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五种 SARS-CoV-2 抗体检测试剂的临床性能和实用性比较。

Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests.

机构信息

Department of Clinical Laboratory, Juntendo University Hospital, Tokyo, Japan.

Department of Clinical Laboratory Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan.

出版信息

PLoS One. 2021 Feb 8;16(2):e0246536. doi: 10.1371/journal.pone.0246536. eCollection 2021.

DOI:10.1371/journal.pone.0246536
PMID:33556086
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7870088/
Abstract

We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.

摘要

我们使用 34 名日本 COVID-19 患者在不同时间点的 114 份血清样本,评估了五种 COVID-19 抗体检测试剂盒的实用性。我们检测了罗氏的 Elecsys Anti-SARS-CoV-2,以及杭州莱和生物技术公司、爱康生物技术公司、奇乐生物技术公司和 Nadal 公司的四种免疫层析试剂盒。在发病后第一周,Elecsys 在 S 组(重症病例)的阳性率为 40%,但在 M 组(轻症-中度病例)为阴性。免疫层析试剂盒在 S 组和 M 组的阳性率分别为 40-60%和 0-8%。在第二周,Elecsys 的阳性率分别为 75%和 50%,免疫层析试剂盒在 S 组和 M 组的阳性率分别为 5-80%和 50-75%。在第三周后,Elecsys 在两组中均显示出 100%的阳性率。免疫层析试剂盒在 S 组中显示出 100%的阳性率。在 M 组中,Chil 的阳性率下降至 50%,Artron 和 Lyher 的阳性率为 75-89%。Elecsys 和免疫层析试剂盒的特异性均为 91-100%。Elecsys 在第二周到第六周,在两组中,其截止指数值的时间变化具有可比性。目前的 SARS-CoV-2 抗体检测试剂盒不能对严重程度和感染状况进行有意义的解释。其用途可能仅限于短期的流行病学研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba5/7870088/9d7431bfaddc/pone.0246536.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba5/7870088/d43c1a394ba5/pone.0246536.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba5/7870088/9d7431bfaddc/pone.0246536.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba5/7870088/d43c1a394ba5/pone.0246536.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba5/7870088/9d7431bfaddc/pone.0246536.g002.jpg

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