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Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation
- Source :
- Journal of Clinical Virology
- Publication Year :
- 2020
-
Abstract
- Highlights • Microneutralisation test (MNT) was carried out for 62 COVID-19 patients. • Results from six commercial SARS-CoV-2 immunoassays were compared to MNT. • Performance of different immunoassays were variable.<br />There is an urgent need for reliable high-throughput serological assays for the management of the ongoing COVID-19 pandemic. Preferably, the performance of serological tests for a novel virus should be determined with clinical specimens against a gold standard, i.e. virus neutralisation. We compared the performance of six commercial immunoassays for the detection of SARS-COV-2 IgG, IgA and IgM antibodies, including four automated assays [Abbott SARS-COV-2 IgG (CE marked), Diasorin Liaison® SARS-COV-2 S1/S2 IgG (research use only, RUO), and Euroimmun SARS-COV-2 IgG and IgA (CE marked)], and two rapid lateral flow (immunocromatographic) tests [Acro Biotech 2019-nCoV IgG/IgM (CE marked) and Xiamen Biotime Biotechnology SARS-COV-2 IgG/IgM (CE marked)] with a microneutralisation test (MNT). Two specimen panels from serum samples sent to Helsinki University Hospital Laboratory (HUSLAB) were compiled: the patient panel (N=70) included sera from PCR confirmed COVID-19 patients, and the negative panel (N=81) included sera sent for screening of autoimmune diseases and respiratory virus antibodies in 2018 and 2019. The MNT was carried out for all COVID-19 samples (70 serum samples, 62 individuals) and for 53 samples from the negative panel. Forty-one out of 62 COVID-19 patients showed neutralising antibodies.The specificity and sensitivity values of the commercial tests against MNT, respectively, were as follows: 95.1 %/80.5 % (Abbott Architect SARS-CoV-2 IgG), 94.9 %/43.8 % (Diasorin Liaison SARS-CoV-2 IgG; RUO), 68.3 %/87.8 % (Euroimmun SARS-CoV-2 IgA), 86.6 %/70.7 % (Euroimmun SARS-CoV-2 IgG), 74.4 %/56.1 % (Acro 2019-nCoV IgG), 69.5 %/46.3 % (Acro 2019-nCoV IgM), 97.5 %/71.9 % (Xiamen Biotime SARS-CoV-2 IgG), and 88.8 %/81.3 % (Xiamen Biotime SARS-CoV-2 IgM). This study shows variable performance values. Laboratories should carefully consider their testing process, such as a two-tier approach, in order to optimize the overall performance of SARS- CoV-2 serodiagnostics.
- Subjects :
- 0301 basic medicine
Male
Antibodies, Viral
Neutralization
Serology
0302 clinical medicine
COVID-19 Testing
Medicine
030212 general & internal medicine
Child
Aged, 80 and over
Immunoassay
0303 health sciences
biology
Middle Aged
Hospitals
3. Good health
Infectious Diseases
Child, Preschool
Respiratory virus
Female
Antibody
Coronavirus Infections
IgA
Adult
Adolescent
IgG
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
030106 microbiology
Pneumonia, Viral
Sensitivity and Specificity
Virus
Article
Neutralisation
03 medical and health sciences
Betacoronavirus
Young Adult
Neutralization Tests
Virology
Humans
Serologic Tests
Pandemics
Aged
Automation, Laboratory
030306 microbiology
business.industry
Clinical Laboratory Techniques
SARS-CoV-2
COVID-19
Gold standard (test)
Immunoglobulin A
body regions
Immunoglobulin M
Novel virus
Immunoglobulin G
biology.protein
business
Subjects
Details
- ISSN :
- 18735967
- Volume :
- 129
- Database :
- OpenAIRE
- Journal :
- Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
- Accession number :
- edsair.doi.dedup.....8aebbca03a66e655b7732d1a8e37ccd4