Evidence map›Paper›PMID 41384933›Full record

ArticleMicrobiology spectrum2026

Clinical evaluation of a commercial culture-free targeted next-generation sequencing test for diagnosis of drug-resistant tuberculosis.

Paolo Miotto, Rebecca E Colman, Andrea M Cabibbe, Paola M V Rancoita, Federico Di Marco, Andres De la Rossa, Christine Hoogland, Swapna Uplekar, Sacha Laurent, Daniela M Cirillo and 8 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Microbiology spectrum, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04239326 (Multicentre Clinical Trial to Assess the Performance of Culture-free, End-to-end Targeted NGS), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04239326 completednot on this map

Multicentre Clinical Trial to Assess the Performance of Culture-free, End-to-end Targeted NGS (tNGS) Solutions for Diagnosis of Drug Resistant TB (DR-TB)

TypeobservationalSponsorFoundation for Innovative New Diagnostics, SwitzerlandRan2021 to 2023Enrolled800ConditionsTuberculosis, Multidrug-ResistantArmstargeted Next Generation Sequencing (tNGS)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Paolo Miotto *Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0003-4610-2427
Rebecca E Colman *FIND, Geneva, Switzerland.ORCID 0000-0002-6854-2100
Andrea M Cabibbe *Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0001-9727-6465
Paola M V RancoitaUniversity Centre for Statistics in the Biomedical Sciences (CUSSB), Vita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0001-9345-691X
Federico Di MarcoEmerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0003-0376-1342
Andres De la RossaFIND, Geneva, Switzerland.ORCID 0009-0009-1040-2648
Christine HooglandFIND, Geneva, Switzerland.ORCID 0000-0002-7341-1551
Swapna UplekarFIND, Geneva, Switzerland.
Sacha LaurentFIND, Geneva, Switzerland.
Daniela M CirilloEmerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0001-6415-1535
Camilla RodriguesHinduja Hospital and Medical Research Centre, Mumbai, India.
Priti KambliHinduja Hospital and Medical Research Centre, Mumbai, India.
Nestani TukvadzeSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Nino MaghradzeSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID 0000-0003-1227-1900
Shaheed V OmarCentre for Tuberculosis, National & WHO Supranational TB Reference Laboratory, National Institute for Communicable Diseases (a division of the National Health Laboratory Service), Johannesburg, South Africa.ORCID 0000-0001-6983-1636
Lavania JosephCentre for Tuberculosis, National & WHO Supranational TB Reference Laboratory, National Institute for Communicable Diseases (a division of the National Health Laboratory Service), Johannesburg, South Africa.
Anita SureshFIND, Geneva, Switzerland.
Timothy C RodwellFIND, Geneva, Switzerland.ORCID 0000-0003-2779-3197

Funding

Emory-Georgia TB Research Training ProgramD43TW007124 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Nestani Tukvadze · 2004 to 2026
$4.6M
FIC NIH HHS D43 TW007124Unitaid 2019-32-FIND MDR
6 · The paper itself

Abstract

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 IMPORTANCE: Drug-resistant tuberculosis (TB) threatens progress in global TB control, yet current molecular tests detect resistance to only a few drugs. Targeted next-generation sequencing (tNGS) can read many resistance-related genes at once, offering faster and broader results than conventional culture-based testing. We evaluated a commercial tNGS workflow (DeepChek 13-Plex KB, ABL Diagnostics) for direct detection of drug resistance in sputum samples from adults with pulmonary TB in India, South Africa, and Georgia. Among 832 participants, sequencing produced valid results for most samples with moderate or high bacterial loads. The assay accurately identified resistance to key drugs-including rifampicin, isoniazid, fluoroquinolones, and newer medicines such as bedaquiline and clofazimine-while maintaining high specificity. These findings show that tNGS can deliver comprehensive resistance profiles, supporting tailored treatment for people with drug-resistant TB. Further refinement in sample preparation may expand its use to specimens with lower bacterial counts. CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT04239326.

Indexed as

Antitubercular AgentsHigh-Throughput Nucleotide SequencingMycobacterium tuberculosisTuberculosis, Multidrug-ResistantAdultAgedCross-Sectional StudiesFemaleHumansIndiaMaleMicrobial Sensitivity TestsMiddle AgedMolecular Diagnostic TechniquesProspective StudiesSensitivity and SpecificityAntitubercular Agentsdrug resistancemolecular diagnosticsmulticenter studytargeted next-generation sequencing (tNGS)tuberculosis

Identifiers

PMID41384933
PMCPMC12889153

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.