Evidence map›Paper›PMID 37400753›Full record

Observational studyBMC infectious diseases2023

Field evaluation of a point-of-care triage test for active tuberculosis (TriageTB).

Tracy R Richardson, Bronwyn Smith, Stephanus T Malherbe, Jane Alexandra Shaw, Firdows Noor, Candice MacDonald, Gian D van der Spuy, Kim Stanley, Alida Carstens, Tarryn-Lee Fisher and 20 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04232618 (Field Evaluation of a Point-of-care Triage Test for Active Tuberculosis), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
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.

NCT04232618 unknown statusnot on this map

Field Evaluation of a Point-of-care Triage Test for Active Tuberculosis

Typeobservational_patient_registrySponsorUniversity of StellenboschRan2020 to 2024Enrolled900ConditionsTuberculosis, Tuberculosis, PulmonaryArmsMulti-biomarker point-of-care test
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  3. Evaluation of C-Reactive Protein and Computer-Aided Analysis of Chest X-rays as Tuberculosis Triage Tests at Health Facilities in Lesotho and South Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Diagnosing Tuberculosis: What Do New Technologies Allow Us to (Not) Do?Respiration; international review of thoracic diseases · 2022
    Review
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

30 authors at 12 institutions in 8 countries.

Tracy R RichardsonStellenbosch University, Cape Town, South Africa. cummins@sun.ac.za.
Bronwyn SmithStellenbosch University, Cape Town, South Africa.
Stephanus T MalherbeStellenbosch University, Cape Town, South Africa.
Jane Alexandra ShawStellenbosch University, Cape Town, South Africa.
Firdows NoorStellenbosch University, Cape Town, South Africa.
Candice MacDonaldStellenbosch University, Cape Town, South Africa.
Gian D van der SpuyStellenbosch University, Cape Town, South Africa.
Kim StanleyStellenbosch University, Cape Town, South Africa.
Alida CarstensStellenbosch University, Cape Town, South Africa.
Tarryn-Lee FisherStellenbosch University, Cape Town, South Africa.
Ilana van RensburgStellenbosch University, Cape Town, South Africa.
Marika FlinnStellenbosch University, Cape Town, South Africa.
Candice SnydersStellenbosch University, Cape Town, South Africa.
Isaac JohnsonStellenbosch University, Cape Town, South Africa.
Bernadine FransmanStellenbosch University, Cape Town, South Africa.
Hazel DockrellLondon School of Hygiene and Tropical Medicine, London, UK.
Guy ThwaitesUniversity of Oxford, Oxford, UK.
Nguyen Thuy Thuong ThuongUniversity of Oxford, Oxford, UK.
Claudia SchachtLINQ Management, Berlin, Germany.
Harriet Mayanja-KizzaMakerere University, Kampala, Uganda.
Mary NserekoMakerere University, Kampala, Uganda.
Elisa M Tjon Kon FatLeiden University Medical Centre, Leiden, The Netherlands.
Paul L A M CorstjensLeiden University Medical Centre, Leiden, The Netherlands.
Annemieke GelukLeiden University Medical Centre, Leiden, The Netherlands.
Morton RuhwaldFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Adam Penn-NicholsonFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Novel N ChegouStellenbosch University, Cape Town, South Africa.
Jayne SutherlandLondon School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Gerhard WalzlStellenbosch University, Cape Town, South Africa.
TrENDx consortium
Stellenbosch University · ZAMakerere University · UGLondon School of Hygiene & Tropical Medicine · GBFoundation for Innovative New Diagnostics · CHGerman Agency for Quality in Medicine · DELeiden University Medical Center · NLLeiden University · NLMRC Unit the Gambia · GMUniversity of Cape Town · ZAUniversity of Oxford · GBCatalysis Foundation for Health · USColorado State University · US

Funding

Medical Research Council MC_U190071468Medical Research Council MC_UU_00031/6
6 · The paper itself

Abstract

backgroundTo improve tuberculosis (TB) diagnosis, the World Health Organisation (WHO) has called for a non-sputum based triage test to focus TB testing on people with a high likelihood of having active pulmonary tuberculosis (TB). Various host or pathogen biomarker-based testing devices are in design stage and require validity assessment. Host biomarkers have shown promise to accurately rule out active TB, but further research is required to determine generalisability. The TriageTB diagnostic test study aims to assess the accuracy of diagnostic test candidates, as well as field-test, finalise the design and biomarker signature, and validate a point-of-care multi-biomarker test (MBT).

methodsThis observational diagnostic study will evaluate sensitivity and specificity of biomarker-based diagnostic candidates including the MBT and Xpert® TB Fingerstick cartridge compared with a gold-standard composite TB outcome classification defined by symptoms, sputum GeneXpert® Ultra, smear and culture, radiological features, response to TB therapy and presence of an alternative diagnosis. The study will be conducted in research sites in South Africa, Uganda, The Gambia and Vietnam which all have high TB prevalence. The two-phase design allows for finalisation of the MBT in Phase 1 in which candidate host proteins will be evaluated on stored serum from Asia, South Africa and South America and on fingerstick blood from 50 newly recruited participants per site. The MBT test will then be locked down and validated in Phase 2 on 250 participants per site. DISCUSSION: By targeting confirmatory TB testing to those with a positive triage test, 75% of negative GXPU may be avoided, thereby reducing diagnostic costs and patient losses during the care cascade. This study builds on previous biomarker research and aims to identify a point-of-care test meeting or exceeding the minimum World Health Organisation target product profile of a 90% sensitivity and 70% specificity. Streamlining TB testing by identifying individuals with a high likelihood of TB should improve TB resources use and, in so doing, improve TB care.

trial registrationNCT04232618 (clinicaltrials.gov) Date of registration: 16 January 2020.

Indexed as

Mycobacterium tuberculosisTuberculosisBiomarkersHumansPoint-of-Care SystemsPoint-of-Care TestingSensitivity and SpecificityTriageBiomarkersBiomarkerBiosignatureNon-sputum based screeningTBTuberculosis

Identifiers

PMID37400753
PMCPMC10318779
OpenAlexW4382938140

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.