| Objective:According to the CLSI evaluation protocols, to verify the main analyzing performance of HA-8180automatic automatic glycated hemoglobin analyzer, which is performed by ARKRAY in Japan. To establish the reference range of HbA1c in Kunming healthy people and analyze the relationship between HbA1c and age or gender. To explore the value of HbA1c in diabetes.Methods:In terms of the EP documents of CLSI, such as EP5-A2(Evaluation of Precision Performance of Clinical Chemistry Devices), EP6-A2(Evaluation of the Linearity of Quantitative Analytical Methods), EP9-A2(Method Comparison and Bias Estimation Using Patient Samples), EP10-A(preliminary evaluation of quantitative clinical laboratory methods),to evaluate the precision,the detection limit,linearity,interference and accuracy of HA-8180.494healthy people and125patients with diabetes were collected and analyzed by HA-8180.494healthy people and125patients with diabetes were collected and analyzed by HA-8180. The95%confidence interval was determined as the reference range of HbA1c by the percentage method and the relationship of HbA1c and age or gender was analyzed. The optimal cut-points of HbA1c in diagnosis of DM were acquired using a receiver operating characteristic curve (ROC curve).Results:The coefficient variance (CV) of within-batch precision was0.58%,0.28%and the CV of total precision was0.89%,0.81%in high/low level respectively.The result of HbA1c between HPLC and latex-enhanced were correlated (R2=0.9748,Y=0.96X+0.035).Linearity was demonstrated well for HPLC when was3.5%-14.8% (Y=0.218+0.992X).The carryover rate of HPLC was0%.The reference range of HbA1c in kunming healthy people was less than5.9%.The optimal cut-point of HbA1c in ROC curve was6.6%, with Sensitivity of95.5%, specificity of94.2%, AUC of0.987[95%CI(0.979,0.994)],Youden index of, positive likelihood (+LR) of19.9, negative likelihood values (-LR) of0.05.Conclusion:HPLC had good performance and it could early be used to screen diabetes... |
PDF Full Text Request