Zhejiang Tuberculosis Diagnosis and Treatment Center, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, Hangzhou, Zhejiang, China.
Eur J Clin Microbiol Infect Dis. 2021 May;40(5):969-977. doi: 10.1007/s10096-020-04113-1. Epub 2020 Nov 26.
To compare the diagnostic efficacy of CapitalBio Mycobacterium real-time polymerase chain reaction (RT-PCR) detection test and the first-generation Xpert MTB/RIF in smear-negative pulmonary tuberculosis (PTB). In this retrospective study of smear-negative PTB, we reviewed patient medical records to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test (positive result for either of the Xpert MTB/RIF and CapitalBio Mycobacterium detection tests) to evaluate their diagnostic accuracy against a composite reference standard. In total, 1553 patients were evaluated. The sensitivity, specificity, PPV, NPV, and AUC of Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test were 57.1%, 92.9%, 81.1%, 95.9%, and 0.75; 53.4%, 97.7%, 98.6%, 41.5%, and 0.76; and 66.2%, 90.8%, 95.5%, 47.7%, and 0.79, respectively. For the bronchoalveolar lavage fluid (BALF) specimens, these values for Xpert MTB/RIF, CapitalBio Mycobacterium detection test, and the parallel test were 68.8%, 97.7%, 99.2%, 43.9%, and 0.83; 61.7%, 97.7%, 99.1%, 38.9%, and 0.80; and 77.0%, 95.5%, 98.6%, 50.9%, and 0.86, respectively. CapitalBio Mycobacterium detection test had moderate accuracy for smear-negative PTB, similar to Xpert MTB/RIF. The parallel test improved the sensitivity. BALF significantly improved the sensitivity and diagnostic accuracy of the test. The maximum diagnostic accuracy for smear-negative PTB was obtained with the parallel test and BALF specimens. BALF was the most effective specimen for diagnosing smear-negative PTB.
比较 CapitalBio 分枝杆菌实时聚合酶链反应 (RT-PCR) 检测试验和第一代 Xpert MTB/RIF 在涂阴肺结核 (PTB) 中的诊断效能。在这项涂阴 PTB 的回顾性研究中，我们查阅了患者的病历，以确定 Xpert MTB/RIF、CapitalBio 分枝杆菌检测试验和并行试验（Xpert MTB/RIF 和 CapitalBio 分枝杆菌检测试验中任一试验阳性）的灵敏度、特异性、阳性预测值 (PPV)、阴性预测值 (NPV) 和曲线下面积 (AUC)，以评估它们相对于综合参考标准的诊断准确性。共评估了 1553 例患者。Xpert MTB/RIF、CapitalBio 分枝杆菌检测试验和并行试验的灵敏度、特异性、PPV、NPV 和 AUC 分别为 57.1%、92.9%、81.1%、95.9%和 0.75；53.4%、97.7%、98.6%、41.5%和 0.76；66.2%、90.8%、95.5%、47.7%和 0.79。对于支气管肺泡灌洗液 (BALF) 标本，Xpert MTB/RIF、CapitalBio 分枝杆菌检测试验和并行试验的这些值分别为 68.8%、97.7%、99.2%、43.9%和 0.83；61.7%、97.7%、99.1%、38.9%和 0.80；77.0%、95.5%、98.6%、50.9%和 0.86。CapitalBio 分枝杆菌检测试验对涂阴 PTB 的准确性中等，与 Xpert MTB/RIF 相似。并行试验提高了灵敏度。BALF 显著提高了试验的灵敏度和诊断准确性。涂阴 PTB 的最大诊断准确性是通过并行试验和 BALF 标本获得的。BALF 是诊断涂阴 PTB 最有效的标本。
