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Ten-year evaluation of homogeneous low-density lipoprotein cholesterol methods developed by Japanese manufacturers. Application of the Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network lipid standardization protoco

Abstract：

AIM:The risk index for atherosclerotic cardiovascular diseases in the Japanese metabolic syndrome-focused health checkup program was changed from total cholesterol (TC) to low-density lipoprotein cholesterol (LDL-C). We discuss the validity of this change with respect to standardization. METHODS:The beta-quantification procedure of the Centers for Disease Control and Prevention (CDC) uses the LDL-C reference value as a target. Clinical laboratories and commercial manufacturers use homogeneous LDL-C methods for standardization. (A) For clinical laboratories, LDL-C in 648 samples requested from 108 hospitals was analyzed. (B) Manufacturers participated in the CDC/Cholesterol Reference Method Laboratory Network LDL-C standardization protocol. The standardization was conducted with a performance follow-up for the 10-year period from 1998 to 2008 at 2-year intervals, 6 times. RESULTS:(A) In clinical laboratories, acceptable LDL-C levels within ±4% of the CDC's criteria remained 70.4%, 456 of 648 subjects. Negative maximum bias deviating from the LDL-C target value was -35.8%, -52.5 mg/dL, and positive maximum bias was +24.5%, +32.3 mg/dL. (B) For manufacturers, the standardization achievement rate of the analytical reagent/instrument/calibrator system in the last four standardizations from 2002 to 2008 remained on average 66.6%, far lower than the level required. CONCLUSIONS:The standardization achievement rate of homogeneous LDL-C methods was much low-er than that of TC. TC should still be used as a risk index for atherosclerotic cardiovascular diseases. The standardization achievement rate of homogeneous LDL-C should be maintained at 100%, at least using samples with normal lipoprotein profiles. The accuracy and specificity of LDL-C should be further improved before practical and clinical use.

journal_name

J Atheroscler Thromb

journal_title

Journal of atherosclerosis and thrombosis

authors

Nakamura M,Koyama I,Iso H,Sato S,Okazaki M,Kayamori Y,Kiyama M,Kitamura A,Shimamoto T,Ishikawa Y

doi

10.5551/jat.5470

subject

Has Abstract

pub_date

2010-12-26 00:00:00

pages

1275-81

issue

eissn

1340-3478

issn

1880-3873

pii

JST.JSTAGE/jat/5470

journal_volume

pub_type

杂志文章

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Ten-year evaluation of homogeneous low-density lipoprotein cholesterol methods developed by Japanese manufacturers. Application of the Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network lipid standardization protoco