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.
【저자키워드】 COVID-19, SARS-CoV-2, Neutralizing antibodies, ELISA, lateral flow assay, 【초록키워드】 vaccination, neutralization, detection, diagnostics, lateral flow, sensitivity, specificity, sera, serological, Euroimmun, convalescent patient, significant difference, vaccinated individuals, vaccinated individual, lowest, highest, tested, collected, negative control sample, evaluated, specific neutralizing antibody, 【제목키워드】 Test, detection, Rapid, Flow, Specific, surrogate, Lateral,