CAJ | 학술논문

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(1 d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)及质最目标.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间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.
목적 통과연구중국인32항상규검험항목적생물학변이수거,계산검험질량목표,위제정아국림상검험질량표준제공의거.방법 삼고국외동행적생물학변이실험설계화계산방법,통과대22명상해중산의원검험과공작인원(남12명,녀10명,년령20～40세,중위년령30세)단기(1 d내5개시간점위채혈시간:8:00、10:00、12:00、14:00화16:00)、장기(련속6주,매주조신8:00위채혈시간)이급대조혈청(체검건강인적신선혼합혈청)적검측,계산생물학변이수거、개체지수(Ⅱ)급질최목표.결과 (1)득도료 32항상규검험항목적단기화장기생물학변이수거이급이장기생물학변이수거위기출적Ⅱ화질량목표.(2)발현음식대부분검험항목적생물학변이유일정영향,기중최명현적시유리지방산,찬후상대찬전적검측치평균편저약30％.기차시초민C반응단백,찬후상대찬전적검측치평균편저약20％.단삼선감유,찬후상대찬전적검측치평균편고약10％.(3)득출적질량목표윤허총오차괄의치여구주생물학윤허총오차괄의치화미국림상실험실개진수정안실간질량평고지표지간존재일정차이.결론 (1)본연구중재지단백E화유리지방산적실험결과미보료구주생물학변이수거고적불족.(2)32항상규검험항목중부소부분수도음식인소적영향.(3)이중국인생물학변이수거위기출설립적분석질량목표화구주생물학질량목표기본일치,단야유소부분항목존재차이.(4)사용생물학변이수거설립분석질량목표비사용CLIA실간평고지표경실제유효.
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 8:00 in 6 weeks consecutively) and serum controls (mixed from healthy people).Results (1) Based on the results of shortterm and long-term biological variation in 32 routine itens,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 variatiou than CLIA standards for setting up quality goals.