Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test
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ORIGINAL ARTICLE
Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test and Xpert MTB/RIF in smear-negative pulmonary tuberculosis Hong Zheng 1 & Fangming Zhong 1 & Guocan Yu 1 & Yanqin Shen 1 Received: 3 September 2020 / Accepted: 20 November 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract 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 smearnegative 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. Keywords CapitalBio Mycobacterium detection test . Xpert MTB/RIF . Smear-negative pulmonary tuberculosis . Bronchoalveolar lavage fluid specimens
Introduction
Hong Zheng and Fangming Zhong contributed equally to this work. * Yanqin Shen [email protected] Hong Zheng [email protected] Fangming Zhong [email protected] Guocan Yu [email protected] 1
Zhejiang Tuberculosis Diagnosis and Treatment Center, Zhejiang Chinese Medicine and Western Medicine Integrated Hospital, Hangzhou, Zhejiang, China
Tuberculosis (TB), which is caused by Mycobacterium tuberculosis (MTB) infection, remains a global threat to human health [1]. In 2018, 10.4 million new cases of TB were detected, 1.4 million TB-related deaths were reported, and an additional 0.4 million human immunodeficiency virus (HIV)– infected TB-related deaths occurred [1]. TB is one of the top ten leading causes of death from a single infectious disease worldwide [2]. Pulmonary tuberculosis (PTB) is the most common cli
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