title: A multicenter study of cross-priming amplification for tuberculosis diagnosis at peripheral level in China.
abstract: Cross-Priming Amplification (CPA) has been shown to rapidly and effectively detect Mycobacterium tuberculosis (MTB) in sputum samples under isothermal conditions. However, no performance data exist from peripheral-level tuberculosis (TB) clinics in tuberculosis-endemic countries. We conducted a clinical trial at four county-level TB clinics in China to evaluate the effectiveness of the CPA assay. TB suspects were continuously enrolled by a clinician at each clinic. Following informed consent, each patient provided two sputum specimens (spot and morning sputum). Sputum samples were tested by smear microscopy, solid culture and CPA. The National TB reference laboratory (NTRL) collected all culture positive strains and performed 16S-23S rDNA internal transcribed spacer (ITS) sequence analysis for strain identification. Solid culture was used as the gold standard to evaluate the effectiveness of CPA in detecting MTB. A total of 2200 TB-suspected patients were enrolled at the four county-level TB clinics. Compared to solid culture, the sensitivity and specificity of the CPA test for MTB detection within this group was 84.1% (95%CI, 79.5-88.6) and 97.8% (95%CI, 97.1-98.5), respectively, and the sensitivity in smear-negative cases was 59.8% (95%CI, 49.8-69.8). The test failure rate of CPA was 0.8% (32/3918), significantly lower than the 1.7% (106/6138) culture contamination rate.
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Xichao
authors.initials: X
authors.lastname: Ou
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Song
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Zhao
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Xia
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Pang
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Shengfen
authors.initials: S
authors.lastname: Wang
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Zhijian
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Shiming
authors.initials: S
authors.lastname: Cheng
authors.affiliation: Chinese PLA General Hospital, Beijing, China. Electronic address: changtingliu@sohu.com.
authors.forename: Changting
authors.initials: C
authors.lastname: Liu
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: zhaoyanlin@chinatb.org.
authors.forename: YanLin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D000554:Ambulatory Care Facilities; D015373:Bacterial Typing Techniques; D045142:Cross-Priming; D021901:DNA, Intergenic / Q000235:genetics; D005240:Feasibility Studies; D006801:Humans; D008403:Mass Screening / Q000379:methods; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010865:Pilot Projects; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*
chemical_list: D021901:DNA, Intergenic; D011933:Reagent Kits, Diagnostic
keywords: CPA; Mycobacterium tuberculosis; Sensitivity; Specificity