There is agreement among clinicians that laboratory analyses are indispensable for correct diagnosis of disease, therapy, and patient monitoring. It is evident that laboratory data should be comparable and independent of measurement system, time, and location, but this is often not the case. The concept of standardization or establishment of metrological traceability has been developed to solve these challenges. Understanding the benefits of traceability of lab results in public healthcare is of increasing importance, and enables the interpretation of results against common reference intervals, development of evidence-based clinical guidelines, translation of research data into patient care and prevention activities, and the inclusion of lab data in electronic patient records. This presentation explains the standardization concept in detail, considering both defined analytes (e.g., creatinine, cholesterol, glucose) and analytes that are not unequivocally defined. One example will focus on serum TSH measurement, a typical heterogeneous glycoprotein. Potential non-commutability encountered with artificial reference materials in the standardization/harmonization process will be discussed, as will the use of large panels of clinically relevant samples to ensure commutability. Implementation in practice may be the biggest challenge, particularly in cases where the standardization process has a major impact on the values the clinical lab community is familiar with. Hence, education of all stakeholders is critical. In addition, the need for continual assessment will be demonstrated by examples.
1) Identify rationale and benefit for standardization in lab medicine
2) Describe basic design and evolution of standardization process
3) Learn the importance of using panels of clinically relevant samples in standardization process
4) Identify requirements to be met before standardization can be implemented
5) Understand what is required after standardization