title: Evaluation of a new tumor marker for cytokeratin 8 and 18 fragments in healthy individuals and prostate cancer patients.
abstract: The serological results from apparently healthy individuals and prostate cancer patients were evaluated with a new assay called TPAcyk ELISA. This assay has a biochemical specificity for fragments of cytokeratins 8 and 18, and exhibits a low within- and between-assay imprecision. The data indicate a significant difference between the results of males and females, but no significant age-dependent relation was found. The cut-off value (95% specificity) for healthy individuals was estimated to be 1.27 ng/mL (n = 190) for males and 0.95 ng/mL (n = 81) for females. When using a cut-off value of 1.27 ng/mL, we found a sensitivity for prostate cancer patients with T2-3 N0M0 of about 20%. For patients with metastatic disease, a sensitivity of 75% was found. A higher sensitivity was obtained with patient sera analyzed with PSA than with TPAcyk, particularly in patients with early stages of the disease. We conclude that the results from this new TPAcyk assay were significantly elevated in patients initially diagnosed with poorly differentiated tumors, that patients with localized tumors exhibited low concentrations, and that patients with metastatic disease showed, on average, 8 times higher concentrations than patients with localized disease. The combination of the TPAcyk and PSA results increased the sensitivity for prostate cancer, particularly in patients with metastatic disease.
authors.affiliation: AB IDL ImmunoDevelopLab, Borlänge, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Silén
authors.forename: B
authors.initials: B
authors.lastname: Wiklund
authors.forename: B J
authors.initials: BJ
authors.lastname: Norlén
authors.forename: S
authors.initials: S
authors.lastname: Nilsson
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor / Q000097:blood*; D001782:Blood Donors; D005260:Female; D006801:Humans; D007633:Keratins / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011336:Probability; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis*; D012016:Reference Values; D012680:Sensitivity and Specificity; D012727:Sex Characteristics
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D007633:Keratins