CAJ | 학술논문

目的通过测量患者血清丙氨酸氨基转移酶的活性，了解参加实验室的检测水平，探讨在临床实验室之间用患者血清开展室间比对和正确度评价的可行性。方法采用方法学比对研究，2013年3至8月经2家国际候选参考实验室应用改良的不含磷酸吡哆醛ALT参考方法为5份患者血清赋值，23家常规实验室在同一时间重复2次测定这5份样品。计算常规实验室检测结果与参考实验室均值的偏倚，并与允许偏倚6％进行比较。计算均值和相对偏移。结果以参考实验室测量均值为靶值，23家实验室5份样品的百分偏倚绝对值最大为31．27％，样品1至样品5偏倚小于允许偏倚的比例范围为26．09％～73．91％。8家实验室5份样品中有4份及以上的偏倚小于允许偏倚（合格率大于或等于80％），15家实验室5份样品中有2份及以上的偏倚大于允许偏倚（合格率小于或等于60％），3家实验室5份样品的偏倚均大于允许偏倚（合格率为0％）。结论使用患者血清同时使用参考方法定值开展室间比对和正确度评价是一种有效的能力验证方式，能更真实地反映实验室检测质量水平。（中华检验医学杂志，2015，38：318－320）
목적통과측량환자혈청병안산안기전이매적활성，료해삼가실험실적검측수평，탐토재림상실험실지간용환자혈청개전실간비대화정학도평개적가행성。방법채용방법학비대연구，2013년3지8월경2가국제후선삼고실험실응용개량적불함린산필치철ALT삼고방법위5빈환자혈청부치，23가상규실험실재동일시간중복2차측정저5빈양품。계산상규실험실검측결과여삼고실험실균치적편의，병여윤허편의6％진행비교。계산균치화상대편이。결과이삼고실험실측량균치위파치，23가실험실5빈양품적백분편의절대치최대위31．27％，양품1지양품5편의소우윤허편의적비례범위위26．09％～73．91％。8가실험실5빈양품중유4빈급이상적편의소우윤허편의（합격솔대우혹등우80％），15가실험실5빈양품중유2빈급이상적편의대우윤허편의（합격솔소우혹등우60％），3가실험실5빈양품적편의균대우윤허편의（합격솔위0％）。결론사용환자혈청동시사용삼고방법정치개전실간비대화정학도평개시일충유효적능력험증방식，능경진실지반영실험실검측질량수평。（중화검험의학잡지，2015，38：318－320）
Objective To explore the feasibility of inter-laboratory comparison and trueness evaluation among clinical laboratories, and assess the quality of participants′measurement, by measuring the activity of alanine aminotransferase ( ALT ) in patient serum samples.Methods Method comparison study was used.Five patients serum samples, whose target values were assigned by two international candidate reference laboratory with reference method of ALT without pyridoxal phosphate, were measured by 23 routine laboratories.The bias between measurement result of each participant and the mean of reference laboratories was calculated, and then compared to allowable bias 6%.Calculate the mean value and the relative bias.Results Compared with the mean of reference laboratories, the maximum absolute value of bias among the 23 routine laboratories was 31.27%.The rate range which bias was less than the allowable bias was 26.09%-73.91 %.The bias acceptability of 8 participants were more than or equal to 80%;15 participants were less than or equal to 60%; and 3 participants were 0%.Conclusions Using patient serum samples and values assigned by reference method is an effective way to carry out inter-laboratory comparison and trueness evaluation.It can reflect the quality of measurement more truly.