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VIDAS结核感染γ干扰素释放试验在辅助诊断结核感染个体中的初步性能。

Preliminary performance of the VIDAS TB-IGRA as an aid in the diagnosis of individuals infected with .

作者信息

Serge Diagbouga Potiandi, Djibougou Arthur Diakourga, Pease Camille, Alcaide Ariana, Berthoux Audrey, Bruiners Natalie, Cirillo Daniela Maria, Combary Ardjouma, Falchero Nadine, Handler Deborah, Kaboré Antoinette, Lardizabal Alfred, Lopes Amanda, Loubet Marissa, Manivet Philippe, Margain Clemence, Meunier Valerie, Mougari Faiza, Onyuka Alberta, Rivoiron Sophie, Sagna Tani, Sanvert Mathilde, Sawadogo Léon, Simporé Jacques, Cambau Emmanuelle, Gennaro Maria Laura

机构信息

Institut de Recherche en Sciences de la Santé, Centre National de la Recherche Scientifique et Technologique (IRSS/CNRST), Ouagadougou, Burkina Faso.

Department of Research and Development for Immunoassays, bioMerieux, Marcy-l'Étoile, Auvergne-Rhône-Alpes, France.

出版信息

J Clin Microbiol. 2025 Jun 11;63(6):e0164124. doi: 10.1128/jcm.01641-24. Epub 2025 May 14.

Abstract

This preliminary study compares VIDAS TB-IGRA (bioMérieux, Marcy-l'Etoile, France) with the established QuantiFERON-TB Gold Plus (QFT-Plus) (Qiagen, Hilden, Germany) to evaluate diagnostic performance for the diagnosis of individuals infected with complex (latent infection and disease). The study was multi-center and performed between 2 October 2019 and 4 February 2020. Participants were divided into tuberculosis (TB) disease, high-risk, and low-risk populations. The confirmed TB disease population included 104 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. Positive and negative percent agreement (PPA and NPA) were determined between the VIDAS TB-IGRA and QFT-Plus. In the TB disease population, sensitivity was measured against bacterial culture and PCR. The VIDAS TB-IGRA produced fewer indeterminate results than the QFT-Plus (1/104 vs 23/104) in the TB disease population and exhibited a sensitivity of 95.0% against bacterial culture. Furthermore, a 98.2% PPA was obtained in comparison to QFT-Plus. In the low-risk population, the VIDAS TB-IGRA demonstrated high specificity (94.9%) and a strong NPA (98.2%) compared to QFT-Plus. In the high-risk population, the VIDAS TB-IGRA exhibited a strong PPA (94.4%) with the QFT-Plus. A lower NPA was observed (85.2%) compared to QFT-Plus, which may be due to a higher sensitivity demonstrated in the TB disease population. The fully automated VIDAS TB-IGRA is a promising aid in the diagnosis of individuals infected with (latent infection and active disease). It exhibits higher sensitivity while maintaining specificity and produces fewer indeterminate interpretations than QFT-Plus. Its easy-to-use, single-patient format may lead to increased TB testing to aid in the adequate diagnosis and management of the disease.IMPORTANCEThis study presents a comprehensive evaluation of the VIDAS TB-IGRA diagnostic test. This test is compared with the established QuantiFERON-TB Gold Plus to assess its effectiveness in diagnosing both latent and active tuberculosis (TB) infections. The study highlights the VIDAS TB-IGRA's higher sensitivity, fewer indeterminate results, and robust performance across different patient populations, including those with confirmed TB disease, high-risk, and low-risk groups. The findings suggest that the VIDAS TB-IGRA could enhance TB diagnosis and management, offering a fully automated, easy-to-use solution that reduces human error and result variability.

摘要

这项初步研究将VIDAS结核感染γ干扰素释放试验(法国马西 - 勒图瓦勒生物梅里埃公司)与已确立的QuantiFERON - TB Gold Plus(QFT - Plus,德国希尔德凯杰公司)进行比较,以评估对复杂(潜伏感染和疾病)感染者的诊断性能。该研究为多中心研究,于2019年10月2日至2020年2月4日进行。参与者被分为结核病(TB)患者组、高危组和低危组。确诊的结核病患者组包括104例患者。高危组包括162名在问卷上有标记的危险因素但无结核病客观临床确诊的个体。低危组包括117名来自法国国家血库的健康献血者。确定了VIDAS结核感染γ干扰素释放试验和QFT - Plus之间的阳性和阴性百分比一致性(PPA和NPA)。在结核病患者组中,针对细菌培养和聚合酶链反应(PCR)测量了敏感性。在结核病患者组中,VIDAS结核感染γ干扰素释放试验产生的不确定结果比QFT - Plus少(1/104对23/104),并且对细菌培养的敏感性为95.0%。此外,与QFT - Plus相比,PPA为98.2%。在低危组中,与QFT - Plus相比,VIDAS结核感染γ干扰素释放试验显示出高特异性(94.9%)和强NPA(98.2%)。在高危组中,VIDAS结核感染γ干扰素释放试验与QFT - Plus的PPA很强(94.4%)。与QFT - Plus相比,观察到较低的NPA(85.2%),这可能是由于在结核病患者组中显示出较高的敏感性。全自动的VIDAS结核感染γ干扰素释放试验在诊断(潜伏感染和活动性疾病)感染者方面是一种有前景的辅助手段。它在保持特异性的同时表现出更高的敏感性,并且比QFT - Plus产生的不确定解读更少。其易于使用的单人份检测形式可能会导致结核病检测增加,有助于对该疾病进行充分的诊断和管理。重要性本研究对VIDAS结核感染γ干扰素释放试验诊断测试进行了全面评估。将该测试与已确立的QuantiFERON - TB Gold Plus进行比较,以评估其在诊断潜伏性和活动性结核病(TB)感染方面的有效性。该研究强调了VIDAS结核感染γ干扰素释放试验在不同患者群体(包括确诊的结核病患者、高危和低危组)中具有更高的敏感性、更少的不确定结果和稳健的性能。研究结果表明,VIDAS结核感染γ干扰素释放试验可以加强结核病的诊断和管理,提供一种全自动、易于使用的解决方案,减少人为误差和结果变异性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ddaf/12153259/232e8dab1880/jcm.01641-24.f001.jpg

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