Certification of AESKULISA® SARS-CoV-2 S1 IgG and IgM for SARS-CoV-2

Abstract

Validation of immunoassay kits of different methodologies such as enzyme-linked immunosorbent assay (ELISA), IFA immunofluorescence analyses, chemiluminescent immunoassay (CLIA), among others; under national and international certification protocols, it is one of the steps to obtain the sanitary registry before the Ministry of Popular Power for Health; and thus be able to be marketed in the Venezuelan territory. The objective is to verify the performance characteristics established by the manufacturer and to evaluate the performance of said methodologies. For this reason, this article shows a retrospective study, which determined the diagnostic performance of two ELISA methodology kits from IgG and IgM spike (S1) antibodies in patients with the SARS-CoV-2 virus, used at autonomous institute university hospital of the Andes. For statistical processing, the SPSS IBM 16® statistical software was used. The results obtained were for S1 IgG: 97,33 % precision > 99 % accuracy, 93,78 % sensitivity, and > 99 % specificity; and for the S1 IgM precision of 94,20 %, accuracy > 99 %, sensitivity 96,51 % and specificity 92,85 %. This corroborates that the characteristics reflected in the documents issued by the manufacturer of AESKULISA® SARS-CoV-2 S1 IgG and IgM in terms of quality, accuracy, precision,  sensitivity and specificity, are optimal for the determination of S1 IgG spike antibodies and IgM against SARS-CoV-2 in human serum or plasma.