Bacteriophage assays for rifampicin resistance detection in Mycobacterium tuberculosis: updated meta-analysis [Review article]
Abstract: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.
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: August 1, 2010
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