检验医学 ›› 2017, Vol. 32 ›› Issue (7): 566-569.DOI: 10.3969/j.issn.1673-8640.2017.07.003

• 脂蛋白(a)检测方法进展专题 • 上一篇    下一篇

不同检测系统脂蛋白(a)测定结果一致性比较

唐文佳, 吴炯, 王蓓丽, 郭玮, 潘柏申   

  1. 复旦大学医学院附属中山医院检验科,上海 200032
  • 收稿日期:2017-01-05 出版日期:2017-08-08 发布日期:2017-08-09
  • 作者简介:null

    作者简介:唐文佳,女,1986年生,学士,主管技师,主要从事临床生化检验工作。

  • 基金资助:
    基金项目:国家自然科学基金面上项目(81572064);上海市卫生计生系统重要薄弱学科建设项目(2015ZB0201);上海市卫生系统先进适宜推广技术项目(2013SY065);上海申康医院发展中心课题(SHDC22014017)

Consistency of different systems for determining lipoprotein(a)

TANG Wenjia, WU Jiong, WANG Beili, GUO Wei, PAN Baishen   

  1. Department of Clinical Laboratory,Zhongshan Hospital,Fudan University,Shanghai 200032,China
  • Received:2017-01-05 Online:2017-08-08 Published:2017-08-09

摘要:

目的 探讨不同脂蛋白(a)[Lp(a)]检测试剂测定结果之间的一致性情况,研究校准品是否能改善检测结果的一致性。方法 选用6种临床常用的Lp(a)试剂(罗氏、九强、德赛、云大、美康及迈克),分别与日立7600全自动生化分析仪组成6种检测系统,同时检测51例患者样本。以罗氏检测系统作为标准检测系统,以罗氏配套校准品对其他5种检测系统进行校准后重复检测上述样本。比较校准前、后同一样本不同检测系统之间测定结果的差异。结果 不同检测系统之间Lp(a)测定结果有明显差异[变异系数(CV)的均值为29.8%、中位数为28.9%],用同一校准品校准后差异减小(CV的均值为17.6%、中位数为13.3%)。校准后各检测系统与标准检测系统回归方程中的截距明显缩小,但结果无法通过系数互通。校准后各检测系统与标准检测系统的差异明显缩小,两检测系统之间偏差< ±30%和< ±15%的比例明显增加。结论 不同检测系统之间Lp(a)的测定结果存在较为明显的差异,统一校准品可以在一定程度上改善结果的差异,但无法完全消除差异。

关键词: 脂蛋白(a), 检测系统, 一致性

Abstract:

Objective To evaluate the consistency of different systems for determining lipoprotein(a) [Lp(a)],and to investigate whether calibrators can improve the consistency or not. Methods A total of 6 different kinds of Lp(a) reagents(Roche,BSBE,Diasys,Yunda,Medicalsystem and Maccura)were chosen,and they were combined with Hitachi 7600 automatic analyzer separately to set up different systems. A total of 51 samples were collected,and each sample was determined by 6 different systems. Roche system was as a reference system,and the samples were retested by the other 5 systems after being calibrated by Roche system. The results of same sample that was determined by different systems before and after calibration were compared. Results There was difference for the determination of Lp(a) among different systems [the mean of coefficient of variation (CV) was 29.8%,and the median of CV was 28.9%]. However,the difference could be decreased after calibration (the mean of CV was 17.6%,and the median of CV was 13.3%]. The intercept of regression equation of each system to the reference system reduced after calibration. The results still can not be exchanged by conversion factor. The difference between the results from Roche system and the other systems was decreased after calibration. Compared with the reference system,the proportions of bias < ±30% and < ±15% were increased. Conclusions The results from different systems have difference. When calibrating systems by using the same calibrator,the difference of results can be decreased,but it still can not be completely eliminated.

Key words: Lipoprotein(a), Determination system, Consistency

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