不同评价方法对胱抑素C标准物质互换性评价结果的影响

Effects of Different Evaluation Methods on Results of Commutability

目的观察不同评价方法对胱抑素C标准物质互换性评价结果的影响。方法收集无溶血、无乳糜的单人份血清42份,将4个浓度的胱抑素C标准物质穿插其中,选用九强公司、迈克公司、迈瑞公司、罗氏公司、中元公司、积水公司、德赛公司、瑞源公司、景源公司9种市场占有率较高的检测方法,对评价样本重复测量3次,采用EP-14A3和IFCC互换性评价方案,分别评价标准物质的互换性。结果4个浓度的胱抑素C标准物质采用EP-14A3评价时互换性结果不理想,采用IFCC互换性评价方案时均具有互换性。结论两种互换性评价结果有明显差异,IFCC互换性评价方案更符合医学预期需求。

Objective To observe the effects of different evaluation methods on results of the commutability of frozen human serum cystatin C reference materials.Methods We collected 42 single serum samples without hemolysis and chyle and selected the top nine companies to evaluate the commutability of four concentrations of cystatin C reference materials.We used EP-14A3 and IFCC evaluation program to evaluate the commutability of reference materials.Results The commutability results of 4 concentrations of Cystatin C reference materials were not ideal when evaluated by EP-14A3 and all were commutable when the IFCC evaluation scheme was adopted.Conclusion There are significant differences between two commutability evaluation results and IFCC commutability evaluation program is more in line with medical expectations.