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  1. Article ; Online: Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies.

    Favresse, Julien / Eucher, Christine / Elsen, Marc / Tré-Hardy, Marie / Dogné, Jean-Michel / Douxfils, Jonathan

    Clinical chemistry

    2020  Volume 66, Issue 8, Page(s) 1104–1106

    MeSH term(s) Antibodies, Viral/blood ; Area Under Curve ; Betacoronavirus/immunology ; Betacoronavirus/isolation & purification ; COVID-19 ; Coronavirus Infections/diagnosis ; Coronavirus Infections/virology ; Humans ; Immunoassay/methods ; Luminescent Measurements ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/virology ; ROC Curve ; Reagent Kits, Diagnostic ; SARS-CoV-2 ; Time Factors
    Chemical Substances Antibodies, Viral ; Reagent Kits, Diagnostic
    Keywords covid19
    Language English
    Publishing date 2020-07-02
    Publishing country England
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa131
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies

    Favresse, Julien / Eucher, Christine / Elsen, Marc / Tré-Hardy, Marie / Dogné, Jean-Michel / Douxfils, Jonathan

    Clin Chem

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #459333
    Database COVID19

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  3. Article ; Online: Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies

    Favresse, Julien / Eucher, Christine / Elsen, Marc / Tré-Hardy, Marie / Dogné, Jean-Michel / Douxfils, Jonathan

    Clinical Chemistry

    2020  Volume 66, Issue 8, Page(s) 1104–1106

    Keywords Clinical Biochemistry ; Biochemistry, medical ; covid19
    Language English
    Publisher Oxford University Press (OUP)
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa131
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Analytical and Clinical Evaluation of the Semiquantitative Elecsys Anti-SARS-CoV-2 Spike Protein Receptor Binding Domain Antibody Assay on the Roche cobas e602 Analyzer.

    Chan, Clarence W / Yi, Xin / Lenza, Michael / Baldwin, Angel D / Jakalski, Jennifer / Tesic, Vera / Yeo, Kiang-Teck J

    American journal of clinical pathology

    2021  Volume 157, Issue 1, Page(s) 109–118

    Abstract: ... that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 ... severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer ... a robust clinical test for qualitative and semiquantitative detection of seropositivity following SARS-CoV ...

    Abstract Objectives: To analytically and clinically evaluate the semiquantitative Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer.
    Methods: The S-Ab assay is a 1-step, double-antigen sandwich electrochemiluminescent immunoassay that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 spike protein in serum or plasma. The S-Ab assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin), cross-reactivity, and clinical performance, and was compared to the qualitative Elecsys anti-nucleocapsid (N-Ab) immunoassay, a lateral flow device that qualitatively detects S-Ab and N-Ab, and an anti-spike enzyme-linked immunosorbent assay (ELISA).
    Results: S-Ab assay is precise, exhibits linearity from 0.4 to 250 U/mL, is unaffected by significant cross-reactivity or interferences, and qualitatively demonstrates greater than 90% concordance with N-Ab assay and lateral flow device. Readouts of S-Ab assay correlate with ELISA, which in turn correlates strongly with SARS-CoV-2 virus neutralization assay, and exhibit 100% sensitivity and specificity for COVID-19 patient samples obtained at or more than 14 days after PCR positivity.
    Conclusions: The S-Ab assay is a robust clinical test for qualitative and semiquantitative detection of seropositivity following SARS-CoV-2 infection or spike-encoding mRNA COVID-19 vaccination.
    MeSH term(s) Antibodies, Viral ; COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Sensitivity and Specificity ; Spike Glycoprotein, Coronavirus
    Chemical Substances Antibodies, Viral ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Language English
    Publishing date 2021-08-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 2944-0
    ISSN 1943-7722 ; 0002-9173
    ISSN (online) 1943-7722
    ISSN 0002-9173
    DOI 10.1093/ajcp/aqab092
    Database MEDical Literature Analysis and Retrieval System OnLINE

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