This company recently received FDA clearance for two new Elecsys PSA assays.
The Elecsys Total PSA (tPSA) immunoassay screening test is indicated for use in conjunction with a digital rectal exam (DRE) as an aid in the detection of prostate cancer in men 50 years or older. Additionally, tPSA is used in monitoring the treatment progress of prostate cancer patients.
The Elecsys Free PSA (fPSA) immunoassay is used with the Elecsys Total PSA immunoassay to develop a ratio (%PSA) of fPSA to tPSA. This ratio helps distinguish prostate cancer from benign conditions in men with an elevated tPSA (4 ng/mL to 10 ng/mL) but a normal DRE. A prostate biopsy is required for diagnosis of prostate cancer.
Both assays run on the Elecsys 1010 rapid response system and the Elecsys 2010, a higher throughput system that may be equipped with disk or rack sampler with high sample-loading capacity. The analytical sensitivity of the Elecsys Total PSA assay is 0.002 ng/mL, making it ideal for monitoring post-prostatectomy patients. The analytical sensitivity of the Elecsys Free PSA assay is 0.01 ng/mL, which exceeds the requirements of the clinical application.
Keyword: assay, psa