The IsoPSA® Reagent is part of the IsoPSA Assay, an in vitro diagnostic test system that combines the results of total prostate specific antigen (PSA) and free PSA from partitioned heparinized plasma into a single numerical index. The IsoPSA reagent vial contains a ready-to-use proprietary mixture of polymers and salts that forms an aqueous two-phase (biphasic) system. This system separates PSA structural variants based on their physicochemical properties.In the IsoPSA Assay workflow, a plasma sample is added to the IsoPSA reagent vial, mixed, and centrifuged to partition PSA isoforms into two distinct phases. An aliquot of the top-phase fraction is removed and analyzed along with the native plasma sample using an immunoanalyzer to quantify total PSA and free PSA. These measurements are used to calculate the IsoPSA Index.The IsoPSA Reagent is intended for use only with IsoPSA Assay components, including IsoPSA Controls, a dedicated centrifuge-mixer device, and Roche Elecsys total PSA and free PSA assays on a compatible immunoanalyzer. The reagent is provided ready to use and is for in vitro diagnostic use.
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
clevelanddx.com