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Standardization Status of Total Cholesterol Concentration Measurement: Analysis of Korean External Quality Assessment Data

Annals of Laboratory Medicine 2021년 41권 4호 p.366 ~ 371
윤영안, 이용화, 김솔잎, 이경훈, 박형두, 전사일, 민원기,
소속 상세정보
윤영안 ( Yoon Young-Ahn ) - Soonchunhyang University College of Medicine Soonchunhyang University Cheonan Hospital Department of Laboratory Medicine
이용화 ( Lee Yong-Wha ) - Soonchunhyang University College of Medicine Soonchunhyang University Bucheon Hospital Department of Laboratory Medicine and Genetics
김솔잎 ( Kim Sol-Lip ) - Inje University Ilsan Paik Hospital Department of Laboratory Medicine
이경훈 ( Lee Kyung-Hoon ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Laboratory Medicine
박형두 ( Park Hyung-Doo ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Laboratory Medicine and Genetics
전사일 ( Chun Sa-Il ) - University of Ulsan College of Medicine Asan Medical Center Department of Laboratory Medicine
민원기 ( Min Won-Ki ) - University of Ulsan College of Medicine Asan Medical Center Department of Laboratory Medicine

Abstract


Background: Total cholesterol concentration measurement is important in the diagnosis of dyslipidemia and evaluation of cardiovascular disease risk factors. Measurement reliability for obtaining an accurate total cholesterol concentration requires procedure standardization. We evaluated the standardization status for total cholesterol concentration measurement through Korean external quality assessment (EQA) data analysis.

Methods: This study involved 1,670 laboratories that participated in the EQA of total cholesterol concentration measurements in 2019 for 32 products from different manufacturers. The target concentrations of three quality control (QC) materials (samples A, B, and C) were measured using the reference method and compared with EQA data. The performance criteria for total cholesterol concentration measurement were based on the National Cholesterol Education Program guidelines, with ±3% inaccuracy.

Results: The target values and inaccuracies of the QC material based on the reference method measurements were 254.65±7.64, 108.30±3.25, and 256.29±7.69 mg/dL (6.59±0.20, 2.80±0.08, and 6.63±0.20 mmol/L) for samples A, B, and C, respectively. The performance criteria were not met in 42.7% laboratories for sample A, 68.4% of laboratories for sample B, and 38.0% laboratories for sample C.

Conclusions: Despite significant efforts to accurately measure total cholesterol concentrations, further actions are needed for measurement standardization. Manufacturers reporting values that differ from target values should check calibrator traceability; additional efforts to accurately measure total cholesterol concentrations are required for laboratories that use products from these manufacturers.

키워드

Inaccuracy; Total cholesterol; External quality assessment; Standardization

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