■比较实验室测定对超声引导的核心针活检样本的诊断性能,以诊断HIV阳性和HIV阴性患者的肺外结核(EPTB)。
■从2017年到2020年,共有217例疑似患有EPTB的患者接受了病变活检。收集活检和非活检样本的实验室测试结果以及临床数据,以对测试实用性进行回顾性分析。根据样本类型和HIV状态对测试的计算诊断准确性进行分层。
■该队列包含118名最终诊断为肺外结核阳性的患者(EPTB组,54.4%)和99最终诊断为无TB(非EPTB组,45.6%)。EPTB的危险因素是HIV合并感染(OR2.22,95%CI1.17-4.28,p=0.014)。在活检样本中,GeneXpert(Xpert)显示出更高的灵敏度(96.6%[91.6-98.7],p<0.0001)比培养物(56.1%[47.0-64.9])。无论HIV感染状况如何,Xpert具有任何方法中最高的灵敏度(>95%)和特异性(接近100%)。在非活检样本中,只有T-SPOT。TB(T-SPOT)显示出比培养更高的敏感性(90.9%[62.3-99.5]vs35.3%[17.3-58.7],p=0.0037)。此外,在非活检样本中,Xpert的敏感性较低(60.0%[23.1-92.9],p=0.022)比活检样本(100%[86.7-100])。即使在涂片阴性的活检样本中,Xpert仍然具有比培养更高的灵敏度并且保持高特异性(100%[95.7-100])。
■无论HIV状况和标本类型如何,都观察到Xpert在诊断EPTB方面的出色表现。然而,活检样本仍大大有助于肺外结核的准确诊断.
To compare the diagnostic performance of laboratory assays on the ultrasound-guided core needle biopsy samples for diagnosis of extra-pulmonary tuberculosis (EPTB) in HIV-positive and HIV-negative patients.
A total of 217 patients suspected to have EPTB underwent lesion biopsy from 2017 to 2020. Results of laboratory tests on the biopsy and non-biopsy samples were collected with clinical data for retrospective analysis of test utility. The calculated diagnostic accuracy of the tests was stratified according to the specimen types and HIV status.
The cohort contained 118 patients with a final positive diagnosis of extrapulmonary tuberculosis (EPTB group, 54.4%) and 99 finally diagnosed as without TB (non-EPTB group, 45.6%). The risk factor for EPTB was HIV co-infection (OR 2.22, 95% CI 1.17-4.28, p = 0.014). In biopsy samples, GeneXpert (Xpert) showed higher sensitivity (96.6% [91.6-98.7], p < 0.0001) than culture (56.1% [47.0-64.9]). Regardless of HIV status, Xpert had the highest sensitivity (>95%) and specificity (nearly 100%) of any methods. In non-biopsy samples, only T-SPOT.TB (T-SPOT) showed higher sensitivity than culture (90.9% [62.3-99.5] vs 35.3% [17.3-58.7], p = 0.0037). Furthermore, the sensitivities of Xpert were lower in non-biopsy samples (60.0% [23.1-92.9], p = 0.022) than in biopsy samples (100% [86.7-100]). Even in smear-negative biopsy samples, Xpert still had higher sensitivity than culture and retained high specificity (100% [95.7-100]).
Superior performance of Xpert in diagnosing EPTB was observed regardless of HIV status and specimen types. Nevertheless, the biopsy samples still substantially facilitated the accurate diagnosis of extrapulmonary tuberculosis.