Clinical evaluation of commercial automated SARS-CoV-2 immunoassays.
Int J Infect Dis
; 103: 590-596, 2021 Feb.
Article
in En
| MEDLINE
| ID: mdl-33310108
ABSTRACT
OBJECTIVE:
Numerous immunoassays for detecting antibodies directed against SARS-CoV-2 have been rapidly developed and released. Validations of these have been performed with a limited number of samples. The lack of standardisation might lead to significantly different results. This study compared ten automated assays from six vendors in terms of sensitivity, specificity and reproducibility.METHODS:
This study compared ten fully automated immunoassays from the following vendors Diasorin, Epitope Diagnostics, Euroimmun, Roche, YHLO, and Snibe. The retrospective part of the study included patients with a laboratory-confirmed COVID-19 infection, and controls comprised patients with a suspected infection, in whom the disease was excluded. Furthermore, biobanked sera were taken as negative controls (n = 97). The retrospective part involved four groups (1) laboratory-confirmed COVID-19 infection (n = 183); (1B) suspected COVID-19 infection (n = 167) without a qRT-PCR result but positive serological results from at least two different assays, and suspected COVID-19 infection due to a positive serological result from the Roche assay (n = 295); (2) biobanked sera obtained from patients before the emergence of SARS-CoV-2 (n = 97) as negative controls; and (2A) probably COVID-19-negative sera with negative serological results from at least two different assays (n = 152).RESULTS:
Overall diagnostic sensitivities were Euroimmun (IgA) 87%; Epitope Diagnostics (IgG) 83%; YHLO (IgG) 77%; Roche (IgM/IgG) 77%; Euroimmun (IgG) 75%; Diasorin (IgG) 53%; Epitope Diagnostics (IgM) 52%; Snibe (IgG) 47%; YHLO (IgM) 35%; and Snibe (IgM) 26%. Diagnostic specificities were YHLO (IgG) 100%; Roche, 100%; Snibe (IgM/IgG) 100%; Diasorin (IgG) 97%; Euroimmun (IgG) 94%; YHLO (IgM) 94%; Euroimmun (IgA) 83%.CONCLUSION:
Assays from different vendors substantially varied in terms of their performance. These findings might facilitate selection of appropriate serological assays.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Immunoassay
/
SARS-CoV-2
/
COVID-19
/
Antibodies, Viral
Type of study:
Diagnostic_studies
/
Observational_studies
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Int J Infect Dis
Journal subject:
DOENCAS TRANSMISSIVEIS
Year:
2021
Document type:
Article