不同生化检测系统结果的可比性验证及改进措施的研究

摘要

Abastract: Objective To verify the comparability and to improve the consistency of the test results under different biochemical measurement systems by using fresh serum as a temporary calibrator. Methods In accordance with the Chinese health industry standard WS/T 407-2012 documentation requirements, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), glucose (GLU) and total protein (TP) were tested respectively to verify the comparability. They were also compared with one third of the biological variation or the total allowable error. Finally, fresh serum was used as a temporary calibrator to calibrate the project that had no comparability. Results The test results of ALT, GGT and TP were comparable between BECKMAN DXC600 and AU5811 measurement systems. The high and low ratios of deviation for ALT, GGT and TP were:5.04, 2.5;2.29, 1.6;2.98, 0.84 respectively, which were less than the quality target (6.0,3.5,3.0). For ALP, AST and GLU the results were not comparable as the ratio of deviation was:7.9, 15.44;7.7, 6.8;1.11, 5.06 respectively, which were higher than the quality target (6.0, 6.0, 3.0). They were comparable after calibrated using the fresh serum with new value assignment, and the ratios of deviation were lowered to 1.07, 4.2; 1.9, 1.8; 2.88, 2.12. Conclusion WS/T 407-2012 documentation could be used to verify the comparability of different measurement systems. Using fresh serum with new value assignment as a temporary calibrator could effectively improve the comparability among different measurement systems.%目的：验证不同生化检测系统间结果的可比性，并以新鲜血清作为临时校准品来提高不同检测系统间结果的一致性。方法按照中国卫生行业标准WS/T 407-2012的要求，分别用碱性磷酸酶(ALP)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰氨基转移酶(GGT)、葡萄糖(GLU)、总蛋白(TP)作可比性验证，与生物学变异或总允许误差的1/3进行比较，对验证不可通过的项目以新鲜病人血清作临时校准品校准，再进行可比性验证。结果 BECKMAN DXC600和AU5811两种型号配套检测系统检测ALT、GGT、TP具有可比性，高、低浓度样本的比对偏差分别为5.04、2.5，2.29、1.6，2.98、0.84，小于其对应的分析质量目标6.0、3.5、3.0；检测ALP、AST、GLU不具备可比性，比对偏差分别为7.9、15.44，7.7、6.8，1.11、5.06，大于其对应的分析质量目标6.0、6.0、3.0。采用赋值新鲜血清校准，ALP、AST、GLU的测定结果具有可比性，比对偏差分别降低为4.2、1.07，1.8、1.9，2.31、2.12。结论按照WS/T 407-2012文件可以方便验证不同检测系统间结果的可比性；用赋值后的新鲜血清校准，可以有效提高不同检测系统测定结果的可比性。