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确定新型定量化学发光免疫分析(CLIA)在接种 COVID-19 疫苗的志愿者献血者中结合抗体单位(BAU)的最佳水平。

Determination of optimum levels of binding antibody units (BAU) of new quantitative chemiluminescent immuno-assay (CLIA) in COVID-19 vaccinated volunteer blood donors.

机构信息

Department of Transfusion Medicine Medanta-The Medicity, Sector-38, Gurgaon, India.

Department of Transfusion Medicine Medanta-The Medicity, Sector-38, Gurgaon, India.

出版信息

Transfus Apher Sci. 2024 Jun;63(3):103937. doi: 10.1016/j.transci.2024.103937. Epub 2024 Apr 24.

DOI:10.1016/j.transci.2024.103937
PMID:38678985
Abstract

BACKGROUND

For assessment of COVID-19 vaccine efficacy, neutralization activity of anti-SARS-CoV-2 antibody is measured. This study was undertaken to determine optimum levels of binding antibody units (BAU/ml) in new quantitative chemiluminescent assay (CLIA) that corresponded to neutralizing potential (30% inhibition) of sVNT assay.

METHODS

Ninety-one blood samples were analyzed by CLIA and sVNT assays. Test samples (n = 75) were collected from blood donors post-2nd vaccination dose, while control samples (n = 16) were archived pre-COVID donor samples. Correlation between CLIA and sVNT was calculated and receiver operating characteristic (ROC) curve was drawn and analyzed.

RESULTS

Results indicated excellent correlation between 57.5 BAU/ml on CLIA and 30%inhibition on sVNT assay. ROC curve analysis revealed that the area under the curve (AUC) was 0.971.

DISCUSSION

The present study determined that 57.5 BAU/ml on CLIA corresponded to 30% inhibition on sVNT assay. Periodic quantitative analysis.

摘要

背景

为评估 COVID-19 疫苗的功效,会测量抗 SARS-CoV-2 抗体的中和活性。本研究旨在确定新的定量化学发光测定法(CLIA)中与 sVNT 测定的中和潜力(30%抑制率)相对应的最佳结合抗体单位(BAU/ml)水平。

方法

通过 CLIA 和 sVNT 检测分析 91 份血样。检测样本(n=75)取自接种第二剂疫苗后的献血者,而对照样本(n=16)为存档的 COVID 前供体样本。计算 CLIA 和 sVNT 之间的相关性,并绘制和分析接收者操作特性(ROC)曲线。

结果

结果表明,CLIA 上的 57.5 BAU/ml 与 sVNT 检测上的 30%抑制率之间具有极好的相关性。ROC 曲线分析显示曲线下面积(AUC)为 0.971。

讨论

本研究确定 CLIA 上的 57.5 BAU/ml 相当于 sVNT 检测上的 30%抑制率。定期进行定量分析。

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