Verification of the Performance of Roche Cobas e801 Immune Analyzer for Detecting Serum AMH
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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