ArticleThe Journal of infectious diseases2019
Guidance for Studies Evaluating the Accuracy of Sputum-Based Tests to Diagnose Tuberculosis.
Article in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
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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
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Screening tests for active pulmonary tuberculosis in children.The Cochrane database of systematic reviews · 2021Pooled it
- Diagnostic Performance of the Pluslife MiniDock MTB and Molbio MTB Ultima Assays to Detect Tuberculosis From Tongue and Sputum Swabs Among Outpatients and in Active Case Finding in Cameroon.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Simultaneous detection of Mycobacterium tuberculosis complex and rifampin/isoniazid resistance with sanity 2.0 MTBC-MDR: a moderate-complexity automated NAAT.World journal of microbiology & biotechnology · 2026Article
- iFIND INH/FQ: a LC-aNAAT assay for rapid simultaneous detection of isoniazid and fluoroquinolone resistance inMicrobiology spectrum · 2026Article
- Real-world performance of iFIND-TBR for rapid detection ofFrontiers in microbiology · 2026Article
- Systemic Host Proteomic Signatures as Dynamic Markers for Monitoring Pulmonary Tuberculosis Treatment Response.Infection and drug resistance · 2026Review
- A streamlined CRISPR-based test for tuberculosis detection directly from sputum.Science advances · 2025Article
- Simultaneous detection and differentiation ofMicrobiology spectrum · 2025Article
- Multicentric validation of the PathoDetect™ MTB RIF & INH assay for simultaneous detection of Mycobacterium tuberculosis, & drug resistance to rifampicin & isoniazid in presumptive pulmonary tuberculosis & drug-resistant TB patients.The Indian journal of medical research · 2025Article
- Rapid quantitative PCR on tongue swabs for pulmonary tuberculosis in adults: a prospective multicentre study.The European respiratory journal · 2025Article
- Article
- Development and preliminary assessment of the iFIND TBR: all-in- one molecular diagnostic assay for rapid detection ofFrontiers in cellular and infection microbiology · 2024Article
- Early user perspectives on using computer-aided detection software for interpreting chest X-ray images to enhance access and quality of care for persons with tuberculosis.BMC global and public health · 2023Review
- Xpert MTB/RIF Ultra on contaminated liquid cultures for tuberculosis and rifampicin-resistance detection: a diagnostic accuracy evaluation.The Lancet. Microbe · 2023Article
- Diagnostic Accuracy of the Truenat MTB Plus Assay and Comparison with the Xpert MTB/RIF Assay to Detect Tuberculosis among Hospital Outpatients in Cameroon.Journal of clinical microbiology · 2022Article
- Use of DosR and Rpf antigens from Mycobacterium tuberculosis to screen for latent and relapse tuberculosis infection in a tuberculosis endemic community of Huainan City.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022Article
- Asia emerges as a hotbed of diagnostic innovations for tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2021Article
- A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.The European respiratory journal · 2021Article
- Comparative Analytical Evaluation of Four Centralized Platforms for the Detection of Mycobacterium tuberculosis Complex and Resistance to Rifampicin and Isoniazid.Journal of clinical microbiology · 2021Article
- Low Cycle Threshold Value in Xpert MTB/RIF Assay May Herald False Detection of Tuberculosis and Rifampicin Resistance: A Study of Two Cases.Open forum infectious diseases · 2021Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
Tests that can replace sputum smear microscopy have been identified as a top priority diagnostic need for tuberculosis by the World Health Organization. High-quality evidence on diagnostic accuracy for tests that may meet this need is an essential requirement to inform decisions about policy and scale-up. However, test accuracy studies are often of low and inconsistent quality and poorly reported, leading to uncertainty about true test performance. Here we provide guidance for the design of diagnostic test accuracy studies of sputum smear-replacement tests. Such studies should have a cross-sectional or cohort design, enrolling either a consecutive series or a random sample of patients who require evaluation for tuberculosis. Adults with respiratory symptoms are the target population. The reference standard should at a minimum be a single, automated, liquid culture, but additional cultures, follow-up, clinical case definition, and specific measures to understand discordant results should also be included. Inclusion of smear microscopy and Xpert MTB/RIF (or MTB/RIF Ultra) as comparators is critical to allow broader comparability and generalizability of results, because disease spectrum can vary between studies and affects relative test performance. Given the complex nature of sputum (the primary specimen type used for pulmonary TB), careful design and reporting of the specimen flow is essential. Test characteristics other than accuracy (such as feasibility, implementation considerations, and data on impact on patient, population and health systems outcomes) are also important aspects.
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Registered trials
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