Ann Lab Med.  2023 Mar;43(2):167-173. 10.3343/alm.2023.43.2.167.

Performance Evaluation of the DxC 700 AU Chemistry Analyzer in Hemoglobin A1c Measurement

• Choi YJ
• Kang H
• Cho CI
• Rim JH
• Lee SG
• Lim JB

• KMID: 2551693
• DOI: http://doi.org/10.3343/alm.2023.43.2.167

Abstract

Background
Accurate measurement of glycated hemoglobin (HbA1c) is crucial for a diabetes diagnosis and subsequent patient management. The detection method and presence of variant Hb can interfere with HbA1c measurements. We evaluated the HbA1c-measuring performance of the DxC 700 AU (Beckman Coulter, Brea, CA, USA) immunoassay-based device in comparison with another immunoassay device and the reference method.
Methods
A total of 120 normal and 14 variant Hb samples were analyzed using the Cobas c 513 (Roche Diagnostics, Mannheim, Germany) and DxC 700 AU analyzers. Variant Hb samples were also analyzed using the reference method, along with 20 normal samples. The accuracy, precision, linearity, and carryover were determined.
Results
DxC 700 AU results strongly correlated with those of Cobas c 513 and exhibited accuracy in comparison with the reference method. The within-run, between-run, between-day, and total imprecision (%CV) values for the low- and high-concentration control materials were below 2%. The results of DxC 700 AU were linear over a wide HbA1c range (3.39%–18.30%). Although DxC 700 AU performed well in the presence of variant Hb, the HbA1c concentration was underestimated in the presence of fetal Hb. The possibility of interference from a high HbH proportion could not be ruled out.
Conclusions
The overall analytical performance of DxC 700 AU was acceptable. The device is accurate, precise, and linear over a wide HbA1c concentration range. Although DxC 700 AU results highly correlated with those of Cobas c 513, caution should be exercised in cases of high HbF and HbH concentrations.

Keyword

Hemoglobin A1c; Fetal hemoglobin; Variant hemoglobin

Figure

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  Fig. 1 DxC 700 AU compared to Cobas c 513. (A) Comparison between the HbA1c-measuring performance of Cobas c 513 and DxC 700 AU analyzers using Passing–Bablok analysis. (B) Percent difference plot of Cobas c 513 and DxC 700 AU results using Bland–Altman analysis (solid line indicates the mean value, whereas dotted lines indicate mean±1.96×SD values).

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