a multi-center study to evaluate the performance of phage amplified biologically assay for detecting tb in sputum in the pulmonary tb patients一项多中心研究来评估性能的噬菌体生物放大试验检测结核病在肺结核病人的痰.pdfVIP
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a multi-center study to evaluate the performance of phage amplified biologically assay for detecting tb in sputum in the pulmonary tb patients一项多中心研究来评估性能的噬菌体生物放大试验检测结核病在肺结核病人的痰
A Multi-Center Study to Evaluate the Performance of
Phage Amplified Biologically Assay for Detecting TB in
Sputum in the Pulmonary TB Patients
1,2 1 1 1 1 1 1
Changtai Zhu , Zhenling Cui , Ruijuan Zheng , Hua Yang , Ruiliang Jin , Lianhua Qin , Zhonghua Liu ,
1 1
Jie Wang , Zhongyi Hu *
1 Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, People’s Republic of China, 2 Department of
Laboratory Medicine, Changzhou Tumor Hospital Soochow University, Changzhou, People’s Republic of China
Abstract
Objective: To evaluate the performance of phage amplified biologically assay (PhaB) for detecting tuberculosis (TB) in
sputum in the pulmonary tuberculosis (PTB) patients.
Methods: Shanghai Tuberculosis Key Laboratory of Shanghai Pulmonary Hospital participated in the project in collaboration
with the laboratories of six hospitals and a total of 1660 eligible participants (1351 PTB patients and 309 non-TB patients)
were included in the study. The sputum samples from the participants were detected by smear microscopy, PhaB, and
¨
Lowenstein-Jensen (L-J) culture method, respectively.
Results: The overall sensitivity of PhaB were higher than that of L-J culture and smear microscopy (p ,0.05). The sensitivity
of PhaB for detecting smear-negative specimens was obviously higher than that of L-J culture (p ,0.05). Compared with L-J
culture, the overall sensitivity, specificity, PPV, NPV, ACC and Kappa value of PhaB were 98.4 (95% Cl: 96.9–99.3), 71.6 (95%
Cl: 68.4–74.6), 67.7, 98.7, 81.7% and 0.643, respectively. The detection median time of PhaB only needed 48 hours, which
was significantly less than
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