Department of Urology, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, 208 East Huancheng Road, Hangzhou, China.
Eur J Clin Microbiol Infect Dis. 2021 Mar;40(3):559-563. doi: 10.1007/s10096-020-04052-x. Epub 2020 Sep 29.
The purpose of this study is to compare the efficiency difference between CapitalBio™Mycobacterium real-time polymerase chain reaction (RT-PCR) detection test and Xpert MTB/RIF assay for the diagnosis of renal tuberculosis (TB). We analyzed 117 samples collected between July 1, 2018, and October 31, 2019, from patients with suspected renal TB to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the CapitalBio™ Mycobacterium RT-PCR detection test for renal TB and to evaluate its diagnostic accuracy compared with Xpert MTB/RIF assay. Five cases were excluded from this study because of incomplete data. Taking clinical diagnosis as the gold standard, for the Xpert MTB/RIF assay, the sensitivity was 87.95% (78.96-94.07%), specificity 96.55% (82.24-99.91%), PPV 98.65% (92.70-99.97%), NPV 73.68% (56.90-86.60%), and AUC 0.92 (0.86-0.96). For the CapitalBio™Mycobacterium RT-PCR detection test, the overall sensitivity was 84.34% (74.71-91.39%), specificity 93.10% (77.23-99.15%), PPV 97.22% (90.32-99.66%), NPV 67.50% (50.87-81.43%), and AUC 0.89(0.81-0.94). The diagnostic efficiency of the CapitalBio™Mycobacterium RT-PCR detection test was similar to that of the Xpert MTB/RIF assay in patients with renal TB. Hence, the CapitalBio™Mycobacterium RT-PCR detection test presents a valuable alternative for the diagnosis of renal TB.
本研究旨在比较 CapitalBio™分枝杆菌实时聚合酶链反应（RT-PCR）检测试验和 Xpert MTB/RIF 检测对肾结核（TB）诊断的效率差异。我们分析了 2018 年 7 月 1 日至 2019 年 10 月 31 日期间从疑似肾结核患者中采集的 117 个样本，以确定 CapitalBio™分枝杆菌 RT-PCR 检测试验对肾结核的灵敏度、特异性、阳性预测值（PPV）、阴性预测值（NPV）和曲线下面积（AUC），并评估其与 Xpert MTB/RIF 检测的诊断准确性。由于数据不完整，有 5 例病例被排除在本研究之外。以临床诊断为金标准，对于 Xpert MTB/RIF 检测，其灵敏度为 87.95%（78.96-94.07%），特异性为 96.55%（82.24-99.91%），PPV 为 98.65%（92.70-99.97%），NPV 为 73.68%（56.90-86.60%），AUC 为 0.92（0.86-0.96）。对于 CapitalBio™分枝杆菌 RT-PCR 检测试验，总体灵敏度为 84.34%（74.71-91.39%），特异性为 93.10%（77.23-99.15%），PPV 为 97.22%（90.32-99.66%），NPV 为 67.50%（50.87-81.43%），AUC 为 0.89（0.81-0.94）。在肾结核患者中，CapitalBio™分枝杆菌 RT-PCR 检测试验的诊断效率与 Xpert MTB/RIF 检测相当。因此，CapitalBio™分枝杆菌 RT-PCR 检测试验为肾结核的诊断提供了一种有价值的替代方法。
