Validation of a commercially available SARS-CoV-2 serological Immunoassay

Meyer, Benjamin; Torriani, Giulia; Yerly, Sabine; Mazza, Léna; Calame, Adrien; Arm-Vernez, Isabelle; Zimmer, Gert; Agoritsas, Thomas; Stirnemann, Jérôme; Spechbach, Hervé; Guessous, Idris; Stringhini, Silvia; Pugin, Jérôme; Roux‐Lombard, Pascale; Fontao, Lionel; Siegrist, Claire‐Anne; Eckerle, Isabella; Vuilleumier, Nicolas; Kaiser, Laurent

doi:10.1101/2020.05.02.20080879

Cited by 31 publications

(45 citation statements)

References 22 publications

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“…We used manufacturer-defined cutoff points for positivity, although the test performance can increased by using other positive and negative cut-off values. 38 However, prevalence correction using these reported test performances or by the manufacturer are not applicable to our study, since the use of In conclusion, our study shows that the level of seroprevalence remains low in the and is also partly funded by MSD, AstraZeneca, Lundbeck and L'Oreal. Week (first day)…”

Section: Discussionmentioning

confidence: 74%

Seroprevalence of SARS-CoV-2 among adults in three regions of France following the lockdown and associated risk factors: a multicohort study

Carrat

Lamballerie

Rahib

et al. 2020

Preprint

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Aim To estimate the seroprevalence of SARS-CoV-2 infection in May-June 2020 after the lockdown in adults living in three regions in France and to identify the associated risk factors. Methods Participants in a survey on COVID-19 from an existing consortium of three general adult population cohorts living in the Ile-de-France (IDF) or Grand Est (GE), two regions with high rate of COVID-19, or in the Nouvelle-Aquitaine (NA), with a low rate, were asked to take a dried-blood spot (DBS) for anti-SARS-CoV-2 antibodies assessment. The primary outcome was a positive anti-SARS-CoV-2 ELISA IgG result against the spike protein of the virus (ELISA-S). The secondary outcomes were a positive ELISA IgG against the nucleocapsid protein (ELISA-NP), anti-SARS-CoV-2 neutralizing antibodies titers >=40 (SN), and predicted positivity obtained from a multiple imputation model (MI). Prevalence estimates were adjusted using sampling weights and post-stratification methods. Findings Between May 4, 2020 and June 23, 2020, 16,000 participants were asked to provide DBS, and 14,628 were included in the analysis, 983 with a positive ELISA-S, 511 with a positive ELISA-NP, 424 with SN>=40 and 941 (Standard Deviation=31) with a positive MI. Adjusted estimates of seroprevalence (positive ELISA-S) were 10.0% (95%CI 9.1%;10.9%) in IDF, 9.0% (95%CI 7.7%; 10.2%) in GE and 3.1% (95%CI 2.4%; 3.7%), in NA. The adjusted prevalence of positive ELISA-NP, SN and MI were 5.7%, 5.0% and 10.0% in IDF, 6.0%, 4.3% and 8.6% in GE, and 0.6%, 1.3% and 2.5% in NA, respectively. A higher seroprevalence was observed in younger participants and when at least one child or adolescent lived in the same household. A lower seroprevalence was observed in smokers compared to non-smokers. Interpretation At the end of the lockdown the prevalence of anti-SARS-CoV-2 IgG or neutralizing antibodies remained low in the French adult population, even in regions with high reported rates of COVID-19.

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Section: Discussionmentioning

confidence: 74%

Seroprevalence of SARS-CoV-2 among adults in three regions of France following the lockdown and associated risk factors: a multicohort study

Carrat

Lamballerie

Rahib

et al. 2020

Preprint

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“…Residual material leftover from routine diagnostics from 3,186 regular blood donors without any preselection (2,257 (70.84%) men and 929 (29.16%) women), donated in the period between 9 March and 3 June 2020, were screened for the presence of anti-SARS-CoV-2 IgG directed against domain S1 of the SARS-CoV-2 spike protein using the anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) from Euroimmun (Lübeck, Germany). In recent publications, this serological ELISA showed a high specificity of 99-100% and a sensitivity of ca 65% [6][7][8][9]. Semiquantitative results were calculated as the ratio of the extinction of samples over the extinction of a calibrator.…”

Section: Presence Of Anti-sars-cov-2 Igg In Blood Donorsmentioning

confidence: 99%

SARS-CoV-2 IgG seroprevalence in blood donors located in three different federal states, Germany, March to June 2020

2020

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Most cases of coronavirus disease 2019 are mild or asymptomatic. Therefore, many cases remain unrecorded. We determined seroprevalence of IgG antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 3,186 regular blood donors in three German federal states between 9 March and 3 June 2020. The IgG seroprevalence was 0.91% (95% confidence interval (CI): 0.58-1.24) overall, ranging from 0.66% (95%

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“…However, the percentages of individuals not seroconverting (claimed by some studies) seem unlikely, ranging from 10 to 80% (Ref. 19 Other rigorous studies have shown that seroconversion is almost universal after confirmed infections, even when the disease is mild (14,(20)(21)(22)(23). Given the evidence, a statement of, "It is unlikely that COVID-19recovered patients who develop antibodies can be reinfected," would have conveyed a message of assurance rather than hysteria and would have been entirely consistent with the accumulated evidence.…”

Section: Initial Confusion About Immunity and Reinfection By Sars-cov-2mentioning

confidence: 99%

Antibody Responses to SARS-CoV-2: Let’s Stick to Known Knowns

Baumgarth

Nikolich‐Žugich

Lee

et al. 2020

The Journal of Immunology

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The scale of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has thrust immunology into the public spotlight in unprecedented ways. In this article, which is part opinion piece and part review, we argue that the normal cadence by which we discuss science with our colleagues failed to properly convey likelihoods of the immune response to SARS-CoV-2 to the public and the media. As a result, biologically implausible outcomes were given equal weight as the principles set by decades of viral immunology. Unsurprisingly, questionable results and alarmist news media articles have filled the void. We suggest an emphasis on setting expectations based on prior findings while avoiding the overused approach of assuming nothing. After reviewing Ab-mediated immunity after coronavirus and other acute viral infections, we posit that, with few exceptions, the development of protective humoral immunity of more than a year is the norm. Immunity to SARS-CoV-2 is likely to follow the same pattern.

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Validation of a commercially available SARS-CoV-2 serological Immunoassay

Abstract: 44Objectives: To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA 45 immunoassay for Methods: In this unmatched (1:1) case-control validation study, we used sera of 181 laboratory-47

Cited by 31 publications

References 22 publications

Seroprevalence of SARS-CoV-2 among adults in three regions of France following the lockdown and associated risk factors: a multicohort study

Seroprevalence of SARS-CoV-2 among adults in three regions of France following the lockdown and associated risk factors: a multicohort study

SARS-CoV-2 IgG seroprevalence in blood donors located in three different federal states, Germany, March to June 2020

Antibody Responses to SARS-CoV-2: Let’s Stick to Known Knowns

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