Diagnostic indexes of a rapid immunoglobulin G/immunoglobulin M combined antibody test for severe acute respiratory syndrome coronavirus 2

作者：Ying Liu, Yueping Liu, Bo Diao, Jin-Ya Ding, Meng-Xue Yuan, Feifei Ren, Yue Wang, Qianchuan Huang · 发表于：Chinese Medical Journal · 年份：2020 · DOI：10.1097/cm9.0000000000001204 · 被引用次数：20 · 研究领域：SARS-CoV-2 and COVID-19 Research、SARS-CoV-2 detection and testing、COVID-19 Clinical Research Studies

Detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a supplemental option for reverse transcription polymerase chain reaction (RT-PCR) detection, regardless of whether it is immunoglobulin M (IgM), immunoglobulin G (IgG) or combined detection. However, there are inadequate data on the sensitivity and specificity of IgM/IgG detection, which is of paramount importance for the decision of whether, when, and how to use IgM/IgG antibody detection. The aim of this study was to evaluate the sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of IgM/IgG antibody detection, especially the anti-interference ability and kappa coefficient compared with the SARS-CoV-2 RT-PCR, which was defined as a standard diagnosis in this study. A total of 179 participants who visited or were admitted to General Hospital of the Central Theatre Command between January 1, 2020 and March 12, 2020 were enrolled in this retrospective observational study. Approximately 5 mL fasting blood samples were drawn from all the enrolled participants for SARS-CoV-2 IgG/IgM antibodies detection (Innovita Biological Technology Co., Ltd, Tangshan, Hebei, China). The nasal or pharyngeal swab specimens for all the 179 participants were also collected for SARS-CoV-2 RT-PCR (DAAN Gene Co., Ltd, Guangzhou, Guangdong, China). A confirmed COVID-19 case was defined as a patient who has clinical background, including the acute respira...