Lab Med Online.  2017 Apr;7(2):59-65. 10.3343/lmo.2017.7.2.59.

Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay

Affiliations
  • 1Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea. comforter6@yuhs.ac

Abstract

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.

Keyword

Hemoglobin A1c; Bio-Rad D-100; Analytical performance
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