In 2019, a novel coronavirus emerged in Wuhan in the province of Hubei, China. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread across the globe, causing the neoteric COVID-19 pandemic. SARS-CoV-2 is commonly transmitted by droplet infection and aerosols when coughing or sneezing, as well as high-risk exposures to infected individuals by face-to-face contact without protective gear. To date, a broad variety of techniques have emerged to assess and quantify the specific antibody response of a patient towards a SARS-CoV-2 infection. Here, we report the first comprehensive comparison of five different assay systems: Enzyme-Linked Immunosorbent Assay (ELISA), Chemiluminescence Immunoassay (CLIA), Electro-Chemiluminescence Immunoassay (ECLIA), and a new Particle-Enhanced Turbidimetric Immunoassay (PETIA) for SARS-CoV-2. Furthermore, we also evaluated the suitability of N-, S1- and RBD-antigens for quantifying the SARS-CoV-2 specific immune response. Linearity and precision, overall sensitivity and specificity of the assays, stability of samples, and cross-reactivity of general viral responses, as well as common coronaviruses, were assessed. Moreover, the reactivity of all tests to seroconversion and different sample matrices was quantified. All five assays showed good overall agreement, with 76% and 87% similarity for negative and positive samples, respectively. In conclusion, all evaluated methods showed a high consistency of results and suitability for the robust quantification of the SARS-CoV-2-derived immune response.
【저자키워드】 COVID-19, CLIA, SARS-CoV-2, ELISA, assay comparison, quantification of immune response, PETIA, 【초록키워드】 Coronaviruses, coronavirus, immune response, SARS-COV-2 infection, COVID-19 pandemic, Antibody Response, Infection, aerosol, Novel coronavirus, cross-reactivity, Spread, China, Seroconversion, stability, Sensitivity and specificity, Wuhan, Patient, quantification, Protective, similarity, linearity, acute respiratory syndrome, Precision, infected individual, coughing, responses, FIVE, face-to-face contact, robust, globe, transmitted, assays, evaluated, variety, reactivity, quantified, negative and positive, the SARS-CoV-2, were assessed, 【제목키워드】 novel, performance, characterization, routine,