Kuechler Anna Sabrina, Heger Eva, Wirtz Maike, Weinhold Sandra, Uhrberg Markus, Boege Fritz, Schulze-Bosse Karin
Central Institute for Clinical Chemistry and Laboratory Diagnostics, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, 40225 Düsseldorf, Germany.
Institute for Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.
Vaccines (Basel). 2023 Mar 6;11(3):598. doi: 10.3390/vaccines11030598.
(1) Background: The high incidence of SARS-CoV-2 infection in vaccinated persons underscores the importance of individualized re-vaccination. PanIg antibodies that act against the S1/-receptor binding domain quantified in serum by a routine diagnostic test (ECLIA, Roche) can be used to gauge the individual ex vivo capacity of SARS-CoV-2 neutralization. However, that test is not adapted to mutations in the S1/-receptor binding domain, having accumulated in SARS-CoV-2 variants. Therefore, it might be unsuited to determine immune-reactivity against SARS-CoV-2 BA.5.1. (2) Method: To address this concern, we re-investigated sera obtained six months after second vaccinations with un-adapted mRNA vaccine Spikevax (Moderna). We related serum levels of panIg against the S1/-receptor binding domain quantified by the un-adapted ECLIA with full virus neutralization capacity against SARS-CoV-2 B.1 or SARS-CoV-2 BA5.1. (3) Results: 92% of the sera exhibited sufficient neutralization capacity against the B.1 strain. Only 20% of the sera sufficiently inhibited the BA5.1 strain. Sera inhibiting BA5.1 could not be distinguished from non-inhibiting sera by serum levels of panIg against the S1/-receptor binding domain quantified by the un-adapted ECLIA. (4) Conclusion: Quantitative serological tests for an antibody against the S1/-receptor binding domain are unsuited as vaccination companion diagnostics, unless they are regularly adapted to mutations that have accumulated in that domain.
(1) 背景：接种疫苗者中SARS-CoV-2感染的高发生率凸显了个性化再接种的重要性。通过常规诊断测试（电化学发光免疫分析，罗氏公司）在血清中定量检测的针对S1/受体结合域的全免疫球蛋白（PanIg）抗体，可用于评估个体体外中和SARS-CoV-2的能力。然而，该测试未针对SARS-CoV-2变体中积累的S1/受体结合域突变进行调整。因此，它可能不适用于确定针对SARS-CoV-2 BA.5.1的免疫反应性。(2) 方法：为解决这一问题，我们重新研究了接种未调整的mRNA疫苗Spikevax（莫德纳）第二次疫苗接种六个月后获得的血清。我们将通过未调整的电化学发光免疫分析定量检测的针对S1/受体结合域的全免疫球蛋白血清水平与针对SARS-CoV-2 B.1或SARS-CoV-2 BA5.1的全病毒中和能力相关联。(3) 结果：92%的血清对B.1毒株表现出足够的中和能力。只有20%的血清充分抑制了BA5.1毒株。通过未调整的电化学发光免疫分析定量检测的针对S1/受体结合域的全免疫球蛋白血清水平，无法区分抑制BA5.1的血清和未抑制的血清。(4) 结论：针对S1/受体结合域抗体的定量血清学检测不适用于作为疫苗接种伴随诊断，除非它们定期针对该域中积累的突变进行调整。
