摘要
目的:对罗氏cobas e801免疫分析仪检测血清抗缪勒管激素(AMH)进行性能验证,评估其是否能够满足临床需求.方法:参照美国临床和实验室标准协会文件,对罗氏cobas e801免疫分析仪检测血清AMH的精密度、准确度、线性范围、携带污染率进行性能验证.结果:罗氏cobas e801免疫分析仪检测低值、高值AMH的批内精密度变异系数分别为4.8％、3.7％,批间精密度变异系数分别为3.5％、5.1％,符合厂家要求临床应用批内精密度、批间精密度＜10％的标准.室间质评5个样品检测结果与靶值进行比对,相对偏倚分别为0.81％、-0.22％、0.85％、-2.73％、1.77％,符合厂家准确性相对偏倚的要求范围±10％.AMH的携带污染率为0.39％,符合厂家≤2.0％的要求.AMH的线性回归方程为Y=0.980 9X+0.658 8,斜率a为0.980 9,R2为0.996,结果符合厂家要求,a值1±0.05,R2值≥0.95.结论:罗氏cobas e801免疫分析仪检测AMH的精密度、准确度、携带污染率、线性范围均通过验证,检测结果准确可靠,可以满足临床的需求.
Abstract
Objective:To verify the performance of Roche cobas e801 immune analyzer for detecting serum antimullerian hormone(AMH),and to evaluate whether it can meet the clinical needs.Methods:According to the documents of American Institute of Clinical and Laboratory Standards,the precision,accuracy,linear range and contamination rate of serum AMH were verified by Roche cobas e801 immune analyzer.Results:The coefficients of variation of in-batch precision and inter-batch precision of Roche cobas e801 immune analyzer for detecting low and high AMH were 4.8％and 3.7％,respectively,and 3.5％and 5.1％,respectively,which met the requirements of the manufacturers for in-batch precision and inter-batch precision＜10％.The results of the 5 samples from the room quality assessment were compared with the target values,and the relative bias was 0.81％,-0.22％,0.85％,-2.73％and 1.77％,respectively,which met the manufacturer's requirements for relative bias of accuracy within±10％.The contamination rate of AMH was 0.39％,which met the manufacturer's requirement of ≤2.0％.The linear regression equation of AMH was Y=0.980 9X+0.658 8,the slope a was 0.980 9,R2 was 0.996,and the results met the requirements of the manufacturer,a value was 1±0.05,and R2 ≥ 0.95.Conclusion:The precision,accuracy,linear range and contamination rate of AMH detected by Roche cobas e801 immune analyzer have been verified.The detection results are accurate and reliable,which can meet the clinical needs.
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