ArticleThe Lancet. Infectious diseases2025
Evaluating culture-free targeted next-generation sequencing for diagnosing drug-resistant tuberculosis: a multicentre clinical study of two end-to-end commercial workflows.
Article in The Lancet. Infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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Who cites it
33 citing papers in PubMed.
- Characteristics, Treatment Strategies, and Long-term Health Outcomes of People With Bedaquiline-resistant Tuberculosis in Karakalpakstan, Uzbekistan-A Retrospective Cohort Study.Open forum infectious diseases · 2026Article
- Targeted next-generation sequencing for direct drug-resistant tuberculosis detection in sputum samples in Indonesia: an implementation study (2024-25).The Lancet regional health. Southeast Asia · 2026Article
- Use of reverse dot blot hybridization DNA-array and targeted next-generation sequencing for the detection of drug resistance in patients with tuberculosis: a prospective diagnostic accuracy study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Article
- Accuracy of nanopore-based targeted next-generation sequencing assay for detection ofJournal of clinical microbiology · 2026Article
- Nanopore-targeted sequencing improves the diagnosis and treatment of patients with infectious ascites.Journal of translational medicine · 2026Article
- Bedaquiline resistance in patients with Xpert MTB/RIF Ultra-tested rifampicin-resistant tuberculosis in the Western Cape, South Africa: a prospective study.The Lancet. Microbe · 2026Article
- Tuberculosis diagnosis and the complete drug resistance pattern from a single sample within a single day by use of a composite platform of MAX MDR-TB and AmPORE-TB.Journal of clinical microbiology · 2026Article
- Clinical evaluation of a commercial culture-free targeted next-generation sequencing test for diagnosis of drug-resistant tuberculosis.Microbiology spectrum · 2026Article
- Article
- Drug-Resistant Tuberculous Meningitis (DR-TBM) in a Low-Incidence Setting: Two Cases and an Evidence Review Highlighting Key Advances and Knowledge Gaps in Clinical Management.Open forum infectious diseases · 2026Article
- Application of FreezeTB, a targeted nanopore sequencing assay, for identification of drug resistance and lineages among pulmonary tuberculosis cases in Alaska.Microbiology spectrum · 2026Article
- Targeted Next-Generation Sequencing in Drug-Resistant Tuberculosis: WHO Guidance and Practical Implementation Priorities.Biomedicines · 2026Review
- Evaluation of the GenoScreen Deeplex Myc-TB workflow for drug-resistant tuberculosis testing in South Africa.Frontiers in public health · 2026Article
- Clinical utility of targeted next-generation sequencing for rapid detection, species differentiation, drug resistance profiling, and prognostic evaluation inFrontiers in cellular and infection microbiology · 2026Article
- The transformative impact of ultra-rapid nanopore sequencing in precision medicine.Frontiers in immunology · 2026Review
- From mutation detection to treatment decisions: CRISPR-enabled diagnostics for drug-resistant tuberculosis.Frontiers in bioengineering and biotechnology · 2026Review
- Targeted and whole-genome sequencing for drug resistance and genetic relatedness inference of rifampicin-resistantERJ open research · 2026Article
- Research overview-2025: integrating scientific progress to accelerate global tuberculosis elimination.Frontiers in tuberculosis · 2026Article
- Characterizing the epidemiology ofEmerging microbes & infections · 2025Article
- Pretomanid for the treatment of drug resistant pulmonary tuberculosis: a comprehensive review.Archives of microbiology · 2025Review
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15 authors.
Funding
Abstract
backgroundDrug-resistant tuberculosis remains a major obstacle in ending the global tuberculosis epidemic. Deployment of molecular tools for comprehensive drug resistance profiling is imperative for successful detection and characterisation of tuberculosis drug resistance. We aimed to assess the diagnostic accuracy of a new class of molecular diagnostics for drug-resistant tuberculosis.
methodsWe conducted a prospective, cross-sectional, multicentre clinical evaluation of the performance of two targeted next-generation sequencing (tNGS) assays for drug-resistant tuberculosis at reference laboratories in three countries (Georgia, India, and South Africa) to assess diagnostic accuracy and index test failure rates. Eligible participants were aged 18 years or older, with molecularly confirmed pulmonary tuberculosis, and at risk for rifampicin-resistant tuberculosis. Sensitivity and specificity for both tNGS index tests (GenoScreen Deeplex Myc-TB and Oxford Nanopore Technologies [ONT] Tuberculosis Drug Resistance Test) were calculated for rifampicin, isoniazid, fluoroquinolones (moxifloxacin, levofloxacin), second line-injectables (amikacin, kanamycin, capreomycin), pyrazinamide, bedaquiline, linezolid, clofazimine, ethambutol, and streptomycin against a composite reference standard of phenotypic drug susceptibility testing and whole-genome sequencing.
findingsBetween April 1, 2021, and June 30, 2022, 832 individuals were invited to participate in the study, of whom 720 were included in the final analysis (212, 376, and 132 participants in Georgia, India, and South Africa, respectively). Of 720 clinical sediment samples evaluated, 658 (91%) and 684 (95%) produced complete or partial results on the GenoScreen and ONT tNGS workflows, respectively, with 593 (96%) and 603 (98%) of 616 smear-positive samples producing tNGS sequence data. Both workflows had sensitivities and specificities of more than 95% for rifampicin and isoniazid, and high accuracy for fluoroquinolones (sensitivity approximately ≥94%) and second line-injectables (sensitivity 80%) compared with the composite reference standard. Importantly, these assays also detected mutations associated with resistance to critical new and repurposed drugs (bedaquiline, linezolid) not currently detectable by any other WHO-recommended rapid diagnostics on the market. We note that the current format of assays have low sensitivity (≤50%) for linezolid and more work on mutations associated with drug resistance is needed.
interpretationThis multicentre evaluation demonstrates that culture-free tNGS can provide accurate sequencing results for detection and characterisation of drug resistance from Mycobacterium tuberculosis clinical sediment samples for timely, comprehensive profiling of drug-resistant tuberculosis.
fundingUnitaid.
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