Validation and clinical performance of a non-commercial ELISA for SARS-CoV-2 anti-RBD IgA antibodies.

 0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Lismary Ávila-Díaz, Yahima Chacón-Quintero, Sheila Chávez-Valdés, Edelgis Coizeau-Rodríguez, Giselle Freyre-Corrales, Nivaldo Gómez-Hernández, Hany González-Formental, Gerardo Guillen, Gilda Lemos-Pérez, Ana K Marichal-Rodríguez, Ricardo Martínez-Rosales, Amalia Vázquez-Arteaga

Ngôn ngữ: eng

Ký hiệu phân loại: 920.71 Men

Thông tin xuất bản: United States : Analytical biochemistry , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 97118

COVID-19 is caused by SARS-CoV-2, first identified in 2019. The Cuban vaccines, Abdala and Mambisa, have demonstrated efficacy in preventing SARS-CoV-2 infection. Immunoglobulin A (IgA) are the main line of defense against pathogens invading the respiratory or digestive tract and its presence in serum can be measured to assess vaccine efficacy. ELISAs are a valuable tool for assessing vaccine immunogenicity. These tests should be validated to ensure their reliability and suitability. The objective of this study was to validate a non-commercial ELISA for the quantification of total anti-RBD IgA in serum samples to support clinical studies. This assay demonstrated high clinical specificity (97.3 %). The accuracy and precision of the assay showed an overall error of less than 20 % at all levels in QCs. Re-evaluation of samples showed a mean difference of less than 30 % in 90.2 % of cases. Anti-RBD IgA titers correlated with viral neutralization titers and percentage inhibition of RBD-ACE2 binding. This assay was found to be highly accurate and reproducible for the quantification of anti-RBD IgA, met the most stringent acceptance criteria and is fit for purpose. It is currently being used to evaluate the immunogenicity of the Abdala and Mambisa vaccines.
Tạo bộ sưu tập với mã QR

THƯ VIỆN - TRƯỜNG ĐẠI HỌC CÔNG NGHỆ TP.HCM

ĐT: (028) 36225755 | Email: tt.thuvien@hutech.edu.vn

Copyright @2024 THƯ VIỆN HUTECH