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Clinical performance of three fully automated anti‐SARS‐CoV‐2 immunoassays targeting the nucleocapsid or spike proteins
Author(s) -
Favresse Julien,
Cadrobbi Julie,
Eucher Christine,
Elsen Marc,
Laffineur Kim,
Dogné JeanMichel,
Douxfils Jonathan
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26669
Subject(s) - covid-19 , virology , medicine , coronavirus , antibody , immunoassay , reverse transcription polymerase chain reaction , polymerase chain reaction , cross reactions , spike protein , real time polymerase chain reaction , serology , severe acute respiratory syndrome coronavirus , immunology , disease , biology , infectious disease (medical specialty) , messenger rna , gene , biochemistry
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.