Development of the optimal procedure for increasing HbA1c concentration in control materials for external quality assessment (original) (raw)
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Background: HbA1c as valuable marker in management of diabetes is measured in the most of medical laboratories in Croatia. Aim of this study is to present the results of external quality control assessment (EQA) in Croatian medical laboratories for HbA1c. Material and methods: Results were obtained from 93 laboratories that participated in cycle of EQA scheme in 2013.The control sample was commercial, lyophilized human blood specimen with normal HbA1c value. The results were entered on-line, as a dual system of reporting: DCCT (%) and IFCC (mmol/mol), and DCCT results were analyzed. Outliers (N=14) were excluded according to Tukey´s model and mean (X), standard deviation (SD) and coefficient of variation (CV) were calculated. According to quality specifications established in CROQALM, the allowable deviation from the mean was ±5%. Results: The results were divided in two groups according to the method (immunoassay and colorimetric method). For immunoassay methods (82 participants, s...
International Journal of Current Research and Review, 2013
Introduction: India has an overwhelming diabetic population and the importance of HbA1c testing is felt. However the need of an additional EDTA sample and due to lack of standardised laboratories in most part of India, samples are stored and transported for testing. The study aims to check the variation in HbA1c measurement in K 3 EDTA, Na-citrate, lithium-heparin and Na-fluoride/Na 2 EDTA anticoagulant vials and check for its stability when sample are stored at 2-8°C for 7 days. Methods and materials: HbA1c was measured by cation exchange HPLC based BioRad D-10 analyser after collection of sample in K 3 EDTA, Na-citrate, lithium-heparin and Na-fluoride/Na 2 EDTA from 25 diabetic and 25 non-diabetic subjects on day 1 and on day 3, day 5 and day 7 of sample collection, after storage at 2-8°C. Result: There were no variation in the measured value of HbA1c in these anticoagulant vials (CV = 0.0-0.8%). There were no significant differences in the mean values of the HbA1c measured on day 1 and day 7 (8.2 ± 1.16 vs. 8.2 ± 1.18, P = 0.962 in diabetic and 5.3 ± 0.25 vs. 5.3 ± 0.24, P = 0.955 in non-diabetic). There were significant correlations between the HbA1c values measured on day 1 and after 7 days storage (r = 0.991 in diabetic and r = 0.957 in non-diabetic). Conclusion: HbA1c values in fresh and stored whole blood sample does not change when analysed in K 3 EDTA, Na-citrate, lithium-heparin and Na-fluoride/Na 2 EDTA anticoagulant vials.
Comparison of Calculated HBA1C with Measured HBA1C by High Pressure Liquid Chromatography Method
International Journal of Science Innovations and Discoveries
AIM: Diabetes mellitus is a metabolic disorder assessed by measurement of plasma glucose and Glycated hemoglobin (HbA1c) that denotes the preceding mean blood glucose value. Measurement of HbA1c along with glucose level found beneficial to know the monitoring status that prevents the onset of associated complications. The present study is taken up to compare HbA1c value determined by the HPLC method with HbA1c derived from a simple cost effective calculation using a mathematical tool. This study further presents the values obtained in terms of IFCC units and compared with Standards. MATERIALS AND METHODS: 60 Diabetic subjects, 60 healthy controls attending to R. L. Jalapa hospital, Kolar were recruited in the study. HbA1c Measured by HPLC method calculated HbA1c using Plasma glucose and converted to the IFCC Norms. RESULTS: The Mean ± SD levels of measured HbA1c 8.9 ± 2.02 %, calculated HbA1c 8.1 ± 3.07% fasting plasma glucose 182.58 ± 10.2 mg/dl in diabetic and measured HbA1c 5.8 ±...
Clinical Chemistry
BACKGROUND A major objective of the IFCC Committee on Education and Use of Biomarkers in Diabetes is to generate awareness and improvement of HbA1c assays through evaluation of the performance by countries and manufacturers. METHODS Fresh whole blood and lyophilized hemolysate specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. RESULTS At the country level with fresh whole blood specimens, 6 countries met the IFCC criterion, 2 did not, and 2 were borderline. With lyophilized hemolysates, 5 countries met the criterion, 2 did not, and 3 were borderline. At the manufacturer level using fresh whole blood specimens, 13 manufacturers met the criterion, 8 did not, and 3 were borderline. Using lyophilized hemolysates, 7 manufacturers me...
INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY
According to the National Glycohemoglobin Standardization Program (NGSP) and The Diabetes Control and Complication Trial(DCCT) the standard method of measuring HbA1c is High-Performance Liquid Chromatography (HPLC), but HPLC requiresparticular instrument investments, trained staff, long and relatively expensive sample processing. This an instrument that hassimilar performance to HPLC but its operation process is relatively simple and not costly. The purpose of this study was to analysethe HbA1c level using Turbidimetry Inhibition Immunoassay (TII) method and the HPLC method; to analyse HbA1 level using LatexAgglutination Inhibition (LAI) method and HPLC method. This research was conducted with a cross-sectional design during theperiod of March-April 2017. The total sample consisted of 160 samples divided into two groups. For the first group, HbA1c levelusing TII method and HPLC method was measured. For the second group, HbA1c level was measured using LAI method and HPLCmethod.The da...
Comparative Analytical Performance of Various HbA1c Assays in Iran
2016
INTRODUCTION Hemoglobin A1c (HbA1c) measurement devices are widely used to evaluate glycemic control in diabetic patients. The aim of this study was to investigate the comparability of various HbA1c instruments used in Iran. METHODS In the present study, 154 fresh whole blood samples from diabetic patients, with different HbA1c levels (4.0%-10%) and no types of hemoglobinopathy were analyzed by six HbA1c assays including one high performance liquid chromatography (HPLC) method (D10 HbA1c), two immunoassay methods (COBAS INTEGRA 400 and Pars Azmoon kit), one Boronate affinity method (Nycocard Reader II), and two ion exchange methods (Biosystems and DS5). The two National Glycohemoglobin Standardization Programs (NGSP) certified system, D10 and COBAS INTEGRA 400 which are certified as secondary reference measurement procedures, were considered as reference methods. The CLSI document (EP9-A2) - Method comparison and Bias estimation using patient samples, approved guideline - was used t...
LABORATORY R_T
Introduction: Glycated haemoglobin (HbA1c) is a test commonly measured in many clinical laboratories to monitor and diagnose diabetes mellitus (DM). The laboratory in Hospital Tengku Ampuan Afzan (HTAA) receives HbA1c samples internally and from several other hospitals and clinics in the state of Pahang, at which, before transportation and analysis, the samples are often stored. This study determined the stability of HbA1c samples following different storage temperatures and duration for up to 30 days. Method: Whole blood samples for HbA1c analysis were collected from 222 healthy blood donors and type 2 DM (T2DM) patients. Each sample was prepared into four aliquots, which were then stored at temperatures -20°C and -80°C. HbA1c analyses were performed at baseline, days 15 and 30 using ion-exchange high-performance liquid chromatography (HPLC) assay technique on Bio-Rad D-10 analyser. HbA1c levels following sample storage were compared to the levels at baseline. Results: The baseline...
Medical Laboratory Journal , 2016
Background and Objective: The current challenge of diabetes mellitus is to prevent its complications. These complications are directly associated with hyperglycemia in diabetics. The HbA1c measurement is essential for long-term glycemic control. Synchronization of HbA1c measurement is important in order to avoid discrepancies between results reported by laboratories. This study aimed to evaluate the accuracy, precision and agreement of five HbA1c measurement methods with HPLC reference method. Methods: HbA1c levels of 55 samples were measured using six methods of microcapillary electrophoresis (Sepia), enzymatic method (Pishtaz Teb), immunoturbidometry (Pars Azmoon), boronate affinity (Nycocard), immunofluorescence (ichroma) and Tosoh G8 HPLC. Results: The five tested methods showed a good agreement with the HPLC method with correlation coefficient of less than 95%. Regression testing of HPLC method and other methods showed slope of 0.99 (P<0.05) for Sebia, 1.02 (P<0.05) for Pishtaz Teb, 0.79 (P<0.05) for Pars Azmoon, 0.82 (P<0.05) for Nycocard and 0.89 (P<0.05) for ichroma. Average inaccuracy for the Sebia, Pishtaz Teb, Pars Azmoon, Nycocard and ichroma in comparison with the HPLC reference method were-0.09,-0.004,-0.75,-0.79 and-0.78, respectively. Conclusion: The Sebia microcapillary method and Pishtaz teb enzymatic method have appropriate accuracy and precision. Therefore, these methods can be used as alternatives to the HPLC method for HbA1c measurement. Other methods such as Pars Azmoon, Nycocard and ichroma have significant shortcomings in terms of accuracy.
Approved IFCC Reference Method for the Measurement of HbA1c in Human Blood
Clinical Chemistry and Laboratory Medicine, 2000
of the network showed excellent results with intralaboratory CVs of 0.5 to 2% and inter-laboratory CVs of 1.4 to 2.3%. Possible interferences have been carefully investigated. Due to the higher specificity of the reference method the results are lower than those generated with most of the present commercial methods which currently are calibrated with unspecific designated comparison methods. The new reference method has been approved by the member societies of the International Federation of Clinical Chemistry and Laboratory Medicine and will be the basis for the future uniform standardization of HbA 1c routine assays worldwide. Clin Chem Lab Med 2002; 40(1):78-89
COMPARISON OF CATION EXCHAGE HPLC AND IMMUNOTURBIDIMETRIC METHOD FOR DETERMINATION OF HbA 1c
2011
Objective: The objective of this study was to compare and correlate the analytical performance of D10 Hemoglobin Testing System based on Cation Exchange HPLC and Roche Hitachi 902 Immunoturbidimetric method. Subjects and Methods: A total of 110 patients of Type 2 Diabetes Mellitus were included in the study. HbA 1c was determined using D-10 Hemoglobin Testing system and Roche Hitachi 902 Analyzer. Results: Both methods showed good correlation with the correlation coefficient (r) of 0.95. Between run Coefficient of variance was found to be lower for HPLC system compared to immunoturbidimtric method. HPLC method also produces a chromatogram that shows the different hemoglobin fractions, allowing identification of different hemoglobin variants. Conclusion: In the present study both methods showed good correlation but the D10 HPLC system provided adequate throughput and improved precision as compared to immunoturbidimetric method.