Modern tools for improving comparability and stability of in vitro diagnostic tests

Quality assurance in the clinical laboratory is essential to guarantee appropriate interpretation of clinical tests. In that regard, internal quality control and external quality assessment have earned a well-established position. However, these tools don't necessarily reflect the reality of patient testing due to commutability issues. We have, therefore, proven that the Empower project is a valid tool to circumvent that problem. When this project is integrated in the quality control environment, it can establish a bottom-up approach to quality assessment which facilitates collaboration between laboratories and in vitro diagnostic manufacturers. It has the potential to create reliable evidence about the intrinsic quality of assays and how this quality is sustained under field conditions. The Percentiler and Flagger are efficient tools for monitoring of the mid- to long-term stability of assays, instruments, calibrators, and reagents. In addition, they create evidence about the reasons for the observed variation (lab or manufacturer performance), and translate the effect of analytical instability on the flagging rate. Although some issues, such as population variation and stratification differences, must still be taken into account, clinical laboratories can use these tools to directly relate analytical instabilities to their effect on the patient medians and on the hypo-and hyper-flagging rates. Therefore, these tools can be applied as a stimulus for both laboratories and manufacturers to work towards improved assay stability. The Master Comparison surveys, which focus on the current standardization and comparability status of commonly used commercial assays, showed that even for "simple" clinical chemistry measurands such as enzymes and electrolytes, the standardization and harmonization status of certain assays is still a matter of concern and there is much room for improvement.

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