The role of EQA in the verification of in vitro medical diagnostics

Presenter: Federica Braga (IT)
Moderator: Anne Stavelin (NO)

Recorded on 17th April 2018

The participation to EQA schemes that meet specific metrological criteria is mandatory for the evaluation of performance of participating laboratories in terms of standardization and clinical suitability of their measurements. The requirements for this type of EQA are as follows: in addition to the use of commutable control materials, it is necessary to assign values (and uncertainty) to them with reference measurement procedures (RMP) performed by an accredited laboratory and to define and apply clinically allowable performance specifications to verify the suitability of laboratory measurements in a clinical setting. Unfortunately, there are few permanent EQA programs covering these requirements because some practical constraints including technical, psychological and economic aspects, which limit their introduction. It is, however, clear that these aspects should be immediately solved. Indeed, EQA schemes are in a unique position to add substantial value to the practice of Laboratory Medicine, by identifying analytes that need improved harmonization and by stimulating and sustaining standardization initiatives that are needed to support clinical practice guidelines. This will definitively help those manufacturers that produce superior products to demonstrate the superiority of those products and oblige users (and consequently industry) to abandon assays with demonstrated insufficient quality.