TITLE:
Analysis of Commercial Assays for the Detection of SARS-CoV-2 Antibodies or Antigens
AUTHORS:
John M. González, William J. Shelton, Manuel Díaz-Vallejo, Victoria E. Rodriguez-Castellanos, Juan Diego H. Zuluaga, Diego F. Chamorro, Daniel Arroyo-Ariza
KEYWORDS:
Antibody, Antigen, Coronavirus, Immunoassay, SARS
JOURNAL NAME:
Open Journal of Immunology,
Vol.10 No.2,
June
18,
2020
ABSTRACT: Background: COVID-19 produced by SARS-CoV-2 infection has spread worldwide. There is
a growing need for immunological assays to detect viral specific antibodies or
viral antigen. Current standard of diagnosis is reverse-transcriptase
polymerase chain reaction (RT-PCR) in nasopharyngeal swabs. However
serological tests can be used to determine previous exposure to the virus and
complement the diagnosis. IgM and IgG SARS-CoV-2 specific antibodies can be
detected as early as one week after infection and assays can be useful to test
large groups of individuals. This work revised the available information concerning
assays that detect antibodies and antigens for SARS-CoV-2. Methods: Three
sources of information were used: technical data sheets (TDS) web pages of the
company’s
products and published articles in Pubmed with reference to the use of
diagnostic kits. All the information was revised until April 5th 2020. Results: There were 226 tests coming from 20 countries mainly
from China. TDS were found only in 50 (22.1%). Most assays detect specific
antibodies (n 180) based on immunochromatography methods (n 110) and use blood-derived samples (n
105). Assays for antibodies detection measured mainly IgM/IgG (n 112) and the
most common procedure time was in vitro diagnosis (IVD). A total 165 articles were found on PubMed 15
were included and only 4 used the commercial kits reviewed. Conclusions: Due
to the urgency of producing diagnostic tests for SARS-CoV-2 there is a broad
offer of kits. Many tests need additional information for their application.
The data collected may be useful in the selection of assays but more and
higher quality information is needed.