Accuracy of molecular diagnostic tests for drug-resistant tuberculosis detection in China: a systematic review

Int J Tuberc Lung Dis. 2019 Aug 1;23(8):931-942. doi: 10.5588/ijtld.18.0550.

Abstract

OBJECTIVE: To evaluate the accuracy of molecular diagnostics for the detection of drug-resistant tuberculosis (TB) in Chinese patients.METHOD: Seven databases were searched for eligible studies that evaluated the accuracy of molecular diagnostics against drug susceptibility testing (DST) for detecting drug resistance. A bivariate random-effects meta-analysis was conducted to pool sensitivity and specificity by the index test and drug resistance type.RESULTS: A total of 159 studies were included. Compared with DST (reference standard), Xpert® could diagnose rifampicin (RMP) resistant TB accurately, with a pooled sensitivity and pooled specificity of 92% (95%CI 90-94) and 98% (95%CI 97-98), respectively. Line-probe assays (LPAs) also performed well for RMP resistance, with a pooled sensitivity of 91% (95%CI 88-93) and pooled specificity of 98% (95%CI 96-99), but not for isoniazid (INH) or second-line drugs due to lower sensitivity (<80%). The pooled sensitivity of GeneChip® microarrays for RMP, INH and multidrug resistance was 89% (95%CI 86-91), 79% (95%CI 75-82) and 79% (95%CI 73-84), respectively, and the specificities were all >97%. Similarly, the MeltPro® TB/STR assay had better sensitivity and specificity for first-line drugs, varying from 87% to 89% and 97% to 98%, respectively, than for second-line drugs.CONCLUSION: The Xpert assay, LPA, GeneChip assay, and MeltPro assay are credible methods with high accuracy for RMP resistance detection, but they may not be appropriate for other anti-tuberculosis drugs due to low sensitivity.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Antitubercular Agents / pharmacology*
  • China
  • Humans
  • Microbial Sensitivity Tests
  • Molecular Diagnostic Techniques / methods*
  • Mycobacterium tuberculosis / drug effects
  • Mycobacterium tuberculosis / isolation & purification
  • Sensitivity and Specificity
  • Tuberculosis, Multidrug-Resistant / diagnosis*

Substances

  • Antitubercular Agents