AI Article Synopsis
- The study focuses on evaluating two new diagnostic tests for tuberculosis (TB) infection, Cy-Tb and Standard F TB, which aim to improve accuracy and reduce costs in low-resource settings.
- It involves a cross-sectional trial with participants divided into three groups: those with confirmed TB, household contacts, and people without TB, comparing these tests with a standard reference test, QFT-Plus.
- Ethical approval has been obtained, and the research findings will be shared with the scientific community and policymakers through publications.
Article Abstract
Introduction: The large reservoir of tuberculosis (TB) infections is one of the main reasons for the persistent incidence of TB. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The rdESAT-6 and rCFP-10 (Cy-Tb) injection ('Cy-Tb'), a TB-specific antigen skin test and STANDARD F TB-Feron FIA ('Standard F TB') measuring interferon-gamma by fluorescence immunoassay assay are two novel tools for the diagnosis of TB infection which offer advantages compared with current tests in low-resource settings and reduced costs to both health systems and TB-affected people. The proposed study aims to evaluate the diagnostic accuracy of these two new tests for TB infection diagnosis.
Methods And Analysis: This cross-sectional study aims to assess the diagnostic accuracy for TB infection of the Cy-Tb skin test and Standard F TB assay (investigational tests) compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay as the immunological reference standard. Three different cohorts of study participants will be recruited at the Vietnam National Lung Hospital: adults with bacteriologically confirmed pulmonary TB (n=100), household contacts of people with TB (n=200) and people without TB infection (n=50). All consenting participants will undergo simultaneous testing with Cy-Tb, Standard F TB and QFT-Plus. The primary endpoint is the diagnostic accuracy of the Cy-Tb skin test and Standard F TB assay, expressed as sensitivity and specificity against the reference standard.
Ethics And Dissemination: Ethical approval was granted by the Vietnam National Lung Hospital Institutional Review Board (65/23/CN-HDDD-BVPTU) and the Swedish Ethical Review Authority (Dnr 2023-04271-01). Study results will be disseminated to the scientific community and policymakers through scientific publications.
Trial Registration Number: NCT06221735.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11331973 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2024-085614 | DOI Listing |
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