Performance of Three SARS-CoV-2 Immunoassays, Three Rapid Lateral Flow Tests, and a Novel Bead-Based Affinity Surrogate Test for the Detection of SARS-CoV-2 Antibodies in Human Serum

Krone, Manuel; Gütling, Julia; Wagener, Johannes; Lâm, Thiên-Trí; Schoen, Christoph; Vogel, Ulrich; Stich, August; Wedekink, Florian; Wischhusen, Jörg; Kerkau, Thomas; Beyersdorf, Niklas; Klingler, Silvana; Backes, Simone; Dölken, Lars; Gasteiger, Georg; Kurzai, Oliver; Schubert‐Unkmeir, Alexandra

doi:10.1128/jcm.00319-21

Cited by 13 publications

(17 citation statements)

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“…Overall, SARS-CoV-2 convalescent as well as COVID-19 vaccinated and hybrid immunized HCWs presented Anti-SARS-CoV-2-Spike levels indicating at least a moderate neutralizing capacity [21]. Mean Anti-SARS-CoV-2-Spike IgG titres increased with the number of administered doses of COVID-19 vaccines (92.2 BAU/ml for single, 140.9 BAU/ml for double and up to 1,144.4 BAU/ml after threefold vaccination).…”

Section: Discussionmentioning

confidence: 99%

“…Anti-SARS-CoV-2-Spike IgG titres were determined by SERION ELISA agile SARS-CoV-2 IgG (SERION Diagnostics, Wuerzburg, Germany), technically carried out as an enzyme linked immunoassay (ELISA). This assay was selected as it has proven to be superior to comparable SARS-CoV-2 IgG ELISA [20] methods, having a high correlation with the neutralization titres [21][22][23].…”

Section: Sars-cov-2 Igg Elisamentioning

confidence: 99%

“…The threshold IgG values in the selected SERION assay were defined as < 10.0 U/ml (21.0 BAU/ml) for negative, ≥ 10.0 U/ml (21.0 BAU/ml) to < 15.0 U/ml (31.5 BAU/ml) for results at the borderline and ≥ 15.0 U/ml (31.5 BAU/ml) as positive. These values were chosen according to manufacturer's instruction and IgG values above the threshold of 31.5 BAU/ml indicate at least a moderate neutralization capacity [21]. For detecting Anti-SARS-CoV-2-Spike IgG antibody levels beyond the maximum limit of 250 U/ml (525.0 BAU/ml), serum blood samples were diluted based on a dilution series with dilution factors both 10 and 100.…”

Section: Sars-cov-2 Igg Elisamentioning

confidence: 99%

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Influencing factors of Anti-SARS-CoV-2-Spike IgG antibody titres in healthcare workers – A cross-section study

Reusch

Wagenhäuser

Gabel

et al. 2022

Preprint

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BackgroundAgainst the background of the current COVID-19 infection dynamics with the rapid spread of SARS-CoV-2 variants of concern (VOC), above all the Omicron VOC, the immunity of healthcare workers (HCWs) against SARS-CoV-2 continues to be of high importance. Vaccination plays a central role in reducing the severity and potentially the spread of the disease. In healthcare, this is important to prevent disease-related staff shortages. However, there is a lack of data on factors influencing the humoral immune response.AimThe aim of our study was to determine factors influencing the level of Anti-SARS-CoV-2-Spike IgG after SARS-CoV-2 infection or vaccination in healthcare workers.Methods1,750 study participants were recruited who met the following inclusion criteria: age ≥ 18 years, PCR-confirmed SARS-CoV-2 infection and/or at least one dose of COVID-19 vaccination, working in health care. Anti-SARS-CoV-2-Spike IgG titres were determined by SERION ELISA agile SARS-CoV-2 IgG.ResultsMean Anti-SARS-CoV-2-Spike IgG levels increased significantly with the number of COVID-19 vaccinations (92.2 BAU/ml for single dose, 140.9 BAU/ml for two doses and 1,144.3 BAU/ml after threefold vaccination). Hybrid COVID-19 immunized respondents (after infection and vaccination) had significantly higher antibody titres compared with participants after infection only (525.4 BAU/ml vs. 105.7 BAU/ml). Anti-SARS-CoV-2-Spike IgG titres declined significantly with time after administration of the second vaccine dose. Smoking and high age were associated with lower titres.ConclusionBoth recovered and vaccinated HCWs presented a predominantly good humoral immune response with decreasing antibody levels over the temporal course. Smoking and higher age limited the humoral SARS-CoV-2 immunity. This reduced immune response is an important aspect as people with these risk factors are recognized as people with an increased risk for a severe course of disease.

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Section: Discussionmentioning

confidence: 99%

Section: Sars-cov-2 Igg Elisamentioning

confidence: 99%

Section: Sars-cov-2 Igg Elisamentioning

confidence: 99%

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Influencing factors of Anti-SARS-CoV-2-Spike IgG antibody titres in healthcare workers – A cross-section study

Reusch

Wagenhäuser

Gabel

et al. 2022

Preprint

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“…To circumvent the need for laborious and time-consuming tissue culture infecting dose-(TCID-) assays for the assessment of the neutralizing potency of anti-SARS-CoV-2-antibodies, alternative diagnostic strategies were implemented and tested. Those attempts comprised correlations of total and neutralizing anti-SARS-CoV-2-antibodies [12][13][14][15]. In addition, however, specific antigenic target structures were identified in order to develop surrogate neutralization assays for testing for antibodies specific to those critical epitopes [16,17].…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Anti-SARS-CoV-2 Surrogate Neutralization Assays by TECOmedical and DiaPROPH-Med with Samples from Vaccinated and Infected Individuals

Münsterkötter

Hollstein

Hahn³

et al. 2022

Viruses

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Anti-SARS-CoV-2-specific serological responses are a topic of ongoing evaluation studies. In the study presented here, the anti-SARS-CoV-2 surrogate neutralization assays by TECOmedical and DiaPROPH -Med were assessed in a head-to-head comparison with serum samples of individuals after vaccination as well as after previous infection with SARS-CoV-2. In case of discordant results, a cell culture-based neutralization assay was applied as a reference standard. The TECOmedical assay showed sensitivity and specificity of 100% and 61.3%, respectively, the DiaPROPH-Med assay 95.0% and 48.4%, respectively. As a side finding of the study, differences in the likelihood of expressing neutralizing antibodies could be shown for different exposition types. So, 60 of 81 (74.07%) of the samples with only one vaccination showed an expression of neutralizing antibodies in contrast to 85.71% (60 of 70 samples) of the samples with two vaccinations and 100% (40 of 40) of the samples from previously infected individuals. In conclusion, the both assays showed results similar to previous assessments. While the measured diagnostic accuracy of both assays requires further technical improvement of this diagnostic approach, as the calculated specificity values of 61.3% and 48.4%, respectively, appear acceptable for diagnostic use only in populations with a high percentage of positive subjects, but not at expectedly low positivity rates.

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“…Due to previous performance evaluation studies, this serological assay was found to be reliable in terms of neutralisation activity compared with other available tests. 17,18…”

Section: Methodsmentioning

confidence: 99%

Immunogenicity and safety of coadministration of COVID-19 and influenza vaccination among healthcare workers

Wagenhäuser

Reusch

Gabel

et al. 2022

Preprint

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Background A third dose of COVID-19 vaccination (COVID booster vaccination) has become established as an important measure to strengthen the immune response against SARS-CoV-2. In contrast, seasonal influenza vaccination has been an important infection prevention measure for years, especially among highly exposed healthcare workers (HCWs). Coadministration of vaccines against COVID-19 and seasonal influenza could be an efficient strategy to protect HCWs from two major viral respiratory infections. Yet, the immunogenicity and safety of coadministration remains to be evaluated. Methods This study examines the differences in Anti-SARS-CoV-2-Spike IgG antibody formation as well as side effects based on a digital questionnaire after a third COVID-19 vaccination with or without coadministration of a seasonal quadrivalent influenza vaccine (Influvac Tetra vaccine 2021/2022). 1,231 HCWs were recruited who received a mRNA-based booster COVID-19 vaccination (mRNA-1273 or BNT162b2mRNA) after basic immunisation with BNT162b2mRNA twice. Anti-SARS-CoV-2-Spike IgG levels were determined at least 14 days after vaccination by SERION ELISA agile SARS-CoV-2 IgG. Findings Anti-SARS-CoV-2-Spike IgG concentrations were by 25.4% lower in individuals with coadministration of the seasonal quadrivalent influenza vaccination than without (p<0.01). There was no statistically significant difference in the reported side effects. The concentration of Anti-SARS-CoV-2-Spike IgG was higher in HCWs who had received the influenza vaccine concomitantly with mRNA-1273 than with BNT162b2mRNA as third COVID-19 vaccine (p<0.0001). Interpretation Coadministration of the seasonal quadrivalent influenza vaccine significantly limits the levels in Anti-SARS-CoV-2-Spike IgG levels, with a more restricted elevation in case of a BNT162b2mRNA booster vaccination compared with mRNA-1273 vaccine. The reduced humoral immune response in case of coadministration needs to be considered in seasonal vaccination recommendations, although the consequences of lower Anti-SARS-CoV-2-Spike IgG levels for the protection against SARS-CoV-2 infection and severe COVID-19 disease course are currently unknown. An augmented mRNA-based COVID-19 vaccine dosage may compensate for the restricted immunogenicity in case of coadministration. Funding This study was funded by the Federal Ministry for Education and Science (BMBF) through a grant provided to the University Hospital of Wuerzburg by the Network University Medicine on COVID-19 (B-FAST, grant-No 01KX2021) as well as by the Free State of Bavaria with COVID-research funds provided to the University of Wuerzburg, Germany. Nils Petri is supported by the German Research Foundation (DFG) funded scholarship UNION CVD.

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Performance of Three SARS-CoV-2 Immunoassays, Three Rapid Lateral Flow Tests, and a Novel Bead-Based Affinity Surrogate Test for the Detection of SARS-CoV-2 Antibodies in Human Serum

Cited by 13 publications

References 38 publications

Influencing factors of Anti-SARS-CoV-2-Spike IgG antibody titres in healthcare workers – A cross-section study

Influencing factors of Anti-SARS-CoV-2-Spike IgG antibody titres in healthcare workers – A cross-section study

Comparison of the Anti-SARS-CoV-2 Surrogate Neutralization Assays by TECOmedical and DiaPROPH-Med with Samples from Vaccinated and Infected Individuals

Immunogenicity and safety of coadministration of COVID-19 and influenza vaccination among healthcare workers

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