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使用商业检测试剂盒检测 SARS-CoV-2 抗体及住院患者的血清转化模式。

Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients.

机构信息

Pathogenesis and Control of Chronic Infections, University of Montpellier, INSERM, EFS; CHU Montpellier, Montpellier, France.

Pathogenesis and Control of Chronic Infections, University of Montpellier, INSERM, EFS, Montpellier, France.

出版信息

J Infect. 2020 Aug;81(2):e39-e45. doi: 10.1016/j.jinf.2020.05.077. Epub 2020 Jun 3.

Abstract

OBJECTIVES

SARS-CoV-2 antibody assays are needed for serological surveys and as a complement to molecular tests to confirm COVID-19. However, the kinetics of the humoral response against SARS-CoV-2 remains poorly described and relies on the performance of the different serological tests.

METHODS

In this study, we evaluated the performance of six CE-marked point-of-care tests (POC) and three ELISA assays for the diagnosis of COVID-19 by exploring seroconversions in hospitalized patients who tested positive for SARS-CoV-2 RNA.

RESULTS

Both the ELISA and POC tests were able to detect SARS-CoV-2 antibodies in at least half of the samples collected seven days or more after the onset of symptoms. After 15 days, the rate of detection rose to over 80% but without reaching 100%, irrespective of the test used. More than 90% of the samples collected after 15 days tested positive using the iSIA and Accu-Tell® POC tests and the ID.Vet IgG ELISA assay. Seroconversion was observed 5 to 12 days after the onset of symptoms. Three assays suffer from a specificity below 90% (EUROIMMUN IgG and IgA, UNscience, Zhuhai Livzon).

CONCLUSIONS

The second week of COVID-19 seems to be the best period for assessing the sensitivity of commercial serological assays. To achieve an early diagnosis of COVID-19 based on antibody detection, a dual challenge must be met: the immunodiagnostic window period must be shortened and an optimal specificity must be conserved.

摘要

目的

SARS-CoV-2 抗体检测对于血清学调查以及作为分子检测的补充以确认 COVID-19 非常重要。然而,针对 SARS-CoV-2 的体液反应动力学仍描述不足,且依赖于不同血清学检测的性能。

方法

在这项研究中,我们通过探索对 SARS-CoV-2 RNA 检测呈阳性的住院患者的血清转化,评估了 6 种 CE 标记的即时检测(POC)和 3 种 ELISA 检测试剂盒用于 COVID-19 诊断的性能。

结果

ELISA 和 POC 检测均能在症状出现后至少 7 天采集的至少一半样本中检测到 SARS-CoV-2 抗体。15 天后,检测率上升至 80%以上,但无论使用哪种检测方法,均未达到 100%。在 15 天后采集的超过 90%的样本使用 iSIA 和 Accu-Tell® POC 检测和 ID.Vet IgG ELISA 检测呈阳性。血清转化发生在症状出现后 5 至 12 天。有 3 种检测试剂盒的特异性低于 90%(EUROIMMUN IgG 和 IgA、UNscience、珠海丽珠)。

结论

COVID-19 的第二周似乎是评估商业血清学检测敏感性的最佳时期。为了基于抗体检测实现 COVID-19 的早期诊断,必须满足双重挑战:免疫诊断窗口期必须缩短,同时保持最佳的特异性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c714/7834649/2d672d25f292/gr1_lrg.jpg

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