检验医学 ›› 2014, Vol. 29 ›› Issue (9): 961-963.DOI: 10.3969/j.issn.1673-8640.2014.09.020

• 技术研究与评价·论著 • 上一篇    下一篇

SYSMEX CA1500和SYSMEX CA7000凝血检测系统的比对分析

史梅,沈宇骅,史伟峰   

  1. 常州市第一人民医院检验科,江苏 常州 213003
  • 收稿日期:2013-08-26 出版日期:2014-09-30 发布日期:2014-09-25
  • 作者简介:史 梅,女,1976年生,硕士,副主任技师,主要从事临床免疫检验工作

Comparison analysis on the results of SYSMEX CA1500 and SYSMEX CA7000 coagulation analyzers

SHI Mei, SHEN Yuhua, SHI Weifeng   

  1. Department of Clinical Laboratory, the First People's Hospital of Changzhou, Jiangsu Changzhou 213003, China
  • Received:2013-08-26 Online:2014-09-30 Published:2014-09-25

摘要: 目的 研究SYSMEX CA1500全自动血凝分析仪(简称CA1500)和SYSMEX CA7000全自动血凝分析仪(简称CA7000)的检测结果是否具有可比性。方法 以CA7000为比较方法(X),CA1500为实验方法(Y),分别检测60例不同浓度范围的患者新鲜血浆活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)、纤维蛋白原(FIB)项目,并对结果进行配对t检验和相关回归统计学分析,以医学决定水平处的系统误差来判断检测系统间的结果是否为临床可接受性。结果 CA1500的PT和FIB测定结果与CA7000比较,差异无统计学意义(P>0.05),APTT测定结果差异有统计学意义(P<0.05)。相关和回归分析表明2种检测系统间的结果相关性和一致性较好,在医学决定水平处的系统误差低于美国临床实验室修正法规(CLIA'88)规定的室间质量评价允许误差范围的1/2。结论 对同一实验室不同凝血分析仪应该定期进行比对实验,以保证检验结果间的可比性。

关键词: 凝血酶原时间, 活化部分凝血活酶时间, 纤维蛋白原, 比对实验, 凝血分析仪

Abstract: Objective To study the comparability of the results between SYSMEX automatic coagulation analyzer CA1500 (CA1500) and SYSMEX automatic coagulation analyzer CA7000(CA7000) coagulation analyzers. Methods Activated partial thromboplastin time (APTT), prothrombin time (PT) and fibrinogen(FIB) were detected by CA7000 (comparison method, X) and CA1500 (experimental method, Y) in 60 serum samples. The results were analyzed by t test and regression analysis. Clinical acceptability was evaluated by systematic error at medical determining level. Results There was no statistical significance between the results of PT and FIB by CA1500 and CA7000(P>0.05), and there was statistical significance between the results of APTT by CA7000 and CA1500(P<0.05). The results of APTT, PT and FIB by CA1500 were consistent with those by CA7000 according to the results of regression analysis. The systematic errors were within the 1/2 allowable error of the Clinical Laboratory Improvement Amendment 88 (CLIA'88). Conclusions The different coagulation analyzers in the same laboratory should be conducted periodically comparative experiments to ensure the comparability between test results.

Key words: Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Comparison test, Coagulation analyzer

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