西门子特定蛋白仪测定ASO的分析性能验证与评价

Assessment on the detection of ASO by Siemens automated protein analysis

目的验证和评价西门子特定蛋白仪测定抗链球菌溶血素O(ASO)的分析性能。方法依据美国临床实验室标准化组织(CLSI)文件和科室制定的相关文件的实验方案,分析西门子特定蛋白仪测定ASO的精密度、正确度、携带污染率、线性及可报告范围,对结果与质量标准比较。结果批内精密度CV分别为2.9%、2.8%,符合判断标准≤6.3%。批间精密度CV分别为3.94%、2.70%,符合判断标准≤8.3%。正确度:平均偏倚为4.03%,符合判断标准≤12.5%。携带污染率为0.24%。线性:Y=0.983 4X-1.704 4,a=0.983 4,r2=0.99,实测线性范52.8～1 500 IU/ml。结论仪器分析性能验证是为保证检验结果的准确性。西门子特定蛋白仪测定ASO的精密度、正确度、携带污染率、线性及可报告范围,结果与质量目标比较,均符合要求,可用于临床标本检测。

Objective To evaluate the performance of an automated protein analysis BN II of Siemens for detecting ASO. Methods CLSI protocols and other relevant literature were used to evaluate the precision, accuracy, contamination rate, linearity of ASO detection by the auto - analyzer system, and the results were compared with the recognized standards. Results Intra - assay preci- sion： CV was 2.9% and 2.8% , in line with the criteria for judging ~〈 6.3%. The inter - assay precision： CV was 3.94% and 2. 70% , in line with the criteria for judging ~ 8.3%. Accuracy： the average bias of 4.03% , in line with the criteria for judging ~〈 12. 5%. And the contamination rate was 0.24%, linearity： Y = 0.9834X- 1. 7044, a =0.9834, r2 = 0.99, and the tests with a linearity range of 52.8 - 1500 IU/mL. Conclusion The performance of an automated protein analysis BN ]I of Siemens basically meet the recog- nized standards in clinical detection of ASO.