一种新的互换性评价方案在总胆红素候选标准物质材料互换性评价中的应用

Application of a new program in commutability evaluation process of candidate total bilirubin reference materials

目的观察利用国际临床化学和检验医学联合会（IFCC）工作组互换性评价更新方案评价总胆红素候选标准物质的可行性。方法收集实验当日1.9～273.8μmol/L不同总胆红素浓度无溶血、乳糜的单人份血清25份,每个血清分成2份;采用IFCC参考方法和常规方法同时测量单人份血清和各待评价候选标准物质材料的血清总胆红素含量;采用IFCC工作组互换性评价更新方案评价8种不同来源的总胆红素候选标准物质材料的互换性。结果采用血清总胆红素参考方法分别测量国家一级标准物质GBW09184和GBW09185,测量结果分别为108.1μmol/L和44.8μmol/L;测量CFAS 10次,CV为0.55%。25份新鲜单人份血清参考方法的测量结果为1.9～273.8μmol/L,常规方法的测量结果为2.1～312.6μmol/L。8个待评价候选标准物质材料的参考方法的测量结果分别为32.3、53.9、139.4、89.6、229.2、72.2、22.8、99.2μmol/L,常规方法的测量结果分别为37.4、64.4、159.8、100.5、187.5、87.5、26.8、113.8μmol/L,常规方法结果偏移分别为15.8%、19.5%、14.6%、12.2%、-18.2%、21.2%、17.5%和14.7%。按IFCC方案以各样本常规方法与参考方法测量结果的均值为X轴、以常规方法与参考方法测量结果的偏移为Y轴绘制标准物质的互换性结果评价图,以WS/T 403-2012标准中血清总胆红素的5%允许偏移为临床预期需求判断8个候选标准材料的互换性,其中材料3、4、8有互换性,材料2、5、6无互换性,材料1和7需进一步研究。结论依据IFCC工作组互换性评价更新方案可建立起一种新的能满足临床实验室预期要求的血清总胆红素候选标准物质材料的互换性评价方案。

Objective To observe the feasibility of using update program of IFCC（ International Federation of Clinical Chemistry and Laboratory Medicine） working group on commutability to evaluate commutability evaluation of candidate total bilirubin reference materials. Methods Twenty-five single sera at various concentrations 1. 9 to 273. 8 μmol/L of total bilibrubin without hemolysis and chylemia were collected,each of which was divided into two parts. The IFCC reference method and the routine method were used to measure total bilirubin levels of single sera and candidate total bilirubin reference materials. IFCC working group commutability update program was used to evaluate the commutability of 8 different sources of total bilirubin candidate reference materials. Results The results of the national certificated reference material GBW09184 and GBW09185 measured by IFCC reference method and the routine method were 108. 1 μmol/L and 44. 8 μmol/L. CV of Cfas was 0. 55% by measuring for 10 times. The results of 25 single sera were 1. 9 to273. 8 μmol/L by measuring with reference methods,and 2. 1 to 312. 6 μmol/L by measuring with routine methods. The results of 8candidate reference materials were 32. 3,53. 9,139. 4,89. 6,229. 2,72. 2,22. 8 and 99. 2 μmol/L by measuring by reference methods,37. 4,64. 4,159. 8,100. 5,187. 5,87. 5,26. 8 and 113. 8 μmol/L by measuring with routine methods. The biases of routine methods were 15. 8%,19. 5%,14. 6%,12. 2%,-18. 2%,21. 1%,17. 5% and 14. 7% respectively. Using the means of results measured by reference method and routine methods were used as X-axis,the biases were used as Y-axis. The 5% of allowable bias was used as the clinical expectant demand which was proposed by WS/T 403-2012 standard to draw the commutability evaluation diagram according to the IFCC program. The materials 3,4 and 8 were commutable but 2,5 and 6 were non-commutable. Further study for the materials 1 and 7 were needed. Conclusion A new commutability evaluation program in the commutability evaluation process of candidate total bilirubin reference material which was satisfied with clinical expectant requirements could be established according to IFCC working group commutability update program.