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免疫测定法筛查 SARS-CoV-2 抗体与中和抗体检测的相关性。

Correlation between SARS-COV-2 antibody screening by immunoassay and neutralizing antibody testing.

机构信息

undação Pro Sangue Hemocentro de São Paulo, São Paulo, Brazil.

Laboratory of Medical Investigation in Pathogenesis and Directed Therapy in Onco-Immuno-Hematology (LIM-31) HCFMUSP, University of Sao Paulo Medical School, Sao Paulo, Brazil.

出版信息

Transfusion. 2021 Apr;61(4):1181-1190. doi: 10.1111/trf.16268. Epub 2021 Jan 25.

Abstract

BACKGROUND

The efficacy of convalescent plasma (CP), an alternative for the treatment of COVID-19, depends on high titers of neutralizing antibodies (nAbs), but assays for quantifying nAbs are not widely available. Our goal was to develop a strategy to predict high titers of nAbs based on the results of anti-SARS-CoV-2 immunoassays and the clinical characteristics of CP donors.

STUDY DESIGN AND METHODS

A total of 214 CP donors were enrolled and tested for the presence of anti-SARS-CoV-2 antibodies (IgG) using two commercial immunoassays: EUROIMMUN (ELISA) and Abbott (Chemiluminescence). Quantification of nAbs was performed using the Cytopathic Effect-based Virus Neutralization test. Three criteria for identifying donors with nAbs ≥ 1:160 were tested: - C1: Curve ROC; - C2: Conditional decision tree considering only the IA results and - C3: Conditional decision tree including both the IA results and the clinical variables.

RESULTS

The performance of the immunoassays was similar referring to both S/CO and predictive value for identifying nAbs titers ≥1:160. Regarding the studied criteria for identifying CP donors with high nAbs titers: (a) C1 showed 76.1% accuracy if S/CO = 4.65, (b) C2 presented 76.1% accuracy if S/CO ≥4.57 and (c) C3 had 71.6% accuracy if S/CO was ≥4.57 or if S/CO was between 2.68-4.57 and the last COVID-19-related symptoms were recent (within 19 days).

CONCLUSION

SARS-CoV-2 IgG immunoassays (S/CO) can be used to predict high anti-SARS-CoV-2 nAbs titers. This study has proposed different criteria for identifying donors with ≥1:160 nAbs titers, all with high efficacy.

摘要

背景

恢复期血浆(CP)是治疗 COVID-19 的一种替代方法,其疗效取决于中和抗体(nAbs)的高滴度,但定量检测 nAbs 的方法并不广泛。我们的目标是开发一种基于抗 SARS-CoV-2 免疫检测结果和 CP 供体临床特征预测高滴度 nAbs 的策略。

研究设计和方法

共纳入 214 例 CP 供体,使用两种商业免疫检测试剂盒(EUROIMMUN(ELISA)和 Abbott(化学发光法))检测抗 SARS-CoV-2 抗体(IgG)的存在。使用基于细胞病变效应的病毒中和试验定量检测 nAbs。测试了三种识别 nAbs≥1:160 的供体的标准:- C1:曲线 ROC;- C2:仅考虑 IA 结果的条件决策树- C3:包括 IA 结果和临床变量的条件决策树。

结果

两种免疫检测方法在 S/CO 和预测 nAbs 滴度≥1:160 方面的性能相似。关于识别高 nAbs 滴度 CP 供体的研究标准:(a)如果 S/CO = 4.65,C1 显示 76.1%的准确性,(b)如果 S/CO≥4.57,C2 显示 76.1%的准确性,(c)如果 S/CO≥4.57 或 S/CO 在 2.68-4.57 之间并且最近有最后一次 COVID-19 相关症状(在 19 天内),C3 显示 71.6%的准确性。

结论

SARS-CoV-2 IgG 免疫检测(S/CO)可用于预测高抗 SARS-CoV-2 nAbs 滴度。本研究提出了不同的标准来识别 nAbs 滴度≥1:160 的供体,所有标准的疗效都很高。

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