Comparison of eight commercial, high-throughput, automated or ELISA assays detecting SARS-CoV-2 IgG or total antibody

Trabaud, Mary‐Anne; Icard, Vinca; Milon, Marie Paule; Bal, Antonin; Lina, Bruno; Escuret, Vanessa

doi:10.1016/j.jcv.2020.104613

Cited by 56 publications

(75 citation statements)

References 16 publications

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“…The study was conducted to provide information on performance characteristics of commercially available serological assays. Thus, it contributes to previously described assessments [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 ] and provides an additional piece of the puzzle in terms of interpreting the results of serological approaches for the retrospective diagnosis of infections with SARS-CoV-2.…”

Section: Discussionsupporting

confidence: 57%

“…In the study performed here, five commercially available serological assays targeting SARS-CoV-2-specific antibodies were assessed. The comparison comprised previously described products such as the assays from EUROIMMUN (Lübeck, Germany) [ 26 , 27 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 52 , 53 ], Roche (Basel, Switzerland) [ 54 , 55 , 56 , 57 , 58 , 59 ], Mikrogen (Neuried, Germany) [ 60 , 61 , 62 ], and Virotech Diagnostics (Rüsselsheim am Main, Germany) [ 46 , 55 , 63 ] as well as a newly evaluated kit from Vircell (Vircell, Granada, Spain). As positive controls, residual serum samples from patients with PCR-confirmed COVID-19 were used, while samples from blood donors and patients with Epstein–Barr virus (EBV) were applied as negative controls.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

Dörschug

Schwanbeck

Hahn³

et al. 2021

Diagnostics

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Serological assays can contribute to the estimation of population proportions with previous immunologically relevant contact with the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) virus. In this study, we compared five commercially available diagnostic assays for the diagnostic identification of SARS-CoV-2-specific antibodies. Depending on the assessed immunoglobulin subclass, recorded sensitivity ranged from 17.0% to 81.9% with best results for immunoglobulin G. Specificity with blood donor sera ranged from 90.2% to 100%, with sera from EBV patients it ranged from 84.3% to 100%. Agreement from fair to nearly perfect was recorded depending on the immunoglobulin class between the assays, the with best results being found for immunoglobulin G. Only for this immunoglobulin class was the association between later sample acquisition times (about three weeks after first positive PCR results) and positive serological results in COVID-19 patients confirmed. In conclusion, acceptable and comparable reliability for the assessed immunoglobulin G-specific assays could be shown, while there is still room for improvement regarding the reliability of the assays targeting the other immunoglobulin classes.

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Section: Discussionsupporting

confidence: 57%

Section: Introductionmentioning

confidence: 99%

Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

Dörschug

Schwanbeck

Hahn³

et al. 2021

Diagnostics

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show abstract

“…Such improved sensitivity of the combinedIgM/IgG tests early after symptom onset might also be useful for the diagnosis of suspected COVID-19 cases with negative PCR(13-15, 17, 18).Overall, the clinical performance of the VIDAS ® SARS-CoV-2 assays was excellent. It was in a range comparable to that reported for existing EUA serological assays(22,33,42,(51)(52)(53)(54)(55)(56)(57).Moreover, in several side-by-side comparisons of six to nine commercial serological assays (specific for SARS-CoV-2 IgA, IgM, IgG or total antibodies), VIDAS ® SARS-CoV-2 IgG outperformed on January 17, 2021 by guest http://jcm.asm.org/ Downloaded from some of the IgG-specific competitor assays in terms of specificity and/or PPA with PCR positivity (42, 56, 57). The high specificity of the VIDAS ® SARS-CoV-2 IgG assay alone should be well suited for epidemiological surveillance.…”

supporting

confidence: 83%

Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays

et al. 2021

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The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemics, notably through epidemiological surveillance. Well validated and highly specific SARS-CoV-2 serological assays are urgently needed. We describe here the analytical and clinical performance of VIDAS® SARS-CoV-2 IgM and VIDAS® SARS-CoV-2 IgG, two CE-marked, EUA-authorized, automated, qualitative assays for the detection of SARS-CoV-2-specific IgM and IgG, respectively. Both assays showed high within-run and within-laboratory precision (coefficients of variation < 11.0%) and very low cross-reactivity towards sera of patients with a past common coronavirus or respiratory virus infection. Clinical specificity determined on up to 989 pre-pandemic healthy donors was ≥ 99% with a narrow 95% confidence interval for both IgM and IgG assays. Clinical sensitivity was determined on up to 232 samples from 130 RT-PCR-confirmed SARS-CoV-2 patients. The positive percent agreement (PPA) with SARS-CoV-2 PCR reached 100% at ≥ 16 days (VIDAS® SARS-CoV-2 IgM) and ≥ 32 days (VIDAS® SARS-CoV-2 IgG) of symptom onset. Combined IgM/IgG test results improved the PPA compared to each test alone. SARS-CoV-2 IgG seroconversion followed closely that of SARS-CoV-2 IgM and remained stable over time, while SARS-CoV-2 IgM levels rapidly declined. Interestingly, SARS-CoV-2-specific IgM and IgG responses were significantly higher in COVID-19 hospitalized vs. non-hospitalized patients. Altogether, the VIDAS® SARS-CoV-2 IgM and IgG assays are highly specific and sensitive serological tests suitable for the reliable detection of past acute SARS-CoV-2 infections.

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“…It has been proposed that most neutralizing antibodies against SARS-CoV-2 act by binding the RBD of the spike glycoprotein and blocking binding to ACE-2. The Siemens SARS-CoV-2 IgG assay measures binding of IgG to recombinant RBD [ 14 ]. We wished to assess the potential correlation between our pseudovirion neutralization test and Siemens SARS-CoV-2 IgG.…”

Section: Resultsmentioning

confidence: 99%

Neutralization assay with SARS-CoV-1 and SARS-CoV-2 spike pseudotyped murine leukemia virions

Zheng

Larragoite

Williams

et al. 2021

Virol J

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Background Virus neutralization by antibodies is an important prognostic factor in many viral diseases. To easily and rapidly measure titers of neutralizing antibodies in serum or plasma, we developed pseudovirion particles composed of the spike glycoprotein of SARS-CoV-2 incorporated onto murine leukemia virus capsids and a modified minimal murine leukemia virus genome encoding firefly luciferase. This assay design is intended for use in laboratories with biocontainment level 2 and therefore circumvents the need for the biocontainment level 3 that would be required for replication-competent SARS-CoV-2 virus. To validate the pseudovirion assay, we set up comparisons with other available antibody tests including those from Abbott, Euroimmun and Siemens, using archived, known samples. Results 11 out of 12 SARS-CoV-2-infected patient serum samples showed neutralizing activity against SARS-CoV-2-spike pseudotyped MLV viruses, with neutralizing titers-50 (NT50) that ranged from 1:25 to 1:1,417. Five historical samples from patients hospitalized for severe influenza infection in 2016 tested negative in the neutralization assay (NT50 < 25). Three serum samples with high neutralizing activity against SARS-CoV-2/MLV pseudoviruses showed no detectable neutralizing activity (NT50 < 25) against SARS-CoV-1/MLV pseudovirions. We also compared the semiquantitative Siemens SARS-CoV-2 IgG test, which measures binding of IgG to recombinantly expressed receptor binding domain of SARS-CoV-2 spike glycoprotein with the neutralization titers obtained in the pseudovirion assay and the results show high concordance between the two tests (R2 = 0.9344). Conclusions SARS-CoV-2 spike/MLV pseudovirions provide a practical means of assessing neutralizing activity of antibodies in serum or plasma from infected patients under laboratory conditions consistent with biocontainment level 2. This assay offers promise also in evaluating immunogenicity of spike glycoprotein-based candidate vaccines in the near future.

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Comparison of eight commercial, high-throughput, automated or ELISA assays detecting SARS-CoV-2 IgG or total antibody

Abstract: Highlights 8 commercial assays detecting similar class of SARS-CoV-2 -specific antibodies. Discrepancies found not linked to sensitivity, target Ag, total vs IgG antibodies. False negative results possible in pauci-symptomatic subjects.

Cited by 56 publications

References 16 publications

Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays

Neutralization assay with SARS-CoV-1 and SARS-CoV-2 spike pseudotyped murine leukemia virions

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