Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies

Favresse, Julien; Eucher, Christine; Elsen, Marc; Tré-Hardy, Marie; Dogné, Jean Michel; Douxfils, Jonathan

doi:10.1093/clinchem/hvaa131

Cited by 107 publications

(117 citation statements)

References 4 publications

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“…Furthermore, while it is expected that neutralizing antibodies confer some protection against SARS-CoV-2, the titer required for this protective effect has not been established (11). Due to the low sensitivity of serological assays for diagnosing early SARS-CoV-2 infection (15,27), some studies have suggested lowering the assay cutoff ratios to improve sensitivity (28,29). However, if the intended utility of serology is to determine the presence of neutralizing antibodies, our ROC analyses suggest that the assay cutoff should be increased to improve the NPA.…”

Section: Discussionmentioning

confidence: 92%

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

Tang

Case

Franks

et al. 2020

Preprint

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AbstractIntroductionCommercially available SARS-CoV-2 serological assays based on different viral antigens have been approved for the qualitative determination of anti-SARS-CoV-2 antibodies. However, there is limited published data associating the results from commercial assays with neutralizing antibodies.Methods67 specimens from 48 patients with PCR-confirmed COVID-19 and a positive result by the Roche Elecsys SARS-CoV-2, Abbott SARS-CoV-2 IgG, or EUROIMMUN SARS-CoV-2 IgG assays and 5 control specimens were analyzed for the presence of neutralizing antibodies to SARS-CoV-2. Correlation, concordance, positive percent agreement (PPA), and negative percent agreement (NPA) were calculated at several cutoffs. Results were compared in patients categorized by clinical outcomes.ResultsThe correlation between SARS-CoV-2 neutralizing titer (EC50) and the Roche, Abbott, and EUROIMMUN assays was 0.29, 0.47, and 0.46 respectively. At an EC50 of 1:32, the concordance kappa with Roche was 0.49 (95% CI; 0.23-0.75), with Abbott was 0.52 (0.28-0.77), and with EUROIMMUN was 0.61 (0.4-0.82). At the same neutralizing titer, the PPA and NPA for the Roche was 100% (94-100) & 56% (30-80); Abbott was 96% (88-99) & 69% (44-86); and EUROIMMUN was 91% (80-96) & 81% (57-93) for distinguishing neutralizing antibodies. Patients who died, were intubated, or had a cardiac injury from COVID-19 infection had significantly higher neutralizing titers relative to those with mild symptoms.ConclusionCOVID-19 patients generate an antibody response to multiple viral proteins such that the calibrator ratios on the Roche, Abbott, and EUROIMMUN assays are all associated with SARS-CoV-2 neutralization. Nevertheless, commercial serological assays have poor NPA for SARS-CoV-2 neutralization, making them imperfect proxies for neutralization.

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Section: Discussionmentioning

confidence: 92%

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

Tang

Case

Franks

et al. 2020

Preprint

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“…Sensitivities two weeks post-symptoms were 89.4% (n=47) [7], 91.1% (n=79) [6], and 100% (n=18) [8], using the manufacturer's cut-off (i.e., COI ≥ 1.0). In one of these studies, optimization of the cut-off, as determined by ROC curve analyses, was associated with a sensitivity of 95.1% without diminishing the specificity of 100%, suggesting that cut-off optimization may increase the detection rate in the population [6]. Antibody kinetics is a matter of concern, especially because emerging data showed that the persistence of antibodies may last only 2 to 3 months, offering a strong note of caution against the idea of "immunity certificate" [9].…”

Section: To the Editormentioning

confidence: 98%

“…In our study, all measurements were performed on the cobas ® e801 (Roche Diagnostics ® ). Three independent studies found a specificity ranging from 98.7 to 100% [6][7][8]. Sensitivities two weeks post-symptoms were 89.4% (n=47) [7], 91.1% (n=79) [6], and 100% (n=18) [8], using the manufacturer's cut-off (i.e., COI ≥ 1.0).…”

Section: To the Editormentioning

confidence: 99%

“…Three independent studies found a specificity ranging from 98.7 to 100% [6][7][8]. Sensitivities two weeks post-symptoms were 89.4% (n=47) [7], 91.1% (n=79) [6], and 100% (n=18) [8], using the manufacturer's cut-off (i.e., COI ≥ 1.0). In one of these studies, optimization of the cut-off, as determined by ROC curve analyses, was associated with a sensitivity of 95.1% without diminishing the specificity of 100%, suggesting that cut-off optimization may increase the detection rate in the population [6].…”

Section: To the Editormentioning

confidence: 99%

“…However, even low levels of neutralizing antibodies may still be protective, arguing for the use of optimized cut-off to detect those with low antibody levels. The aim of the present study was to assess the longitudinal kinetics of anti-SARS-CoV-2 antibodies since symptom onset, in a large cohort of patients, and by using the manufacturer's cut-off and the optimized cut-off (i.e., COI > 0.165) recently published [6].…”

Section: To the Editormentioning

confidence: 99%

See 2 more Smart Citations

Response of anti-SARS-CoV-2 total antibodies to nucleocapsid antigen in COVID-19 patients: a longitudinal study

Favresse

Eucher

Elsen

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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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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Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies

Cited by 107 publications

References 4 publications

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays

Response of anti-SARS-CoV-2 total antibodies to nucleocapsid antigen in COVID-19 patients: a longitudinal study

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

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