B-367 Analytical Validation of New CLIA Based TPS Assay as a Biomarker in Cancer Management

Abstract Background Tissue polypeptide-specific antigen (TPS) has been described as a potentially useful serum marker of tumor activity in adult epithelial tumors such as breast, ovarian, prostate, and other malignancies. Here we developed and analytically validated Chemiluminescence immunoassay (CLIA) for TPS on the CIA series analyzer and FOSUN series analyzer in collaboration with Jiangsu ZECEN Biotech Co., Ltd (Jiangsu and Beijing, China). Methods The TPS-CLIA relies on two monoclonal antibodies generated against peptides that bind to cytokeratin 18 (CK18). The TPS-CLIA assay has been analytically validated and a reference range was established by using sera from blood donors (n = 101), and potential applicability was demonstrated in sera from patients with different malignant diseases (n = 54). The same serum samples were also analyzed with TPS-ELISA for comparison. Results The TPS-CLIA had a limit of the blank of 6 U/L with a limit of detection of 10 U/L and a dynamic range of 10–1200 U/L. The total assay precision was below 20% and no hook effect was observed up to 3265 U/L. Linear dilution of high endogenous TPS sera at 1:4 to 1:256 had shown a recovery in the range of 85%–115%. No significant interference was observed with bilirubin, hemoglobin, and triglycerides (