Evaluation of commercial assays for the assessment of SARS-CoV-2 antibody response in hemodialysis patients.

Autor: Di Meo A; Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada., Ma L; Precision Medicine & Therapeutics Program (Laboratory Medicine), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Yau K; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Abe KT; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada., Colwill K; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada., Gingras AC; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada., Kozak R; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada; Precision Medicine & Therapeutics Program (Laboratory Medicine), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Hladunewich MA; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Yip PM; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada; Precision Medicine & Therapeutics Program (Laboratory Medicine), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. Electronic address: paul.yip@sunnybrook.ca.
Jazyk: angličtina
Zdroj: Clinical biochemistry [Clin Biochem] 2023 Nov; Vol. 121-122, pp. 110681. Date of Electronic Publication: 2023 Oct 31.
DOI: 10.1016/j.clinbiochem.2023.110681
Abstrakt: Background: Hemodialysis patients exhibit variable immunogenicity following administration of the SARS-CoV-2 mRNA vaccine. The aim of the current study was to evaluate the use of two commercial assays in the assessment of SARS-CoV-2 antibody response in hemodialysis patients and to compare their utility to commonly used SARS-CoV-2 serological assays developed in Canada.
Methods: We evaluated serologic antibody response in 85 hemodialysis patients up to 6 months after receiving both doses of the Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine. In addition, antibody response was assessed in 46 chronic kidney disease patients and 40 COVID-19 naïve health care workers (HCW) up to 3 months and 9 months, respectively. Anti-spike (S) and anti-nucleocapsid (N) levels were measured using Elecsys anti-SARS-CoV-2 immunoassays on the Roche analyzer and compared to ELISA-based detection of anti-S, anti-receptor binding domain (RBD), and anti-N.
Results: The Elecsys anti-N immunoassay showed 93 % concordance with the anti-N ELISA. The Elecsys anti-S immunoassay showed 97 % concordance with the anti-S ELISA and 89 % concordance with the anti-RBD ELISA. HCWs exhibited significantly higher anti-S levels relative to hemodialysis patients. Anti-S levels decreased significantly over a 6-month period (p < 0.001) in patients receiving maintenance hemodialysis. In addition, anti-S levels decreased significantly over a 9-month (p < 0.001) and 3-month period (p < 0.001) in HCWs and CKD patients, respectively.
Conclusions: There is high concordance between commercial SARS-CoV-2 serological assays and SARS-CoV-2 serological assays developed in Canada. Hemodialysis patients exhibited varying immunogenicity following two doses of the COVID-19 mRNA vaccine with anti-S levels decreasing over time.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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