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 protocol
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 protocol
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DOI：
10.5551/jat.5470
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发表时间：
2010-01-01
影响因子：
4.4
通讯作者：
Ishikawa, Yoshinori
中科院分区：
文献类型：
--
作者：
Nakamura, Masakazu;Koyama, Isao;Ishikawa, Yoshinori
目的：在日本以代谢综合征为重点的健康体检计划中，动脉粥样硬化性心血管疾病的危险指数从总胆固醇(TC)改为低密度脂蛋白胆固醇(LDL-C)。我们讨论了这一变化在标准化方面的有效性。方法：美国疾病控制和预防中心(CDC)的β-量化程序以低密度脂蛋白-C参考值为目标。临床实验室和商业制造商使用同质低密度脂蛋白方法进行标准化。(A)在临床实验室方面，对108家医院索取的648份样本中的低密度脂蛋白-C进行了分析。(B)制造商参加了疾控中心/胆固醇参考法实验室网络低密度脂蛋白-C标准化议定书。结果：(A)在临床实验室中，648名受试者中，456名受试者的低密度脂蛋白胆固醇水平在疾病预防控制中心标准的+/-4%范围内的可接受水平保持在70.4%。负最大偏差为-35.8%，-52.5 mg/dL，正最大偏差为+24.5%，+32.3 mg/dL。(B)对生产厂家而言，2002-2008年分析试剂/仪器/校准器系统在最近4次标准化中的标准化达标率平均为66.6%，远低于要求的水平。结论：均相低密度脂蛋白胆固醇方法的标准化达标率远低于TC。TC仍应作为动脉粥样硬化性心血管疾病的危险指标。均相低密度脂蛋白-C的标准化达标率应保持在100%，至少使用脂蛋白谱正常的样本。在实际应用和临床应用之前，应进一步提高低密度脂蛋白-C的准确性和特异性。
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 lower 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.