Evidence map›Paper›PMID 39190813›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

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.

Shannon Bosman, Irene Ayakaka, Josephine Muhairwe, Mashaete Kamele, Alastair van Heerden, Thandanani Madonsela, Niklaus D Labhardt, Gregor Sommer, Jens Bremerich, Thomas Zoller and 9 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04666311 (Prospective, Multicentre Evaluation of the Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for the Diagnosis of Pulmonary Tuberculosis in Presumptive Adult TB Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04666311 completednot on this map

Prospective, Multicentre Evaluation of the Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for the Diagnosis of Pulmonary Tuberculosis in Presumptive Adult TB Patients (TB TRIAGE+ Accuracy)

TypeobservationalSponsorKlaus ReitherRan2021 to 2022Enrolled1,400ConditionsPulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIVArmsAccuracy of CAD4TB and Afinion CRP assay for pulmonary TB, CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
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  4. Article
  5. 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

19 authors.

Shannon BosmanCentre for Community Based Research, Human Sciences Research Council, Sweetwaters, South Africa.
Irene AyakakaSolidarMed, Partnerships for Health, Maseru, Lesotho.
Josephine MuhairweUS Agency for International Development (USAID), Washington, DC, USA.
Mashaete KameleSolidarMed, Partnerships for Health, Maseru, Lesotho.
Alastair van HeerdenCentre for Community Based Research, Human Sciences Research Council, Sweetwaters, South Africa.
Thandanani MadonselaCentre for Community Based Research, Human Sciences Research Council, Sweetwaters, South Africa.
Niklaus D LabhardtDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
Gregor SommerUniversity of Basel, Basel, Switzerland.
Jens BremerichUniversity of Basel, Basel, Switzerland.
Thomas ZollerCharité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Infectious Diseases, Respiratory and Critical Care Medicine, Berlin, Germany.
Keelin MurphyDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Bram van GinnekenDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Alfred K KeterDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Bart K M JacobsDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Moniek BresserUniversity of Basel, Basel, Switzerland.
Aita SignorellUniversity of Basel, Basel, Switzerland.
Tracy R GlassUniversity of Basel, Basel, Switzerland.
Lutgarde LynenDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Klaus ReitherUniversity of Basel, Basel, Switzerland.ORCID 0000-0001-6195-8237

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo improve tuberculosis case-finding, rapid, non-sputum triage tests need to be developed according to the World Health Organization target product profile (TPP) (>90% sensitivity, >70% specificity). We prospectively evaluated and compared artificial intelligence-based, computer-aided detection software, CAD4TBv7, and C-reactive protein assay (CRP) as triage tests at health facilities in Lesotho and South Africa.

methodsAdults (≥18 years) presenting with ≥1 of the 4 cardinal tuberculosis symptoms were consecutively recruited between February 2021 and April 2022. After informed consent, each participant underwent a digital chest X-ray for CAD4TBv7 and a CRP test. Participants provided 1 sputum sample for Xpert MTB/RIF Ultra and Xpert MTB/RIF and 1 for liquid culture. Additionally, an expert radiologist read the chest X-rays via teleradiology. For primary analysis, a composite microbiological reference standard (ie, positive culture or Xpert Ultra) was used.

resultsWe enrolled 1392 participants, 48% were people with HIV and 24% had previously tuberculosis. The receiver operating characteristic curve for CAD4TBv7 and CRP showed an area under the curve of .87 (95% CI: .84-.91) and .80 (95% CI: .76-.84), respectively. At thresholds corresponding to 90% sensitivity, specificity was 68.2% (95% CI: 65.4-71.0%) and 38.2% (95% CI: 35.3-41.1%) for CAD4TBv7 and CRP, respectively. CAD4TBv7 detected tuberculosis as well as an expert radiologist. CAD4TBv7 almost met the TPP criteria for tuberculosis triage.

conclusionsCAD4TBv7 is accurate as a triage test for patients with tuberculosis symptoms from areas with a high tuberculosis and HIV burden. The role of CRP in tuberculosis triage requires further research. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov identifier: NCT04666311.

Indexed as

C-Reactive ProteinTriageAdolescentAdultArtificial IntelligenceDiagnosis, Computer-AssistedFemaleHealth FacilitiesHumansLesothoMaleMiddle AgedMycobacterium tuberculosisProspective StudiesRadiography, ThoracicSensitivity and SpecificityC-Reactive Proteinchest X-raycomputer-aided detectionC-reactive proteintriage testtuberculosis

Identifiers

PMID39190813
PMCPMC11581699

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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.