Clinical evaluation of a commercial culture-free targeted next-generation sequencing test for diagnosis of drug-resistant tuberculosis
Abstract
UNLABELLED: Rapid molecular diagnostics have significantly improved access to tuberculosis (TB) drug resistance detection and reduced turnaround times. However, these tools remain limited in their capacity to generate comprehensive resistance profiles, particularly for newer and repurposed anti-TB drugs. Targeted next-generation sequencing (tNGS) offers a promising alternative, enabling a broader resolution of Mycobacterium tuberculosis genomes and faster reporting compared to phenotypic drug susceptibility testing (DST). We conducted a prospective, cross-sectional, multicenter evaluation of the DeepChek 13-Plex KB Drug Susceptibility Testing (ABL Diagnostics S.A., France) tNGS assay for direct detection of TB drug resistance from clinical sputum samples. The study was performed at three reference laboratories in India, South Africa, and Georgia between April 2021 and June 2022. Adults (≥18 years) with confirmed pulmonary TB were enrolled. Sensitivity and specificity were assessed for key anti-TB drugs against a composite reference standard combining phenotypic DST and whole-genome sequencing. Of 832 participants enrolled, 694 (83.4%) were included in the final analysis. Sequencing was successful in 75.6% of samples. Failure rates were higher in samples with low or very low Xpert MTB/RIF categories. The ABL tNGS workflow showed ≥95% sensitivity for rifampicin, isoniazid, and levofloxacin; 92%-93% for pyrazinamide and moxifloxacin; 88% for ethambutol; and 72%-82% for…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 832 participants or records.
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