检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2014年
2期
143-147
,共5页
游离脂肪酸%精密度%正确度%方法学评价%生物学变异%个体内生物学变异
遊離脂肪痠%精密度%正確度%方法學評價%生物學變異%箇體內生物學變異
유리지방산%정밀도%정학도%방법학평개%생물학변이%개체내생물학변이
Free fatty acid%Precision%Trueness%Methodology evaluation%Biological variation%Within-subject biological variation
目的：评价血清游离脂肪酸（FFA）酶学比色法（简称酶法）的精密度和正确度，并且研究血清FFA个体间和个体内生物学变异。方法采用美国临床和实验室标准化协会（CLSI）EP5-A2和EP15-A文件评价酶法测定血清FFA的精密度和正确度。生物学变异的研究对象为13名健康志愿者，在6周时间内每2周测定1次血清FFA浓度，利用SAS9．1软件中MIXED分析过程计算个体间生物学变异和个体内生物学变异。结果精密度实验样品的血清 FFA 浓度总均数为0．796 mmol/L，批内、批间、日间和室内不精密度分别为2．15％、3．44％、3．67％和5．46％。测定3个室间质评样品的百分比偏差分别为24．20％、-0．90％、-1．50％。血清FFA个体间和个体内生物学变异分别为8．43％、19．36％。结论酶法测定血清FFA的精密度和正确度能满足相关实验室质量控制要求。血清FFA的个体间和个体内生物学变异可为制定实验室质量规范和临床课题的科研设计提供参考依据。
目的：評價血清遊離脂肪痠（FFA）酶學比色法（簡稱酶法）的精密度和正確度，併且研究血清FFA箇體間和箇體內生物學變異。方法採用美國臨床和實驗室標準化協會（CLSI）EP5-A2和EP15-A文件評價酶法測定血清FFA的精密度和正確度。生物學變異的研究對象為13名健康誌願者，在6週時間內每2週測定1次血清FFA濃度，利用SAS9．1軟件中MIXED分析過程計算箇體間生物學變異和箇體內生物學變異。結果精密度實驗樣品的血清 FFA 濃度總均數為0．796 mmol/L，批內、批間、日間和室內不精密度分彆為2．15％、3．44％、3．67％和5．46％。測定3箇室間質評樣品的百分比偏差分彆為24．20％、-0．90％、-1．50％。血清FFA箇體間和箇體內生物學變異分彆為8．43％、19．36％。結論酶法測定血清FFA的精密度和正確度能滿足相關實驗室質量控製要求。血清FFA的箇體間和箇體內生物學變異可為製定實驗室質量規範和臨床課題的科研設計提供參攷依據。
목적：평개혈청유리지방산（FFA）매학비색법（간칭매법）적정밀도화정학도，병차연구혈청FFA개체간화개체내생물학변이。방법채용미국림상화실험실표준화협회（CLSI）EP5-A2화EP15-A문건평개매법측정혈청FFA적정밀도화정학도。생물학변이적연구대상위13명건강지원자，재6주시간내매2주측정1차혈청FFA농도，이용SAS9．1연건중MIXED분석과정계산개체간생물학변이화개체내생물학변이。결과정밀도실험양품적혈청 FFA 농도총균수위0．796 mmol/L，비내、비간、일간화실내불정밀도분별위2．15％、3．44％、3．67％화5．46％。측정3개실간질평양품적백분비편차분별위24．20％、-0．90％、-1．50％。혈청FFA개체간화개체내생물학변이분별위8．43％、19．36％。결론매법측정혈청FFA적정밀도화정학도능만족상관실험실질량공제요구。혈청FFA적개체간화개체내생물학변이가위제정실험실질량규범화림상과제적과연설계제공삼고의거。
Objective To evaluate the precision and trueness of enzymatic colorimetric assay (enzymatic assay) for the determination of serum free fatty acid (FFA),and to study the between-subject and within-subject biological variations of serum FFA.Methods EP5-A2 and EP1 5-A were employed to evaluate the precision and trueness of serum FFA by enzymatic assay,which were published by the Clinical and Laboratory Standards Institute (CLSI).The serum samples from 1 3 healthy subjects for biological variation were collected and determined for FFA once every 2 weeks over a period of 6 weeks.The between-subject and within-subject biological variations were calculated by MIXED analysis of SAS9.1 software.Results The overall mean of serum FFA was 0.796 mmol/L,and imprecisions of within-batch, between-batch,inter-day and intra-laboratory were 2.1 5%,3.44%,3.67%and 5.46%,respectively.The deviations for the 3 external quality assessment control samples were 24.20%,-0.90%and -1 .50%.The between-subject and within-subject biological variations were 8.43%and 1 9.36%,respectively.Conclusions The precision and trueness of serum FFA by enzymatic assay could meet the requirements of relevant laboratory quality control.The between-subject and within-subject biological variations have important significations for establishing laboratory accreditation and providing clinical research design′s reference.
