Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method

As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c.MethodsWhole blood EDTA samples from subjects (n=100) with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at −20 °C for 14 and 28 days post collection.ResultsMedian (IQR) HbA1c was 60 (44.0–71.2) mmol/mol (7.6 (6.17–8.66) %) and 62 (45.0–69.0) mmol/mol (7.8 (6.27–8.46) %) for D10 and Quo-Test, respectively, with very good agreement (R2=0.969, P<0.0001). Mean (range) intra- and inter-assay variation was 1.2% (0.0–2.7%) and 1.6% (0.0–2.7%) for the D10 and 3.5% (0.0–6.7%) and 2.7% (0.7–5.1%) for the Quo-Test. Mean change in HbA1c after 28 days storage at −20 °C was −0.7% and +0.3% for D10 and Quo-Test respectively. Compared to the D10, Quo-Test showed 98% agreement for diagnosis of glucose intolerance (IGT and T2DM) and 100% for diagnosis of T2DM.ConclusionGood agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method

Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis

This study utilizes three unique data sets to demonstrate the state of the art of HbA1c analyzers in a range of settings and compares their performance against the international guidance set by the IFCC task force for HbA1c standardization. The data is used to demonstrate the effect of tightening of those criteria and the study serves as a guide to the practical implementation of the sigma metrics approach in a range of clinical settings

Prevalence of Diabetes on Santa Cruz Island in Galapagos Archipelago.

This was an observational study offering a screening program for diabetes in a health clinic in Puerto Ayora town on Santa Cruz Island to determine the prevalence of this disorder and identify those at risk. A 1-month screening program was undertaken. Of 141 patients screened, 85% of men and 83% of women were overweight or obese; 16 (11%) had suspected undiagnosed diabetes and 22 (16%) were at high risk of developing diabetes. This is the first reported study of glucose intolerance prevalence in Galapagos. Urgent education and prevention programs are required to address this public health problem

An Emerging Diabetes Mellitus Diagnosis Modality: HbA1c

Classically, the diagnosis of diabetes has been made using the fasting plasma glucose, random plasma glucose, or a 2-hr 75-g oral glucose tolerance test. There are many problems with the definition of diabetes based on blood glucose levels, such as the high intra-individual biological variability, variability in the collection and storage methods, and difficulty in ensuring a fasting state before measuring the blood glucose [1]. Recently, the hemoglobin A1c (HbA1c) assay has also been recommended for the diagnosis of diabetes. The HbA1c concentration is a good indicator of glycemic control over the previous 8-12 weeks; the time period is dictated by the 120-day lifespan of erythrocytes. HbA1c is used as the standard biomarker for the adequacy of glycemic management since it correlates well with both microvascular and, to a lesser extent, macrovascular complications based on

Male gender is an important clinical risk factor for iron deficiency in healthy infants

Author's personal copy ; Acknowledgements to the children and families who were involved in this study, and to BH Pathology Clinic Dpt.Background & aims: To identify ID risk factors in infancy, and try to explore why ID is more prevalent in boys than in girls in the first year of life. Methods: A multiple logistic regression was performed on data of 201 infants, with ferritin<12 ng/ml as the dependent variable and months of breastfeeding, weight gain from birth to 9 months (WG), and gender as independent variables. To compare haematological parameters we used Manne-Whitney and t test. Results: From the 39 infants with IDA (19.4%), 24 (61.5%) were male and of the 162 infants without IDA, 50% were male (p ¼ 0.195). The median(minimum; maximum) ferritin concentrations in male infants at 9 months was of 9.8 ng/ml (0.5e67.0 ng/ml) and in females 14 ng/ml (0.5e74.5 ng/ml), p < 0.001. The average (±SD) WG was of 5863.3 g (±855.4 g) in male infants and 5556.9 g (±1054.3 g) in female infants (p = 0.027). A multiple logistic regression (OR; 95%CI) showed that male gender was the most important risk factor (OR: 3.3; 1.7e6.3; p < 0.001), followed by a higher weight increase (OR: 1.6; CI [1.1; 2.2]; p = 0.016) and longer breastfeeding time (OR: 1.1; CI [0.98; 1.2]; p = 0.099). Comparison of other haematological parameters at 9 months in relation to gender (males (M): 105; females (F): 96) showed significant differences in: mean ± SD, Mean Corpuscular Haemoglobin (M: 25.0 ± 2.1; F: 25.8 ± 2.4 pg, p = 0.001), Mean Corpuscular Volume (M: 73.4 ± 4.1; F: 75.3 ± 4.2 fl, 0.009), RDW (M: 14.6 ± 1.5; F: 14.1 ± 1.6%, p = 0.048), Plaquelets (M: 324.9 ± 77.9; F: 350.5 ± 81.4 x 10³/µl, p = 0.026). Conclusions: ID was significantly more frequent in male infants, independent of rapid growth or longer breastfeeding duration. The clinical risk profile for ID in infants includes male gender and not only rapid growth, and longer breastfeeding duration.This study received a scholarship from the Foment Commission for Investigation in Health Care, from the Health Ministry P.I. nº 87/07

Impact of HbA1c Criterion on the Detection of Subjects with Increased Risk for Diabetes among Health Check-Up Recipients in Korea

BackgroundWe performed the study to examine the impact of hemoglobin A1c (HbA1c) criterion on the screening of increased risk for diabetes among health check-up subjects in Korea.MethodsWe retrospectively analyzed clinical and laboratory data of 37,754 Korean adults (age, 20 to 89 years; 41% women) which were measured during regular health check-ups. After excluding subjects with previously diagnosed diabetes mellitus (n=1,812) and with overt anemia (n=318), 35,624 subjects (21,201 men and 14,423 women) were included in the analysis.ResultsAmong the 35,624 subjects, 11,316 (31.8%) subjects were categorized as increased risk for diabetes (IRD) by fasting plasma glucose (FPG) criteria, 6,531 (18.1%) subjects by HbA1c criteria, and 13,556 (38.1%) subjects by combined criteria. Therefore, although HbA1c criteria alone identifies 42% [(11,316-6,531)/11,316] fewer subjects with IRD than does FPG criteria, about 20% [(13,556-11,316)/11,316] more subjects could be detected by including new HbA1c criteria in addition to FPG criteria. Among the 13,556 subjects with IRD, 7,025 (51.8%) met FPG criteria only, 2,240 (16.5%) met HbA1c criteria only, and 4,291 (31.7%) met both criteria. Among subjects with impaired fasting glucose, 65% were normal, 32% were IRD, and 3% were diabetes by HbA1c criterion. In receiver operating characteristic curve analysis, cutoff point of HbA1c with optimal sensitivity and specificity for identifying IRD was 5.4%.ConclusionAlthough HbA1c criteria alone identifies fewer subjects with IRD than does FPG criteria, about 20% more could be detected by addition of HbA1c criteria. Further studies are needed to define optimal cutoff point of HbA1c and to establish screening and management guidelines for IRD

Investigating concordance in diabetes diagnosis between primary care charts (electronic medical records) and health administrative data: a retrospective cohort study

<p>Abstract</p> <p>Background</p> <p>Electronic medical records contain valuable clinical information not readily available elsewhere. Accordingly, they hold important potential for contributing to and enhancing chronic disease registries with the goal of improving chronic disease management; however a standard for diagnoses of conditions such as diabetes remains to be developed. The purpose of this study was to establish a validated electronic medical record definition for diabetes.</p> <p>Methods</p> <p>We constructed a retrospective cohort using health administrative data from the Institute for Clinical Evaluative Sciences Ontario Diabetes Database linked with electronic medical records from the Deliver Primary Healthcare Information Project using data from 1 April 2006 - 31 March 2008 (N = 19,443). We systematically examined eight definitions for diabetes diagnosis, both established and proposed.</p> <p>Results</p> <p>The definition that identified the highest number of patients with diabetes (N = 2,180) while limiting to those with the highest probability of having diabetes was: individuals with ≥2 abnormal plasma glucose tests, or diabetes on the problem list, or insulin prescription, or ≥2 oral anti-diabetic agents, or HbA1c ≥6.5%. Compared to the Ontario Diabetes Database, this definition identified 13% more patients while maintaining good sensitivity (75%) and specificity (98%).</p> <p>Conclusions</p> <p>This study establishes the feasibility of developing an electronic medical record standard definition of diabetes and validates an algorithm for use in this context. While the algorithm may need to be tailored to fit available data in different electronic medical records, it contributes to the establishment of validated disease registries with the goal of enhancing research, and enabling quality improvement in clinical care and patient self-management.</p

Diabetes screening by telecentric digital holographic microscopy

Diabetes is currently the world's fastest growing chronic disease and it is caused by deficient production of insulin by the endocrine pancreas or by abnormal insulin action in peripheral tissues. This results in persistent hyperglycaemia that over time may produce chronic diabetic complications. Determination of glycated haemoglobin level is currently the gold standard method to evaluate and control sustained hyperglycaemia in diabetic people. This measurement is currently made by high-performance liquid chromatography, which is a complex chemical process that requires the extraction of blood from the antecubital vein. To reduce the complexity of that measurement, we propose a fully-optical technique that is based in the fact that there are changes in the optical properties of erythrocytes due to the presence of glucose-derived adducts in the haemoglobin molecule. To evaluate these changes, we propose to perform quantitative phase maps of erythrocytes by using telecentric digital holographic microscopy. Our experiments show that telecentric digital holographic microscopy allows detecting, almost in real time and from a single drop of blood, significant differences between erythrocytes of diabetic patients and healthy patients. Besides, our phase measurements are well correlated with the values of glycated haemoglobin and the blood glucose values