Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wrocław University of Science and Technology, Wrocław, Poland.
Greater Poland Cancer Centre, Department of Laboratory Diagnostics, Poznań, Poland.
Ann Lab Med. 2019 Jul;39(4):373-380. doi: 10.3343/alm.2019.39.4.373.
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 diagnostic assays that rely on mouse monoclonal IgG.
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).
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.
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.
血清前列腺特异抗原（PSA）浓度的测量仍然是诊断前列腺癌的主要方法之一。我们开发并评估了一种基于免疫球蛋白 Y（IgY）的 ELISA 来测量人血清中的总 PSA（tPSA）浓度，可作为依赖于小鼠单克隆 IgG 的商业诊断检测的替代方法。
开发了一种基于抗 PSA IgY 抗体的夹心 ELISA。我们评估了抗 PSA IgY 抗体在相同摩尔比下检测游离和结合 PSA 的能力。优化了该检测方法，并通过计算背景限（LoB）、检测限（LoD）和定量限（LoQ）来验证其分析性能。我们对我们的 ELISA 和商业检测（罗氏诊断公司的 Cobas 6000 和 IBL 国际公司的 PSA 总 ELISA）测量的 tPSA 浓度进行了相关性和回归分析。
LoB、LoD 和 LoQ 分别为 0.061、0.083 和 0.100ng/mL，线性范围为 0.100-3.375ng/mL。我们的基于 IgY 的 ELISA 测量的 tPSA 浓度与商业检测结果具有很强的相关性。
我们的基于 IgY 的 ELISA 是上述商业检测的有效替代品。使用 IgY 作为检测剂可以降低假阳性结果的风险，同时降低分析的总成本。
