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Free Content Bacteriophage assays for rifampicin resistance detection in Mycobacterium tuberculosis: updated meta-analysis [Review article]

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OBJECTIVE: To update a previously reported meta-analysis of evidence regarding the diagnostic accuracy and performance characteristics of commercial and non-commercial phage-based assays for the detection of rifampicin (RMP) resistant tuberculosis (TB).

DESIGN AND OUTCOMES: We conducted a systematic review and meta-analysis of test accuracy using bivariate random effects regression and hierarchical summary receiver operating characteristics (HSROC) analysis. Tests included the commercial FASTPlaque™ assays, luciferase reporter phage (LRP) assays, and in-house phage amplification tests. Sensitivity and specificity for RMP resistance were the main outcomes.

RESULTS: By updating previous literature searches, a total of 31 studies (with 3085 specimens) were included in this meta-analysis. Evaluations of commercial phage amplification assays yielded more variable estimates of sensitivity (range 81–100%) and specificity (range 73–100%) compared to evaluations of in-house amplification assays (sensitivity range 88–100%, specificity range 84–100%). LRP evaluations yielded the most consistent estimates of diagnostic accuracy, with seven of eight studies reporting 100% sensitivity and four of eight reporting 100% specificity. Estimates of accuracy failed to capture a major failing of the commercial assay, i.e., the rate of contaminated and indeterminate results. These ranged from 3% to 36% in studies looking at direct detection of RMP resistance from patient specimens (mean 20%).

CONCLUSION: Phage-based assays will require further development to maximise interpretable results and reduce technical failures. Once technical issues are resolved, impact on patient-important outcomes and cost-effectiveness need to be determined to inform policy for widespread use.
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Keywords: MDR-TB; bacteriophage assays; diagnosis; rifampicin; tuberculosis

Document Type: Review Article

Affiliations: Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, and Respiratory Epidemiology & Clinical Research Unit, Montreal Chest Institute, Montreal, Quebec, Canada

Publication date: 01 August 2010

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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