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

Humans Point-of-Care Systems Triage Tuberculosis / diagnosis Point-of-Care Testing Sensitivity and Specificity Biomarkers Mycobacterium tuberculosis

Biomarker Biosignature Non-sputum based screening TB Tuberculosis

Journal

BMC infectious diseases

ISSN: 1471-2334

Titre abrégé: BMC Infect Dis

Pays: England

ID NLM: 100968551

Informations de publication

Date de publication:
03 Jul 2023

Historique:

received: 14 03 2023

accepted: 22 05 2023

medline: 5 7 2023

pubmed: 4 7 2023

entrez: 3 7 2023

Statut: epublish

Résumé

To 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). This 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. 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. NCT04232618 (clinicaltrials.gov) Date of registration: 16 January 2020.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

This 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 CONCLUSIONS

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 REGISTRATION BACKGROUND

NCT04232618 (clinicaltrials.gov) Date of registration: 16 January 2020.

Identifiants

DOI: 10.1186/s12879-023-08342-5 PMID: 37400753 PMC: PMC10318779

pubmed: 37400753

doi: 10.1186/s12879-023-08342-5

pii: 10.1186/s12879-023-08342-5

pmc: PMC10318779

doi:

Substances chimiques

Biomarkers 0

Banques de données

ClinicalTrials.gov

['NCT04232618']

Types de publication

Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

447