Diagnostic Performance of Unstimulated IFN-γ (IRISA-TB) for Pleural Tuberculosis: A Prospective Study in South Africa and India.

IF 3.8 4区医学 Q2 IMMUNOLOGY Open Forum Infectious Diseases Pub Date : 2024-09-24 eCollection Date: 2024-10-01 DOI:10.1093/ofid/ofae533

Devasahayam J Christopher, Aliasgar Esmail, Alex J Scott, Lindsay Wilson, Philippa Randall, Balamugesh Thangakunam, Deepa Shankar, Sekar Rajasekar, Christhunesa S Christudass, Louié Kühn, Jeremi Swanepoel, Tahlia Perumal, Anil Pooran, Suzette Oelofse, Keertan Dheda

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Abstract

Background: Tuberculous pleural effusion (TPE) is the most common form of extrapulmonary tuberculosis in many settings. The diagnostic performance of the frontline polymerase chain reaction-based GeneXpert MTB/RIF Ultra (Xpert Ultra) remains suboptimal (sensitivity of ∼30%), but data are limited. Improved diagnostic approaches are urgently needed to detect extrapulmonary tuberculosis (EPTB) in tuberculosis (TB)-endemic settings.

Methods: This multicenter, prospective cohort study evaluated the diagnostic performance of a rapid (same-day) interferon gamma rapid immunosuspension assay (IRISA-TB) in patients with presumed TPE from South Africa and India. Participants underwent pleural biopsy, and testing with other available same-day diagnostic assays (adenosine deaminase [ADA], Xpert Ultra, and IRISA-TB) was concurrently undertaken. The reference standard for TB was microbiological and/or histopathological confirmation using pleural fluid and/or pleural biopsy samples.

Results: A total of 217 participants with presumed TPE were recruited (106 from South Africa, 111 from India). The sensitivity of IRISA-TB (cut-point 20.5 pg/mL) was significantly better than that of Xpert Ultra (81.8% [70.4-90.2] vs 32.9% [22.1-45.1]; P < .001) and ADA at the 40 IU/mL cut-point used in India (81.8% [70.4-90.2] vs 53.8% [41.0-66.3]; P = .002). Compared with ADA at the 30 IU/mL cut-point used in South Africa, IRISA-TB had a higher specificity (96.6% [90.3-99.3] vs 87.1% [78.6-93.2]) and a higher positive predictive value (94.7% [85.5-97.3] vs 81.8% [72.4-88.5]). The negative predictive value (NPV; rule-out value) of IRISA-TB was significantly better than that of Xpert Ultra (87.5% [83.2-93.0] vs 64.9% [61.1-68.6]; P < .001) and ADA at the 40 IU/mL cut-point (87.5% [83.2-93.0] vs 74.1% [68.7-79.0]; P < .001).

Conclusions: IRISA-TB demonstrated markedly better sensitivity and NPV than Xpert Ultra and excellent specificity for the diagnosis of TPE. These data have implications for clinical practice in TB-endemic settings.

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未经刺激的 IFN-γ (IRISA-TB) 对胸膜结核的诊断性能：南非和印度的前瞻性研究。

背景：结核性胸腔积液（TPE）是许多环境中最常见的肺外结核形式。基于聚合酶链反应的 GeneXpert MTB/RIF Ultra（Xpert Ultra）的一线诊断性能仍不理想（灵敏度为 30%），但数据有限。在结核病（TB）流行的环境中，迫切需要改进诊断方法来检测肺外结核病（EPTB）：这项多中心、前瞻性队列研究评估了快速（当天）γ干扰素快速免疫悬浮检测法（IRISA-TB）在南非和印度推定肺结核患者中的诊断效果。参试者接受了胸膜活检，并同时接受了其他可用的当天诊断测定（腺苷脱氨酶 [ADA]、Xpert Ultra 和 IRISA-TB）的检测。结核病的参考标准是使用胸腔积液和/或胸膜活检样本进行微生物学和/或组织病理学确认：结果：共招募了 217 名推测为 TPE 的参与者（其中 106 人来自南非，111 人来自印度）。IRISA-TB（切点 20.5 pg/mL）的灵敏度明显优于 Xpert Ultra（81.8% [70.4-90.2] vs 32.9% [22.1-45.1]；P < .001）和印度使用的切点为 40 IU/mL 的 ADA（81.8% [70.4-90.2] vs 53.8% [41.0-66.3]；P = .002）。与南非使用的 30 IU/mL 切点 ADA 相比，IRISA-TB 的特异性更高（96.6% [90.3-99.3] vs 87.1% [78.6-93.2]），阳性预测值更高（94.7% [85.5-97.3] vs 81.8% [72.4-88.5]）。IRISA-TB 的阴性预测值（NPV；排除值）明显优于 Xpert Ultra（87.5% [83.2-93.0] vs 64.9% [61.1-68.6]；P < .001）和 40 IU/mL 切点的 ADA（87.5% [83.2-93.0] vs 74.1% [68.7-79.0]；P < .001）：IRISA-TB对TPE诊断的灵敏度和NPV明显优于Xpert Ultra，特异性也非常好。这些数据对结核病流行地区的临床实践具有重要意义。

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来源期刊

Open Forum Infectious Diseases Medicine-Neurology (clinical)

CiteScore

6.70

自引率

4.80%

发文量

630

审稿时长

9 weeks

期刊介绍： Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.