title: Evaluation of three rapid assays for Mycobacterium tuberculosis complex detection in a comprehensive hospital from West China.
abstract: OBJECTIVE
  To assess the capacity of rapid and accurate confirmation of the Mycobacterium tuberculosis complex (MTBC) in a Chinese clinical laboratory.
  
  
  METHODS
  This prospective study investigated three rapid assays, the Amplified Mycobacterium Tuberculosis Direct (MTD) test, real-time PCR, and acid-fast bacilli (AFB) smear, for direct detection of MTBC in a large consecutive series of different clinical specimens. Performance parameters were estimated and compared overall and for separate specimen categories using a combined reference gold standard.
  
  
  RESULTS
  The overall sensitivities were similar for MTD and real-time PCR (62.26% vs. 58.49%), significantly higher than those of AFB smear (31.13%). Among three assays, MTD had a satisfactory sensitivity in respiratory specimen (73.33%) and a nearly perfect detection for smear-positive samples (96.97%). Real-time PCR showed a high positive rate (58.97%) in regard to nonrespiratory specimen. A combination of molecular assays with conventional methods reached marked additive diagnostic values (sensitivity up to 76.42%), higher than each method individually. All detection systems showed excellent specificities (>96.00%).
  
  
  CONCLUSIONS
  The present study indicated that our lab had a moderate diagnostic performance for tuberculosis. Quality guarantee for specimen pretreatment, as well as combination analysis, will enable these assays to better incorporate into the routine laboratory workflow in China.
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Xuejiao
authors.initials: X
authors.lastname: Hu
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Mengqiao
authors.initials: M
authors.lastname: Shang
authors.affiliation: Division of Pulmonary Disease, Department of Respiratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Xuerong
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xie
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Yuanxin
authors.initials: Y
authors.lastname: Ye
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Juan
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Xingbo
authors.initials: X
authors.lastname: Song
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.
authors.forename: Xiaojun
authors.initials: X
authors.lastname: Lu
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China. Electronic address: docbwy@126.com.
authors.forename: Binwu
authors.initials: B
authors.lastname: Ying
authors.affiliation: Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China. Electronic address: huaxiwangll@gmail.com.
authors.forename: Lanlan
authors.initials: L
authors.lastname: Wang
mesh_terms: D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods*; D002681:China; D003710:Demography; D005260:Female; D006761:Hospitals; D006801:Humans; D008297:Male; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D014376:Tuberculosis / Q000175:diagnosis / Q000382:microbiology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: AFB smear; Diagnosis; MTD; Real-time PCR; Tuberculosis