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KMID : 1100820170070020059
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Laboratory Medicine Online
2017 Volume.7 No. 2 p.59 ~ p.65
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Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay
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Liu Chang-Seung
Choi Eun-Hye
Bae In-Cheol
Lee Sang-Guk
Kim Jeong-Ho
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Abstract
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Background: Hemoglobin A1c (HbA1c) is considered a marker useful for the follow-up and diagnosis of diabetes and implies the importance of reliable assay methods that are traceable to a reference method. We evaluated analytical performance of a new high-performance liquid chromatography system for the HbA1c assay: D-100 from Bio-Rad Laboratories (USA).
Methods: We evaluated precision, linearity, and carry-over of D-100, according to the Clinical and Laboratory Standards Institute's guidelines. Comparative analysis of D-100 with Integra 800 (Roche Diagnostics, Germany) and Capillarys 3 (Sebia, France) was conducted. Additionally, we evaluated the throughput of the three instruments.
Results: Precision of low- and high-concentration controls in D-100 showed a CV of less than 1%. The linearity was excellent (R2=0.999) in the range of 3.51-18.7%, and carry-over was not observed. HbA1c results of D-100 (n=144) showed good correlation with those of Integra 800 (r=0.993) and Capillarys 3 (r=0.996). The % bias between D-100 and Integra 800 or Capillarys 3 was within the allowable range at all 3 medical decision levels (5.7%, 6.5%, and 10.0%). Elapsed time in the analysis of the first sample by D-100 was shorter than that of Integra 800 (2.4 vs. 11.1 minutes), but subsequent samples took more time (0.8 vs. 0.3 minutes per sample).
Conclusions: D-100 showed reliable analytical performance with good precision and linearity, minimal carry-over, and acceptable comparative characteristics relative to other instruments. D-100 is expected to be useful for clinical measurements of HbA1c for diabetes diagnosis and theranostics.
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KEYWORD
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Hemoglobin A1c, Bio-Rad D-100, Analytical performance
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