title: Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis of 26999 specimens from 17 Studies.
abstract: Since 2010, studies on the diagnostic accuracy of COBAS TaqMan MTB (CTM) have been frequently reported with an unignorable discrepancy. The key inclusion criterion for this systematic review was original studies that could provide sufficient data for calculating the sensitivity and the specificity of CTM for M tuberculosis (TB) or M tuberculosis complex. The reference test was Mycobacterium culture. We used bivariate model for meta-analyses. Of the 201 candidate articles, we finally identified 17 eligible articles.Concerning the respiratory specimens, 1900 culture positive specimens and 20983 culture negative specimens from 15 studies were assessed. This provided the summary estimate sensitivity of 0.808 (95% CI 0.758-0.850) and the summary estimate specificity of 0.990 (95% CI 0.981-0.994). The area under curve was 0.956. The diagnostic odds ratio was 459 (95% CI 261-805, I(2) 26%). For the smear positive respiratory specimens, the sensitivity was 0.952 (95% CI 0.926-0.969) and the specificity was 0.916 (95% CI 0.797-0.968). For the smear negative respiratory specimens, the sensitivity and the specificity were 0.600 (95% CI 0.459-0.726) and 0.989 (95% CI 0.981-0.993), respectively. The diagnostic accuracy was poorer for the non-respiratory specimens, than for the respiratory specimens, but was acceptable. We believe that the information obtained from this study will aid physicians' decision making.
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Horita
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Toshinori
authors.initials: T
authors.lastname: Tsukahara
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Nagakura
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Tashiro
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Shibata
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Watanabe
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Nagai
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Nakashima
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Ryota
authors.initials: R
authors.lastname: Ushio
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Misako
authors.initials: M
authors.lastname: Ikeda
authors.affiliation: Department of Biostatistics, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sakamaki
authors.affiliation: Division of Respiratory Medicine, Japan-Anti-Tuberculosis Association Fukujuji Hospital. 3-1-24, Matsuyama, Kiyose, Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yoshiyama
authors.affiliation: Department of Pulmonology, Yokohama City University Graduate School of Medicine. 3-9, Fukuura, Kanazawa, Yokohama, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kaneko
mesh_terms: D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000302:isolation & purification; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000382:microbiology