Este articulo es un Preprint
Los preprints son informes de investigación preliminares que no han sido certificados por revisión por pares. No deben considerarse para guiar la práctica clínica o los comportamientos relacionados con la salud y no deben publicarse en los medios como información establecida.
Los preprints publicados en línea permiten a los autores recibir comentarios rápidamente, y toda la comunidad científica puede evaluar de forma independiente el trabajo y responder adecuadamente. Estos comentarios se publican junto con los preprints para que cualquiera pueda leer y servir como una revisión pospublicación.
Performance of SARS-CoV-2 Serology tests: Are they good enough? (preprint)
medrxiv; 2020.
Preprint
en Inglés
| medRxiv | ID: ppzbmed-10.1101.2020.11.13.20229625
ABSTRACT
BackgroundIn the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations. MethodsSARS-CoV-2 patient samples (n=43) were analysed alongside pre-pandemic control specimen (n=50), confirmed respiratory infections (n=50), inflammatory polyarthritis (n=22) and positive for thyroid stimulating immunoglobulin (n=30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen. ResultsEDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2% - 8.1% and 8.2% - 9.6% respectively. Diagnostic sensitivity of the assays were 100% (CI 80-100%) for Abbott, EDI and EuroImmun and 95% (CI 73-100%) for DiaSorin at [≥]14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%. ConclusionsSerological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.
Texto completo:
Disponible
Colección:
Preprints
Base de datos:
medRxiv
Idioma:
Inglés
Año:
2020
Tipo del documento:
Preprint
Similares
MEDLINE
...
LILACS
LIS