Analytical performances of a glycated albumin assay that is traceable to standard reference materials and reference range determination

Tao, Xinran; Koguma, Ryosuke; Nagai, Yoko; Kohzuma, Takuji

doi:10.1002/jcla.24509

Cited by 4 publications

(2 citation statements)

References 41 publications

(70 reference statements)

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“…In brief, even though the findings of our study suggest a correlation between EPG or AGE and BMD in individuals with diabetes, the extent of this association remains uncertain due to existing literature, indicating that osteoporotic fractures can occur in diabetic patients even in the absence of noticeable changes in bone density, a phenomenon referred to as the “diabetic paradox” [ 40 ].…”

Section: Discussionmentioning

confidence: 79%

Differential Association of Glycation Products with Bone Mineral Density and Fat Mass in Healthy and Diabetes Type 2 Subjects from Mexican Southeastern: A Cross Sectional Study

Ferreyro-Bravo,

Ceballos-Cruz,

Urruchua-Rodríguez

et al. 2023

Medicina

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Background: Glycation products have been linked to decreased bone mineral density (BMD) in a number of clinical settings. This study examined the correlation between early glycation products (HbA1c and glycated albumin (ALB-g)) and advanced glycation end products (pentosidine (PTD)) with BMD in two groups of participants: those with type 2 diabetes mellitus (DM2) and those without diabetes or any other comorbidities (noDM). All of the participants had resided in southeastern Mexico for a minimum of 10 years. Material and Methods: This study included 204 participants: 112 (55%) with DM2 and 92 (45%) healthy subjects. We utilized dual X-ray absorptiometry (DXA) to measure both the total and segment-specific BMD and adipose mass. In addition, the fasting blood glucose, HbA1c, PTD, and ALB-g parameters were measured. Correlation and logistic regression analyses were conducted. Results: There was an inverse correlation between PTD and BMD in all anatomical regions among postmenopausal women (PMW) in the DM2 group, whereas in non-PMW, only the waist-to-height ratio was statistically significant. A negative correlation was observed between HbA1c levels and BMD in the arms and legs of DM2 individuals. However, in the noDM group, a negative correlation was found between HbA1c levels and BMD in the pelvis, while a positive association was observed between HbA1c and indicators of adipose tissue. ALB-g, demonstrated a negative correlation with fat mass. After performing binary logistic regressions, the following odds ratios (OR) for osteopenia/osteoporosis risk were determined: PTD OR 1.1 (p = 0.047) for DM2 PMW, HbA1c OR 1.4 (p = 0.048), and fat mass content OR 1.011 (p = 0.023) for the entire sample. Conclusions: Glycation products are associated with BMD differentially depending on the analyzed anatomical segment, but PTD, HbA1c, and fat mass are significant predictors of low bone mass. In prospective studies, this association could be determined using other techniques involving three-dimensional analysis of bone architecture to evaluate bone architecture.

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Section: Discussionmentioning

confidence: 79%

Differential Association of Glycation Products with Bone Mineral Density and Fat Mass in Healthy and Diabetes Type 2 Subjects from Mexican Southeastern: A Cross Sectional Study

Ferreyro-Bravo,

Ceballos-Cruz,

Urruchua-Rodríguez

et al. 2023

Medicina

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“…The Lucica Glycated Albumin–L test (Asahi Kasei Pharma) is an enzymatic assay for GA in which a ketoamine oxidase and peroxidase reaction is used to eliminate endogenous glycated amino acids and peroxide ( 9 , 10 ). The remaining GA is hydrolyzed to amino acids or peptides by an albumin-specific proteinase and measured quantitatively.…”

mentioning

confidence: 99%

Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine

Desouza

Rosenstock

Kohzuma

et al. 2023

The Journal of Clinical Endocrinology &Amp; Metabolism

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Context Intermediate-term glycemic control metrics may represent a viable alternative to continuous glucose monitoring (CGM) in patients without access to CGM. Objective Compare relationship between CGM parameters and glycated albumin (GA), HbA1c, and fructosamine for 24 weeks. Design Exploratory comparative analyses of CGM subgroup data from a previously published 24-week prospective study of assay performance. Setting 8 US clinics. Participants 34 subjects with type 1 (n = 18) and type 2 diabetes (n = 16) undergoing changes to improve glycemic control (n = 22; Group 1) or with stable diabetes therapy (n = 12; Group 2). Interventions Not applicable. Main Outcome Measures Pearson correlations between CGM and glycemic indices and receiver operator characteristic (ROC) analysis of glycemic index values predictive of time in range (TIR) > 70%. Results At Weeks 4 and 8, GA correlations with TIR were higher than HbA1c correlations in Group 1. In Group 2, GA correlations with TIR were significant, whereas HbA1c correlations were not. In both groups over the first 12 weeks, GA correlations with TIR were higher than fructosamine-TIR correlations. In the ROC analysis, GA predicted a TIR >70% during Weeks 2-24 (area under the curve [AUC] > 0.80); HbA1c was predictive during Weeks 12-24. Cutoff values for TIR >70% were 17.5% (sensitivity and specificity, 0.88) for GA and 7.3% (0.86) for HbA1c. Conclusions GA is the most accurate predictor of TIR over 8 weeks compared with other glycemic indices, which may assist in clinical evaluation of changes in treatment where CGM is not possible and it is too early to use HbA1c (NCT02489773).

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Analytical performances of a glycated albumin assay that is traceable to standard reference materials and reference range determination

Tao

Koguma

Nagai

et al. 2022

Clinical Laboratory Analysis

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Background: Glycated albumin (GA) is an intermediate-term marker for monitoring glycemic control (preceding 2-3 weeks) in patients with diabetes mellitus. We evaluated the performance of Lucica Glycated Albumin-L, a new GA assay that is traceable to standard reference materials and determined the reference range in healthy subjects without diabetes. Methods:The performance and reference range studies were conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) Guidelines. The traceability was established using reference material recommended by the Japan Society of Clinical Chemistry (JSCC). Results:The coefficient of variation (CV) of overall repeatability, within-laboratory precision, and overall reproducibility values of GA values were not more than 2.6%, 3.3%, and 1.6%, respectively, among laboratories. The GA values showed good linearity from 173 to 979 mmol/mol (9.4%-54.9%) across the assay range. The GA reference range in 262 healthy subjects was between 183 and 259 mmol/mol (9.9%-14.2%) while that of subjects with diabetes was 217-585 mmol/mol (11.8-32.6%). The reagent was stable for 2 months on the bench at room temperature. The limits of blank, detection, and qualification were 6.9, 7.9, and 9.7 μmol/L for GA concentration, and 3.8, 7.0, and 21.8 μmol/L for albumin concentration, respectively. Hemoglobin slightly affected the assay, while other classical interfering substances had no significant impact. Conclusions:The present GA assay shows comparable performance to current clinical assays and could be used for intermediate-term monitoring of glycemic control in diabetes patients.

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Analytical performances of a glycated albumin assay that is traceable to standard reference materials and reference range determination

Cited by 4 publications

References 41 publications

Differential Association of Glycation Products with Bone Mineral Density and Fat Mass in Healthy and Diabetes Type 2 Subjects from Mexican Southeastern: A Cross Sectional Study

Differential Association of Glycation Products with Bone Mineral Density and Fat Mass in Healthy and Diabetes Type 2 Subjects from Mexican Southeastern: A Cross Sectional Study

Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine

Analytical performances of a glycated albumin assay that is traceable to standard reference materials and reference range determination

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