Clinical performance of SARS-CoV-2 IgG antibody tests and potential protective immunity

Kohmer, Niko; Westhaus, Sandra; Rühl, Cornelia; Ciesek, Sandra; Rabenau, H.

doi:10.1101/2020.05.08.085506

Cited by 27 publications

(35 citation statements)

References 9 publications

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“…EUROIMMUN ELISA IgG and IgA was, in global terms, the ELISA with the highest sensitivity (88.9%) and speci city (100%). IgA values were high, in line with previously published results 8,9 . However, the sensitivity for the isolated detection of IgG was very low (37.8%), in contrast to other studies (67-93.8%) 8,9. Something similar happened with COVID-19 ELISA IgG Vircell®.…”

Section: Discussionsupporting

confidence: 92%

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Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.

Namoos

Frutos

García

et al. 2020

Preprint

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BackgroundAntibody detection is essential to establish exposure, infection and immunity to SARS-CoV-2, as well as to perform epidemiological studies. The worlwide urge for new diagnostic tools to control the pandemic has led to a quick in- corporation in clinical practice of the recently developed serological assays.MethodsWe evaluated the diagnostic accuracy to detect Ig G, Ig M+A and/or IgA anti SARS-CoV-2 of 10 different assays: 3 Lateral Flow card inmunoassays, 4 en- zyme-linked inmunoabsorbent assay (ELISA) and 3 chemiluminescent particle immunoassays (CMIA). Using PCR for COVID-19 as gold standard, sensitivity, specificity, PPV, and NPV were determined. Each assay was tested in 2 groups: Positive Controls, formed by 50 sera from 50 patients with SARS-CoV-2 pneu- monia with positive PCR; Negative Controls, formed by 50 sera from 50 pa- tients with respiratory infection non-COVID-19.ResultsSensitivity range of the 10 assays evaluated for patients with positive COVID-19 PCR was 40-77% (65-81% considering IgG plus IgM). Specificity ranged 83-100%. VPP and VPN were respectively 81-100% and 61.6-81%.ConclusionsResults obtained varied widely among the assays evaluated.Highest diagnostic accuracy was obtained with ELISA and CMIAs, but they last much longer.

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Section: Discussionsupporting

confidence: 92%

“…However, the sensitivity for the isolated detection of IgG was very low (37.8%), in contrast to other studies (67-93.8%) 8,9. Something similar happened with COVID-19 ELISA IgG Vircell®. Facing Kohmer et al 8 results (100% sensitivity, 95.2% speci city), in our study the sensitivity was 65%, maintaining a high speci city (96%) with 94% PPV.…”

Section: Discussionsupporting

confidence: 72%

Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.

Namoos

Frutos

García

et al. 2020

Preprint

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“…A meta-analysis of 38 studies on the performance of different format SARS-CoV-2 antibody tests mainly manufactured from Chinese companies was reported recently [ 23 ]. Furthermore, studies on the sensitivity and specificity of SARS-CoV-2 IgG tests, including ELISAs from the Epitope, Euroimmun, and Mikrogen companies, were published previously [ 20 , 21 , 22 , 24 ]. A recent prospective study examined the sensitivity of seven antibody tests from Abbott, Euroimmun, Mediagnost, Novatec, Virotech, Roche, and Siemens companies but did not provide data on their specificities or on the correlation of the assay results to the presence of SARS-CoV-2-neutralizing antibodies [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…This also covered follow-up sera (reference method 2). Testing was done under biosafety level 3 conditions and was in accordance to previous reports [ 20 , 21 ] with minor modifications. One to two days before infection, 1.0 × 10 5 cells were seeded into each well of 48-well plates.…”

Section: Methodsmentioning

confidence: 99%

Kinetics of Nucleo- and Spike Protein-Specific Immunoglobulin G and of Virus-Neutralizing Antibodies after SARS-CoV-2 Infection

Strömer

Rose

Grobe³

et al. 2020

Microorganisms

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Kinetics of neutralizing antibodies and immunoglobulin G (IgG) against the nucleo (N) or spike (S) proteins of severe acute respiratory syndrome coronavirus type2 (SARS-CoV-2) were studied in patients up to 165 days after PCR diagnosis of infection. Two immunoassays were selected out of eight IgG or total antibody tests by comparing their specificities and sensitivities. Sensitivities were calculated with convalescent sera from 26 PCR-confirmed cases, of which 76.9% had neutralizing antibodies (>1:10). Stored sera collected during the summer 2018 (N = 50) and winter seasons 2018/2019 (N = 50) were included to demonstrate the test specificities. IgG kinetics, avidities, and virus-neutralizing capacities were recorded over up to 165 days in eleven patients and five individuals from routine diagnostics. Sensitivities, specificities, and diagnostic accuracies ranged between 80.8–96.3%, 96.0–100%, and 93.7–99.2%, respectively. Nearly all results were confirmed with two different SARS-CoV-2-specific immunoblots. Six (54.4%) patients exhibited stable N-specific IgG indices over 120 days and longer; three of them developed IgG of high avidity. The S-specific IgG response was stable in ten (91.0%) patients, and eight (72.7%) had neutralizing antibodies. However, the titers were relatively low, suggesting that sustained humoral immunity is uncertain, especially after outpatient SARS-CoV-2 infection.

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“…Although the sensitivity of RT-PCR is very high, its overall diagnostic accuracy depends on the quality of sampling (nasopharyngeal swab) and subsequent sample handling. Antibody tests used might show cross-reactivity with other viruses, such as endemic coronavirus strains [ 19 ]. In a Dutch summary of various ELISA tests, the sensitivity of the Vircell IgG test at >14 days after illness onset was 97% in severe and 89% in mild/asymptomatic cases and the specificity was 94%.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Current and Past SARS-CoV-2 Infections among Police Employees in Poland, June–July 2020

Gujski

Jankowski

Pinkas

et al. 2020

JCM

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Background: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We aimed to determine the prevalence of current and past SARS-CoV-2 infections among police employees. Methods: This cross-sectional survey was undertaken among 5082 police employees from Mazowieckie Province, Poland. RT-PCR testing for current SARS-CoV-2 infection and serological tests (ELISA) for the presence of anti-SARS-CoV-2 IgM+IgA and IgG antibodies were performed. Results: All RT-PCR tests were negative. The anti-SARS-CoV-2 IgM+IgA index was positive (>8) in 8.9% of participants, including 11.2% women and 7.7% men (p < 0.001). Equivocal IgM+IgA index (6–8) was found in 9.8% of participants, including 11.9% women and 8.7% men (p < 0.001). The IgG index was positive (>6) in 4.3% and equivocal (4–6) in 13.2% of participants. A higher odds of positive IgM+IgA index was found in women vs. men (OR: 1.742) and police officers vs. civilian employees (OR: 1.411). Participants aged ≥60 years had a higher odds of positive IgG index vs. those aged 20–29 years (OR: 3.309). Daily vaping also increased the odds of positive IgG index (OR: 2.058). Conclusions: The majority of Polish police employees are seronegative for SARS-CoV-2 infection. Vaping and older age (≥60 years) were associated with a higher risk of SARS-CoV-2 infection.

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Clinical performance of SARS-CoV-2 IgG antibody tests and potential protective immunity

Abstract: 24As the current SARS-CoV-2 pandemic continues, serological assays are urgently needed for rapid 25 diagnosis, contact tracing and for epidemiological studies.

Cited by 27 publications

References 9 publications

Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.

Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.

Kinetics of Nucleo- and Spike Protein-Specific Immunoglobulin G and of Virus-Neutralizing Antibodies after SARS-CoV-2 Infection

Prevalence of Current and Past SARS-CoV-2 Infections among Police Employees in Poland, June–July 2020

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