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RISS 인기검색어
- 검색키워드
- 주제어 : Glycated Hb (검색결과 3 건)
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Accurate and Rapid Measurement of Glycated Hemoglobin Using HLC-723 G11 Variant Mode
박민승,이경훈,이경훈,송정한,박형두 대한진단검사의학회 2019 Annals of Laboratory Medicine Vol.39 No.3
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.
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Jose-Maria Maesa,,Patricia Fernandez-Riejos,Concepcion Gonzalez-Rodriguez,Victor Sanchez-Margalet 대한진단검사의학회 2019 Annals of Laboratory Medicine Vol.39 No.6
Background: Physiological changes during pregnancy, such as dilutional anemia and a reduced half-life of red blood cells, have prevented the use of glycated Hb (HbA1c) as a biomarker for gestational diabetes mellitus (GDM). Nevertheless, increasing evidence supports the use of HbA1c in GDM diagnostic strategies.We studied HbA1c as a biomarker of GDM and its possible use as a screening test to avoid the use of the glucose challenge test (GCT). Methods: This case-control study involved 607 pregnant women between the 24th and 28th week of gestation. HbA1c level was determined, and GDM was diagnosed according to the National Diabetes Data Group criteria. The area under the ROC curve (AUC) was determined; two low and two high cut-off points were established to rule out GDM and classify high-risk pregnant women, respectively. For each cut-off, sensitivity (S), specificity (SP), and total number and percentage of GCTs avoided were determined. Results: The AUC for HbA1c diagnostic performance was 0.68 (95% confidence interval 0.57–0.79). Using 4.6% HbA1c (27 mmol/mol) as the lower cut-off (S=100%), 14% of participants could avoid the GCT. Using 5.5% HbA1c (36 mmol/mol) as the upper cut-off (SP =94.5%), 6% of participants would be considered at high risk. Conclusions: HbA1c can be used as a screening test prior to the GCT, thereby reducing the need for the GCT among pregnant women at a low risk of GDM.
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