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五种市售血清学检测方法检测 SARS-CoV-2 抗体的性能比较及识别高中和抗体滴度个体。

Comparative Performance of Five Commercially Available Serologic Assays To Detect Antibodies to SARS-CoV-2 and Identify Individuals with High Neutralizing Titers.

机构信息

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

出版信息

J Clin Microbiol. 2021 Jan 21;59(2). doi: 10.1128/JCM.02257-20.


DOI:10.1128/JCM.02257-20
PMID:33139419
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8111143/
Abstract

Accurate serological assays to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to characterize the epidemiology of SARS-CoV-2 infection and identify potential candidates for coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) donation. This study compared the performances of commercial enzyme immunoassays (EIAs) with respect to detection of IgG or total antibodies to SARS-CoV-2 and neutralizing antibodies (nAbs). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) for detection of IgG or total antibodies to SARS-CoV-2 was evaluated using cross-sectional samples from potential CCP donors who had prior molecular confirmation of SARS-CoV-2 infection ( = 214) and samples from prepandemic emergency department patients without SARS-CoV-2 infection ( = 1,099). Of the 214 potential CCP donors, all were sampled >14 days since symptom onset and only a minority ( = 16 [7.5%]) had been hospitalized due to COVID-19; 140 potential CCP donors were tested by all five EIAs and a microneutralization assay. Performed according to the protocols of the manufacturers to detect IgG or total antibodies to SARS-CoV-2, the sensitivity of each EIA ranged from 76.4% to 93.9%, and the specificity of each EIA ranged from 87.0% to 99.6%. Using a nAb titer cutoff value of ≥160 as the reference representing a positive test result ( = 140 CCP donors), the empirical area under the receiver operating curve for each EIA ranged from 0.66 (Roche) to 0.90 (Euroimmun). Commercial EIAs with high diagnostic accuracy to detect SARS-CoV-2 antibodies did not necessarily have high diagnostic accuracy to detect high nAb titers. Some but not all commercial EIAs may be useful in the identification of individuals with high nAb titers among convalescent individuals.

摘要

需要准确的血清学检测方法来检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)抗体,以描述 SARS-CoV-2 感染的流行病学,并确定潜在的 2019 年冠状病毒病(COVID-19)恢复期血浆(CCP)捐献者。本研究比较了商业酶联免疫吸附试验(EIA)在检测 SARS-CoV-2 抗体 IgG 或总抗体和中和抗体(nAb)方面的性能。使用先前通过分子检测证实 SARS-CoV-2 感染(n=214)的潜在 CCP 供体的横断面样本和未感染 SARS-CoV-2 的大流行前急诊室患者的样本(n=1099)评估了五种市售 EIA(雅培、欧蒙、EDI、免疫诊断和罗氏)检测 SARS-CoV-2 IgG 或总抗体的诊断准确性。在 214 名潜在的 CCP 供体中,所有供体均在症状发作后 14 天以上采样,只有少数(n=16 [7.5%])因 COVID-19 住院;140 名潜在的 CCP 供体接受了所有五种 EIA 和微量中和测定的检测。按照制造商的方案进行 IgG 或总抗体 SARS-CoV-2 检测,每种 EIA 的灵敏度范围为 76.4%至 93.9%,每种 EIA 的特异性范围为 87.0%至 99.6%。使用 nAb 滴度截断值≥160 作为代表阳性检测结果的参考值(n=140 名 CCP 供体),每种 EIA 的经验接收器操作曲线下面积范围为 0.66(罗氏)至 0.90(欧蒙)。具有高 SARS-CoV-2 抗体检测诊断准确性的商业 EIA 不一定具有高 nAb 滴度检测诊断准确性。一些(但不是全部)商业 EIA 可能有助于确定恢复期个体中的高 nAb 滴度个体。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dc1/8111143/e41118f31359/JCM.02257-20-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dc1/8111143/c855d0d14043/JCM.02257-20-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dc1/8111143/e41118f31359/JCM.02257-20-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dc1/8111143/c855d0d14043/JCM.02257-20-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dc1/8111143/e41118f31359/JCM.02257-20-f0002.jpg

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本文引用的文献

[1]
Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples.

Am J Clin Pathol. 2021-2-4

[2]
Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization.

J Clin Microbiol. 2020-12-17

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Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison.

Lancet Infect Dis. 2020-9-23

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Transfus Apher Sci. 2021-2

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Emerg Microbes Infect. 2020-12

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SARS-CoV-2 seroprevalence and neutralizing activity in donor and patient blood.

Nat Commun. 2020-9-17

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Transfusion. 2021-1

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Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19:Serologic Testing.

Clin Infect Dis. 2020-9-12

[9]
Serological Assays Estimate Highly Variable SARS-CoV-2 Neutralizing Antibody Activity in Recovered COVID-19 Patients.

J Clin Microbiol. 2020-11-18

[10]
SARS-CoV-2 Antibody Avidity Responses in COVID-19 Patients and Convalescent Plasma Donors.

J Infect Dis. 2020-11-13

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