ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Non-actionable Results, Accuracy, and Effect of First- and Second-line Line Probe Assays for Diagnosing Drug-Resistant Tuberculosis, Including on Smear-Negative Specimens, in a High-Volume Laboratory.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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10 citing papers in PubMed, 16 citations in OpenAlex.
- iFIND INH/FQ: a LC-aNAAT assay for rapid simultaneous detection of isoniazid and fluoroquinolone resistance inMicrobiology spectrum · 2026Article
- Peripheral blood neutrophil proteomic profiling with transcriptomic data integration reveals biomarkers for tuberculosis infection diagnosis.EBioMedicine · 2025Article
- Waste to worth: diagnostic accuracy of Xpert MTB/XDR on contaminated liquid cultures to salvage the detection of drug-resistant tuberculosis.Journal of clinical microbiology · 2025Article
- Diagnostic Accuracy of LiquidArray MTB-XDR VER 1.0 for the Detection of Mycobacterium tuberculosis Complex, Fluoroquinolone, Amikacin, Ethambutol, and Linezolid Susceptibility.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Xpert MTB/RIF Ultra-resistant and MTBDRAntimicrobial agents and chemotherapy · 2025Article
- Evaluation of T-NGS, Xpert Ultra, and Line Probe Assay on Clinical Samples for the Diagnosis of Drug-Resistant Pulmonary Tuberculosis in Rio de Janeiro.Revista da Sociedade Brasileira de Medicina Tropical · 2025Article
- ISCCM Position Statement on the Approach to and Management of Critically Ill Patients with Tuberculosis.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024Article
- Point-of-care C-reactive protein and Xpert MTB/RIF Ultra for tuberculosis screening and diagnosis in unselected antiretroviral therapy initiators: a prospective, cross-sectional, diagnostic accuracy study.The Lancet. Global health · 2024Article
- Evaluation of Diagnostic Performance of Line Probe Assay on Smear-Negative Samples of Pulmonary Tuberculosis.Cureus · 2024Article
- To Test or Not? Xpert MTB/RIF as an Alternative to Smear Microscopy to Guide Line Probe Assay Testing for Drug-Resistant Tuberculosis.Journal of clinical microbiology · 2023Article
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundRapid tuberculosis (TB) drug susceptibility testing (DST) is crucial. Genotype MTBDRsl is a widely deployed World Health Organization (WHO)-endorsed assay. Programmatic performance data, including non-actionable results from smear-negative sputum, are scarce.
methodsSputa from Xpert MTB/RIF individuals (n = 951) were routinely-tested using Genotype MTBDRplus and MTBDRsl (both version 2). Phenotypic DST was the second-line drug reference standard. Discrepant results underwent Sanger sequencing.
findings89% (849 of 951) of individuals were culture-positive (56%, 476 of 849 smear-negative). MTBDRplus had at least 1 nonactionable result (control and/or TB-detection bands absent or invalid, precluding resistance reporting) in 19% (92 of 476) of smear-negatives; for MTBDRsl, 40% (171 of 427) were nonactionable (28%, 120 of 427 false-negative TB; 17%, 51 of 427 indeterminate). In smear-negatives, MTBDRsl sensitivity for fluoroquinolones was 84% (95% confidence interval, 67%-93), 81% (54%-95%) for second-line injectable drugs, and 57% (28%-82%) for both. Specificities were 93% (89%-98%), 88% (81%-93%), and 97% (91%-99%), respectively. Twenty-three percent (172 of 746) of Xpert rifampicin-resistant specimens were MTBDRplus isoniazid-susceptible. Days-to-second-line-susceptibility reporting with the programmatic advent of MTBDRsl improved (6 [5-7] vs 37 [35-46]; P < .001).
conclusionsMTBDRsl did not generate a result in 4 of 10 smear-negatives, resulting in substantial missed resistance. However, if MTBDRsl generates an actionable result, that is accurate in ruling-in resistance. Isoniazid DST remains crucial. This study provides real-world, direct, second-line susceptibility testing performance data on non-actionable results (that, if unaccounted for, cause an overestimation of test utility), accuracy, and care cascade impact.
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