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Performance Evaluation of the ARKRAY HA-8180 Automatic Glycosylated Hemoglobin Analyzer for HbA1c

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  • Center of Clinical Laboratory, Zhongshan Hospital, Xiamen University, Xiamen 361004, China

Received date: 2014-06-17

  Revised date: 2014-10-12

  Online published: 2014-12-26

Abstract

Objective To evaluate the performance of ARKRAY HA-8180 automatic glycosylated hemoglobin analyzer (HA-8180) for the determination of glycosylated hemoglobin A1c (HbA1c) in whole blood with the principle of ion-exchange high performance liquid chromatography (HPLC). Methods The precision, carryover, accuracy, recovery test, linearity and reference interval of HbA1c were determined by HA-8180 based on the Clinical and Laboratory Standards Institute (CLSI) evaluation protocols EP15-A2, EP6-A, EP28-A3C. The results were compared with the performance analysis of the manufacturer or recognized quality index. Results The repeatability and within-laboratory precision coefficients of variation (CV) of both low and high levels of HbA1c were 0.76%, 0.50% and 0.79%, 0.51%, respectively. There was no obvious carryover when high level and low level samples were analyzed sequentially, and the carryover rate was 1.08%.The relative bias was between -1.39 to 1.29%, and the bias coincidence was 100%.The average recovery rate was 101.54%. The results showed a good linearity in a range of 4.7 - 15.8%. The biotic reference intervals were in the range of 4.0 - 6.0%, provided by Diabetes Control and Complication Trail/United Kingdom Prospective Diabetes Study (DCCT/UKPDS).Conclusion HA-8180 has a good performance for HbA1c determination, and can be widely used in clinical application

Cite this article

JIN Hong-wei, HUANG Hui-bin, WANG Xin-xin . Performance Evaluation of the ARKRAY HA-8180 Automatic Glycosylated Hemoglobin Analyzer for HbA1c[J]. Labeled Immunoassays and Clinical Medicine, 2014 , 21(6) : 729 . DOI: 10.11748/bjmy.issn.1006-1703.2014.06.034

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