PMID- 20813587 OWN - NLM STAT- MEDLINE DCOM- 20101019 LR - 20230815 IS - 1474-4457 (Electronic) IS - 1473-3099 (Linking) VI - 10 IP - 10 DP - 2010 Oct TI - Microscopic-observation drug susceptibility and thin layer agar assays for the detection of drug resistant tuberculosis: a systematic review and meta-analysis. PG - 688-98 LID - 10.1016/S1473-3099(10)70165-1 [doi] AB - BACKGROUND: Simple, rapid, and affordable tests are needed to detect drug resistance in Mycobacterium tuberculosis. We did a systematic review and meta-analysis to investigate the accuracy of microscopic-observation drug susceptibility (MODS) and thin layer agar (TLA) assays for rapid screening of patients at risk of drug-resistant tuberculosis. METHODS: In accordance with protocols and methods recommended by the Cochrane Diagnostic Test Accuracy Working Group, we systematically searched PubMed, Embase, and Biosis for reports published between January, 1990, and February, 2009. We included studies investigating detection of drug resistance in M tuberculosis with the MODS or TLA assay, and in which an accepted reference standard was used. Data extracted from the studies were combined by use of bivariate random-effects regression models and hierarchical summary receiver operating characteristic curves to estimate sensitivity and specificity for detection of resistance to specific drugs. FINDINGS: We identified 12 studies, of which nine investigated the MODS assay and three investigated the TLA assay. For the MODS assay of rifampicin resistance, pooled estimates were 98.0% (95% CI 94.5-99.3) for sensitivity and 99.4% (95.7-99.9) for specificity. For the MODS assay of isoniazid resistance with a 0.1 mug/mL cutoff, pooled sensitivity was 97.7% (94.4-99.1) and pooled specificity was 95.8% (88.1-98.6), but with a 0.4 mug/mL cutoff, sensitivity decreased to 90.0% (84.5-93.7) and specificity increased to 98.6% (96.9-99.4). All assessments of rifampicin and isoniazid resistance with the TLA assay yielded 100% accuracy. Mean turnaround time was 9.9 days (95% CI 4.1-15.8) for the MODS assay and 11.1 days (10.1-12.0) for the TLA assay. INTERPRETATION: MODS and TLA assays are inexpensive, rapid alternatives to conventional methods for drug susceptibility testing of M tuberculosis. Our data and expert opinion informed WHO's recommendation for use of selected non-commercial drug susceptibility tests, including MODS, as an interim solution until capacity for genotypic or automated liquid culture drug susceptibility testing is developed. FUNDING: Stop TB Department of WHO. CI - Copyright (c) 2010 Elsevier Ltd. All rights reserved. FAU - Minion, Jessica AU - Minion J AD - Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada. FAU - Leung, Erika AU - Leung E FAU - Menzies, Dick AU - Menzies D FAU - Pai, Madhukar AU - Pai M LA - eng PT - Evaluation Study PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20100831 PL - United States TA - Lancet Infect Dis JT - The Lancet. Infectious diseases JID - 101130150 RN - 0 (Antitubercular Agents) SB - IM CIN - Lancet Infect Dis. 2010 Oct;10(10):656-8. PMID: 20813586 CIN - Lancet. 2010 Nov 20;376(9754):1712. PMID: 21093635 CIN - Lancet Infect Dis. 2011 Mar;11(3):161-2; author reply 162. PMID: 21371651 MH - Antitubercular Agents/*pharmacology MH - *Drug Resistance, Bacterial MH - Humans MH - Microbial Sensitivity Tests/economics/methods MH - Microscopy/methods MH - Mycobacterium tuberculosis/*drug effects/*isolation & purification MH - ROC Curve MH - Sensitivity and Specificity MH - Time Factors MH - Tuberculosis, Multidrug-Resistant/*diagnosis/*microbiology EDAT- 2010/09/04 06:00 MHDA- 2010/10/20 06:00 CRDT- 2010/09/04 06:00 PHST- 2010/09/04 06:00 [entrez] PHST- 2010/09/04 06:00 [pubmed] PHST- 2010/10/20 06:00 [medline] AID - S1473-3099(10)70165-1 [pii] AID - 10.1016/S1473-3099(10)70165-1 [doi] PST - ppublish SO - Lancet Infect Dis. 2010 Oct;10(10):688-98. doi: 10.1016/S1473-3099(10)70165-1. Epub 2010 Aug 31.