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 > 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 > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
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; Piezzi, Vanja; Damonti, Lauro; Hauser, Christoph Victor; Fröhlich, Tanja; Villiger, Peter; Bachmann, Martin; Leib, Stephen; Bittel, Pascal; Fiedler, Georg Martin; Largiadèr, Carlo Rodolfo; Marschall, Jonas; Stalder, Hanspeter; Eggel, Alexander and 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:

08 Mar 2021 01:32

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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