Clinical performance of three fully automated anti-SARS-CoV-2 immunoassays targeting the nucleocapsid or spike proteins.

Journal of Medical Virology
Julien FavresseJonathan Douxfils

Abstract

This study assesses the clinical performance of three anti-SARS-CoV-2 assays, namely EUROIMMUN anti-SARS-CoV-2 nucleocapsid (IgG) ELISA, Elecsys anti-SARS-CoV-2 nucleocapsid (total antibodies) assay, and LIAISON anti-SARS-CoV-2 spike proteins S1 and S2 (IgG) assay. One hundred and thirty-seven coronavirus disease 2019 (COVID-19) samples from 96 reverse-transcription polymerase chain reaction confirmed patients were chosen to perform the sensitivity analysis. Non-SARS-CoV-2 sera (n = 141) with a potential cross-reaction to SARS-CoV-2 immunoassays were included in the specificity analysis. None of these tests demonstrated a sufficiently high clinical sensitivity to diagnose acute infection. Fourteen days since symptom onset, we did not find any significant difference between the three techniques in terms of sensitivities. However, Elecsys performed better in terms of specificity. All three anti-SARS-CoV-2 assays had equivalent sensitivities 14 days from symptom onset to diagnose past-COVID-19 infection. We also confirmed that anti-SARS-CoV-2 determination before Day 14 is of less clinical interest.

References

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Jul 9, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Julien FavresseJonathan Douxfils
Jul 16, 2020·Journal of Medical Virology·Marie Tré-HardyLaurent Blairon

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Citations

Feb 9, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Julien FavresseJonathan Douxfils
Feb 9, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Julien FavresseMarco Perrone
Apr 14, 2021·Annals of Clinical Biochemistry·Emma HeffernanMaria Fitzgibbon

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Methods Mentioned

BETA
ELISA

Software Mentioned

GraphPad Prism®
MedCalc®

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