Commutability assessment of SERO’s products

Offentlig prosjektsammendrag

SERO throughout nearly 60 years of its activity in the in vitro diagnostic market has developed and produced quality control materials that are used to control diagnostic instruments in clinical laboratories in more than 60 countries worldwide. For the quality control material to be able to perform this function, it needs to respond to measuring procedure in a similar manner as a patient sample does. Commutability is a term used to describe a parameter of quality control material that provides an information on how similar the material behaves to the patient sample for given measurement procedure. SERO's goal is to provide customers with control materials that are commutable and are responding to measurement procedures in a similar manner as patient samples, and SERO accomplishes it by using approximately 90 % genuine human serum with no stabilizers or preservatives added and carefully selected raw materials. The assessment of commutability is a complex and costly process, and its application is not widely spread in the field. Through this project, SERO intends to assess commutability of selected analytes and/ or key performance indicators in selected products. To achieve this goal SERO will develop new processes that, following verification, could be readily applied to other analytes and products in SERO's product portfolio.