化学发光法检测新型冠状病毒抗体的临床评价及应用

Clinical evaluation and application of chemiluminescence detection of SARS-CoV-2 antibodies

目的:探讨化学发光微粒子免疫法对新型冠状病毒(SARS-CoV-2)总抗体及IgM抗体的检测效果及两种抗体的产生规律。方法:选取武汉大学中南医院收治的197例确诊新型冠状病毒肺炎患者,其中包含了24例核酸检测阴性但通过临床症状和CT检测确诊的患者;已排除新型冠状病毒感染的其他就诊患者142例作为对照组,通过化学发光法对这些患者的总抗体及IgM抗体进行检测。收集所有确诊患者不同发病时间的抗体检测样本(血清或血浆)242份、核酸检测样本853份,对不同发病时间的样本检测结果进行统计分析。结果:SARS-CoV-2总抗体及IgM抗体的临床检测灵敏度分别为97.97%、82.23%,临床特异性分别为98.59%、100%。病人特异性总抗体的检出率随时间推移而升高,IgM抗体的检出率则呈先升后降的变化趋势。24例核酸检测阴性的患者中,24例SARS-CoV-2总抗体阳性,21例IgM特异性抗体阳性。结论:SARS-CoV-2总抗体和IgM均有较好的特异性和灵敏度,可作为SARS-CoV-2感染的有效判定指标,但不适用于早期诊断。

Objective:To investigate the detection effect and danamic changes of total antibodies and IgM antibodies of Novel Coronavirus(SARS-CoV-2)by chemiluminescence microparticle immunoassay.Methods:The confirmed COVID-19 group consisted of 197 patients admitted in the Zhongnan Hospital of Wuhan University,including 24 patients who with negative nucleic acid tests but confirmed by clinical symptoms and CT tests.In addition,142 patients without COVID-19 were set as control group.The total antibodies and IgM antibodies in the blood samples of these patients were detected by chemiluminescence.From all subjects involved in this study,we collected 242 samples for antibodies test and 853 nucleic acid test samples of all diagnosed patients at different onset times,and conducted statistical analysis on the test results of samples at different onset time points.Results:The clinical detection sensitivity respectively for total SARS-CoV-2 antibodies and IgM antibodies was 97.97%and 82.23%,respectively,and the clinical specificity was 98.59%and 100%,respectively.The detection rate of patient-specific total antibodies increased with time,and the detection rate of IgM antibodies showed a trend of first increasing and then decreasing.The 24 patients with negative nucleic acid tests included 24 cases had positive SARS-CoV-2 total antibodies and 21 cases had positive IgM-specific antibodies.Conclusion:Both detection methods have good specificity and sensitivity.The total SARS-CoV-2 total and IgM antibodies can be used as effective indicators for SARS-CoV-2 infection,but it is not suitable for early diagnosis.