Abstract
The coronavirus disease 19 (COVID-19) pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remain important, laboratories must now pivot and consider an assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here, we have utilized the latest Abbott Alinity semiquantitative IgM and quantitative IgG spike protein (SP) serology assays (IgM SP and IgG SP ) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgG NC ) to assess antibody responses in a cohort of 1,236 unique participants comprised of naive, SARS-CoV-2-infected, and vaccinated (including both naive and recovered) individuals. The IgM SP and IgG SP assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgM SP and IgG SP assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naive, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgG SP and IgM SP values, with a major rise in IgG SP following the booster (second) dose in the naive group. In contrast, SARS-CoV-2-recovered individuals had several-fold higher IgG SP responses than naive following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.
Keywords: COVID-19; IgG; IgM; SARS-CoV-2; antibody; immunoassays; nucleocapsid; spike; vaccine.
【저자키워드】 COVID-19, SARS-CoV-2, IgG, IgM, spike, antibody, vaccine., immunoassays, nucleocapsid, 【초록키워드】 coronavirus disease, Vaccine, coronavirus, vaccination, pandemic, Immunity, antibody, Antibody Response, Infection, severe acute respiratory syndrome Coronavirus, Spike protein, Laboratory, cross-reactivity, immunoassays, Coronavirus infections, sensitivity, Cohort, Antibody responses, COVID-19 vaccines, Health, Serological assay, nucleocapsid, clinical, immune responses, response, Antibody test, respiratory, utility, Quantitative, booster, serological response, Containment, Combination, dose, clinical sensitivity, Abbott, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, significant increase, individual, participant, serology assays, while, serologic assay, collected, unique, individuals, dampened response, serology assay, 【제목키워드】 clinical, group, recovered, Abbott, IgG and IgM,