Open AccessLarge scale production and characterization of SARS‐CoV‐2 whole antigen for serological test development
Author(s) -
Cerutti Helena,
Ricci Veronica,
Tesi Giulia,
Soldatini Claudia,
Castria Marinunzia,
Vaccaro Marco Natale,
Tornesi Stefania,
Toppi Simona,
Verdiani Silvana,
Brogi Alessandra
Publication year - 2021
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.23735
Subject(s) - serology , immunoassay , virology , antibody , antigen , immunology , medicine , virus , coronavirus , covid-19 , pandemic , biology , disease , infectious disease (medical specialty) , pathology
Background The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has generated a pandemic with alarming rates of fatality worldwide. This situation has had a major impact on clinical laboratories that have attempted to answer the urgent need for diagnostic tools, since the identification of coronavirus disease 2019 (COVID‐19). Development of a reliable serological diagnostic immunoassay, with high levels of sensitivity and specificity to detect SARS‐CoV‐2 antibodies with improved differential diagnosis from other circulating viruses, is mandatory. Methods An enzyme‐linked immunosorbent assay (ELISA) using whole inactivated virus cultured in vitro , was developed to detect viral antigens. WB and ELISA investigations were carried out with sera of convalescent patients and negative sera samples. Both analyses were concurrently performed with recombinant MABs to verify the findings. Results Preliminary data from 10 sera (5 patients with COVID‐19, and 5 healthy controls) using this immunoassay are very promising, successfully identifying all of the confirmed SARS‐CoV‐2‐positive individuals. Conclusion This ELISA appears to be a specific and reliable method for detecting COVID‐19 antibodies (IgG, IgM, and IgA), and a useful tool for identifying individuals which have developed immunity to the virus.