Bias Assessment of General Chemistry Analytes using Commutable Samples.

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Science

Background:

• Harmonizing reference intervals for clinical chemistry analytes is a long-standing goal.
• Analytical bias between methods can hinder the establishment of consistent reference intervals.
• Matrix effects can complicate the comparison of different analytical methods.

Purpose of the Study:

• To evaluate the presence of analytical bias in general chemistry analytes.
• To assess the utility of commutable samples for identifying analytical bias.
• To explore the potential for harmonizing country-specific reference intervals internationally.

Main Methods:

• Utilized commutable samples, which mimic clinical samples, to eliminate matrix effects.
• Compared analytical methods to identify between-method biases.
• Analyzed 27 general chemistry analytes in a pilot study.

Main Results:

• Commutable samples have successfully identified unacceptable analytical performance in some regions.
• A pilot study by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is underway.
• In Australia and New Zealand, 19 out of 27 analytes showed minimal bias, not preventing reference interval harmonization.

Conclusions:

• Determining analytical bias using commutable material is essential for harmonizing reference intervals.
• Commutable samples are a valuable tool for ensuring the comparability of laboratory results across different countries.
• Evidence-based approaches are crucial for achieving globally harmonized clinical chemistry reference intervals.