The IsoPSA® Controls are in vitro diagnostic quality control materials intended for use with the IsoPSA Assay. The control set consists of two levels of control material designed to monitor the performance of the IsoPSA Assay across its reportable range. Each control level contains human serum-based material with assigned IsoPSA Index values.The IsoPSA Controls are processed in the same manner as patient samples, including mixing with IsoPSA Reagent, centrifugation to form a biphasic system, and subsequent measurement of total prostate specific antigen (PSA) and free PSA using a compatible immunoanalyzer. The measured values are used to verify that the IsoPSA Assay is performing within established specifications.The IsoPSA Controls are intended for use only with IsoPSA Assay components, including IsoPSA Reagent, a dedicated centrifuge-mixer device, and Roche Elecsys total PSA and free PSA assays. The controls are provided for in vitro diagnostic use and are not intended for use as calibrators.
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).
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