血清总胆红素厂家校准品不同示值来源对互换性评价结果的影响

Effect of indicating values of calibrator for serum total bilirubin sourced from different manufacturers on commutability evaluation

目的观察血清总胆红素厂家校准品不同示值来源对互换性评价结果的影响。方法按血清总胆红素厂家校准品3种示值来源(a.厂家校准品证书示值,b.Doumas参考方法赋值,c.有证标准物质传值)分别给某厂家校准品定值,并校准该厂家常规测量系统,分别命名为A、B、C常规测量系统。采用Doumas参考方法和A、B、C常规测量系统同时测量该校准品和26份不同浓度单人份血清样本;按国际临床化学和检验医学联合会(IFCC)工作组互换性更新方案评价该校准品的互换性。结果a方式下校准品不具备互换性,b和c方式下校准品互换性评价结果基本一致且均具备互换性。结论血清总胆红素厂家校准品不同示值来源对互换性评价存在一定的影响,具备溯源性的厂家校准品可获得相对一致的互换性评价结果。

Objective To study the indicating values of calibrator for serum total bilirubin sourced from different manufacturers on commutability evaluation. Methods A calibrator of certain manufacturer for serum total bilirubin was assigned its value according to the three sources of indicating values,i. e.,the certificate of manufacturer,assigned value by Doumas reference method and transferred value from certified reference material（ CRM）. The routine measuring system of the manufacturer was calibrated simultaneously.The calibrated measurement system was named as routine measurement system A,B and C. The calibrator of this manufacturer as well as a group of 26 serum samples with different concentrations of total bilirubin were measured by Doumas reference method and the routine measurement system A,B and C simultaneously. The commutability of this calibrator was evaluated according to Update from the IFCC Working Group on Commutability. Results The calibrator of the manufacturer could not be commutable in measurement system A mode. The evaluating results in measurement system B and C modes were generally coincident and were provided with commutability.Conclusion The sources of calibrator from different manufacturer showed certain impacts for the commutability evaluation of serum total bilirubin. Using the traceable calibrators from the manufacturers may acquire relatively consistent results of commutability evaluation.