Abstract
Various diagnostic companies have developed high throughput molecular assays for tuberculosis (TB) and resistance detection for rifampicin and isoniazid. We performed a systematic review and meta-analyses to assess the diagnostic accuracy of five of these tests for pulmonary specimens. The tests included were Abbott RealTime MTB, Abbott RealTime RIF/INH, FluoroType MTB, FluoroType MTDBR and BD Max MDR-TB assay.
A comprehensive search of six databases for relevant citations was performed. Cross-sectional, case-control, cohort studies, and randomised controlled trials of any of the index tests were included. Respiratory specimens (such as sputum, bronchoalveolar lavage, tracheal aspirate, etc.) or their culture isolates.
A total of 21 included studies contributed 26 datasets. We could only meta-analyse data for three of the five assays identified, as data were limited for the remaining two. For TB detection, the included assays had a sensitivity of 91% or more and the specificity ranged from 97% to 100%. For rifampicin resistance detection, all the included assays had a sensitivity of more than 92%, with a specificity of 99–100%. Sensitivity for isoniazid resistance detection varied from 70 to 91%, with higher specificity of 99–100% across all index tests. Studies that included head-to-head comparisons of these assays with Xpert MTB/RIF for detection of TB and rifampicin resistance suggested comparable diagnostic accuracy.
In people with symptoms of pulmonary TB, the centralised molecular assays demonstrate comparable diagnostic accuracy for detection of TB, rifampicin and isoniazid resistance to Xpert MTB/RIF assay, a WHO recommended molecular test.
Abstract
In people with symptoms of pulmonary TB, the centralised molecular assays demonstrate comparable diagnostic accuracy for detection of TB, rifampicin resistance, and isoniazid resistance to existing WHO recommended tests https://bit.ly/3kQE20V
Footnotes
This article has supplementary material available from erj.ersjournals.com
Conflict of interest: E. MacLean has nothing to disclose.
Conflict of interest: M. Pai has nothing to disclose.
Conflict of interest: S.G. Schumacher has nothing to disclose.
Conflict of interest: C.M. Denkinger has nothing to disclose.
Conflict of interest: M. Kohli has nothing to disclose.
Support statement: This work was supported by the Government of the UK. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received March 18, 2020.
- Accepted July 30, 2020.
- Copyright ©ERS 2021