VIDAS® TB-IGRA Accuracy in Tuberculosis Patients and Persons at Varying Risk of Exposure

Background: Detection and treatment of individuals with presumed latent tuberculosis (TB) infection (i.e., excluding active disease; LTBI) is imperative to achieve global TB control, as they represent a potential transmission reservoir. However, more sensitive and user–friendly diagnostic tools are needed. Methods: We evaluated the accuracy for TB infection detection of the new VIDAS® TB–IGRA (bioMérieux), a fully automated, single tube (thus eliminating the need for batch testing) overnight incubation assay, compared to the QuantiFERON®–TB Gold Plus (QFT–Plus, QIAGEN), in a global multi–centre cross–sectional study ([NCT04048018][1]) that included patients with TB disease (n=200) or participants at varying levels of TB exposure (n=1460; mixed exposure–risk–population). Results: VIDAS® TB–IGRA identified TB disease with greater sensitivity than QFT–Plus (97.5% vs. 80.7%, P<0.01%), and yielding significantly fewer false–negatives (2.5% vs. 17.5%; P<0.01%) and indeterminate results (1.0% vs. 9.5%; P=0.02%). In the mixed exposure–risk–population, negative (NPA) and positive percent agreement (PPA) were 90.1% (1097/1217) and 92.1% (223/242), respectively. PPA increased with TB–exposure risk (up to 95.7% for high–risk participants), whereas NPA decreased (starting from 96.9% for low–risk participants). Regression analyses revealed that VIDAS® TB–IGRA had a better fit with the risk–exposure gradient than the QFT‑Plus. Specificity in extremely low TB–exposure risk participants (n = 125) was high for both VIDAS® TB–IGRA and QFT–Plus (97.6% vs. 95.2%; P=8.33%). Conclusions: VIDAS® TB–IGRA displayed greater sensitivity than QFT–Plus, had a lower indeterminate rate, correlated better with an exposure gradient, and was highly specific, suggesting that it is a potentially valuable tool for the diagnosis of LTBI. ### Competing Interest Statement All authors had financial support from bioMérieux for performing this study. ### Clinical Trial NCT04048018 ### Funding Statement This study was funded by bioMérieux ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The following gave ethical approval for this work: - The French National Ethics committee (CPP, ref. 2019-A00998-49) - The UK Health Research Authority (Wales Research Ethics Committee 7, REC refs: 19/WA/0284 and 19/WA/0285) - The INMI "L. Spallanzani" (Rome, Italy) Ethics Committee (approval n°35/2019) - The "Comité de Ética en Investigación del Hospital General de Mexicali" (Mexico, ref. 02-01-HGMXL/FMED-UABC-2019-08-29-254) - In South Africa: - Pharma ethics refs. 190822774 and 190822777 - University of Cape Town Human Research Ethics Committee ref. 840/2019 - In USA: - Western Institutional Review Board (WIRB, tracking numbers: 20191965; 20192037; 20192039) - The Rutgers University Institutional Review Board (Refs: Pro2019001840 and Pro2019001936) - The Stanford University Institutional Review Board (eProtocol number: 53485) - The University of Illinois at Chicago Institutional Review Board (research protocol number: 2019-1145) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04048018&atom=%2Fmedrxiv%2Fearly%2F2024%2F07%2F05%2F2024.07.03.24309158.atom