Zhejiang Tuberculosis Diagnosis and Treatment Center, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, Hangzhou, Zhejiang, China.
Zhejiang Tuberculosis Diagnosis and Treatment Center, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, Hangzhou, Zhejiang, China.
Int J Infect Dis. 2020 Sep;98:1-5. doi: 10.1016/j.ijid.2020.06.042. Epub 2020 Jun 14.
To evaluate the accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction (RT-PCR) detection test for pulmonary Mycobacterium tuberculosis (MTB) and nontuberculous mycobacterial (NTM) infection.
This study analyzed 2,460 samples from patients with suspected pulmonary mycobacterial infection collected between 01 June 2018 and 31 July 2019. It aimed to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the CapitalBio Mycobacterium detection test for MTB and NTM infections, and to evaluate its diagnostic accuracy compared with mycobacterial culture.
The sensitivity, specificity, PPV, NPV, and AUC of the CapitalBio Mycobacterium detection test for MTB was 83.0%, 79.9%, 80.8%, 82.2%, and 0.81, respectively. This was similar to the diagnostic accuracy of Xpert MTB/RIF for MTB and was significantly higher than that of smear. For pulmonary NTM infection, the sensitivity, specificity, PPV, NPV, and AUC of the test was 82.0%, 99.6%, 94.1%, 98.5%, and 0.91, respectively. The diagnostic accuracy of the CapitalBio Mycobacterium detection test was also significantly higher than that of smear for NTM.
The CapitalBio Mycobacterium detection test had good diagnostic accuracy for MTB and NTM infections. This is of great significance for the differential diagnosis of early pulmonary mycobacterial infection.
评估 CapitalBio 分枝杆菌实时聚合酶链反应（RT-PCR）检测试验对肺部结核分枝杆菌（MTB）和非结核分枝杆菌（NTM）感染的准确性。
本研究分析了 2018 年 6 月 1 日至 2019 年 7 月 31 日期间收集的 2460 例疑似肺部分枝杆菌感染患者的样本。旨在确定 CapitalBio 分枝杆菌检测试验对 MTB 和 NTM 感染的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和曲线下面积（AUC），并评估其与分枝杆菌培养的诊断准确性。
CapitalBio 分枝杆菌检测试验对 MTB 的敏感性、特异性、PPV、NPV 和 AUC 分别为 83.0%、79.9%、80.8%、82.2%和 0.81，与 Xpert MTB/RIF 对 MTB 的诊断准确性相当，明显高于涂片。对于肺部 NTM 感染，该试验的敏感性、特异性、PPV、NPV 和 AUC 分别为 82.0%、99.6%、94.1%、98.5%和 0.91，诊断准确性明显高于涂片。
CapitalBio 分枝杆菌检测试验对 MTB 和 NTM 感染具有良好的诊断准确性。这对于早期肺部分枝杆菌感染的鉴别诊断具有重要意义。
