Evaluation of Commercial Anti-SARS-CoV-2 Antibody Assays and Comparison of Standardized Titers in Vaccinated Health Care Workers.
Evaluation of Commercial Anti-SARS-CoV-2 Antibody Assays and Comparison of Standardized Titers in Vaccinated Health Care Workers.
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DOI：
10.1128/jcm.01746-21
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发表时间：
2022-01-19
影响因子：
9.4
通讯作者：
Trabaud MA
中科院分区：
文献类型：
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作者：
Saker K;Escuret V;Pitiot V;Massardier-Pilonchéry A;Paul S;Mokdad B;Langlois-Jacques C;Rabilloud M;Goncalves D;Fabien N;Guibert N;Fassier JB;Bal A;Trouillet-Assant S;Trabaud MA
随着疫苗的可用性，检测抗严重急性呼吸综合征冠状病毒-2抗体（Ab）的商业检测方法逐渐发展成为针对刺突糖蛋白或其受体结合结构域（RBD）的定量检测方法。本研究的主要目的是比较卫生保健工作者（HCW）接种一剂（恢复期个体）或两剂（首次接种个体）疫苗后，通过定量商业结合Ab测定获得的Ab滴度。采用5种定量免疫测定法（Abbott RBD IgG II quant、bioMérieux RBD IgG、DiaSorin Trimeric spike IgG、Siemens Healthineers RBD IgG、Wantai RBD IgG）测量了255份血清（来自150例HCW）中的抗体滴度。使用一种定性总抗体抗RBD检测试验（万泰）检测接种前的既往感染。结果以结合抗体单位（BAU）/mL表示，如可能，采用生产商提供的换算因子，并根据世界卫生组织内标物确定。接种两剂疫苗后评价的所有检测试剂盒的血清转化率均为100%。使用允许BAU/mL校正的测定，Ab滴度相关（Pearson相关系数，ρ，范围：0.85-0.94）。Siemens和bioMérieux检测试剂盒之间的滴度差异平均为10.6%，Abbott和DiaSorin检测试剂盒之间的滴度差异平均为60.9%。这些结果强调了BAU转换对于比较使用不同定量测定法获得的Ab滴度的重要性。然而，显著差异持续存在，特别是在检测针对不同抗原的Ab的试剂盒之间。检测试剂盒的真正标准化是将国际标准品纳入各检测试剂盒的校准中，以IU/mL表示结果。
With the availability of vaccines, commercial assays detecting anti-severe acute respiratory syndrome coronavirus-2 antibodies (Ab) evolved toward quantitative assays directed to the spike glycoprotein or its receptor binding domain (RBD). The main objective of the present study was to compare the Ab titers obtained with quantitative commercial binding Ab assays, after one dose (convalescent individuals) or two doses (naive individuals) of vaccine, in health care workers (HCW). Antibody titers were measured in 255 sera (from 150 HCW) with five quantitative immunoassays (Abbott RBD IgG II quant, bioMérieux RBD IgG, DiaSorin Trimeric spike IgG, Siemens Healthineers RBD IgG, Wantai RBD IgG). One qualitative total antibody anti-RBD detection assay (Wantai) was used to detect previous infection before vaccination. The results are presented in binding Ab units (BAU)/mL after application, when possible, of a conversion factor provided by the manufacturers and established from a World Health Organization internal standard. There was a 100% seroconversion with all assays evaluated after two doses of vaccine. With assays allowing BAU/mL correction, Ab titers were correlated (Pearson correlation coefficient, ρ, range: 0.85–0.94). The titer differences varied by a mean of 10.6% between Siemens and bioMérieux assays to 60.9% between Abbott and DiaSorin assays. These results underline the importance of BAU conversion for the comparison of Ab titer obtained with the different quantitative assays. However, significant differences persist, notably, between kits detecting Ab against the different antigens. A true standardization of the assays would be to include the International Standard in the calibration of each assay to express the results in IU/mL.