Preliminary diagnostic performance of the VIDAS® TB-IGRA for the detection of Mycobacterium tuberculosis infection and disease

Importance Accurate diagnosis of tuberculosis (TB) infection can be achieved with interferon-γ release assays. Their performance can be improved by utilizing fully automated, single-patient formats. Objective Establish clinical thresholds for a new interferon-γ release assay, the VIDAS® TB-IGRA, and compare diagnostic performance in detecting tuberculosis infection and disease with the established QuantiFERON-TB Gold Plus (QFT-Plus). Design Preliminary diagnostic performance study (October 2nd, 2019–February 20th, 2020). Setting Multicenter. Participants Participants were divided into TB disease, high-risk, and low-risk populations. The confirmed TB disease population included 107 patients. The high-risk population included 162 individuals with flagged risk factors on a questionnaire but without objective clinical confirmation of TB. The Low-risk population included 117 healthy blood donors from the French National Blood Bank. Exposures Tuberculosis. Main Outcomes and Measures Positive and negative percent agreement (PPA, NPA) were determined between the VIDAS® TB-IGRA and QFT-Plus. In the TB disease and low-risk populations, sensitivity was also measured against bacterial culture and PCR. Results The VIDAS® TB-IGRA produced fewer indeterminate results than the QFT-Plus (1/107 vs. 23/107) in the TB disease population. One analysis included indeterminate results as false negatives (94 positives and 10 false negatives vs. 56 positives and 48 false negatives), and the VIDAS® TB-IGRA exhibited higher sensitivity than the QFT-Plus (90.4% vs. 53.8%) (p<0.0001). Another analysis excluded indeterminate results (76 positives and 4 false negatives vs. 55 positives and 25 false negatives), and the VIDAS® TB-IGRA again exhibited higher sensitivity than the QFT-Plus (95.0% vs. 68.8%) (p<0.0001). A 98.2% PPA was calculated between the two tests with this dataset. In the high-risk population, the VIDAS® TB-IGRA exhibited a strong PPA (94.4%) with the QFT-Plus. However, a lower than expected NPA was observed (85.2%). In the low-risk population, the VIDAS® TB-IGRA demonstrated high specificity (94.9%) and a strong NPA (98.2%) with the QFT-Plus. Conclusions and Relevance The fully automated VIDAS® TB-IGRA is a promising diagnostic test for both TB infection and disease. It exhibits higher sensitivity while maintaining specificity and produces fewer indeterminate interpretations. Its easy-to-use, single-patient format may lead to increased TB testing to help with the worldwide eradication of the disease. Question What is the diagnostic performance of the VIDAS® TB-IGRA in detecting tuberculosis infection and disease? Findings The VIDAS® TB-IGRA exhibited high sensitivity in individuals with tuberculosis disease (90.4–95.0%), high specificity in healthy blood donors (94.9%), a high positive percent agreement (PPA) in individuals with a high risk of tuberculosis infection (94.4%), and it produced a low number of indeterminate results (1/386). Meaning The VIDAS® TB-IGRA is a promising diagnostic test for both tuberculosis infection and disease. ### Competing Interest Statement The Hospital of Paris, the Institute for Health Sciences Research of Ouagadougou, and Rutgers University all received research funding from bioMérieux for this study. Pf. Gennaro declares a consulting contract with bioMérieux. Pf. Cirillo has been member of the bioMérieux advisory board. ### Funding Statement This study was funded by bioMérieux company ### 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: Ethics committee of Institute of Health Sciences Research, Biomedical/Public Health Department, Ouagadougou, Burkina Faso gave ethical approval of this work (25 A012-2019/CEIRES). IRB of Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark, NJ, USA gave ethical approval of this work (IRB00000607). ethical committee of Hôpital Lariboisèire AP-HP/Assistance Publique-Hopitaux de Paris gave ethical approval of this work (BB-0033-00064). Ethical committee of Etablissement Français du Sang gave ethical approval of this work (AC-2017-2958). 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 and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors