新型冠状病毒抗体检测临床应用的初步研究

Detection Method for Antibodies Against SARS-CoV-2 and Clinical Application

探讨新型冠状病毒(SARS-CoV-2)特异性总抗体检测的临床应用价值。本研究通过回顾性研究,使用酶联免疫法检测39例确诊的新型冠状病毒肺炎患者、90例健康人群血清样本中的抗体;后对确诊病例不同发病时间的血清样本和40例疑似病例的血清样本进行检测,将抗体检测结果结合核酸检测结果、病例资料进行分析。SARSCoV-2特异性总抗体检测灵敏度为92.31%,特异性为100%;病人血清样本中的总抗体产生时间随时间推移而升高,中位检出时间为13d;1例确诊病例的抗体检测结果先于核酸检测结果呈阳性,40例疑似排除病例的抗体检测结果均为阴性。SARS-CoV-2总抗体检测可作为SARS-CoV-2感染的辅助诊断指标,也可作为排除核酸检测阴性的疑似病例和疫情高发地区人群补充手段,减少非SARS-CoV-2感染患者的核酸检测次数。

To determine if a method to detect antibodies against SARS-CoV-2 can be applied clinically.In this retrospective study,the sera samples of 39 patients with newly diagnosed coronavirus disease 2019(COVID-19)and 90 healthy people were analyzed by antibody-detection reagents within enzyme-linked immunosorbent assays.The sera samples of confirmed cases at different onset times and 40 suspected cases were also tested.Then,we combined the results of antibody tests,nucleic-acid tests,and patient data.The sensitivity and specificity for SARS-CoV-2-specific total antibodies was 92.31%and 100%,respectively.The production time of total antibodies in serum samples increased with time,and the median detection time was 13 days.The result of antibody testing of one confirmed case preceded the result of the nucleic-acid test.Moreover,the antibodies of40 suspected cases were all negative.Detection of the total antibodies against SARS-CoV-2 can be used as an auxiliary diagnostic indicator of infection by this virus,as well as a supplementary means to exclude suspected cases/populations in areas with a high prevalence of negative detection of the nucleic acids of SARS-CoV-2.