Background: The persisting Coronavirus disease 2019 (COVID-19) pandemic and limited vaccine supply has led to a shift in global health priorities to expand vaccine coverage. Relying on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing alone cannot reveal the infection proportion, which could play a critical role in vaccination prioritization. We evaluated the utility of a combination orthogonal serological testing (COST) algorithm alongside RT-PCR to quantify prevalence with the aim of identifying candidate patient clusters to receive single and/or delayed vaccination. Methods: We utilized 108,505 patients with suspected COVID-19 in a retrospective analysis of SARS-CoV-2 RT-PCR vs. IgG-nucleocapsid (IgG NC ) antibody testing coverage in routine practice for the estimation of prevalence. Prospectively, an independent cohort of 21,388 subjects was simultaneously tested by SARS-CoV-2 RT-PCR and IgG NC to determine the prevalence. We used 614 prospective study subjects to assess the utility of COST (IgG NC , IgM-spike (IgM SP ), and IgG-spike (IgG SP )) in establishing the infection proportion to identify a single-dose vaccination cohort. Results: Retrospectively, we observed a 6.3% (6871/108,505) positivity for SARS-CoV-2 RT-PCR, and only 2.3% (2533/108,505) of cases had paired IgG NC serology performed. Prospectively, IgG NC serology identified twice the number of COVID-positive cases in relation to RT-PCR alone. COST further increased the number of detected positive cases: IgG NC + or IgM SP + (18.0%); IgG NC + or IgG SP + (23.5%); IgM SP + or IgG SP + (23.8%); and IgG NC + or IgM SP + or IgG SP + (141/584 = 24.1%). Conclusion: COST may be an effective tool for the evaluation of infection proportion and thus could define a cohort for a single dose and/or delayed vaccination.
【저자키워드】 COVID-19, SARS-CoV-2, IgG, IgM, Vaccine, spike, nucleocapsid, orthogonal antibody testing, vaccine prioritization, 【초록키워드】 Coronavirus disease 2019, Antibody testing, coronavirus, vaccination, pandemic, serology, Prospective Study, Infection, RT-PCR, Prevalence, Cohort, Coverage, Health, Serological testing, Algorithm, Patient, Cluster, Retrospective analysis, SARS-CoV-2 RT-PCR, molecular, utility, Critical, single dose, Combination, acute respiratory syndrome, subject, positive, effective, independent, tested, identify, performed, proportion, evaluated, determine, expand, receive, 【제목키워드】 Testing, role, Combined,