Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies

Beavis, Kathleen G.; Matushek, Scott; Abeleda, Ana; Bethel, Cindy; Hunt, Carlissa; Gillen, Stephanie; Moran, Angelica; Tešić, Vera

doi:10.1016/j.jcv.2020.104468

Cited by 241 publications

(205 citation statements)

References 5 publications

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“…Because the ELISA assay could exhibit cross-reactivity with antibodies to other seasonal human coronaviruses, some results may represent false positives, leading to overestimation of seroprevalence data [32]. The EUROIMMUN assay used in this study was evaluated in different studies showing a specificity ranging from 96.2% to 100% and sensitivity ranging from 86.4% to 100% [15,17,33]. The sensitivity and specificity of the ELISA can vary considerably depending on the timing of the sample, in particular from samples collected ≥4 days after COVID-19 diagnosis by PCR.…”

Section: Discussionmentioning

confidence: 99%

“…The sensitivity and specificity of the ELISA can vary considerably depending on the timing of the sample, in particular from samples collected ≥4 days after COVID-19 diagnosis by PCR. The sensitivity can increase from 67% to 100% between samples analyzed at the time of PCR and samples analyzed at least four days later [15]. VNT, currently considered the gold standard, is the most specific serological assay capable of detecting true positive cases and functional neutralizing antibodies [34].…”

Section: Discussionmentioning

confidence: 99%

“…Wells were coated with recombinant structural protein of SARS-CoV-2. This immunoassay was chosen because it has already been evaluated by numerous studies [15][16][17][18][19][20] and is on the list of authorized serological tests for the national health authorities in France.…”

Section: Serological Analysesmentioning

confidence: 99%

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Seroprevalence of SARS-CoV-2 IgG Antibodies in Corsica (France), April and June 2020

Capai

Ayhan

Masse

et al. 2020

JCM

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Our aim was to assess the seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection after the lockdown in a sample of the Corsican population. Between 16 April and 15 June 2020, 2312 residual sera were collected from patients with a blood analysis conducted in one of the participating laboratories. Residual sera obtained from persons of all ages were tested for the presence of anti-SARS-CoV-2 Immunoglobulin G (IgG) using the EUROIMMUN enzyme immunoassay kit for semiquantitative detection of IgG antibodies against the S1 domain of viral spike protein (ELISA-S). Borderline and positive samples in ELISA-S were also tested with an in-house virus neutralization test (VNT). Prevalence values were adjusted for sex and age. A total of 1973 residual sera samples were included in the study. The overall seroprevalence based on ELISA-S was 5.27% (95% confidence interval (CI), 4.33–6.35) and 5.46% (4.51–6.57) after adjustment. Sex was not associated with IgG detection. However, significant differences were observed between age groups (p-value = 1 E-5). The highest values were observed among 10–19, 30–39, and 40–49 year-old age groups, ranging around 8–10%. The prevalence of neutralizing antibody titers ≥40 was 3% (2.28–3.84). In conclusion, the present study showed a low seroprevalence for COVID-19 in Corsica, a finding that is in accordance with values reported for other French regions in which the impact of the pandemic was low.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Seroprevalence of SARS-CoV-2 IgG Antibodies in Corsica (France), April and June 2020

Capai

Ayhan

Masse

et al. 2020

JCM

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“…The sensitivity, specificity, positive predictive value, negative predictive value, positive percent agreement and Cohen’s Kappa were calculated to assess the performance of each assay with the positive SARS-CoV-2 RT-PCR patients ( Whitman et al, 2020 , Beavis et al, 2020 ). Specificity and cross-reactivity of each assay were assessed using the pre-pandemic control samples.…”

Section: Methodsmentioning

confidence: 99%

Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Yassine¹,

Al-Jighefee²,

Al-Sadeq³

et al. 2021

International Journal of Infectious Diseases

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Highlights Performances of five commercial ELISA (EDI, AnshLabs, Dia.Pro, NovaTec, and Lionex) for detecting anti-SARS-CoV-2 IgG was evaluated. Samples used in this study are from diverse national background and the negative group contains samples that are seropositive for all other HCoV. All assays showed low sensitivity during the early stages (≤7 from symptom onset); however, it was greatly improved overtime. Lionex showed the highest specificity (98.6%), followed by EDI and Dia.Pro (97.1%,), NovaTec (85.7%), and AnshLabs (75.7%). Lionex, which measures antibodies to the S1 protein, demonstrated the best performance and doesn’t cross-react with any other HCoV.

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“…The use of IgM and IgA in the two-step ELISA protocol were also explored, however IgM was found to have lower sensitivity with only 4/18 of the 7+ day COVID-19 samples being seropositive, compared with 18/18 (100%) for IgG. IgA was deemed unsuitable as the assay window was inferior to that of IgG (OD range 0.01-0.82 compared with 0.01-1.42), and recent reports highlighted reduced sensitivity and specificity for IgA based SARS-CoV-2 ELISA (Meyer et al, 2020;Beavis et al, 2020).…”

Section: Resultsmentioning

confidence: 99%

Peer Review #1 of "Collaborative networks enable the rapid establishment of serological assays for SARS-CoV-2 during nationwide lockdown in New Zealand (v0.1)"

2020

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Background: Serological assays that detect antibodies to SARS-CoV-2 are critical for determining past infection and investigating immune responses in the COVID-19 pandemic. We established ELISA-based immunoassays using locally produced antigens when NewZealand went into a nationwide lockdown and the supply chain of diagnostic reagents was a widely held domestic concern. The relationship between serum antibody binding measured by ELISA and neutralising capacity was investigated using a surrogate viral neutralisation test (sVNT). Methods: A pre-pandemic sera panel (n=113), including respiratory infections with symptom overlap with COVID-19, was used to establish assay specificity. Sera from PCR-confirmed SARS-CoV-2 patients (n=21), and PCR-negative patients with respiratory symptoms suggestive of COVID-19 (n=82) that presented to the two largest hospitals in Auckland during the lockdown period were included. A two-step IgG ELISA based on the receptor binding domain (RBD) and Spike protein was adapted to determine seropositivity, and neutralising antibodies that block the RBD/hACE-2 interaction were quantified by sVNT. Results: The calculated cutoff (> 0.2) in the two-step ELISA maximised specificity by classifying all prepandemic samples as negative. Sera from all PCR-confirmed COVID-19 patients were classified as seropositive by ELISA ≥7 days after symptom onset. There was 100% concordance between the two-step ELISA and the sVNT with all 7+ day sera from PCR-confirmed COVID-19 patients also classified as positive with respect to neutralising antibodies. Of the symptomatic PCR-negative cohort, one individual with notable travel history was classified as positive by two-step ELISA and sVNT, demonstrating the value of serology in detecting prior infection.

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Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies

Cited by 241 publications

References 5 publications

Seroprevalence of SARS-CoV-2 IgG Antibodies in Corsica (France), April and June 2020

Seroprevalence of SARS-CoV-2 IgG Antibodies in Corsica (France), April and June 2020

Performance evaluation of five ELISA kits for detecting anti-SARS-COV-2 IgG antibodies

Peer Review #1 of "Collaborative networks enable the rapid establishment of serological assays for SARS-CoV-2 during nationwide lockdown in New Zealand (v0.1)"

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