2022
DOI: 10.1128/spectrum.02289-21
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Implementation and Extended Evaluation of the Euroimmun Anti-SARS-CoV-2 IgG Assay and Its Contribution to the United Kingdom’s COVID-19 Public Health Response

Abstract: Serology assays have been useful in determining those with previous SARS-CoV-2 infection in a wide range of research and serosurveillance projects. However, assays vary in their sensitivity at detecting SARS-CoV-2 antibodies. Here, we detail an extended evaluation and characterization of the Euroimmun anti-SARS-CoV-2 IgG assay, one that has been widely used within the United Kingdom on over 160,000 samples.

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Cited by 7 publications
(6 citation statements)
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“…Intra-assay and inter-assay variations have been estimated as <7% and <5% respectively; sensitivity and specificity have been reported as 91.39% and 98.56% respectively. 9 Results are expressed as the ratio of the extinction of the sample over the extinction of the calibrator, and are interpreted in terms of IgG response to vaccine as follows: <0.8 denotes negative; ≥0.8 to <1.1 borderline/indeterminate; ≥1.1 positive. 9 …”
Section: Methodsmentioning
confidence: 99%
“…Intra-assay and inter-assay variations have been estimated as <7% and <5% respectively; sensitivity and specificity have been reported as 91.39% and 98.56% respectively. 9 Results are expressed as the ratio of the extinction of the sample over the extinction of the calibrator, and are interpreted in terms of IgG response to vaccine as follows: <0.8 denotes negative; ≥0.8 to <1.1 borderline/indeterminate; ≥1.1 positive. 9 …”
Section: Methodsmentioning
confidence: 99%
“…Seroprevalence (the proportion of samples above the 1.1 cut-off value recommended by the manufacturer) was estimated to be about 5% in the whole country and 10% in Ile-de-France (Paris area). This 1.1 threshold (optical density ratio) was associated with a sensitivity of 91.4% (92.7% when excluding tests realized less than 14 days after symptoms onset) and a specificity of 98.6% [11]. At the population scale, deducing cumulative incidence (the proportion of persons having been infected since the beginning of the pandemic) from seroprevalence requires to take sensitivity and specificity into account, possibly through Bayesian methods (as a mean to preserve uncertainty) [12].…”
Section: Introductionmentioning
confidence: 94%
“…Seroprevalence (the proportion of samples above the 1.1 cut-off value recommended by the manufacturer) was estimated to be about 5% in the whole country and 10% in Ile-de-France (Paris area). This 1.1 threshold (optical density ratio) was associated with a sensitivity of 91.4% (92.7% when excluding tests realized less than 14 days after symptoms onset) and a specificity of 98.6% [11].…”
Section: Introductionmentioning
confidence: 99%
“…The latter assay was used during the first phase of recruitment but abandoned when vaccination started because of cross-reactivity with vaccination-induced antibodies and because it did not allow quantification of high antibody levels expected to be induced by vaccination. A third ELISA test was used to quantify IgG antibodies against the SARS-CoV-2 spike receptor–binding domain (EUROIMMUN, product number: EI 2606-9601-10) [38]. This quantitative method offers a linear range between 3.2 to 384 BAU/mL (binding antibody unit).…”
Section: Establishing the Cohortmentioning
confidence: 99%