Conclusions The SABackground 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） and negative predictive value （NPV） for each diagnostic test were investigated and calculated using confirmed tuberculosis （TB） and non-TB cases.The time required for detection of MTB was also measured for each method.Results Ninety-two patients （33％） were diagnosed as definitive TB,112 patients （40％） were probable PTB,and 76 （27％） were non-TB.The sensitivity,specificity,PPV,and NPV of SAT-TB in smear-negative PTB suspects were 93％ （95％ CI,84％-98％）,98％ （95％ CI,90％-100％）,98％ （95％ Cl,91％-100％）,and 93％ （95％ CI,83％-98％）.In sputum scarce PTB suspects,the sensitivity,specificity,PPV,and NPV of the SAT-TB assay on bronchial washing fiuids were 90％ （95％Cl,74％-98％）,100％ （95％ Cl,85％-100％）,100％ （95％ Cl,88％-100％）,and 88％ （95％ CI,69％-97％）.The accuracy of the SAT-TB assay is consistent with the bacteria culture assay.The median time required for detecting MTB in the SAT-TB assay was 0.5 day,which was much faster than bacteria culture （28 days）.Conclusions The SA

关 键 词：nucleic acid amplification techniques smear-negative sputum scarce diagnosis TUBERCULOSIS 

分 类 号：R521[医药卫生—内科学]