Low diagnostic accuracy of Xpert MTB/RIF assay for extrapulmonary tuberculosis: A multicenter surveillance

Sci Rep. 2019 Dec 6;9(1):18515. doi: 10.1038/s41598-019-55112-y.

Abstract

Diagnostic accuracy of Xpert MTB/RIF assay for pulmonary tuberculosis (PTB) and extrapulmonary TB (EPTB) has not been investigated in Iran. This study was aimed to assess the diagnostic accuracy of Xpert MTB/RIF assay for both PTB and EPTB. A total of 2111 clinical samples (1218 pulmonary and 838 extra-pulmonary) were collected from 16 medical centers during the study period and were analyzed for detection of PTB and EPTB by both Xpert MTB/RIF assay and standard conventional methods (culture and direct smear microscopy). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of Xpert MTB/RIF assay for PTB were found to be 95.5%, 96.7%, 83.8%, and 99.1% respectively. For EPTB, the sensitivity, specificity, PPV and NPV of Xpert MTB/RIF assay counted for 76.5%, 95.9%, 62%, and 97.9% respectively. Xpert MTB/RIF assay found to be highly sensitive, specific and comparable to standard conventional methods for the diagnosis of PTB. However, the sensitivity and specificity of Xpert MTB/RIF for EPTB specimens were highly variable; thus, Xpert MTB/RIF cannot be recommended to replace standard conventional tests for diagnosis of EPTB.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibiotics, Antitubercular / therapeutic use*
  • Cross-Sectional Studies
  • Drug Resistance, Bacterial
  • Humans
  • Iran / epidemiology
  • Molecular Diagnostic Techniques / methods*
  • Mycobacterium tuberculosis
  • Predictive Value of Tests
  • Reproducibility of Results
  • Rifampin / therapeutic use
  • Sensitivity and Specificity
  • Sputum / microbiology
  • Tuberculosis / diagnosis*
  • Tuberculosis, Pulmonary / diagnosis*

Substances

  • Antibiotics, Antitubercular
  • Rifampin