Fifth-Generation Digital Immunoassay for Prostate Specific Antigen Using Single Molecule Arrays

摘要

BACKGROUNDMeasurement of prostate specific antigen (PSA) in prostate cancer patients following radical prostatectomy (RP) has been limited by the sensitivity of available assays. Because radical prostatectomy removes the tissue responsible for PSA production, post-surgical PSA is typically undetectable with current assay methods. However, evidence suggests that more sensitive determination of PSA status following RP could improve assessment of patient prognosis, response to treatment, and better target secondary therapy to those who may benefit most. We report the development and validation of an investigational digital immunoassay with two logs greater sensitivity than today’s ultrasensitive third-generation PSA assays.