title: A multi-center study to evaluate the performance of phage amplified biologically assay for detecting TB in sputum in the pulmonary TB patients.
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 Löwenstein-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 that (31 days) of L-J culture method.
  
  
  CONCLUSIONS
  PhaB method is a rapid and sensitive method for detecting TB in sputum in PTB patients; especially for the diagnosis of smear-negative PTB, PhaB method is obviously more sensitive than L-J culture method.
authors.affiliation: Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China.
authors.forename: Changtai
authors.initials: C
authors.lastname: Zhu
authors.forename: Zhenling
authors.initials: Z
authors.lastname: Cui
authors.forename: Ruijuan
authors.initials: R
authors.lastname: Zheng
authors.forename: Hua
authors.initials: H
authors.lastname: Yang
authors.forename: Ruiliang
authors.initials: R
authors.lastname: Jin
authors.forename: Lianhua
authors.initials: L
authors.lastname: Qin
authors.forename: Zhonghua
authors.initials: Z
authors.lastname: Liu
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.forename: Zhongyi
authors.initials: Z
authors.lastname: Hu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001435:Bacteriophages / Q000378:metabolism; D001681:Biological Assay / Q000379:methods*; D002648:Child; D002681:China; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000378:metabolism; D015203:Reproducibility of Results; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology*