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Related Experiment Video

Updated: Apr 30, 2026

Cell-free Biochemical Fluorometric Enzymatic Assay for High-throughput Measurement of Lipid Peroxidation in High Density Lipoprotein
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Can Reference Materials Prepared Following CLSI C37-A Be Utilized Without Commutability Assessment? Perspectives

Jong Do Seo1, Gye Cheol Kwon2, Jeong-Ho Kim3

  • 1Department of Laboratory Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.

Annals of Laboratory Medicine
|September 3, 2025
PubMed
Summary

Reference materials (RMs) prepared using CLSI C37-A guidelines are generally commutable for total cholesterol and triglycerides. However, elevated triglyceride levels in RMs can impact the commutability of HDL-C and LDL-C measurements.

Keywords:
CholesterolCommutabilityExternal quality assessment materialLipidsReference materialTriglycerides

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Reference Materials

Background:

  • Commutability of reference materials (RMs) is vital for measurement traceability and standardizing laboratory tests.
  • Assessment of RM commutability is not consistently performed.
  • This study evaluated RM commutability for lipid measurements using established protocols.

Purpose of the Study:

  • To assess if RMs prepared according to CLSI C37-A guidelines can be used without explicit commutability assessment.
  • To evaluate the commutability of RMs for four key lipid measurements.
  • To investigate the impact of triglyceride concentration on RM commutability.

Main Methods:

  • Analyzed total cholesterol (TC), triglycerides (TGs), HDL-C, and LDL-C in 11 RMs and 20 individual sera.
  • Utilized six routine measurement procedures (MPs) and CLSI EP14 protocols.
  • Employed the IFCC protocol to assess inter-MP biases and the effect of TG concentration on commutability.

Main Results:

  • RMs demonstrated commutability for most MP pairs for TC and TG.
  • Commutability for HDL-C and LDL-C varied among RMs, with higher TG levels (RM10, RM11) showing reduced commutability.
  • Increased bias percentages were observed in RMs with higher TG concentrations.

Conclusions:

  • RMs prepared per CLSI C37-A guidelines exhibit good commutability for TC and TG.
  • Elevated TG levels in RMs negatively affect HDL-C and LDL-C commutability.
  • Consideration of TG concentrations and commutability assessment are crucial for RM standardization.