Ann Lab Med.  2019 May;39(3):237-244. 10.3343/alm.2019.39.3.237.

Accurate and Rapid Measurement of Glycated Hemoglobin Using HLC-723 G11 Variant Mode

• Park MS
• Lee K
• Lee K
• Song J
• Park HD

• KMID: 2431600
• DOI: http://doi.org/10.3343/alm.2019.39.3.237

Abstract

BACKGROUND
Type II diabetes mellitus causes many complications, and its prevalence continues to increase in Korea. Accurate measurement of glycated Hb (HbA1c) is important because of its usefulness in diagnosis, follow-up, and prediction of prognosis. We tested the analytical performance of the HLC-723 G11 Variant Mode (G11vr; Tosoh Bioscience, Inc., Tokyo, Japan), recently introduced to Korea, in detecting HbA1c.
METHODS
We evaluated precision, linearity, carry-over, and turnaround time. Using 208 samples, including 108 flagged samples, we compared HbA1c concentrations from four analyzers through correlation analysis: G11vr, HLC-723 G8 Variant Mode (G8vr, Tosoh Bioscience), HLC-723 G11 Standard Mode (G11st, Tosoh Bioscience), and HLC-723 G8 Standard Mode (G8st, Tosoh Bioscience). We used HPLC mass spectrometry (MS) and capillary electrophoresis (CE) to confirm the HbA1c concentrations of 15 additional known Hb variant samples.
RESULTS
Repeatability (% CV) in measuring low- and high-concentration controls was 0.57% and 0.35%, respectively; within-laboratory precision was 0.86% and 0.69%, respectively. In a linearity test, the coefficient of determination was 0.9999 (measurement range: 3.64% to 18.59%) for HbA1c. The correlations between G11vr and other analyzers were weaker for flagged samples than for non-flagged samples. The carry-over effect was less than 0.4%. Turnaround time for a single sample was lower in G11vr (one minute) than in G8vr (1.6 minutes). For 15 samples with Hb variants, G11vr HbA1c results were more similar than those of other analyzers to HPLC-MS and CE results.
CONCLUSIONS
G11vr showed adequate performance and rapid turnaround time in measuring HbA1c.

Keyword

HbA1c; Hb variants; Glycated Hb; Tosoh HLC-723 G11 analyzer; Performance

MeSH Terms

Chromatography, High Pressure Liquid
Diabetes Mellitus
Diagnosis
Electrophoresis, Capillary
Follow-Up Studies
Hemoglobin A, Glycosylated*
Korea
Mass Spectrometry
Prevalence
Prognosis

Figure

• 

  Fig. 1 Correlations and difference plots of HbA1c measurements between different analyzers. (A) G11vr vs G8vr in samples without flags, (B) G11vr vs G11st in samples without flags, (C) G11vr vs G8st in samples without flags, (D) G11vr vs G8vr in samples with flags, (E) G11vr vs G11st in samples with flags, (F) G11vr vs G8st in samples with flags.Abbreviations: G11vr, HLC-723 G11 Variant Mode (Tosoh Bioscience, Inc., Tokyo, Japan); G8vr, HLC-723 G8 Variant Mode (Tosoh Bioscience); G11st, HLC-723 G11 Standard Mode (Tosoh Bioscience); G8st, HLC-723 G8 Standard Mode (Tosoh Bioscience).

• 

  Fig. 2 Box-and-whisker plot of the differences between each analyzer and HPLC-MS HbA1c results for 15 known Hb variants. The central box represents the interquartile range, and the middle line indicates the median (G11vr, 0.2; G8vr, −0.5; G11st, −1.3; G8st, −1.2). A line extends from the minimum to the maximum value, excluding single outlier in G8st, which is displayed as a separate point for G8st.Abbreviations: G11vr, HLC-723 G11 Variant Mode (Tosoh Bioscience, Inc., Tokyo, Japan); G8vr, HLC-723 G8 Variant Mode (Tosoh Bioscience); G11st, HLC-723 G11 Standard Mode (Tosoh Bioscience); G8st, HLC-723 G8 Standard Mode (Tosoh Bioscience).

• 

  Fig. 3 Chromatograms of the three samples with known Hb-variant. The black part in the chromatogram represents the HbA1c region. (A) Sample B-4 (Hb G-Coushatta): (B) Sample B-8 (Hb G-Coushatta): (C) Sample B-9 (Hb Queens [α]).Abbreviations: G11vr, HLC-723 G11 Variant Mode (Tosoh Bioscience, Inc., Tokyo, Japan); G8vr, HLC-723 G8 Variant Mode (Tosoh Bioscience).

• 

  Fig. 4 Turnaround times from sample mounting to result reporting. Turnaround times for one sample (A), 10 samples (B), and 30 samples (C) on the different analyzers. No flagged sample was detected.Abbreviations: G11vr, HLC-723 G11 Variant Mode (Tosoh Bioscience, Inc., Tokyo, Japan); G8vr, HLC-723 G8 Variant Mode (Tosoh Bioscience); G11st, HLC-723 G11 Standard Mode (Tosoh Bioscience); G8st, HLC-723 G8 Standard Mode (Tosoh Bioscience).

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