Background As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection. Methods Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated. Results 512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93–97% sensitivity) and using serum did not improve the sensitivity or specificity. Conclusions Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.
【초록키워드】 COVID-19, CLIA, Antibody testing, COVID-19 vaccine, mechanical ventilation, Hospitalization, antibody, POC, Infection, outcome, virus, nucleocapsid protein, Antigen, lateral flow, immunoassay, point-of-care, serum, sensitivity, specificity, COVID-19 vaccines, PCR, Screen, COVID-19 infection, nucleocapsid, vaccine response, symptomatic, COVID-19 antibody, antibody assay, Blood, SARS-CoV-2 spike, subject, individual, PCR-positive, positive PCR, variable, effective, IMPROVE, Result, enrolled, produced, resulting, identify, performed, detectable, evaluated, required, screened, determine, subjects, correlated, feasible, individuals with COVID-19, the immunoassay, 【제목키워드】 COVID-19, point-of-care, serology test,