Accuracy of serological testing for SARS-CoV-2 antibodies: first results of a large mixed-method evaluation study.

Brigger, D.; Horn, M. P.; Pennington, L. F.; Powell, A. E.; Siegrist, D.; Weber, B.; Engler, O.; Piezzi, V.; Damonti, L.; Iseli, P.; Hauser, C.; Froehlich, T. K.; Villiger, P. M.; Bachmann, Martin F.; Leib, S. L.; Bittel, P.; Fiedler, M.; Largiadèr, C.; Marschall, J.; Stalder, H.; ... (2021). Accuracy of serological testing for SARS-CoV-2 antibodies: first results of a large mixed-method evaluation study. Allergy, 76(3), pp. 853-865. Wiley 10.1111/all.14608

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BACKGROUND

Serological immunoassays that can identify protective immunity against SARS-CoV-2 are needed to adapt quarantine measures, assess vaccination responses, and evaluate donor plasma. To date, however, the utility of such immunoassays remains unclear. In a mixed-design evaluation study, we compared the diagnostic accuracy of serological immunoassays that are based on various SARS-CoV-2 proteins and assessed the neutralizing activity of antibodies in patient sera.

METHODS

Consecutive patients admitted with confirmed SARS-CoV-2 infection were prospectively followed alongside medical staff and biobank samples from winter 2018/2019. An in-house enzyme-linked immunosorbent assay utilizing recombinant receptor-binding domain (RBD) of the SARS-CoV-2 spike protein was developed and compared to three commercially available enzyme-linked immunosorbent assays (ELISAs) targeting the nucleoprotein (N), the S1 domain of the spike protein (S1) and a lateral flow immunoassay (LFI) based on full-length spike protein. Neutralization assays with live SARS-CoV-2 were performed.

RESULTS

One-thousand four-hundred and seventy-seven individuals were included comprising 112 SARS-CoV-2 positives (defined as a positive real-time PCR result; prevalence 7.6%). IgG seroconversion occurred between day 0 and day 21. While the ELISAs showed sensitivities of 88.4% for RBD, 89.3% for S1, and 72.9% for N protein, the specificity was above 94% for all tests. Out of 54 SARS-CoV-2 positive individuals, 96.3% showed full neutralization of live SARS-CoV-2 at serum dilutions ≥1:16, while none of the 6 SARS-CoV-2 negative sera revealed neutralizing activity.

CONCLUSIONS

ELISAs targeting RBD and S1 protein of SARS-CoV-2 are promising immunoassays which shall be further evaluated in studies verifying diagnostic accuracy and protective immunity against SARS-CoV-2.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Rheumatologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Rheumatologie

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Rheumatology, Clinical Immunology and Allergology
04 Faculty of Medicine > Service Sector > Institute for Infectious Diseases > Infection Serology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Infectiology
04 Faculty of Medicine > Service Sector > Institute for Infectious Diseases
05 Veterinary Medicine > Department of Infectious Diseases and Pathobiology (DIP) > Institute of Virology and Immunology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Hämatologie (Erwachsene)

UniBE Contributor:

Brigger, Daniel, Horn, Michael (B), Piezzi, Vanja, Damonti, Lauro (B), Hauser, Christoph Victor, Fröhlich, Tanja, Villiger, Peter Matthias, Bachmann, Martin (B), Leib, Stephen, Bittel, Pascal, Fiedler, Georg Martin, Largiadèr, Carlo Rodolfo, Marschall, Jonas, Stalder, Hanspeter, Eggel, Alexander, Nagler, Michael

Subjects:

600 Technology > 610 Medicine & health
600 Technology > 630 Agriculture
500 Science > 570 Life sciences; biology

ISSN:

1398-9995

Publisher:

Wiley

Language:

English

Submitter:

Karin Balmer

Date Deposited:

03 Nov 2020 12:34

Last Modified:

29 Mar 2023 23:37

Publisher DOI:

10.1111/all.14608

PubMed ID:

32997812

Uncontrolled Keywords:

Antibodies COVID-19 COVID-19 diagnostic testing Enzyme-Linked Immunosorbent Assay Neutralizing Severe Acute Respiratory Syndrome Coronavirus 2

BORIS DOI:

10.7892/boris.147052

URI:

https://boris.unibe.ch/id/eprint/147052

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