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Methodological comparison and bias estimation between two hemoglobin A1c detection systems

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Author:
No author available
Journal Title:
Chinese Journal of Diabetes
Issue:
10
DOI:
10.3969/j.issn.1006-6187.2017.09.008
Key Word:
糖化血红蛋白;检测系统;方法学比对;EP9-A2;Hemoglobin Alc;Detection system;Methodological comparison;EP9-A2

Abstract: Objective To evaluate the result's comparability of Point-of-Care Testing system by the methodological comparison and bias estimation between Afinion AS100 and POCT system.Methods Afinion AS100 and the POCT system were used as the control(X) and the comparison(Y) respectively.According to the EP9-A2 file of the Clinical and Laboratory Standards Institute (CLSI),the two systems were used to detect HbA1 c.Using half of permissible error range of CLIA'88 document rated external quality assessment as reference,the clinical acceptance of the result deviation was evaluated according to the test results,outlier detection,correlation coefficient and linear regression equation.Results The two detection methods showed that intra-batch coefficient of variation (CV) was less than 5 % and inter-batch CVwas less than 6.67%,achieving the requirements of CLSI.No outlier was detected,in this two methods.Regression equation was generated after statistical analysis (Y=1.0075X-0.0693,R2 =0.9982).Conclusion The experimental method correlates well with the reference method,and the deviation was within permissible error range in clinical practice.

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