Quantitative Evaluation of the Real-World Harmonization Status of Laboratory Test Items Using External Quality Assessment Data

  • 0Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.

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Summary

This summary is machine-generated.

A new Real-World Harmonization Index (RWHI) quantifies laboratory test harmonization using external quality assessment data. This index reveals varying harmonization levels across common clinical tests, aiding big data applications.

Area Of Science

  • Clinical Chemistry
  • Laboratory Medicine
  • Biostatistics

Background

  • Analytical quality of clinical laboratory results has improved significantly.
  • Utilizing big data and machine learning requires understanding test harmonization.
  • A quantitative index is needed to assess real-world laboratory test harmonization.

Purpose Of The Study

  • To develop a quantitative harmonization index for real-world laboratory tests.
  • To assess the harmonization status of common clinical laboratory tests.

Main Methods

  • Collected 2021-2022 external quality assessment (EQA) data for eight common tests.
  • Calculated total analytical error based on bias% and CV% within peer groups.
  • Developed the Real-World Harmonization Index (RWHI) by dividing analytical error by allowable error derived from biological variation at minimum, desirable, and optimal levels.

Main Results

  • Total cholesterol, triglyceride, and CEA demonstrated optimal harmonization (RWHI ≤ 1).
  • HDL-cholesterol, AFP, and PSA showed desirable harmonization.
  • Creatinine achieved minimum harmonization, while HbA1c did not meet the minimum harmonization level.

Conclusions

  • A quantitative RWHI was successfully developed using regional EQA data.
  • The RWHI provides a metric to reflect the actual harmonization level of laboratory tests in clinical practice.

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