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Commutability evaluation of glycated albumin candidate EQA materials
Rui Wu1,2, Huijuan Zhou3, Xiaerbanu Nizhamnuding1,2
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
Clinical Chemistry and Laboratory Medicine
|May 29, 2025
Summary
Glycated albumin (GA) measurement consistency is a challenge. Pooled serum sample cRM2 demonstrated commutability across most enzymatic kits, making it a potential candidate for external quality assessment (EQA) programs.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biomarker Analysis
Background:
- Glycated albumin (GA) is a crucial biomarker for monitoring diabetes blood glucose control.
- Ensuring consistency of GA results across different laboratory detection systems is a significant challenge.
Purpose of the Study:
- To evaluate the commutability of 10 samples for identifying suitable external quality assessment (EQA) materials for glycated albumin (GA) measurement.
- To compare the commutability assessment using Clinical and Laboratory Standards Institute (CLSI) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approaches.
Main Methods:
- Utilized isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) as the reference method.
- Evaluated six commercial enzymatic kits for GA determination.
- Assessed commutability of clinical samples, pregnancy samples, and evaluated samples according to CLSI EP14-A3 and IFCC protocols.
Main Results:
- Using the CLSI approach, pooled serum samples (cRM1-3), particularly cRM2 at medium concentration, showed commutability in 5 out of 6 evaluated kits.
- The IFCC approach did not identify any commutable samples among the evaluated set.
Conclusions:
- The CLSI and IFCC evaluation approaches yielded different results regarding sample commutability.
- The pooled serum sample cRM2 exhibits commutability in the majority of enzymatic GA kits, positioning it as a viable candidate for EQA schemes.
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