Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma

Bundschuh, Christian; Egger, Margot; Wiesinger, K; Gabriel, Christian; Clodi, Martin; Mueller, Thomas; Dieplinger, Benjamin

doi:10.1016/j.cca.2020.05.047

Cited by 40 publications

(39 citation statements)

References 13 publications

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“…Our results showed that most of the evaluated assays demonstrated a very good performance during the first week after symptoms onset compared to other studies ( Adams et al, 2020 , Bundschuh et al, 2020 , Colavita et al, 2020 , Lassaunière et al, 2020 ). Expectedly, the agreement between the outcome of each ELISA kit and RT-PCR increased with time after symptoms onset, consistent with a time lag between the onset of infection and the development of detectable antibodies.…”

Section: Discussionsupporting

confidence: 56%

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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Section: Discussionsupporting

confidence: 56%

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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“…17 Another study examined the sensitivity and specificity of the EDI ELISA for detecting SARS-CoV-2 IgM and IgG antibodies in 64 RT-PCR samples of confirmed COVID-19 patients with serial blood samples at different time points. 15 The study found that the sensitivity of the ELISA test was 5.9% for IgM and 2.9% for IgG 5 days after symptom onset. 15 Between 5 and 10 days, the sensitivity of the ELISA test increased to 37.1% for IgM and 37.1% for IgG.…”

Section: Austrian Antibody Studiesmentioning

confidence: 93%

“…15 The study found that the sensitivity of the ELISA test was 5.9% for IgM and 2.9% for IgG 5 days after symptom onset. 15 Between 5 and 10 days, the sensitivity of the ELISA test increased to 37.1% for IgM and 37.1% for IgG. 15 After 10 to 15 days, the sensitivity of the ELISA test increased to 76.4% for IgM and 82.4% for IgG.…”

Section: Austrian Antibody Studiesmentioning

confidence: 93%

“…Several reports in Austria examined the accuracy of commercially available antibody tests. [15][16][17] One study assessed the sensitivity and specificity of four commercial ELISA and two RDT tests in 77 COVID-19 patients compared with the nasopharyngeal RT-PCR. 17 The study found that sensitivities for the ELISA and RDT antibody tests were around 80% within the first week of infection.…”

Section: Austrian Antibody Studiesmentioning

confidence: 99%

“…15 Between 5 and 10 days, the sensitivity of the ELISA test increased to 37.1% for IgM and 37.1% for IgG. 15 After 10 to 15 days, the sensitivity of the ELISA test increased to 76.4% for IgM and 82.4% for IgG. After 3 weeks, the sensitivity increased to 94.4% for IgM and 100% for IgG.…”

Section: Austrian Antibody Studiesmentioning

confidence: 99%

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Antibody tests for COVID-19

Kopel

Goyal

Perisetti

2020

Baylor University Medical Center Proceedings

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The SARS-CoV-2 virus caused a globally growing pandemic called coronavirus disease 2019 (COVID-19) that has disrupted social, political, and medical environments around the world. Nations are assessing ways to reopen businesses while trying to balance health care risks and economic fallouts. Strategies involving antibody testing have been proposed before phased reopening of the economy. Therefore, assessing the sensitivity and specificity of antibody tests for symptomatic and asymptomatic COVID-19 patients remains paramount to prevent COVID-19 outbreaks. The antibody tests for SARS-CoV-2 detect the presence of IgA, IgM, or IgG antibodies produced by B cells. There are four major types of antibody tests: rapid diagnostic tests, enzymelinked immunosorbent assays, neutralization assays, and chemiluminescent immunoassays. Currently, there is no standard antibody test for detecting SARS-CoV-2 antibodies during or after exposure or infection. The antibody tests for SARS-CoV-2 have a low specificity within the first week of exposure and increase in the second and third weeks. The current data on antibody tests have several limitations in quality and the presence of bias. Specifically, many antibody tests have a high false-negative rate and a high risk of bias for participant selection, application of index tests, reference standard used, and flow and timing for antibody tests that may incorrectly report the accuracy of COVID-19 antibody tests. In this review, we summarize the current methods, sensitivity/specificity, and gaps in knowledge concerning COVID-19 antibody testing.

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Antibody tests for identification of current and past infection with SARS-CoV-2

Fox

Geppert

Dinnes

et al. 2022

Cochrane Database of Systematic Reviews

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Background The diagnostic challenges associated with the COVID‐19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS‐CoV‐2 infection. Serology tests to detect the presence of antibodies to SARS‐CoV‐2 enable detection of past infection and may detect cases of SARS‐CoV‐2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS‐CoV‐2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS‐CoV‐2 epidemiology. Objectives To assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS‐CoV‐2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS‐CoV‐2. Sources of heterogeneity investigated included: timing of test, test method, SARS‐CoV‐2 antigen used, test brand, and reference standard for non‐SARS‐CoV‐2 cases. Search methods The COVID‐19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co‐ordinating Centre (EPPI‐Centre) ‘COVID‐19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID‐19 evidence’. We did not apply language restrictions. Selection criteria We included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT‐PCR test. Small studies with fewer than 25 SARS‐CoV‐2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS‐CoV‐2 (including reverse transcription polymerase chain reaction tests (RT‐PCR), clinical diagnostic criteria, and pre‐pandemic samples). Data collection and analysis We use standard screening procedures with three reviewers. Quality assessment (using the QUADAS‐2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta‐analysis, we fitted univariate random‐effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random‐effects logistic regression models. We tabulated result...

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Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma

Cited by 40 publications

References 13 publications

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

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

Antibody tests for COVID-19

Antibody tests for identification of current and past infection with SARS-CoV-2

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