12 February 2021
PSA Ultra Low Quality Control is a product that we developed in response to numerous requests for a low level control to keep pace with the ever-increasing sensitivity of PSA assays. The control is widely used in Ireland by cancer testing centres as it is ideal for monitoring PSA levels post-prostatectomy.
The control is validated against the Roche immunoassay on the Roche Cobas® analyser.
The ‘PSA: Low level’ control is manufactured as stabilised serum from human origin. The concentrations of the QC have been chosen to ensure optimal assay performance at a critical sensitivity level.
A low level or undetectable PSA level is defined as ≤0.06 ng/mL or 0.02ng/mL by the ‘American Society for therapeutic radiology and oncology consensus panel’. As defined by the intuition it is agreed that a 6-12 month ‘undetectable PSA’ level is a prediction of disease-free survival ‘DFS’. Therefore an ultra-sensitive assay is beneficial.
Reference: Int. J. Radiation Oncology Biol. Phys Vol.37 No.5 pp 1035-1041, 1997
The control is stable up to the expiry date when stored at 2-8°c. When opened the control is stable for a period of 14 days when stored at 2-8°c. The kit size is 10 x 1ml.
Contact us for instrument specific values or further information.