CAJ | 학술논문

目的：建立酶学参考方法不确定度研究模型，系统地对丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）、α-淀粉酶（AMY）、谷氨酰基转移酶（GGT）和肌酸激酶（CK）6个酶学参考方法的不确定度影响因素进行研究，以明确各参考方法影响的关键因素，更好地指导参考方法的建立和运行。方法参照 JJF1059-1999《测量不确定度评定与表示》、JJF1135-2005《化学分析测量不确定度评定》、CNAS-GL06《化学分析中不确定度的评估指南》和 CNAS-CL33《检测和校准实验室能力认可准则在临床酶学参考测量领域的应用说明》，采用理论评估和实验设计相结合的方法对6个酶学参考方法不确定度进行评定。结果建立的酶学不确定度评定模型为 C＝ΔAΔt ·1ε·1L ·V 1＋V 2＋V SV ·fT ·f pH ·fλ·f 试剂·f 测试结果。结论建立了S酶学参考方法不确定度的评定模型，并成功运用于6个酶学参考方法不确定度的评定。
목적：건립매학삼고방법불학정도연구모형，계통지대병안산안기전이매（ALT）、천문동안산안기전이매（AST）、유산탈경매（LDH）、α-정분매（AMY）、곡안선기전이매（GGT）화기산격매（CK）6개매학삼고방법적불학정도영향인소진행연구，이명학각삼고방법영향적관건인소，경호지지도삼고방법적건립화운행。방법삼조 JJF1059-1999《측량불학정도평정여표시》、JJF1135-2005《화학분석측량불학정도평정》、CNAS-GL06《화학분석중불학정도적평고지남》화 CNAS-CL33《검측화교준실험실능력인가준칙재림상매학삼고측량영역적응용설명》，채용이론평고화실험설계상결합적방법대6개매학삼고방법불학정도진행평정。결과건립적매학불학정도평정모형위 C＝ΔAΔt ·1ε·1L ·V 1＋V 2＋V SV ·fT ·f pH ·fλ·f 시제·f 측시결과。결론건립료S매학삼고방법불학정도적평정모형，병성공운용우6개매학삼고방법불학정도적평정。
Objective To develop an uncertainty study model of the enzymological reference method to systematically research the uncertainty influencing factors of 6 enzymological reference methods ALT,AST,LDH,AMY,GGT and CK for determining the key factors influencing the reference method and better guiding the establishment and operation of the enzymological reference methods.Methods The uncertainty of the six enzymological reference methods was evaluated by the theoretical evaluation com-bined with the experiment design according to series of standards including JJF1059-1999 Evaluation and Expression of Uncertainty in Measurement,JJF1135-2005 Evaluation of Uncertainty in Chemical Analytical Measurement,CANA-GL06 Guidance on Evalua-ting the Uncertainty in Chemical Analysis and CNAS-CL33 Guidance on the Application of Testing and Calibration Laboratories Competence Accreditation Criteria in the Field of Clinical Enzymology Reference Measurement.Results The established enzymo-logical uncertainty study model was C=ΔAΔt · 1ε · 1L ·V 1 +V 2 +V SV ·fT ·f pH ·fλ·fkit ·fresult .Conclusion The uncertainty e-S valuation model is set up and successfully applied in the uncertainty evaluation of the six enzymological reference methods.