未刺激的干扰素-γ（IRISA-TB）对胸膜结核的诊断性能：在南非和印度的一项前瞻性研究
Diagnostic Performance of Unstimulated IFN-γ (IRISA-TB) for Pleural Tuberculosis: A Prospective Study in South Africa and India.
作者信息
Christopher Devasahayam J, Esmail Aliasgar, Scott Alex J, Wilson Lindsay, Randall Philippa, Thangakunam Balamugesh, Shankar Deepa, Rajasekar Sekar, Christudass Christhunesa S, Kühn Louié, Swanepoel Jeremi, Perumal Tahlia, Pooran Anil, Oelofse Suzette, Dheda Keertan
机构信息
Department of Pulmonary Medicine, Christian Medical College, Vellore, India.
Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town Lung Institute, Cape Town, South Africa.
出版信息
Open Forum Infect Dis. 2024 Sep 24;11(10):ofae533. doi: 10.1093/ofid/ofae533. eCollection 2024 Oct.
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]; < .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]; .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]; < .001) and ADA at the 40 IU/mL cut-point (87.5% [83.2-93.0] vs 74.1% [68.7-79.0]; < .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.
背景
在许多情况下，结核性胸腔积液（TPE）是肺外结核最常见的形式。基于聚合酶链反应的一线GeneXpert MTB/RIF Ultra（Xpert Ultra）检测的诊断性能仍不理想（敏感性约为30%），但数据有限。在结核病（TB）流行地区，迫切需要改进诊断方法以检测肺外结核（EPTB）。
方法
这项多中心前瞻性队列研究评估了快速（当日）干扰素γ快速免疫悬浮测定法（IRISA-TB）对来自南非和印度疑似TPE患者的诊断性能。参与者接受了胸膜活检，并同时使用其他可用的当日诊断检测方法（腺苷脱氨酶[ADA]、Xpert Ultra和IRISA-TB）进行检测。TB的参考标准是使用胸水和/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例疑似TPE患者（106例来自南非，111例来自印度）。IRISA-TB（切点为20.5 pg/mL）的敏感性显著优于Xpert Ultra（81.8%[70.4-90.2]对32.9%[22.1-45.1]；P<0.001）以及印度使用的40 IU/mL切点时的ADA（81.8%[70.4-90.2]对53.8%[41.0-66.3]；P = 0.002）。与南非使用的30 IU/mL切点时的ADA相比，IRISA-TB具有更高的特异性（96.6%[90.3-99.3]对87.1%[78.6-93.2]）和更高的阳性预测值（94.7%[85.5-97.3]对81.8%[72.4-88.5]）。IRISA-TB的阴性预测值（NPV；排除值）显著优于Xpert Ultra（87.5%[83.2-93.0]对64.9%[61.1-68.6]；P<0.001）以及40 IU/mL切点时的ADA（87.5%[83.2-93.0]对74.1%[68.7-79.0]；P<0.001）。
结论
IRISA-TB在TPE诊断中表现出比Xpert Ultra明显更好的敏感性和NPV，以及出色的特异性。这些数据对TB流行地区的临床实践具有重要意义。
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