CAJ | 학술논문

目的根据美国临床实验室标准化委员会(NCCLS)EP9-A2文件,对日立7600-020湿化学分析系统(以下简称7600-020系统)和美国强生Vitros-950干化学分析系统(以下简称Vitros-950系统)进行方法学比对、相关性分析和预期偏倚评估,为向临床解答2种生化分析系统测定结果差异的可接受性提供实验依据.方法按照NCCLS EP9-A2文件的要求,以7600-020系统为比较方法,以Vitros-950系统为实验方法,对患者样本的尿素(Urea)、丙氨酸氨基转移酶(ALT)、肌酸激酶(CK)和血糖(Glu)4个较常用的项目进行方法学比对、相关性分析和预期偏倚评估,并判断偏倚是否可以接受.结果 Urea、ALT、Glu和CK比对结果的相关系数(r)均高于EP9-A2文件规定的要求(r≥0.975),有较好的相关性;除Urea测定在医学决定水平2.5和6.4 mmol/L处偏倚不可接受外,其余项测定结果预期偏倚均未超出要求范围.结论在做好质控的基础上,7600-020系统和Vitros-950系统对ALT、Glu、CK和高浓度的Urea的检测能得到一致的结果,两者无明显差异.
목적 근거미국림상실험실표준화위원회(NCCLS)EP9-A2문건,대일립7600-020습화학분석계통(이하간칭7600-020계통)화미국강생Vitros-950간화학분석계통(이하간칭Vitros-950계통)진행방법학비대、상관성분석화예기편의평고,위향림상해답2충생화분석계통측정결과차이적가접수성제공실험의거.방법 안조NCCLS EP9-A2문건적요구,이7600-020계통위비교방법,이Vitros-950계통위실험방법,대환자양본적뇨소(Urea)、병안산안기전이매(ALT)、기산격매(CK)화혈당(Glu)4개교상용적항목진행방법학비대、상관성분석화예기편의평고,병판단편의시부가이접수.결과 Urea、ALT、Glu화CK비대결과적상관계수(r)균고우EP9-A2문건규정적요구(r≥0.975),유교호적상관성;제Urea측정재의학결정수평2.5화6.4 mmol/L처편의불가접수외,기여항 측정결과예기편의균미초출요구범위.결론 재주호질공적기출상,7600-020계통화Vitros-950계통대ALT、Glu、CK화고농도적Urea적검측능득도일치적결과,량자무명현차이.
Objective To evaluate the wet type analyzer (HITACHI 7600-020) and the dry type analyzer (Johnson & Johnson Vitros-950) on their methodology,correlation and anticipated bias,according to the Document EP9-A2 of the National Committee for Clinical Laboratory Standards (NCCLS) and prove that the result deviation between the two systems can be accepted in clinic. Methods According to the NCCLS EP9-A2,HITACHI 7600-020(as the comparison method) and Johnson & Johnson Vitros-950(as the laboratory method) were used respectively to determine urea,alanine aminotransferase (ALT),creatine kinase(CK) and glucose(Glu) of the samples and evaluated the bias within methodological linear limitation. Results Among these testing results,the correlation of urea,ALT,CK and Glu was fine(r≥0.975). Except that the bias of urea was unacceptable at medical decision level 2.5 and 6.4 mmol/L,the biases of other routine biochemical tests could be accepted between two analytical systems. Conclusions The ALT,Glu,CK and high level urea can be tested by the two biochemical and analytical systems.