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快速抗体和 ELISA 检测在评估 SARS-CoV-2 PCR 阳性患者血清学反应中的作用。

Role of rapid antibody and ELISA tests in the evaluation of serological response in patients with SARS-CoV-2 PCR positivity.

机构信息

General Directorate of Public Health, Department of Microbiology Reference and Biological Products Laboratories, Ministry of Health, Ankara, Turkey.

Department of Infectious Disease and Clinical Microbiology, Yildirim Beyazit University, Ankara City Hospital, Ankara, Turkey.

出版信息

Folia Microbiol (Praha). 2021 Aug;66(4):579-586. doi: 10.1007/s12223-021-00861-5. Epub 2021 Apr 7.

DOI:10.1007/s12223-021-00861-5
PMID:33825112
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8024037/
Abstract

From 7 to 8 days after the onset of symptoms in COVID-19 infection, the sensitivity of serological tests was found to be higher than that of nucleic acid tests. The aims of this study were to investigate antibody levels in patients with SARS-CoV-2 infection, to examine the relationship between antibody levels and virus load, and to evaluate the performance of 2 different commercial kits. A total of 103 patients with confirmed SARS-CoV-2 infection were included in the study. Antibodies against SARS-CoV-2 in serum samples taken from patients were investigated simultaneously with anti-SARS-CoV-2 IgG and IgA ELISAs (Euroimmun) and COVID-19 (SARS-CoV-2) IgG/IgM (Deep Blue) kits. No positivity was detected with any of the test kits in 18 (17.4%) of the 103 samples. In symptomatic patients, 100% of IgM and IgA tests were found to be positive in the group sampled after 10 days, while 100% of IgG tests were found positive after 20 days. The sensitivity of the Deep Blue COVID-19 IgG antibody kit was calculated as 81.48% and the specificity was 97.96%. While there was no statistically significant difference between the PCR CT and ELISA OD values, a positive correlation was found between the ELISA OD values and the days since the date of symptom initiation. The sensitivity and specificity of the rapid antibody test used in this study were found to be quite high. In conditions where ELISA tests cannot be applied, it is thought that it can give an idea in terms of the presence of antibodies as a simple and fast test. Although ELISA tests are valuable in the diagnosis of COVID-19 during the acute period, they are tests that can be used safely in the diagnosis of previous infections and seroepidemiological studies.

摘要

从 COVID-19 感染症状出现后的第 7 至 8 天,血清学检测的敏感性被发现高于核酸检测。本研究的目的是调查 SARS-CoV-2 感染患者的抗体水平,研究抗体水平与病毒载量之间的关系,并评估两种不同商业试剂盒的性能。共纳入 103 例确诊 SARS-CoV-2 感染患者。使用 Euroimmun 公司的抗 SARS-CoV-2 IgG 和 IgA ELISA 试剂盒以及 Deep Blue 公司的 COVID-19(SARS-CoV-2)IgG/IgM 试剂盒,同时检测患者血清样本中的 SARS-CoV-2 抗体。在 103 例样本中,有 18 例(17.4%)任何检测试剂盒均未检测到阳性。在有症状的患者中,在第 10 天采样的组中,100%的 IgM 和 IgA 检测呈阳性,而在第 20 天采样的组中,100%的 IgG 检测呈阳性。Deep Blue COVID-19 IgG 抗体试剂盒的灵敏度计算为 81.48%,特异性为 97.96%。虽然 PCR CT 值与 ELISA OD 值之间无统计学差异,但 ELISA OD 值与症状起始日期之间存在正相关。本研究中使用的快速抗体检测的灵敏度和特异性都很高。在无法进行 ELISA 检测的情况下,它可以作为一种简单快速的检测方法,提供抗体存在的信息。虽然 ELISA 检测在 COVID-19 急性期的诊断中很有价值,但它们也是可用于既往感染和血清流行病学研究的安全诊断检测方法。

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