ArticleThe Lancet. Microbe2024
Performance of a stool-based quantitative PCR assay for the diagnosis of tuberculosis in adolescents and adults: a multinational, prospective diagnostic accuracy study.
Article in The Lancet. Microbe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Performance of stool-based molecular tests and processing methods for paediatric tuberculosis diagnosis: a systematic review and meta-analysis.The Lancet. Microbe · 2025Pooled it
- Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial.The Lancet. Infectious diseases · 2026Trial
- Comparative evaluation of Anyplex™ MTB/NTM, Xpert MTB/RIF ultra, culture, and microscopy for the diagnosis of pediatric tuberculosis using gastric aspirates.Annals of clinical microbiology and antimicrobials · 2026Article
- Plasma kynurenine/tryptophan ratio as a sensitive blood-based diagnostic tool for tuberculosis: a diagnostic accuracy study among children living with HIV.Frontiers in microbiology · 2026Article
- Improving Tuberculosis Diagnosis Through Artificial Intelligence (CAD4TB) and Stool Xpert MTB/RIF Testing: A Prospective Study From Oromia, Ethiopia.Open forum infectious diseases · 2026Article
- Utility of alternative specimens in the diagnosis of pulmonary tuberculosis in people living with human immunodeficiency virus in Guinea.BMC infectious diseases · 2025Article
- Defining the role forJournal of clinical tuberculosis and other mycobacterial diseases · 2025Article
- Stool-Based Molecular Tuberculosis Treatment Monitoring: A Faster Means for Detecting Persistent Mycobacteria Compared to Phenotypic Culture.Open forum infectious diseases · 2025Article
- Identification and quantification ofJournal of clinical microbiology · 2025Article
- Performance of stool Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis among adults living with HIV: a multicentre, prospective diagnostic study.The Lancet. Microbe · 2025Observational
- Performance of a Novel Stool Quantitative Polymerase Chain Reaction Assay for Pediatric Tuberculosis Detection in Sub-Saharan Africa.Journal of the Pediatric Infectious Diseases Society · 2025Article
- Tuberculosis and HIV coinfection: Progress and challenges towards reducing incidence and mortality.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025Review
- Performance of stool-based Xpert MTB/RIF assay in the diagnosis of presumptive pulmonary tuberculosis in adults unable to expectorate sputum.Microbiology spectrum · 2025Article
- Drug susceptibility testing for TB using the Xpert MTB/XDR assay on stool specimens.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2025Article
- Article
- Screening and targeted sequencing of stool for microbiologic confirmation and drug resistance determination in paucibacillary tuberculosis.PLOS global public health · 2025Article
- A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2025 Update for Clinicians and Scientists.Pathogens & immunity · 2025Review
- From Tradition to Innovation: Diverse Molecular Techniques in the Fight Against Infectious Diseases.Diagnostics (Basel, Switzerland) · 2024Review
- Stool Sampling as a Non-invasive Method to Confirm Miliary Tuberculosis in a Patient With a History of HIV Infection.Cureus · 2024Article
- Advances in TB diagnostics: A critical element for the elimination toolkit.The Indian journal of medical research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors.
Funding
Abstract
backgroundDespite increasing availability of rapid molecular tests for the diagnosis of tuberculosis in high-burden settings, many people with tuberculosis are undiagnosed. Reliance on sputum as the primary specimen for tuberculosis diagnostics contributes to this diagnostic gap. We evaluated the diagnostic accuracy and additive yield of a novel stool quantitative PCR (qPCR) assay for the diagnosis of tuberculosis in three countries in Africa with high tuberculosis burdens.
methodsWe undertook a prospective diagnostic accuracy study in Eswatini, Mozambique, and Tanzania from Sept 21, 2020, to Feb 2, 2023, to compare the diagnostic accuracy for tuberculosis of a novel stool qPCR test with the current diagnostic standard for Mycobacterium tuberculosis DNA detection from sputum and stool, Xpert-MTB/RIF Ultra (Xpert Ultra). Sputum, stool, and urine samples were provided by a cohort of participants, aged 10 years or older, diagnosed with tuberculosis. Participants with tuberculosis (cases) were enrolled within 72 h of treatment initiation for tuberculosis diagnosed clinically or following laboratory confirmation. Participants without tuberculosis (controls) consisted of household contacts of the cases who did not develop tuberculosis during a 6-month follow-up. The performance was compared with a robust composite microbiological reference standard (CMRS).
findingsThe cohort of adolescents and adults (n=408) included 268 participants with confirmed or clinical tuberculosis (cases), 147 (55%) of whom were living with HIV, and 140 participants (controls) without tuberculosis. The sensitivity of the novel stool qPCR was 93·7% (95% CI 87·4-97·4) compared with participants with detectable growth on M tuberculosis culture, and 88·1% (81·3-93·0) compared with sputum Xpert Ultra. The stool qPCR had an equivalent sensitivity as sputum Xpert Ultra (94·8%, 89·1-98·1) compared with culture. Compared with the CMRS, the sensitivity of the stool qPCR was higher than the current standard for tuberculosis diagnostics on stool, Xpert Ultra (80·4%, 73·4-86·2 vs 73·5%, 66·0-80·1; p=0·025 on paired comparison). The qPCR also identified 17-21% additional tuberculosis cases compared to sputum Xpert Ultra or sputum culture. In controls without tuberculosis, the specificity of the stool qPCR was 96·9% (92·2-99·1).
interpretationIn this study, a novel qPCR for the diagnosis of tuberculosis from stool specimens had a higher accuracy in adolescents and adults than the current diagnostic PCR gold standard on stool, Xpert-MTB/RIF Ultra, and equivalent sensitivity to Xpert-MTB/RIF Ultra on sputum.
fundingNational Institutes of Health (NIH) Allergy and Infectious Diseases, and NIH Fogarty International Center.
Indexed as
Identifiers
What OpenQuestion holds
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.