CAJ | 학술논문

目的：探讨实验室间不同生化检测系统结果的可比性，为推动实验室间检验结果的互认提供参考。方法五家实验室检测病人新鲜血清，连续20次分别测定 Urea 和 Cr 等10个生化项目，进行精密度分析；参照美国临床和实验室标准协会（CLSI ）EP9-A2文件，以攀钢集团总医院生化检测系统作为比较系统，其余四家医院生化检测系统作为待评系统，检测病人新鲜血清，均分别检测五个生化组合项目（Urea，Cr），（AST，ALT），（TP，ALB），（TG，TC）和（HDL-C，LDL-C），每个组合项目连续测定5天，测定结果进行比对分析，计算比较系统和待评系统之间的相关系数、直线回归方程和不同医学决定水平处的相对偏倚（SE％），并以美国临床实验室改进修正案能力验证（CLIA’88）允许总误差（TEa）的1／2为标准，判断待评系统与比较系统之间的可比性和临床可接受性。结果以 Urea 和 Cr 测定为例，五家实验室间 Urea 和 Cr 两项目的 CV 值均小于 CLIA’88允许总误差的1／3，精密度均符合要求。检测结果显著相关（r 2＞0.975）；临床可接受性能评价中，在 Urea 低医学决定水平处，有两家实验室的测定结果为临床不可接受；在 Urea 高医学决定水平处，有一家实验室的测定结果为临床不可接受；在 Cr 低医学决定水平处，有两家实验室的测定结果为临床不可接受；其余待评系统 Urea 和 Cr 项目在各医学决定水平与比较系统比较，其 SE％均小于 CLIA’88允许总误差的1／2，为临床可接受。结论实验室间不同生化检测系统的测定结果存在不同程度的偏倚，部分项目偏倚超出允许误差范围。
목적：탐토실험실간불동생화검측계통결과적가비성，위추동실험실간검험결과적호인제공삼고。방법오가실험실검측병인신선혈청，련속20차분별측정 Urea 화 Cr 등10개생화항목，진행정밀도분석；삼조미국림상화실험실표준협회（CLSI ）EP9-A2문건，이반강집단총의원생화검측계통작위비교계통，기여사가의원생화검측계통작위대평계통，검측병인신선혈청，균분별검측오개생화조합항목（Urea，Cr），（AST，ALT），（TP，ALB），（TG，TC）화（HDL-C，LDL-C），매개조합항목련속측정5천，측정결과진행비대분석，계산비교계통화대평계통지간적상관계수、직선회귀방정화불동의학결정수평처적상대편의（SE％），병이미국림상실험실개진수정안능력험증（CLIA’88）윤허총오차（TEa）적1／2위표준，판단대평계통여비교계통지간적가비성화림상가접수성。결과이 Urea 화 Cr 측정위례，오가실험실간 Urea 화 Cr 량항목적 CV 치균소우 CLIA’88윤허총오차적1／3，정밀도균부합요구。검측결과현저상관（r 2＞0.975）；림상가접수성능평개중，재 Urea 저의학결정수평처，유량가실험실적측정결과위림상불가접수；재 Urea 고의학결정수평처，유일가실험실적측정결과위림상불가접수；재 Cr 저의학결정수평처，유량가실험실적측정결과위림상불가접수；기여대평계통 Urea 화 Cr 항목재각의학결정수평여비교계통비교，기 SE％균소우 CLIA’88윤허총오차적1／2，위림상가접수。결론실험실간불동생화검측계통적측정결과존재불동정도적편의，부분항목편의초출윤허오차범위。
Objective To investigate the different biochemical testing system inter laboratory comparability of results,provide reference for promoting inter laboratory test results of the recognition.Methods Five patients with laboratory detection of fresh mixed serum,20 consecutive determination of 10 biochemical items,precision analysis.According to America clinical and Laboratory Standards Institute (CLSI)Document EP9-A2,the Panzhihua Iron and Steel Group General Hospital detec-tion system as the reference system,the remaining four hospital detection system as the detection system,with a fresh mixed serum,determination of five biochemical items (Urea,Cr),(AST,ALT),(TP,ALB),(TG,TC)and (HDL-C,LDL-C),the determination results were compared and analyzed,calculated reference system and the correlation coefficient,linear regres-sion equation between the system and the various medical decision level relative deviation (SE%),and to America Clinical Laboratory Improvement Amendment ability test (CLIA’88)allowed total error of 1/2 as the standard,to the assessment system and the reference system between the comparability and clinical acceptability.Results In Urea,Cr determination for example,CV of five laboratories on Urea and Cr two project was less than CLIA’88 allowed total error of 1/3,the precision could meet the clinical requirements.The detection results significantly correlated (r2 >0.975).The evaluation of clinical ac-ceptability,in Urea low at medical decision level,there were two laboratory determination results that could not be accepted for clinical.In Urea high at medical decision level,there was a laboratory measurement result that could not be accepted for clinical.In the low Cr at medical decision level,there were two laboratory determination results that could not be accepted for clinical.The rest of the system Urea,Cr projects in various medical decision level compared with the system,the SE% was less than CLIA’88 allowed total error of 1/2,for clinical acceptable.Conclusion Laboratory determination results between different biochemical testing system had bias in different degrees,bias part of the project exceeds the allowed error range.