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pISSN 2950-9114 eISSN 2950-9122
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Original Article

J Lab Med Qual Assur 2014; 36(2): 84-91

Published online June 30, 2014


Copyright © Korean Association of External Quality Assessment Service.

Evaluation of the Analytical Performance of a Direct Quantitative Assay of Small Dense LDL

Mi-Na Lee1,2, Jong- Ryol Kim1, Hee Jae Huh1,2, Soo-Youn Lee1,2, Eun-Suk Kang1,2, and Hyung-Doo Park1,2

1Department of Laboratory Medicine and Genetics, Samsung Medical Center; 2Department of Laboratory Medicine and Genetics, Sungkyunkwan University School of Medicine, Seoul, Korea

Correspondence to:Hyung-Doo Park
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea
Tel: +82-2-3410-0290
Fax: +82-2-3410-2719
E-mail: nayadoo@hanmail.net

Received: February 3, 2014; Revised: April 16, 2014; Accepted: May 7, 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: Small dense low density lipoprotein (sdLDL) plays a critical role in the progression of coronary vascular disease. However, regardless of the accuracy of the analytical technique, routine measurement of LDL does not precisely ascertain LDL particle size. Therefore, we evaluated the performance of a direct quantitative assay of sdLDL that combines a precipitation method with filtration (Denka Seiken, Japan). Methods: We evaluated the precision, linearity, carry-over, and sample stability of a sdLDL reagent. A reference interval was established, and method comparison was performed with the Lipoprint LDL system using polyacrylamide gel tube electrophoresis (Quantimetrix, USA). Results: The within-run precision was 0.9% to 1.4%, with a total precision of 3.2% to 3.5%. The analytical measurement ranged from 4.1 to 101.3 mg/dL. The calculated carry-over was negligible (0.1%). Based on a comparison conducted using the Lipoprint LDL system, the median sdLDL concentration of 57 individuals with phenotype non-A was found to be significantly higher than that of 51 subjects with phenotype A (43 vs. 22 mg/dL, P<0.0001). The levels in samples retested after storage showed more than 95% recovery when stored in a refrigerator (5°C) for 2 weeks and at -20°C or lower for 4 weeks. The reference interval of sdLDL was between 7.6 and 52.0 mg/dL. Conclusions: This method of sdLDL measurement showed good performance and can be easily applied to automated analysers in clinical laboratories. (J Lab Med Qual Assur 2014;36:84-91)

Keywords: Small dense low density lipoprotein, Coronary disease, Reference values

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