Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Krzysztof Lukaszuk; Jolanta Kiewisz; Karolina Rozanska; Malgorzata Dabrowska; Amira Podolak; Grzegorz Jakiel; Izabela Woclawek-Potocka; Aron Lukaszuk; Lukasz Rabalski

doi:10.3390/vaccines9080840

Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Vaccines (Basel). 2021 Jul 31;9(8):840. doi: 10.3390/vaccines9080840.

Authors

Affiliations

¹ Invicta Research and Development Center, 81-740 Sopot, Poland.
² Department of Obstetrics and Gynecology Nursing, Medical University of Gdansk, 80-210 Gdansk, Poland.
³ Department of Human Histology and Embryology, Medical Faculty, Collegium Medicum, University of Warmia and Mazury in Olsztyn, 10-082 Olsztyn, Poland.
⁴ Central Clinical Laboratory, University Clinical Centre, 80-214 Gdansk, Poland.
⁵ The Center of Postgraduate Medical Education, 1st Department of Obstetrics and Gynecology, University of Gdansk, 01-004 Warsaw, Poland.
⁶ Department of Gamete and Embryo Biology, Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, 10-748 Olsztyn, Poland.
⁷ Laboratory of Recombinant Vaccines, Intercollegiate Faculty of Biotechnology, University of Gdansk, 80-307 Gdansk, Poland.

Abstract

Background: The introduction of the vaccination against SARS-CoV-2 infection creates the need for precise tools for the quality control of vaccination procedures, detection of poor humoral response, and estimation of the achieved protection against the disease. Thus, the study aimed to compare the results of the anti-SARS-CoV-2 tests to evaluate the application of the WHO standard unitage (the binding antibody units; BAU/mL) for a measurement of response to the vaccination.

Methods: Patients undergoing vaccination against SARS-CoV-2 with Pfizer/BioNTech BNT162b2 (BNT162b2) (n = 79), referred for SARS-CoV-2 antibody measurement prior to vaccination and 21 days after dose 1, and 8, 14, and 30 days after dose 2 were included. The sera were tested with three assays: Elecsys SARS-CoV-2 S (Roche), LIAISON^® SARS-CoV-2 TrimericS IgG (DiaSorin), and SARS-CoV-2 IgG II Quant (Abbott).

Results: The three assays showed varying correlations at different time points in the study. The overall agreement for all samples was moderate to high (ρ = 0.663-0.902). We observed the most uniform agreement for the day of dose 2 (ρ = 0.775-0.825), while it was least consistent for day 8 (ρ = -0.131-0.693) and 14 (ρ = -0.247-0.603) after dose 2. The dynamics of changes of the SARS-CoV-2 antibody levels in patients without history of prior SARS-CoV-2 infection appears homogenous based on the Roche results, more heterogenous when considering the DiaSorin results, and in between for the Abbott results.

Conclusions: The results highlight the need for further work on the international standard of measurement of SARS-CoV-2 Ig, especially in the era of vaccination. The serological assays can be useful to detect IgG/IgM antibodies to assess the response to the vaccination. However, they cannot be used interchangeably. In terms of the evaluation of the immune response to the BNT162b2 vaccine, Roche and Abbott kits appear to be more useful.

Keywords: Abbott; COVID-19; DiaSorin; Pfizer/BioNTech; Roche; SARS-CoV-2; assay comparison; vaccination.