11个总胆红素校准品不确定度信息的调查

Investigation on uncertainty information of 11 total bilirubin calibrators

目的调查我国医疗市场血清总胆红素试剂盒中校准品测量不确定度的现状。方法根据卫生计生委临床检验中心网站信息收集国内医疗市场用户排名前十位的血清总胆红素试剂;采用购买试剂盒和与厂家技术支持沟通的方式获取各厂家校准品不确定度信息并汇总;与相关国际、国内标准比较并分析各校准品测量不确定度信息的合理性。结果 11个校准品说明书中均不带有校准品不确定度信息,但各厂家均可提供其校准品的不确定度信息,其中5个校准品不确定度以＂%＂形式提供,其他以＂μmol/L＂形式提供。11个校准品的示值范围为33.0～228.2μmol/L,不确定度值范围为1.21～19.0μmol/L,相对不确定度值范围为0.57%～10.0%。部分校准品不确定度信息不完整,表现为无包含因子值;2号、6号校准品的不确定度值低于总胆红素参考方法的测量不确定度水平,缺乏合理性;8号校准品的不确定度超过WS/T 403-2012中总胆红素的允许偏移标准5%,缺少实用价值。结论血清总胆红素校准品的不确定度评定方法、表述方式有待规范。

Objective To investigate the measurement uncertainty of serum total bilirubin kit in medical market of China. Methods The top ten serum total bilirubin kits in the domestic medical market were collected according to the website of the National Center for Clinical Laboratories. The information of measurement uncertainty of reagent kits were obtained and summarized from technical support of manufacturers. Compare with the relevant international and domestic standards were compared and the reasonableness of the uncertainty information of each calibrator was analyzed. Results None of the 11 calibrators contained uncertainty information,but each manufacturer provided information on the uncertainty of the calibrator. The uncertainty of five calibrators was provided in the form of ＂ % ＂,and others were provided in ＂ μmol/L＂ form. The calibration range of 11 calibrators was 33. 0 to 228. 2 μmol/L,the uncertainty range was 1. 21 to 19. 0 μmol/L,the relative uncertainty range was 0. 57% to 10. 0%. The uncertainty information of partial calibrator was incomplete,and it showed ＂ no coverage factor value＂. The uncertainty values of calibrators 2 and 6 were lower than those of total bilirubin reference method,and lack of rationality. The uncertainty of calibrator 8 exceeds the allowable offset of total bilirubin by 5% in WS/T 403-2012,and was of little practical value. Conclusion The method of assessing the uncertainty of serum total bilirubin calibrator and the way of expression should be standardized.