Abstract

        Background and Objective: According to recent changes in diagnostic criteria for diabetes, the harmonization of results obtained from various methods and systems by considering their accuracy and precision is essential. This study aimed to evaluate the accuracy, precision and consensus of some routine laboratory glucose kits in comparison with Hexokinase reference method.

           Material and Methods: The participants were 38 diabetic patients with fasting blood sugar (FBS) ≥126 mg/dl, nine prediabetic patients with FBS of 100-125 mg/dl, 15 non-diabetic people with FBS of 60-100 mg/dl and 9 hypoglycemic patients with FBS of ≤60 mg/dl. Their FBS were measured by four routine laboratory glucose kits:    Glucose oxidase on BT3000 analyzer with an open system and Hexokinase reference method on a close system (COBAS INTEGRA^®400plus analyzer, Roche kit). Accuracy and precision were determined and compared with reference method.

         Results: Glucose oxidase methods showed a good agreement with the reference method, in Correlation Coefficient>0.99. based on  regression analysis, the  slope of 1.114 for Pars Azmoon, 1.105 for Bionik, 1.121 for Elitech and 1.087 for Human were reported (P<0.05). Error of the mean for ParsAzmoon was 12.79, for Bionik 10.86, for Elitech 12.58 and for Human were 8.46. Coefficient of Variation   showed more imprecision for Bionik and Human kits.

       Conclusion: given the same almost standard errors, standard devisions and regression analysis, the precision in four methods is the same but in comparison with Hexokinase, reference method has not the accuracy.

          Keywords: Blood Glucose, Glucose Oxidase, Hexokinase, Methods, Consensus

Abstract

     Background and Objective: Diabetes mellitus is the most common risk factor for coronary artery disease (CAD). Cholesteryl ester transfer protein (CETP) TaqIB polymorphism is associated with changes in lipid profile and may be a risk factor for CAD in patients with diabetes. This study aimed to evaluate the association of CETP TaqIB polymorphism with CAD in patients with type 2 diabetes.

     Methods: In this case-control study, 292 diabetic patients were divided into two groups based on angiography reports (150 participants with normal angiogram as the control group and 142 participants with more than 50% stenosis of at least one coronary artery as the case group). The CETP TaqIB genotypes were determined by PCR-RFLP analysis. Fasting blood glucose was measured using glucose oxidase and lipid profile (triglycerides, total cholesterol, high density lipoprotein-cholesterol and low density lipoprotein-cholesterol) by an enzymatic method.

       Results: There was no significant difference in the frequency of genotypes and alleles between the case group and controls (the control group: B1B1, 17.3%; B1B2, 63.3%; and B2B2, 19.3%; the case group: B1B1, 18.3%; B1B2, 64.1%; and B2B2, 17.6%) (P=0.92). In the control group, heterozygous participants (genotype B1B2) had higher levels of cholesterol compared with other genotypes (B1B1 and B2B2). Also, the patients with genotype B1B2 had significantly higher weight (P=0.013).

       Conclusion: There is no significant correlation between CETP TaqIB polymorphism and the increased risk of coronary artery disease in patients with type 2 diabetes.

      Keywords: Cholesterol Ester Transfer Protein, Polymorphism, Diabetes Mellitus, Type 2, Coronary Artery Disease

ABSTRACT

      Background and Objective: Ochratoxin is a fungal toxin produced by Penicillium verrucosum and some Aspergillus species. Ochratoxin is usually found in grains, cereal products and also animal feed of livestock. The aim of this study was to measure the level of Ochratoxin in pasteurized milk samples of Golestan Province, Iran.

      Methods: Overall, 38 milk samples were collected from East and West of the Golestan province in accordance with standards 326 and 419 of the Institute of Standards and Industrial Research of Iran. The level of Ochratoxin was measured by ELISA method.

      Results: The mean level of Ochratoxin A in 20 raw milk samples collected from the West of the Province was 3.32 ± 3.76 ng/ml. The mean level of Ochratoxin A in 18 raw milk samples collected from the East was 6.02 ± 4.42 ng/ml. Ochratoxin A levels in most samples were higher than the limits established by the European standards.

      Conclusion: Based on the results of this study, Ochratoxin level of 84.2% and 52.6% of the samples from the West and East of the province are higher than the allowed limits (2 ng/ml), respectively.

ABSTRACT

        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.