不同评价方法对标准物质互换性评价结果的影响

Effect of different evaluation methods on evaluation results of commutability

目的观察不同评价方法对标准物质互换性评价结果的影响。方法以A、B、C 3个血清总胆红素候选标准物质、甲厂家校准品D的互换性评价为例,采用血清总胆红素参考方法和甲常规方法同时测量A、B、C、D 4个待评价样本和无溶血、乳糜的26份单人份血清样本的总胆红素含量。分别采用EP30-A、EP14-A3和国际临床化学和检验医学联合会（IFCC）互换性评价更新方案3个互换性评价方法评价待评价样本的互换性,EP30-A和EP14-A3方法的互换性评价判断依据为标准物质应落在Y预测值的±95%置信区间内,IFCC互换性评价更新方案中的互换性评价判断依据为标准物质的偏移/差±不确定度应落在医学允许偏移的固定范围内（该研究设定为5%）。比较采用3个不同判断依据对标准物质互换性评价结果的影响。结果A、B、C、D 4个样品参考方法和常规方法的测量结果分别为108.10、44.60、53.16、200.70μmol/L和94.93、38.27、48.70、189.50μmol/L;26份人血清样本的总胆红素浓度范围分别为4.69～679.73μmol/L和4.2～684.17μmol/L;A、B、C、D 4个样品采用EP30-A、EP14-A3方法评价时均具有互换性,但采用IFCC互换性评价更新方案评价时仅有A和C 2个样品具有互换性。结论评价方法不同,相同样品的互换性评价结果有可能不同,IFCC互换性评价更新方案的评价结果更符合医学预期需求。

Objective To observe the effect of different evaluation methods on the evaluation results of commutability of reference materials. Methods A,B and C serum of total bilirubin candidate reference materials and a manufacture＇s calibrator D were used as examples. The 4 samples（ A,B,C and D） and 26 samples of single serum samples without hemolysis and chylemia were measured with total bilirubin reference method and a routine method. The commutability of the samples was evaluated using the three commutability evaluation methods of EP30-A,EP14-A3 and Update from the IFCC Working Group on Commutability,respectively. According to the EP30-A and EP14-A3 Assessment Criteria,the reference material should fall within the ± 95% confidence interval of the Y-predicted value. According to the commutability assessment criterion in the Update from the IFCC Working Group on Commutability,the bias of the reference material ± uncertainty degrees should fall within a fixed range of medical allowable deviations（ 5% in this study）. The effects of three different criteria on the evaluation of commutability of reference materials were compared. Results The results of the reference methods and routine methods of A,B,C and D were 108. 10,44. 60,53. 16 and 200. 70 μmol/L and 94. 93,38. 27,48. 70 and 189. 50 μmol/L,respectively. The 26 samples of human serum were 4. 69 to 79. 73 μmol/L and 4. 2 to 684. 17 μmol/L. A,B,C and D were commutable when they were evaluated by EP documents,but only samples A and C were commutable when they were evaluated using the IFCC commutability evaluation update scheme. Conclusion The evaluation results of commutability of the same sample may different depending on the evaluation method. The results of the IFCC Commutability Evaluation Update Program should be more in line with medical expectations.