Abstract

BackgroundSputum microscopy, the most important conventional test for tuberculosis, is specific in settings with high burden of tuberculosis and low prevalence of non tuberculous mycobacteria. However, the test lacks sensitivity. Although bacteriophage-based tests for tuberculosis have shown promising results, their overall accuracy has not been systematically evaluated.MethodsWe did a systematic review and meta-analysis of published studies to evaluate the accuracy of phage-based tests for the direct detection of M. tuberculosis in clinical specimens. To identify studies, we searched Medline, EMBASE, Web of science and BIOSIS, and contacted authors, experts and test manufacturers. Thirteen studies, all based on phage amplification method, met our inclusion criteria. Overall accuracy was evaluated using forest plots, summary receiver operating (SROC) curves, and subgroup analyses.ResultsThe data suggest that phage-based assays have high specificity (range 0.83 to 1.00), but modest and variable sensitivity (range 0.21 to 0.88). The sensitivity ranged between 0.29 and 0.87 among smear-positive, and 0.13 to 0.78 among smear-negative specimens. The specificity ranged between 0.60 and 0.88 among smear-positive and 0.89 to 0.99 among smear-negative specimens. SROC analyses suggest that overall accuracy of phage-based assays is slightly higher than smear microscopy in direct head-to-head comparisons.ConclusionPhage-based assays have high specificity but lower and variable sensitivity. Their performance characteristics are similar to sputum microscopy. Phage assays cannot replace conventional diagnostic tests such as microscopy and culture at this time. Further research is required to identify methods that can enhance the sensitivity of phage-based assays without compromising the high specificity.

Highlights

  • Sputum microscopy, the most important conventional test for tuberculosis, is specific in settings with high burden of tuberculosis and low prevalence of non tuberculous mycobacteria

  • Subjective, less comprehensive, and rely on qualitative methods [19], we conducted a systematic review to evaluate the overall accuracy of phage-based tests for the direct detection of M. tuberculosis in clinical specimens

  • Overall accuracy of phage-based tests Our results indicate that phage-based assays are highly specific but not sensitive enough to be equivalent to culture

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Summary

Introduction

The most important conventional test for tuberculosis, is specific in settings with high burden of tuberculosis and low prevalence of non tuberculous mycobacteria. Bacteriophage-based tests for tuberculosis have shown promising results, their overall accuracy has not been systematically evaluated. According to the World Health Organization, about one-third of the world's population is infected with Mycobacterium tuberculosis, and about 8 million new cases of TB occur each year. Despite this large burden and intensive control efforts, only about 46% of the new infectious TB cases are detected each year [1]. Subjective, less comprehensive, and rely on qualitative methods [19], we conducted a systematic review to evaluate the overall accuracy of phage-based tests for the direct detection of M. tuberculosis in clinical specimens. Low-income countries needs diagnostic tools that are sensitive, specific, cost effective, easy to perform, and easy to implement within the current infrastructure [3]

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