ReviewThe Journal of infectious diseases2015
Target product profile of a molecular drug-susceptibility test for use in microscopy centers.
Review in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses 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
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Facilitating the use of the target product profile in academic research: a systematic review.Journal of translational medicine · 2024Pooled it
- Target Product Profiles for medical tests: a systematic review of current methods.BMC medicine · 2020Pooled it
- Target Product Profile for a Machine Learning-Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study.JMIR research protocols · 2024Article
- Development of a target product profile for new glucose self-monitoring technologies for use in low- and middle-income countries.PloS one · 2024Article
- Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.BMC pediatrics · 2023Article
- Tuberculosis Treatment Monitoring and Outcome Measures: New Interest and New Strategies.Clinical microbiology reviews · 2022Review
- Advances in Molecular Diagnosis of Tuberculosis.Journal of clinical microbiology · 2020Review
- Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance.PloS one · 2020Article
- Implementation of XpertPublic health action · 2019Article
- Detection of Mycobacterium tuberculosis in pediatric stool samples using TruTip technology.BMC infectious diseases · 2019Article
- Mycobacterium tuberculosis detection from oral swabs with Xpert MTB/RIF ULTRA: a pilot study.BMC research notes · 2019Article
- What will it take to eliminate drug-resistant tuberculosis?The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019Article
- Defining System Requirements for Simplified Blood Culture to Enable Widespread Use in Resource-Limited Settings.Diagnostics (Basel, Switzerland) · 2019Article
- Redefining typhoid diagnosis: what would an improved test need to look like?BMJ global health · 2019Article
- Developmental roadmap for antimicrobial susceptibility testing systems.Nature reviews. Microbiology · 2019Review
- Genetic sequencing for surveillance of drug resistance in tuberculosis in highly endemic countries: a multi-country population-based surveillance study.The Lancet. Infectious diseases · 2018Article
- Optimising diagnosis of viraemic hepatitis C infection: the development of a target product profile.BMC infectious diseases · 2017Article
- Real-Time Sequencing of Mycobacterium tuberculosis: Are We There Yet?Journal of clinical microbiology · 2017Article
- FIND Tuberculosis Strain Bank: a Resource for Researchers and Developers Working on Tests To Detect Mycobacterium tuberculosis and Related Drug Resistance.Journal of clinical microbiology · 2017Article
- Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis.PloS one · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 6 countries.
Funding
Abstract
backgroundCurrent phenotypic testing for drug resistance in patients with tuberculosis is inadequate primarily with respect to turnaround time. Molecular tests hold the promise of an improved time to diagnosis.
methodsA target product profile for a molecular drug-susceptibility test (DST) was developed on the basis of a collaborative effort that included opinions gathered from researchers, clinicians, policy makers, and test developers on optimal clinical and operational characteristics in settings of intended use. In addition, the current diagnostic ecosystem and the diagnostic development landscape were mapped.
resultsMolecular DSTs for detecting tuberculosis in microscopy centers should ideally evaluate for resistance to rifampin, fluoroquinolones, isoniazid, and pyrazinamide and enable the selection of the most appropriate treatment regimen. Performance characteristics of DSTs need to be optimized, but compromises can be made that depend on the trade-off between a false-positive result and a false-negative result. The operational requirements of a test will vary depending on the site of implementation. However, the most-important considerations pertain to quality control, maintenance and calibration, and the ability to export data.
conclusionThis target product profile defines the needs as perceived by the tuberculosis stakeholder community and attempts to provide a means of communication with test developers to ensure that fit-for-purpose DSTs are being developed.
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.