血清总胆红素常规系统量值传递路径的比较

Comparison of quantity value transmission paths for the routine system of total bilirubin in serum

目的改进血清总胆红素(T-Bil)常规系统测量结果正确度的量值传递路径。方法优选9个国内外生产厂家11种TBil试剂盒,涉及矾酸盐氧化法(5/11)、重氮法(3/11)、化学氧化法(2/11)、酶法(1/11)4种常用测量原理,复现11种T-Bil配套系统,分别测量冰冻人血清基质T-Bil国家一级标准物质GBW09184和GBW09185各3次,依据WS/T 403-2012卫生行业标准判断各系统测量结果的正确度。分别采用4种基于T-Bil参考系统的量值传递路径对测量结果不能满足量值溯源要求的系统修正后再次进行正确度评价。分析4种量值传递路径对不能满足量值溯源要求的各测量系统测量结果的改进效果。结果11个T-Bil配套系统中仅4号系统的测量结果能满足量值溯源要求。用4种量值传递路径向测量结果不能满足量值溯源要求的10个T-Bil配套系统传递量值后,分别有3、7、10、10种T-Bil配套系统可获得可溯源的测量结果。第(1)种路径能修正50%(2/4)矾酸盐氧化法和50%(1/2)化学氧化法原理的配套系统;第(2)种路径能修正100%(4/4)矾酸盐氧化法、67%(2/3)重氮法、50%(1/2)化学氧化法的配套系统测量结果;第(3)、(4)种量值传递路径能修正各种测量结果不能满足量值溯源要求的配套系统的测量结果。结论血清T-Bil测量原理不同,改进测量结果正确度的量值传递路径不同。采用有互通性的人血清T-Bil标准物质进行量值传递可改进各类测量原理的T-Bil配套系统测量结果的正确度,是比较理想的T-Bil量值传递模式。

Objective To improve the quantity value transmission path of measurement result trueness for routine system of total bilirubin（ T-Bil） in serum. Methods Eleven kinds of T-Bil kits（ systems） from 9 domestic and foreign manufacturers were selected,and 4kinds of commonly used measuring principles,including the vitriol acid salt oxidation method（ 5 /11）,diazo method（ 3 /11）,chemical oxidation method（ 2 /11） and enzyme method（ 1 /11）,were applied in these kits. The T-Bil national primary standard materials GBW09184 and GBW09185 in frozen human serum matrix were detected 3 times with these kits respectively,and the measurement result trueness of each kit was judged with the health industry standard WS / T 403-2012. Then,the trueness of the measuring system which measurement results did not meet the requirements of quantity value traceability was evaluated again after the measuring system was corrected by 4 kinds of quantity value transmission paths based on the T-Bil reference system,and the improvement effects of 4kinds of quantity value transmission paths on the measurement results of each measuring system were analyzed. Results Only the measurement result of No. 4 in 11 kinds of measurement systems met the requirement of quantity value traceability. After the other 10 kinds of T-Bil measuring systems which did not meet the requirements of quantity value traceability were corrected by 4 kinds of quantity value transmission paths,the measurement results of No. 3,No. 7,No. 10 and 10 kinds of T-Bil systems for detecting serum samples met the requirements of quantity value traceability. The first path corrected the measurement results of 50%（ 2 /4） of the vitriol acid salt oxidation method,and 50%（ 1 /2） of the chemical oxidation method. The second path corrected the measurement results of100%（ 4 /4） of the vitriol acid salt oxidation method,67%（ 2 /3） of the diazo method and 50%（ 1 /2） of the chemical oxidation method. The third and fourth paths corrected the measurement results of all measuring systems which did not meet the requirements of quantity value traceability. Conclusion The quantity value transmission path improves the measurement results dependent on the measurement principle of T-Bil in serum. The quantity value transmission path using commutable human serum T-Bil standard materials may improve the measurement result trueness of T-Bil measuring systems with different measuring principles,which is a relatively ideal TBil quantity value transmission mode.