Ann Lab Med.  2021 Jul;41(4):366-371. 10.3343/alm.2021.41.4.366.

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

Affiliations
  • 1Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
  • 2Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
  • 3Department of Laboratory Medicine Inje University, Ilsan Paik Hospital, Goyang, Korea
  • 4Department of Laboratory Medicine, Seoul National University Bundang Hospital and College of Medicine, Seongnam, Korea
  • 5Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 6Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea

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.

Keyword

Inaccuracy; Total cholesterol; External quality assessment; Standardization
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