常规生化检验项目生物学变异的研究  

Biological variation in 32 clinical laboratory routine tests

作　　者：陈政君[1] 张晨[1] 宋斌斌[1] 吴炯[1] 王蓓丽[1] 张春燕 郭玮[1] 潘柏申[1] 

机构地区：[1]复旦大学附属中山医院检验科,上海200032

出　　处：《中华检验医学杂志》2012年第10期926-931,共6页Chinese Journal of Laboratory Medicine

基　　金：国家临床重点检验专科建设项目资助项目;国家科技支撑计划资助项目（2012BA137B01）

摘　　要：目的通过研究中国人32项常规检验项目的生物学变异数据，计算检验质量目标，为制定我国临床检验质量标准提供依据。方法参考国外同行的生物学变异实验设计和计算方法，通过对22名上海中山医院检验科工作人员（男12名，女10名，年龄20～40岁，中位年龄30岁）短期（1d内5个时间点为采血时间：8：00、10：00、12：00、14：00和16：00）、长期（连续6周，每周早晨8：00为采血时间）以及对照血清（体检健康人的新鲜混合血清）的检测，计算生物学变异数据、个体指数（Ⅱ）及质量目标。结果（1）得到了32项常规检验项目的短期和长期生物学变异数据以及以长期生物学变异数据为基础的Ⅱ和质量目标。（2）发现饮食对部分检验项目的生物学变异有一定影响，其中最明显的是游离脂肪酸，餐后相对餐前的检测值平均偏低约30％。其次是超敏C反应蛋白，餐后相对餐前的检测值平均偏低约20％。但三酰甘油，餐后相对餐前的检测值平均偏高约10％。（3）得出的质量目标允许总误差适宜值与欧洲生物学允许总误差适宜值和美国临床实验室改进修正案室问质量评估指标之间存在一定差异。结论（1）本研究中载脂蛋白E和游离脂肪酸的实验结果弥补了欧洲生物学变异数据库的不足。（2）32项常规检验项目中仅少部分受到饮食因素的影响。（3）以中国人生物学变异数据为基础设立的分析质量目标和欧洲生物学质量目标基本一致，但也有少部分项目存在差异。（4）使用生物学变异数据设立分析质量目标比使用CLIA室间评估指标更实际有效。Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards. Methods According to the experimental designs and computing methods from foreign counterparts, the results of biological variation, individual indexes and quality goals were calculated through the serum detection of 22 subjects from clinical laboratory of Zhongshan Hospital in Shanghai （ male 12, female 10, ages varying from 20 to 40 years old, median age 30 ） in short-term （ five blood draws within one day at 8： 00, 10： 00,12： 00, 14：00 and 16： 00） and long-term （ one blood draw at 8：O0 in 6 weeks consecutively） and serum controls （ mixed from healthy people）. Results （ 1 ） Based on the results of short- term and long-term biological variation in 32 routine items, the individual indexes and quality goals were obtained. （2）The influence of diet on the biological variation of part of the test items could be observed, especially free fatty acid （ the mean value of post-meal was less than pre-meal about 30% ）, and then followed by high-sensitivity C-reactive protein （ the mean value of post-meal was lower than pre-meal about 20% ） and triglyceride （ the mean value of post-meal was higher than pre-meal about 10% ）. （ 3 ） There were some differences between the quality goals we accessed and the the indicators from Europe and CLIA. Conclusions （1）The results of apolipoprotein E and free fatty acid in this study made up for the inadequate of the European biology database. （2）Only a small part of the 32 routine items were affected by dietary factors. （ 3 ） Most quality goals obtained from this study generally consisted with Europe biology quality goals,but a few items existed different. （4）It＇s more practical and effective to use the results of biological variation than CLIA standards for setting up quality goals.

关 键 词：临床化学试验 诊断试验 常规 质量控制 

分 类 号：R446.1[医药卫生—诊断学]