학술논문

Sensitivity of three commercial tests for SARS-CoV-2 serology in children: an Italian multicentre prospective study
Document Type
article
Source
Italian Journal of Pediatrics, Vol 48, Iss 1, Pp 1-10 (2022)
Subject
COVID-19
SARS-CoV-2
Electrochemiluminescent immunoassay (ECLIA)
Enzyme-linked immunosorbent assay (ELISA)
Children
Pediatrics
RJ1-570
Language
English
ISSN
1824-7288
Abstract
Abstract Background US Food and Drug Administration has issued Emergency Use Authorizations for hundreds of serological assays to support Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) diagnosis. The aim of this study is to evaluate, for the first time in children, the performance of three widely utilized SARS-CoV-2 serology commercial assays, Diesse Diagnostics (IgG, IgA, IgM) and Roche Diagnostics, both Roche Nucleocapsid (N) IgG and Roche Spike (S) IgG assays. Methods Sensitivity and 95% confidence intervals (CIs) were estimated for each of the three different serological tests and mixed and direct comparison were performed. Univariate and multivariate Poisson regression models were fitted to calculate incidence rate ratios and 95% CIs as estimate of the effects of age, gender, time on the serology title. A p-value