An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody response to spike 1 (S1), spike 2 (S) and nucleocapsid (N) antigens using serum from 74 RNA(+) patients and RNA(+) 47 control patients. An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control patients from March 2019. 59 patients were RNA(+) and 15 were RNA(–). A serum (±) classification was derived for all three antigens and a quantitative serological profile was obtained. Serum(+) was identified in 30% (95% CI 11–48) of initially RNA(–) patients, in 36% (95% CI 17–54) of RNA(+) patients before 10 days, 77% (95% CI 67–87) between 10 and 20 days and 95% (95% CI 86–100) after 21 days. The patient-level diagnostic accuracy relative to RNA(±) after 10 days displayed 88% sensitivity (95% CI 75–95) and 75% specificity (95% CI 22–99), although specificity compared with historical controls was 100% (95%CI 91–100). This study provides robust support for further evaluation and validation of this novel technology in a clinical setting and highlights challenges inherent in assessment of serological tests for an emerging disease such as COVID-19.
【초록키워드】 COVID-19, serological test, hospital, diagnostic, Antigen, serum, sensitivity, specificity, IgG antibody, Accuracy, nucleocapsid, IgA, Patient, Control, emerging disease, SARS-CoV-2 RNA, Quantitative, Admission, patients, SARS-CoV-2 IgM, Concentration, Support, 95%CI, 95% CI, control patients, clinical setting, serological profile, serum sample, highlight, robust, tested, conducted, provide, inherent, was obtained, control patient, 【제목키워드】 Antibody detection, SARS-CoV-2 antigen, information, Quantitative, syndrome, presenting, cohort of patient, ESI, with COVID-19,