Open AccessA Large Cohort Study on the Clinical Value of Simultaneous Amplification and Testing for the Diagnosis of Pulmonary Tuberculosis
Author(s) -
Liping Yan,
Shenjie Tang,
Yan Yang,
Xiang Shi,
Yanping Ge,
Wenwen Sun,
Yidian Liu,
Xiaofei Hao,
Xuwei Gui,
Hongyun Yin,
Yang He,
Qing Zhang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Shenjie Tang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Yan Yang,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Xiang Shi,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Yanping Ge,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Wenwen Sun,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Yidian Liu,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xiaofei Hao,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Xuwei Gui,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Hongyun Yin,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Yang He,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang,
Qing Zhang
Publication year - 2016
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000002597
Subject(s) - medicine , sputum , mycobacterium tuberculosis , tuberculosis , pulmonary tuberculosis , sputum culture , gastroenterology , prospective cohort study , pathology
The AmpSure simultaneous amplification and testing method for the detection of Mycobacterium tuberculosis (SAT-TB assay) was designed to diagnose rapidly pulmonary tuberculosis (PTB). Unfortunately, the diagnostic advantage is unclear from previous small sample studies. In the current inquiry, a large sample size was used to reevaluate the clinical accuracy of the SAT-TB assay using sputum specimens. A total of 3608 patients with suspected PTB were enrolled prospectively for diagnosis from sputum specimens using the SAT-TB assay. Of these, 2457 had a definite diagnosis of PTB confirmed by positive microbiology, or pathologic findings of TB in the lung, or clinical diagnosis of active PTB following anti-TB treatment with a favorable response. The sensitivity, specificity and accuracy of the SAT-TB assay were 75.8%, 100%, and 80.2%, respectively. The sensitivity of SAT-TB was significantly higher than that of the sputum smear (23.8%) (X 2 = 1327.437; P = 0.000), wheresa significantly lower than that of sputum culture (89.0%) (X 2 = 148.197; P = 0.000). The specificity of SAT-TB was significantly higher than that of sputum smears (96.3%) (X 2 = 20.375, P = 0.000), whereas no significant difference was found compared with sputum cultures (99.6%) (X 2 = 2.004, P = 0.500). Positive results in the SAT-TB assay using sputum specimens indicates that active PTB is present and anti-TB treatment is strongly recommended regardless of smear and culture test results. Simultaneous amplification and testing method for detection of Mycobacterium tuberculosis is an accurate, cheap, and rapid method for PTB diagnosis.