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Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19
- Source :
- Frontiers in Public Health, Frontiers in Public Health, Vol 8 (2021)
- Publication Year :
- 2021
-
Abstract
- Introduction: Few data on the diagnostic performance of serological tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are currently available. We evaluated sensitivity and specificity of five different widely used commercial serological assays for the detection of SARS-CoV-2–specific IgG, IgM, and IgA antibodies using reverse transcriptase-PCR assay in nasopharyngeal swab as reference standard test.Methods: A total of 337 plasma samples collected in the period April–June 2020 from SARS-CoV-2 RT-PCR positive (n = 207) and negative (n = 130) subjects were investigated by one point-of-care lateral flow immunochromatographic assay (LFIA IgG and IgM, Technogenetics) and four fully automated assays: two chemiluminescence immunoassays (CLIA-iFlash IgG and IgM, Shenzhen YHLO Biotech and CLIA-LIAISON® XL IgG, DiaSorin), one electrochemiluminescence immunoassay (ECLIA-Elecsys® total predominant IgG, Roche), and one enzyme-linked immunosorbent assay (ELISA IgA, Euroimmune).Results: The overall sensitivity of all IgG serological assays was >80% and the specificity was >97%. The sensitivity of IgG assays was lower within 2 weeks from the onset of symptoms ranging from 70.8 to 80%. The LFIA and CLIA-iFlash IgM showed an overall low sensitivity of 47.6 and 54.6%, while the specificity was 98.5 and 96.2%, respectively. The ELISA IgA yielded a sensitivity of 84.3% and specificity of 81.7%. However, the ELISA IgA result was indeterminate in 11.7% of cases.Conclusions: IgG serological assays seem to be a reliable tool for the retrospective diagnosis of SARS-CoV-2 infection. IgM assays seem to have a low sensitivity and IgA assay is limited by a substantial rate of indeterminate results.
- Subjects :
- Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Antibodies, Viral
COVID-19 Serological Testing
law.invention
Serology
03 medical and health sciences
0302 clinical medicine
ECLIA and ELISA
law
Humans
Medicine
030212 general & internal medicine
Reference standards
SARS-CoV-2 RT-PCR
Original Research
Chemiluminescence
0303 health sciences
biology
Plasma samples
SARS-CoV-2
030306 microbiology
business.industry
lcsh:Public aspects of medicine
SARS-CoV-2 infection
Public Health, Environmental and Occupational Health
COVID-19
lcsh:RA1-1270
LFIA
SARS-CoV-2-specific antibodies
Immunoglobulin M
ROC Curve
Fully automated
SARS-CoV-2-specific antibodie
sensitivity and specificity
Immunoglobulin G
Immunology
biology.protein
Public Health
Antibody
CLIA
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Frontiers in Public Health, Frontiers in Public Health, Vol 8 (2021)
- Accession number :
- edsair.doi.dedup.....2df04830258c4cf32d04e41c81814431