Ann Lab Med 2019; 39(4): 373-380  https://doi.org/10.3343/alm.2019.39.4.373
Development and Evaluation of an Immunoglobulin Y-Based ELISA for Measuring Prostate Specific Antigen in Human Serum
Agnieszka Łupicka-Słowik , Ph.D.1, Renata Grzywa , Ph.D.1, Ewa Leporowska , Ph.D.2, Danuta Procyk , Ph.D.2, Józef Oleksyszyn , Ph.D., D.Sc.1, and Marcin Sieńczyk , Ph.D., D.Sc.1
1Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wrocław University of Science and Technology, Wrocław, Poland; 2Greater Poland Cancer Centre, Department of Laboratory Diagnostics, Poznań, Poland
Corresponding author: Marcin Sieńczyk, Ph.D., D.Sc. https://orcid.org/0000-0002-5528-5264
Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wrocław University of Science and Technology, Wybrzeże Wyspiańskiego 27, 50-370 Wrocław, Poland
Tel: +48-71-320-36-46, Fax: +48-71-320-24-27
E-mail: marcin.sienczyk@pwr.edu.pl
Received: September 12, 2018; Revised: November 20, 2018; Accepted: February 5, 2019; Published online: July 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Measurement of serum prostate specific antigen (PSA) concentrations remains one of the leading methods for diagnosing prostate cancer. We developed and evaluated an immunoglobulin Y (IgY)-based ELISA to measure total PSA (tPSA) concentrations in human serum that could be used as an alternative to commercially available in vitro diagnostic assays that rely on mouse monoclonal IgG.
Methods: A sandwich ELISA based on an anti-PSA IgY antibody was developed. We evaluated the ability of the anti-PSA IgY antibody to detect free and complexed PSA at the same molar ratio. The assay was optimized, and its analytical performance was verified by calculating limit of background (LoB), limit of detection (LoD), and limit of quantification (LoQ). We performed correlation and regression analyses between tPSA concentrations measured by our ELISA and those from commercial assays: Cobas 6000 (Roche Diagnostics, Warszawa, Poland) and PSA total ELISA (IBL International, Hamburg, Germany).
Results: LoB, LoD, and LoQ, were 0.061, 0.083, and 0.100 ng/mL, respectively, and linearity range was 0.100–3.375 ng/mL. tPSA concentrations from our IgY-based ELISA strongly correlated with those from the commercial assays.
Conclusions: Our IgY-based ELISA is an efficient equivalent to the above commercial assays. The use of IgY as the detecting agent could reduce the risk of false positive results, as well as decrease the overall cost of analysis.
Keywords: Prostate specific antigen, In vitro diagnostics, Prostate cancer, Immunoglobulin Y, Sandwich ELISA, Performance



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