MSACL 2016 EU Abstract

Accuracy Evaluation of High- and Low-density Lipoprotein Cholesterol Assays in Clinical Laboratories by Comparison with Isotope Dilution Mass Spectrometry

Hanah Kim (Presenter)
Department of Laboratory Medicine, Konkuk Univers

Authorship: Hanah Kim (1), Yeo-Min Yun (1), Junghan Song (2), Chan Ik Cho (3), Kyeong-seob Lee (3)
1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea 2Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, South Korea 3Division of Chronic Disease Control, Korea Centers for Disease Control and Prevention, Cheongju, Chungch

Short Abstract

We evaluated the performance of five HDL/LDL cholesterol assays currently used at 12 clinical laboratories in Korea to assess the traceability of current HDL/LDL cholesterol in vitro diagnostic products to commutable frozen serum (CFS) reference materials (Toshiba-Kyowa [n = 2], Hitachi-Sekisui [n = 3], Siemens ADVIA [n = 2], Roche Cobas or Modular [n = 2], and Beckman Coulter AU series [n = 3]). The HDL-C assays tended to be higher than GC-IDMS measurements, and the degree of bias was not acceptable by National Cholesterol Education Program criteria. Whereas, LDL-C assays did not show any tendency to GS-IDMS measurements, but the degree of bias was acceptable except the Beckman Coulter assays by National Cholesterol Education Program criteria.

Long Abstract

Background: Accurate and precise measurement of blood cholesterol, including high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C), is essential for generating the correct burden and trends of dyslipidemia. We evaluated the performance of five HDL/LDL cholesterol assays currently used at clinical laboratory in Korea to assess the traceability of current HDL/LDL cholesterol in vitro diagnostic products to commutable frozen serum (CFS) reference materials.

Methods: The HDL-C/LDL-C assays were categorized as five groups according to the combination of instrument and reagent. There were two open and three closed systems as follows: Toshiba-Kyowa (n = 2), Hitachi-Sekisui (n = 3), Siemens ADVIA (n = 2), Roche Cobas or Modular (n = 2), and Beckman Coulter AU series (n = 3). Five levels of CFS pools were prepared according to CLSI 37-A, and sent to 12 laboratories at frozen state with quadruplicate measurements. Target reference values were measured at National Medical Reference Laboratory of Korea Centers for Disease Control and Prevention in CDC reference method (β-quantification) using a gas chromatography–isotope dilution mass spectrometry (GC-IDMS) procedure.

Results: The target values of five materials were 43.0 – 50.8 mg/dL for HDL-C and 103.8 – 136.6 mg/dL for LDL-C. The HDL-C assays tended to be higher than GC-IDMS measurements (mean absolute bias: 1.9 – 7.2 mg/dL; mean relative bias: 5.6 – 14.2%), and the degree of bias was not acceptable by National Cholesterol Education Program criteria (< 5%). Whereas, LDL-C assays did not show any tendency to GS-IDMS measurements (mean absolute bias: -2.4 – 11.6 mg/dL; mean relative bias: -7.1 – 9.7%), but the degree of bias was acceptable except the Beckman Coulter assays by National Cholesterol Education Program criteria.

Conclusions: Even routine assays have advanced considerably over recent years, manufacturers" still have to strive for accurate HDL-C and LDL-C measurements for patients with standardization and calibration verification.


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