Girl Philipp, Zwirglmaier Katrin, von Buttlar Heiner, Wölfel Roman, Müller Katharina
Department of Virology and intracellular Pathogens, Bundeswehr Institute of Microbiology, Munich, Germany.
Department of Bacteriology and Toxinology, Bundeswehr Institute of Microbiology, Munich, Germany.
Front Med (Lausanne). 2022 Feb 4;9:820151. doi: 10.3389/fmed.2022.820151. eCollection 2022.
As vaccination against SARS-CoV-2 progresses rapidly around the world, reliable detection of SARS-CoV-2 specific neutralizing antibodies (NAb) has become an indispensable component of serological diagnostics. We evaluated the performance of four commercially available tests, i.e. two lateral flow assays (Coris BioConcept COVID-19 Sero NP/RBD and Concile InfectCheck COVID-19 NAb) and two surrogate ELISA (sELISA) tests (EUROIMMUN SARS-CoV-2 NeutraLISA and AdipoGen SARS-CoV-2 Neutralizing Antibodies Detection Kit) in comparison with an in-house SARS-CoV-2 micro neutralization test as reference. A total of 334 sera were tested, including 30 samples collected prior to the emergence of SARS-CoV-2, 128 sera from convalescent patients as well as 176 sera from partially or fully vaccinated individuals. The overall sensitivity of LFAs differed and was 71.6% for the Coris and 98.4% for the Concile. In contrast, overall sensitivity of the NeutraLISA was 86 and 98% for the AdipoGen. All test showed the highest sensitivity when testing samples from fully vaccinated individuals with both sELISA achieving 100% sensitivity. Overall specificity was 89.3% for the Coris and only 58.3% for the Concile. Similarly, significant differences were observed for both sELISA, with an overall specificity of 82.1% for the NeutraLISA and only 54.8% for the AdipoGen. All tests showed a 100% specificity when testing negative control samples while specificities were lowest when testing samples from only partially vaccinated individuals.
随着全球范围内针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗接种迅速推进，可靠检测SARS-CoV-2特异性中和抗体（NAb）已成为血清学诊断中不可或缺的组成部分。我们评估了四种市售检测方法的性能，即两种侧向流动分析（Coris BioConcept COVID-19血清学NP/RBD和Concile InfectCheck COVID-19 NAb）以及两种替代酶联免疫吸附测定（sELISA）检测方法（EUROIMMUN SARS-CoV-2中性粒细胞酶联免疫吸附测定和AdipoGen SARS-CoV-2中和抗体检测试剂盒），并与内部SARS-CoV-2微量中和试验作为参考进行比较。共检测了334份血清，包括在SARS-CoV-2出现之前采集的30份样本、128份康复患者的血清以及176份部分或完全接种疫苗个体的血清。侧向流动分析的总体敏感性有所不同，Coris的为71.6%，Concile的为98.4%。相比之下，中性粒细胞酶联免疫吸附测定对AdipoGen的总体敏感性分别为86%和98%。在检测完全接种疫苗个体的样本时，所有检测方法均显示出最高的敏感性，两种sELISA的敏感性均达到100%。Coris的总体特异性为89.3%，而Concile的仅为58.3%。同样，两种sELISA也观察到显著差异，中性粒细胞酶联免疫吸附测定的总体特异性为82.1%，而AdipoGen的仅为54.8%。在检测阴性对照样本时，所有检测方法的特异性均为100%，而在检测仅部分接种疫苗个体的样本时，特异性最低。
