Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples

Haselmann, Verena; Kittel, Maximilian; Gerhards, Catharina; Thiaucourt, Margot; Eichner, Romy; Costina, Victor; Neumaier, Michael

doi:10.1016/j.cca.2020.07.007

Cited by 42 publications

(46 citation statements)

References 22 publications

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“…This indicates a heterogeneous landscape of anti-SARS-CoV-2 serological testing in clinical practice. Interestingly, two participants used the Roche Elecsys anti-SARS-CoV-2 test, which had not been officially launched on time of sample dispatch, but has since been externally validated in several studies [12][13][14]. It has to be mentioned that results reported for the Roche assay were only considered for IgG as the test does not differentiate between antibody classes [13,25].…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, given the speed of industrial development and the emergency use authorization (EUA), validation requirements for new test systems had been relaxed [7], resulting in a questionable quality of some assays. Thus, the clinical accuracy and performance of these tests systems are currently being elucidated in several external validation studies [8][9][10][11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

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Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

Haselmann

Porsch-Özçürümez

Klawonn

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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ObjectivesAssessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prevalence and immunity is cornerstones in the fight against CoViD-19 pandemic. For pandemic control, reliable assays for the detection of anti-SARS-CoV-2 antibodies are required. This pilot external quality assessment (EQA) scheme aimed to independently assess the participants’ clinical performance of anti-SARS-CoV-2 testing, to identify shortcomings in clinical practice and to evaluate the suitability of the scheme format.MethodsThe EQA scheme consisted of eight serum samples with variable reactivity against SARS-CoV-2 intended for the analysis of anti-SARS-CoV-2 immunoglobulin (Ig)G, IgA, and IgM antibodies. Laboratories reported: (1) results for each sample and the respective method, (2) raw data from replicate testing of each sample.ResultsThe 16 selected pilot EQA participants reported 294 interpreted results and 796 raw data results from replicate testing. The overall error rate for the anti-SARS-CoV-2 IgG, IgA, and IgM tests was 2.7, 6.9, and 16.7%, respectively. While the overall diagnostic specificity was rated as very high, sensitivity rates between 67 and 98% indicate considerable quality differences between the manufacturers, especially for IgA and IgM.ConclusionsEven the results reported by the small number of participants indicate a very heterogeneous landscape of anti-SARS-CoV-2 serological testing. Differences of available tests and the individual performance of laboratories result in a success rate of 57.1% with one laboratory succeeding for all three antibody-classes. These results are an incentive for laboratories to participate in upcoming open EQA schemes that are needed to achieve a harmonization of test results and to improve serological testing.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

Haselmann

Porsch-Özçürümez

Klawonn

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Cross-reactivity with SARS-CoV and seasonal coronaviruses in different population and timing of IgM and IgG responses need to continue to be considered. Till date, studies on comparative performance serological assays for SARS-CoV-2 show a range of sensitivity of 84–98 % and specificity of 96–99 % [ [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] ]. Two of the three IgG assays in this study used the Spike protein (Receptor binding domain or RBD in THSTI-In-house ELISA and S1/S2 in DiaSorin CLIA), while the specific antigenic epitope(s) of the inactivated virus in the Kavach assay are not defined.…”

Section: Discussionmentioning

confidence: 99%

Comparative evaluation of SARS-CoV-2 IgG assays in India

Chaudhuri

Thiruvengadam

Chattopadhyay

et al. 2020

Journal of Clinical Virology

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Introduction IgG immunoassays have been developed and used widely for clinical samples and serosurveys for SARS-CoV2, with most detecting antibodies against the spike/receptor-binding-domain or nucleocapsid. Limited information is available on comparative evaluation of IgG immunoassays against a clinical reference standard, i.e., RT-PCR positivity with >20 days of illness. This study addresses the need for comparing clinical performance of IgG immunoassays with respect to this alternate reference standard. Methods We compared the performance of three immunoassays, an in-house RBD assay, and two commercial assays, the Diasorin LIAISON SARS-CoV-2 S1/S1 IgG CLIA which detects antibodies against S1/S2 domains of the Spike protein and the Zydus Kavach assay based on inactivated virus using a well-characterized panel of sera. 379 sera and plasma samples from RTPCR positive individuals >20 days of illness in symptomatic or RT-PCR positivity in asymptomatic individuals and 184 samples collected prior to 2019 were used for assay evaluation. Results The sensitivity of the assays were 84.7 (95 %CI 80.6–88.1), 82.6 (95 %CI 78.3–86.2) and 75.7 (95 %CI 71.0–79.9) respectively for RBD, LIAISON and Kavach. Kavach and the in-house RBD ELISA showed a specificity of 99.5 % and 100 %, respectively. The RBD and LIAISON (S1/S2) assays showed high agreement (94.7 %; 95 %CI: 92.0, 96.6) and were able to correctly identify more positive sera/plasma than Kavach. Conclusion Independent comparisons support the evaluation of performance characteristics of immunoassays. All three assays are suitable for serosurveillance studies, but in low prevalence sites, estimation of exposure may require adjustment based on our findings.

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“…21 A subsequent German study using samples from 26 COVID-19 patients found sensitivities for the Roche, Euroimmun, and Epitope of 92.3%, 96.2%-100%, and 100%, respectively; specificities were 100%, 100%, and 84%-86%, respectively. 22 These immunoassays were able to identify 84% to 96% of COVID-19-negative samples and 92.3% to 95.2% of COVID-19-positive samples. 22…”

Section: German Antibody Studiesmentioning

confidence: 93%

“…22 These immunoassays were able to identify 84% to 96% of COVID-19-negative samples and 92.3% to 95.2% of COVID-19-positive samples. 22…”

Section: German Antibody Studiesmentioning

confidence: 93%

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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Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples

Cited by 42 publications

References 22 publications

Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

Comparative evaluation of SARS-CoV-2 IgG assays in India

Antibody tests for COVID-19

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