Clinical Utility of Mutant Antibody-Based Assays for Determination of Internally Cleaved and Intact Forms of Free Prostate-Specific Antigen.

摘要: Background: Subforms of prostate-specific antigen (PSA) have been a subject intensive research, and use multikallikrein immunoassays can add clinical value to the early detection prostate cancer, overcoming known limitations PSA. In this study, we evaluated mutant 4D4 (L3-2) antibody-assisted assay constructs against reference wild-type (wt)-4D4-based assays for determination intact PSA (iPSA) nicked (nPSA) in plasma samples. Methods: Perioperative samples obtained from 105 men who underwent biopsy (73 32 noncancer) were analyzed with sandwich total (tPSA), free (fPSA), iPSA (3 constructs), measured nPSA (2 constructs). Calculated (CN) was fPSA − iPSA. Results: Mutant-assisted lower concentrations than both patient groups. CN separated 2 groups using capture (I-MC) performing best ( P = 0.008). volume group > median, only provided significant discrimination [area under curve (AUC), 0.71; 0.016] but equally wt antibodies. whole cohort, all ratios tPSA performed well (AUC, 0.819–0.870; ≤ 0.0001) based on I-MC scoring highest 0.870). Importantly, median group, I-MC/F CN(I-MC)/T stand out as parameters 0.825 0.861; 0.001 0.0003, respectively). Conclusions: The new construct provides clear improvement separating cancer noncancer subgroups especially patients median. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT01864135.