Department of Laboratory Medicine, The First People's Hospital of Jingmen, Hubei Province, 448000, China.
J Virol Methods. 2020 Sep;283:113919. doi: 10.1016/j.jviromet.2020.113919. Epub 2020 Jun 15.
The purpose of this study was to investigate the feasibility of serological total antibody tests combined with RT-PCR for detection of SARS-COV-2. We conducted a retrospective study in which 375 patients were enrolled during the outbreak of SARS-COV-2 from 25th January to 16th March 2020. Patients were divided into a COVID-19 group (n = 141) and a control group (n = 234). Serum samples and throat swabs were collected from 375 patients for total antibody testing against SARS-COV-2 and RT-PCR analysis, respectively. The results indicated that diagnostic sensitivity and specificity were 95.7 % and 98.7 %, 92.2 % and 100 % by total antibody tests and RT-PCR, respectively. The sensitivity and specificity of total antibody tests combined with RT-PCR were 98.6 % and 98.7 %. The sensitivity of the combined method was significantly higher than RT-PCR (X = 5.16, P < 0.05), and similar to that of total antibody tests (X = 1.15, P> 0.05). This study supported the advantage of the combined method for detection of SARS-COV-2 with a high degree of sensitivity and specificity, as a useful tool for accurate diagnosis and timely treatment of suspected patients, epidemiological investigation, as well as monitoring ongoing outbreaks of infections with SARS-COV-2.
本研究旨在探讨血清总抗体检测联合 RT-PCR 检测 SARS-CoV-2 的可行性。我们进行了一项回顾性研究，共纳入了 2020 年 1 月 25 日至 3 月 16 日期间爆发 SARS-CoV-2 期间的 375 例患者。患者分为 COVID-19 组（n=141）和对照组（n=234）。分别对 375 例患者采集血清样本和咽拭子，用于 SARS-CoV-2 总抗体检测和 RT-PCR 分析。结果表明，总抗体检测的诊断灵敏度和特异性分别为 95.7%和 98.7%，RT-PCR 分别为 92.2%和 100%。总抗体检测联合 RT-PCR 的灵敏度和特异性分别为 98.6%和 98.7%。联合检测方法的灵敏度显著高于 RT-PCR（X=5.16，P<0.05），与总抗体检测相当（X=1.15，P>0.05）。这项研究支持了联合方法检测 SARS-CoV-2 的优势，具有高灵敏度和特异性，可作为疑似患者准确诊断和及时治疗、流行病学调查以及监测 SARS-CoV-2 感染持续爆发的有用工具。
