CAJ | 학술논문

目的探讨临床标本在验证不同批号生化试剂对临床检验结果是否具有一致性的作用.方法分别使用新旧两个批号试剂对5个不同浓度的新鲜血清标本、Roche配套质控品和Biorad质控品的13常规临床生化项目进行测定,并对结果进行统计学分析.计算各项目更换试剂批号前后之间的偏移,以美国临床医学检验部门修正法规(CLIA' 88)允许总误差的1/3为标准,判断结果是否在允许范围内.结果各项目在更换试剂批号后质控结果差异无统计学意义(P＞0.05),而临床标本中的丙氨酸氨基转移酶(ALT)、尿酸(UA)、总胆固醇(TC)和载脂蛋白A(APOA)等四个项目的测定结果却有统计学意义(P＜ 0.05),但其偏移却在1/3 CLIA' 88可接受范围内,分别为2.57％、4.41％、1.81％和3.84％,可以满足临床需要.结论由于质控品基质效应的存在,质控品的结果并不能真实反应更换试剂批号后临床标本结果的一致情况,为了解决这个问题,建议最好同时使用质控品和临床标本进行更换试剂前后的比对.
목적 탐토림상표본재험증불동비호생화시제대림상검험결과시부구유일치성적작용.방법 분별사용신구량개비호시제대5개불동농도적신선혈청표본、Roche배투질공품화Biorad질공품적13상규림상생화항목진행측정,병대결과진행통계학분석.계산각항목경환시제비호전후지간적편이,이미국림상의학검험부문수정법규(CLIA' 88)윤허총오차적1/3위표준,판단결과시부재윤허범위내.결과 각항목재경환시제비호후질공결과차이무통계학의의(P＞0.05),이림상표본중적병안산안기전이매(ALT)、뇨산(UA)、총담고순(TC)화재지단백A(APOA)등사개항목적측정결과각유통계학의의(P＜ 0.05),단기편이각재1/3 CLIA' 88가접수범위내,분별위2.57％、4.41％、1.81％화3.84％,가이만족림상수요.결론 유우질공품기질효응적존재,질공품적결과병불능진실반응경환시제비호후림상표본결과적일치정황,위료해결저개문제,건의최호동시사용질공품화림상표본진행경환시제전후적비대.
Objective To study the role of clinical patient samples in verifying consistency of clinical results between different reagent lots.Methods The results of 5 clinical samples,Roche quality control materials and Biorad quality control materials for 13 clinical routine biochemical tests were obtained by using both old and new reagent lot,and performed the statistics.The bias of 13 measurands were computed after changing reagent lots,and also were judged according to the 1/3 limits of CLIA' 88 defined acceptable error,whether the bias was conform to clinical requirements or not.Results QC material results had no significant difference between two reagent lots (P ＞ 0.05).The results of ALT,UA,TC and ApoA for patient samples had significant difference (P ＜ 0.05),but the bias of these items were within the 1/3 limits of CLIA' 88 defined acceptable error,which were 2.57％,4.41％,1.81％ and 3.84％ respectively,in accordance with clinical requirement.Conclusions As there is matrix effect of quality control materials,the results for QC materials should not be used to verify the consistency of results for patient samples when changing reagent lots.To overcome this situation,we should use quality control materials together with clinical samples to compare consistency of results after changing reagent lots.