CAJ | 학술논문

目的评价胱抑素C标准物质ERM－DA 471／IFCC在8种方法间的互通性。方法实验性能验证。收集2014年1月1日至12月31日检验科检测剩余单人份血清标本46份，将标准物质ERM－DA 471／IFCC、混合血清穿插其中，编号后分为两组，选用雅培公司、西门子公司、罗氏公司、德赛公司、Dako公司、利德曼公司、迈克公司、中生北控公司8种检测方法，在2个工作日内，校准后，分别按正序、逆序测定两次。采用单人份血清测定的均值，用Passing－Bablok 回归计算8方法两两比对的斜率和截距，并计算Pearson 相关系数。采用Deming回归分析并计算其95％置信区间，用于判断ERM－DA 471／IFCC的统计学互通性；根据有生物学变异导出的偏倚的最低要求评价制备物质的临床互通性。结果测定混合人血清的总变异系数范围为0．5％～4．0％；各方法对测定单人份血清结果Passing－Bablock回归的斜率（ Slope）范围为0．765～1．311，截距（ intercept）范围为－0．04～0．242；Pearson回归的决定系数范围为0．988～0．999。根据Deming回归直线95％CI来判断，ERM 471具有互通性的方法对为4／28（14．3％）；根据Cys C生物学变异导出的偏倚的最低要求5．12％来判断，具有互通性的方法对分别为15／28（53．6％）。结论 ERM－DA 471／IFCC在部分方法对间的互通性还不是太理想，将其用作校准品时需评价互通性。（中华检验医学杂志，2015，38：306－309）
목적평개광억소C표준물질ERM－DA 471／IFCC재8충방법간적호통성。방법실험성능험증。수집2014년1월1일지12월31일검험과검측잉여단인빈혈청표본46빈，장표준물질ERM－DA 471／IFCC、혼합혈청천삽기중，편호후분위량조，선용아배공사、서문자공사、라씨공사、덕새공사、Dako공사、리덕만공사、매극공사、중생북공공사8충검측방법，재2개공작일내，교준후，분별안정서、역서측정량차。채용단인빈혈청측정적균치，용Passing－Bablok 회귀계산8방법량량비대적사솔화절거，병계산Pearson 상관계수。채용Deming회귀분석병계산기95％치신구간，용우판단ERM－DA 471／IFCC적통계학호통성；근거유생물학변이도출적편의적최저요구평개제비물질적림상호통성。결과측정혼합인혈청적총변이계수범위위0．5％～4．0％；각방법대측정단인빈혈청결과Passing－Bablock회귀적사솔（ Slope）범위위0．765～1．311，절거（ intercept）범위위－0．04～0．242；Pearson회귀적결정계수범위위0．988～0．999。근거Deming회귀직선95％CI래판단，ERM 471구유호통성적방법대위4／28（14．3％）；근거Cys C생물학변이도출적편의적최저요구5．12％래판단，구유호통성적방법대분별위15／28（53．6％）。결론 ERM－DA 471／IFCC재부분방법대간적호통성환불시태이상，장기용작교준품시수평개호통성。（중화검험의학잡지，2015，38：306－309）
Objective To evaluate the commutability of certified reference material IRMM ERM-DA 471/IFCC for cystatin C measurement among 8 methods.Methods 46 individual samples used for the commutability study were residual serum samples collected from clinical laboratories.The individual samples interspersedwith pooled sera and the certified reference material IRMM ERM-DA 471/IFCC and the whole set of samples was divided into 2 subsets for measurements in 2 days.The measurements were performed by8 different methods o.The samples were measured in duplicate order.Calibration was performed every day. Passing-Bablok regression was performed to compare the slopes and intercepts of mean values of the serum samples derived from different methods. Pearson correlation cofficient was also calculated. Deming regeression and 95%confidence intervals were calculated to evaluate the statistics commutability of ERM-DA 471/IFCC.The minimal specification of bias derived from biological variations was calculated to evaluate the clinical commutability.Results The within-laboratory CVs of pool sera ranged from 0.5% to 4.0%.The Passing-Bablok slope ranged from 0.765 to 1.311 and intercepts ranged from -0.04 to 0.241.The determination coefficient of Pearson regression ranged from 0.988 to 0.999.Deming regeression and 95%confidence intervals demonstrated commutability of ERM-DA 471/IFCC in 4/28 (14.3%) methods pairs. The minimal specfication bias ( 5.12%) demonstrated commutability of ERM-DA 471/IFCC in15/28 (53.6%) methods pairs.Conclusions The ERM-DA 471/IFCC domonstrated poor commutability between some methods pairs. The commutability of ERM-DA 471/IFCC should be evaluated before used as calibrators.