Performance of the rapid high-throughput automated electrochemiluminescence immunoassay targeting total antibodies to the SARS-CoV-2 spike protein receptor binding domain in comparison to the neutralization assay

Rus, Katarina Resman; Korva, Miša; Knap, Nataša; Avšič-Županc, Tatjana; Poljak, Mario

doi:10.1016/j.jcv.2021.104820

Cited by 99 publications

(78 citation statements)

References 20 publications

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“…Second, neutralizing activity was not measured. However, the assay we employed has been shown closely correlated with the titer of neutralizing antibody [ 17 ], and 99.5% of our study subjects achieved a serum antibody level above the cut-off of 133 U/mL to predict a neutralizing activity. Third, we only assessed the antibody responses and did not assess the cellular ones.…”

Section: Discussionmentioning

confidence: 99%

Antibody responses to BNT162b2 mRNA COVID-19 vaccine and their predictors among healthcare workers in a tertiary referral hospital in Japan

Kageyama¹,

Ikeda²,

Tanaka³

et al. 2021

Clinical Microbiology and Infection

118

101

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Objectives This study aimed to determine antibody responses in healthcare workers who receive the BNT162b2 mRNA COVID-19 vaccine and identify factors that predict the response. Methods We recruited healthcare workers receiving the BNT162b2 mRNA COVID-19 vaccine at the Chiba University Hospital COVID-19 Vaccine Center. Blood samples were obtained before the 1 st dose and after the 2 nd dose vaccination, and serum antibody titers were determined using Elecsys® Anti-SARS-CoV-2S, an electrochemiluminescence immunoassay. We established a model to identify the baseline factors predicting post-vaccine antibody titers using univariate and multivariate linear regression analyses. Results Two thousand fifteen individuals (median age 37-year-old, 64.3% female) were enrolled in this study, of which 10 had a history of COVID-19. Before vaccination, 21 participants (1.1%) had a detectable antibody titer (≥0.4 U/mL) with a median titer of 35.9 U/mL (interquartile range [IQR] 7.8 – 65.7). After vaccination, serum anti-SARS-CoV-2S antibodies (≥0.4 U/mL) were detected in all 1,774 participants who received the 2 nd dose with a median titer of 2,060.0 U/mL (IQR 1,250.0 – 2,650.0). Immunosuppressive medication (p<0.001), age (p<0.001), time from 2 nd dose to sample collection (p<0.001), glucocorticoids (p=0.020), and drinking alcohol (p=0.037) were identified as factors predicting lower antibody titers after vaccination, whereas previous COVID-19 (p<0.001), female (p<0.001), time between 2 doses (p<0.001), and medication for allergy (p=0.024) were identified as factors predicting higher serum antibody titers. Conclusions Our data demonstrate that healthcare workers universally have good antibody responses to the BNT162b2 mRNA COVID-19 vaccine. The predictive factors identified in our study may help optimize the vaccination strategy.

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Section: Discussionmentioning

confidence: 99%

Antibody responses to BNT162b2 mRNA COVID-19 vaccine and their predictors among healthcare workers in a tertiary referral hospital in Japan

Kageyama¹,

Ikeda²,

Tanaka³

et al. 2021

Clinical Microbiology and Infection

118

101

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“…Samples with titers above 250 U/ml were manually diluted 1:100 in dilution buffer according to the manufacturer's recommendations to increase the linear range to 25000 U/ml. A mathematical transposition of Elecsys anti-S1-RBD-SARS-CoV-2 specific U/ml to the World Health Organization (WHO) standard BAU/ml was performed using the following equation: U/ml = 0.972 x BAU/ml ( Resman Rus et al, 2021 ). Since it has been previously demonstrated that an anti-S1-RBD-SARS-CoV-2 antibody concentration of more than 133 BAU/ml predicts the presence of neutralizing antibodies after natural infection ( Resman Rus et al, 2021 ).…”

Section: Methodsmentioning

confidence: 99%

“…A mathematical transposition of Elecsys anti-S1-RBD-SARS-CoV-2 specific U/ml to the World Health Organization (WHO) standard BAU/ml was performed using the following equation: U/ml = 0.972 x BAU/ml ( Resman Rus et al, 2021 ). Since it has been previously demonstrated that an anti-S1-RBD-SARS-CoV-2 antibody concentration of more than 133 BAU/ml predicts the presence of neutralizing antibodies after natural infection ( Resman Rus et al, 2021 ). It may thus be a potential surrogate for high protection from COVID-19 after vaccination, we specifically calculated the percentage of different subgroups of our study cohort with antibody titers above this threshold.…”

Section: Methodsmentioning

confidence: 99%

Low SARS-CoV-2 infection rates and high vaccine-induced immunity among German healthcare workers at the end of the third wave of the COVID-19 pandemic

Brehm

Thompson

Ullrich

et al. 2021

International Journal of Hygiene and Environmental Health

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In this longitudinal cohort study, we assessed the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) seroconversion rates and analyzed the coronavirus disease 2019 (COVID-19) vaccine-induced immunity of 872 hospital workers at the University Medical Center Hamburg-Eppendorf between May 11 and May 31, 2021. The overall seroprevalence of anti–NC–SARS-CoV-2 antibodies was 4.7% (n = 41), indicating low SARS-CoV-2 infection rates and persistent effectiveness of hospital-wide infection control interventions during the second and third wave of the pandemic. In total, 92.7% (n = 808) out of the entire study cohort, 98.2% (n = 325) of those who had been vaccinated once and all 393 individuals who had been vaccinated twice had detectable anti-S1-RBD-SARS-CoV-2 antibody titers and no significant differences in vaccine-induced immune response were detected between male and female individuals and between different age groups. Vaccinated study participants with detectable anti–NC–SARS-CoV-2 antibody titers (n = 30) developed generally higher anti-S1-RBD-SARS-CoV-2 antibody titers compared to anti–NC–SARS-CoV-2 negative individuals (n = 694) (median titer: 7812 vs. 345 BAU/ml, p < 0.0001). Furthermore, study participants who received heterologous vaccination with AZD1222 followed by an mRNA vaccine showed markedly higher anti-S1-RBD-SARS-CoV-2 antibody titers than individuals who received two doses of an mRNA vaccine or two doses of AZD1222 (median titer: AZD1222/AZD1222: 1069 BAU/ml, mRNA/mRNA: 1388 BAU/ml, AZD1222/mRNA: 9450 BAU/ml; p < 0.0001). Our results indicate that infection control interventions were generally effective in preventing nosocomial transmission of SARS-CoV-2 and that COVID-19 vaccines can elicit strong humoral responses in the majority of a real-world cohort of hospital workers.

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“…For the total antibody assay, alternative cut-offs (i.e. 15 U/mL and 133 U/mL) 21,22 were also investigated.…”

Section: Analytical Proceduresmentioning

confidence: 99%

“…For the total antibody assay, a mean time of 830 days (95% CI: 508 -1,000) in seronegatives and 718 days (95% CI: 425 -826) in seropositives would be needed to cross the threshold of 15 U/mL which was de ned by the manufacturer as a cut-off for detection of inhibitory effects. 21 Using the threshold of 133 U/mL, 22 the mean time needed would be 470 days (95% CI: 341 -585) and 507 days (95% CI: 359 -591) in seronegative and seropositive subjects, respectively. Among the 1,443 samples analyzed on both assays, IgG and total anti-S antibodies showed an almost perfect agreement (i.e.…”

Section: Igg and Total Antibodiesmentioning

confidence: 99%

Waning of IgG, total and neutralizing antibodies 6 months post-vaccination with BNT162b2 in healthcare workers

Bayart

Douxfils

Gillot

et al. 2021

Preprint

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Data about the duration of humoral response following COVID-19 vaccines are mandatory to establish appropriate population vaccination strategy. This study reports on the antibody decline observed in a population of COVID-19 naïve and COVID-19 positive individuals having received the two dose regimen of the BNT162b2 vaccine. Six months after vaccination, a significant antibody decline was observed in both COVID-19 naïve and positive individuals. The estimated half-life of total and IgG antibodies differs and ranges from several months for total antibodies to only several weeks for IgG antibodies, explaining the significant proportions of participants with non-detectable levels of neutralizing antibodies at 6 months. Whether this decrease correlates with an equivalent drop in the clinical effectiveness against the virus will require appropriate clinical studies. Nevertheless, these data are already important to support the decision-making on the potential use of a booster dose.

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Performance of the rapid high-throughput automated electrochemiluminescence immunoassay targeting total antibodies to the SARS-CoV-2 spike protein receptor binding domain in comparison to the neutralization assay

Cited by 99 publications

References 20 publications

Antibody responses to BNT162b2 mRNA COVID-19 vaccine and their predictors among healthcare workers in a tertiary referral hospital in Japan

Antibody responses to BNT162b2 mRNA COVID-19 vaccine and their predictors among healthcare workers in a tertiary referral hospital in Japan

Low SARS-CoV-2 infection rates and high vaccine-induced immunity among German healthcare workers at the end of the third wave of the COVID-19 pandemic

Waning of IgG, total and neutralizing antibodies 6 months post-vaccination with BNT162b2 in healthcare workers

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