Abstract：
Detection of seroconversion after SARS-CoV-2-infection or vaccination is relevant to discover subclinical cases and recognize patients with a possible immunity.
Test performance, effects of age, time-point of seroconversion and immune status regarding neutralizing antibodies (NAbs) and T-cell-reactivity were investigated.
Two antibody assays (Viramed-Test for S/N-specific IgG, Roche-Test for N-specific IgA, -M, -G) were evaluated with classified samples. In total, 381 subjects aged 6-99 years, who had either recovered from the disease or had been vaccinated, were screened for SARS-CoV-2-specific antibodies. This screening was part of an open observational study with working adults. Additionally, children and adults were analyzed in a longitudinal COVID-19 study in schools. For immunity evaluation, virus neutralization tests and ELISpot tests were performed in a subgroup of subjects.
Viramed revealed a slightly lower test performance than Roche, but test quality was equally well in samples from very young or very old donors. The time-point of seroconversion after the respective immunization detected by the two tests was not significantly different. N-specific antibodies, detected with Roche, highly correlated with NAbs in recovered subjects, whereas a positive Viramed-Test result was paralleled by a positive ELISpot result.
Viramed-Test was not as sensitive as Roche-Test, but highly specific and beneficial to distinguish between recovered and vaccinated status. For both tests correlations with humoral and cellular immunity were found. Of note, the expected early detection of IgA and IgM by the Roche-Test did not prove to be an advantage over IgG testing by Viramed.
Test performance, effects of age, time-point of seroconversion and immune status regarding neutralizing antibodies (NAbs) and T-cell-reactivity were investigated.
Two antibody assays (Viramed-Test for S/N-specific IgG, Roche-Test for N-specific IgA, -M, -G) were evaluated with classified samples. In total, 381 subjects aged 6-99 years, who had either recovered from the disease or had been vaccinated, were screened for SARS-CoV-2-specific antibodies. This screening was part of an open observational study with working adults. Additionally, children and adults were analyzed in a longitudinal COVID-19 study in schools. For immunity evaluation, virus neutralization tests and ELISpot tests were performed in a subgroup of subjects.
Viramed revealed a slightly lower test performance than Roche, but test quality was equally well in samples from very young or very old donors. The time-point of seroconversion after the respective immunization detected by the two tests was not significantly different. N-specific antibodies, detected with Roche, highly correlated with NAbs in recovered subjects, whereas a positive Viramed-Test result was paralleled by a positive ELISpot result.
Viramed-Test was not as sensitive as Roche-Test, but highly specific and beneficial to distinguish between recovered and vaccinated status. For both tests correlations with humoral and cellular immunity were found. Of note, the expected early detection of IgA and IgM by the Roche-Test did not prove to be an advantage over IgG testing by Viramed.
摘要：
SARS-CoV-2感染或疫苗接种后血清转化的检测与发现亚临床病例和识别具有可能免疫力的患者有关。
测试性能，年龄的影响,研究了血清转化的时间点和中和抗体（NAb）和T细胞反应性的免疫状态。
两种抗体测定（S/N特异性IgG的Viramed-Test，罗氏测试N-特异性IgA,-M,-G)用分类样品进行评价。总的来说,381名6-99岁的受试者，他们要么从疾病中康复，要么接种了疫苗，筛选SARS-CoV-2特异性抗体。这项筛查是一项针对在职成年人的开放式观察性研究的一部分。此外,在学校的一项纵向COVID-19研究中，对儿童和成人进行了分析。对于免疫力评估，在一组受试者中进行了病毒中和试验和ELISpot试验.
Viramed的测试性能略低于罗氏，但是来自非常年轻或非常年老的捐献者的样本的测试质量同样好。通过两种测试检测到的各自免疫后血清转化的时间点没有显着差异。N特异性抗体，被罗氏发现,与康复受试者的NAb高度相关，而阳性的Viramed-Test结果与阳性的ELISpot结果平行。
Viramed-Test不如Roche-Test灵敏,但高度特异性，有利于区分恢复和接种状态。对于这两种测试，都发现了与体液和细胞免疫的相关性。值得注意的是，与Viramed的IgG检测相比,预期的Roche-Test早期检测IgA和IgM没有优势.
测试性能，年龄的影响,研究了血清转化的时间点和中和抗体（NAb）和T细胞反应性的免疫状态。
两种抗体测定（S/N特异性IgG的Viramed-Test，罗氏测试N-特异性IgA,-M,-G)用分类样品进行评价。总的来说,381名6-99岁的受试者，他们要么从疾病中康复，要么接种了疫苗，筛选SARS-CoV-2特异性抗体。这项筛查是一项针对在职成年人的开放式观察性研究的一部分。此外,在学校的一项纵向COVID-19研究中，对儿童和成人进行了分析。对于免疫力评估，在一组受试者中进行了病毒中和试验和ELISpot试验.
Viramed的测试性能略低于罗氏，但是来自非常年轻或非常年老的捐献者的样本的测试质量同样好。通过两种测试检测到的各自免疫后血清转化的时间点没有显着差异。N特异性抗体，被罗氏发现,与康复受试者的NAb高度相关，而阳性的Viramed-Test结果与阳性的ELISpot结果平行。
Viramed-Test不如Roche-Test灵敏,但高度特异性，有利于区分恢复和接种状态。对于这两种测试，都发现了与体液和细胞免疫的相关性。值得注意的是，与Viramed的IgG检测相比,预期的Roche-Test早期检测IgA和IgM没有优势.
