Diagnostic performance of an automated chemiluminescence immunoassay for SARS-CoV-2 IgG and IgM antibodies detection: A real life experience.
Anti-SARS-CoV −2 antibodies
Antibody levels
Coronavirus infectious disease 2019 (COVID-19)
Diagnostic accuracy
Serological diagnosis
Journal
Practical laboratory medicine
ISSN: 2352-5517
Titre abrégé: Pract Lab Med
Pays: Netherlands
ID NLM: 101690848
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
01
05
2020
accepted:
14
04
2021
entrez:
26
4
2021
pubmed:
27
4
2021
medline:
27
4
2021
Statut:
ppublish
Résumé
Recently many serological assays for detection of antibodies to SARS-COV-2 virus were introduced on the market. Aim of this study was to assess the diagnostic performance of an automated CLIA for quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies. A total of 354 sera, 89 from consecutive patients diagnosed with COVID-19 (43 mild, 32 severe and 13 critical) and 265 from asymptomatic and negative on rRT-PCR testing healthcare workers, were evaluated for IgM and IgG anti-SARS-CoV-2 antibodies with MAGLUMI immunoassay. The overall sensitivity and specificity were 86.5% (95%CI: 77.6-92.8) and 98.5% (95%CI:96.2-99.6), respectively. PPV, PPN, LR+, LR- and OR were 95.1 (95%CI: 87.8-98.6), 95.6 (95%CI: 92.4-97.7), 57.3 (95%CI: 21.6-152.1), 7.3 (95%CI: 4.31-12.4) and 418.6 (95%CI: 131.2-1335.2), respectively. The levels of SARS-CoV-2 IgM and IgG antibodies were 1.22 ± 1.2 AU/mL and 15.86 ± 24.83 AU/mL, 2.86 ± 2.4 AU/mL and 69.3 ± 55.5 AU/mL, 2.47 ± 1.33 AU/mL and 83.9 ± 83.9 AU/mL in mild, severe and critical COVID-19 groups, respectively. A significant difference in antibody levels between mild and severe/critical subjects has been shown. The CLIA assay showed good diagnostic performance and a significant association between antibody levels and severity of the disease was found.
Sections du résumé
BACKGROUND
BACKGROUND
Recently many serological assays for detection of antibodies to SARS-COV-2 virus were introduced on the market. Aim of this study was to assess the diagnostic performance of an automated CLIA for quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies.
METHODS
METHODS
A total of 354 sera, 89 from consecutive patients diagnosed with COVID-19 (43 mild, 32 severe and 13 critical) and 265 from asymptomatic and negative on rRT-PCR testing healthcare workers, were evaluated for IgM and IgG anti-SARS-CoV-2 antibodies with MAGLUMI immunoassay.
RESULTS
RESULTS
The overall sensitivity and specificity were 86.5% (95%CI: 77.6-92.8) and 98.5% (95%CI:96.2-99.6), respectively. PPV, PPN, LR+, LR- and OR were 95.1 (95%CI: 87.8-98.6), 95.6 (95%CI: 92.4-97.7), 57.3 (95%CI: 21.6-152.1), 7.3 (95%CI: 4.31-12.4) and 418.6 (95%CI: 131.2-1335.2), respectively. The levels of SARS-CoV-2 IgM and IgG antibodies were 1.22 ± 1.2 AU/mL and 15.86 ± 24.83 AU/mL, 2.86 ± 2.4 AU/mL and 69.3 ± 55.5 AU/mL, 2.47 ± 1.33 AU/mL and 83.9 ± 83.9 AU/mL in mild, severe and critical COVID-19 groups, respectively. A significant difference in antibody levels between mild and severe/critical subjects has been shown.
CONCLUSIONS
CONCLUSIONS
The CLIA assay showed good diagnostic performance and a significant association between antibody levels and severity of the disease was found.
Identifiants
pubmed: 33898690
doi: 10.1016/j.plabm.2021.e00227
pii: S2352-5517(21)00027-5
pmc: PMC8054542
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e00227Informations de copyright
© 2021 Published by Elsevier B.V.
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