BACKGROUND: Total PSA assays measure both complexed and non-complexed forms of PSA while free PSA assays only measure non-complexed forms. Free PSA is a mixture of isoforms including immature PSA (proPSA) with retained portions of the leader sequence (e.g. [-7], [-4], and [-2]proPSA) and nicked forms (BPSA). ProPSA isoforms in male sera have been associated with prostate cancer. This study characterized the analytical performance of a chemiluminescent immunoassay for [-2]proPSA. METHODS: The Access Hybritech p2PSA assay is a sandwich immunoassay using an anti-[-2]proPSA monoclonal antibody attached to paramagnetic beads and an anti-PSA monoclonal antibody conjugated to alkaline phosphatase calibrated with recombinant [-2]proPSA. Analytical studies including sensitivity (CLSI EP17-A) and imprecision (CLSI EP5-A2) were performed. RESULTS: The Access Hybritech p2PSA assay for [-2]proPSA had a dynamic range of 0.5 to 5000 pg/ml. The total CV of the assay was <7% for [-2]proPSA concentrations between 20 and 1000 pg/ml. The LOB was 0.50 pg/ml, LOD 0.69 pg/ml, and LOQ 3.23 pg/ml (20% CV). There was no hook effect up to 15,000 pg/ml. There was a <5% difference between calibrator and reagent lots and no interference from normal serum constituents. CONCLUSIONS: The Access Hybritech p2PSA assay is a robust immunoassay for the measurement of serum [-2]proPSA.
BACKGROUND: Total PSA assays measure both complexed and non-complexed forms of PSA while free PSA assays only measure non-complexed forms. Free PSA is a mixture of isoforms including immature PSA (proPSA) with retained portions of the leader sequence (e.g. [-7], [-4], and [-2]proPSA) and nicked forms (BPSA). ProPSA isoforms in male sera have been associated with prostate cancer. This study characterized the analytical performance of a chemiluminescent immunoassay for [-2]proPSA. METHODS: The Access Hybritech p2PSA assay is a sandwich immunoassay using an anti-[-2]proPSA monoclonal antibody attached to paramagnetic beads and an anti-PSA monoclonal antibody conjugated to alkaline phosphatase calibrated with recombinant [-2]proPSA. Analytical studies including sensitivity (CLSI EP17-A) and imprecision (CLSI EP5-A2) were performed. RESULTS: The Access Hybritech p2PSA assay for [-2]proPSA had a dynamic range of 0.5 to 5000 pg/ml. The total CV of the assay was <7% for [-2]proPSA concentrations between 20 and 1000 pg/ml. The LOB was 0.50 pg/ml, LOD 0.69 pg/ml, and LOQ 3.23 pg/ml (20% CV). There was no hook effect up to 15,000 pg/ml. There was a <5% difference between calibrator and reagent lots and no interference from normal serum constituents. CONCLUSIONS: The Access Hybritech p2PSA assay is a robust immunoassay for the measurement of serum [-2]proPSA.
Authors: Safana S Al Saidi; Nafila B Al Riyami; Mohammed S Al Marhoon; Mohammed S Al Saraf; Salim S Al Busaidi; Riad Bayoumi; Waad-Allah S Mula-Abed Journal: Oman Med J Date: 2017-07
Authors: Stacy Loeb; Lori J Sokoll; Dennis L Broyles; Chris H Bangma; Ron H N van Schaik; George G Klee; John T Wei; Martin G Sanda; Alan W Partin; Kevin M Slawin; Leonard S Marks; Isaac A Mizrahi; Sanghyuk S Shin; Amabelle B Cruz; Daniel W Chan; William L Roberts; William J Catalona Journal: J Urol Date: 2012-11-30 Impact factor: 7.450
Authors: Claire de la Calle; Dattatraya Patil; John T Wei; Douglas S Scherr; Lori Sokoll; Daniel W Chan; Javed Siddiqui; Juan Miguel Mosquera; Mark A Rubin; Martin G Sanda Journal: J Urol Date: 2015-01-28 Impact factor: 7.450