About: High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies

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About: High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies
Creator	Gruson, Damien Göbbels, Paul Tré-Hardy, Marie Douxfils, Jonathan Favresse, Julien Dogné, Jean-Michel Elsen, Marc Eucher, Christine Haventith, Caroline Mairesse, Antoine
Source	Elsevier; Medline; PMC
abstract	Abstract Objectives Several serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performances of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated. Design & Methods The precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed patients COVID-19 samples. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay. Results This iFlash® SARS-CoV-2 assay showed excellent analytical performances. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3-71.2%) and 92.9%% (95% CI: 85.7-96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7-88.1%) and 95.9% (95% CI: 89.4-98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6-100) from 28 days since symptom onset. Conclusions This study shows that the iFlash® SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performances. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%).
has issue date	2020-08-25(xsd:dateTime)
bibo:doi	10.1016/j.clinbiochem.2020.08.009
bibo:pmid	32858061
has license	els-covid
sha1sum (hex)	2003dc1d84a10a0cef7bee617c70a32f29125486
schema:url	https://doi.org/10.1016/j.clinbiochem.2020.08.009
resource representing a document's title	High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies
has PubMed Central identifier	PMC7445483
has PubMed identifier	32858061
schema:publication	Clin Biochem
resource representing a document's body	covid:2003dc1d84a10a0cef7bee617c70a32f29125486#body_text
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