Comparison of Hemoglobin A1c assay performance on two different commercial systems

Introduction: Glycated hemoglobin (HbA1c) is formed by non-enzymatic binding of glucose to the free amino group of the N-terminal end of the ß-chain of hemoglobin A. HbA1c is representative of the mean blood glucose level over three months. The aim of the study was to evaluate the Hemoglobin A1c immunoturbidimetric assay performance on two different commercial systems.Methods: We evaluated the precision and trueness for determination of HbA1c in whole blood. Concentrations of total hemoglobin and HbA1c were evaluated on Dimension Xpand (Siemens) and Cobas 501 (Roche) analyzers. HbA1c was measured in a latex agglutination inhibition test. Commercial controls Liquichek Diabetes Control Level 1 and Liquichek Diabetes Control Level 2 (Bio Rad) at two levels were used for quality control. Analytical validation of HbA1c included: within-run imprecision, between-day imprecision, inaccuracy and comparison determination on the human samples on 2 systems: Dimension Xpand and Cobas 501 analyzers. Results: Within-run imprecision on the commercially controls for Level 1 is 4.5% and Level 2 is 3.2% between-day imprecision on commercially controls is 6.1% Level 1 and 5.1% Level 2 for respectively inac- curacy on commercially controls for Level 1 is 1.8% and Level 2 is 4.8%. Method comparison on human samples shows the correlation coefficient of 0.99.Conclusion: The presented results of the analytical evaluation methods for the determination of HbA1c showed an acceptable accuracy and precision

Evaluation of tumor marker HE4 assay on the Elecsys 2010 analyzer

Introduction: Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer. The measured HE4 values may depend on the testing procedure used. The aim of this study was to evaluate the Methods: We evaluated a HE4 method on Elecsys 2010 analyzer. The method for quantitative determination of HE4 is direct, competitive chemiluminescent immunoassay. For quality control we use Elecsys PreciControl HE4 1 and 2. HE4 was measure on sera obtained from 56 women ( 20 healthy and 36 with epithelial ovarian cancer). Results: The Roche HE4 assays showed a good linearity (r=0.99) and precision (intrassayed total CV<5%). The median HE4 serum concentrations was significantly higher among EOC patients than healthy females (p<0,05). Elevated levels HE4 were found in 78 % patients with epithelial ovarian cancer. Conclusions: The presented results of the analytical evaluation methods for the determination of HE4 on the Elecsys 2010 analyzer showed an acceptable accuracy and precision

Correlation of serum lipid profile and glycemic control parameters in patients with type 2 diabetes mellitus

Introduction: Diabetes mellitus type 2 has become a global health-care problem of modern society due to a pronounced increase of prevalence to pandemic proportions and vascular complications. At present, glycated hemoglobin (HbA1c) is widely accepted as a measure of glycemic control in established diabetes. The aim of this study was to analyze the lipid profile in serum of patients with diabetes mellitus type 2, and its relationship with HbA1c levels. Methods: The observational cross-sectional study included 60 diabetic patients, 30 men, and 30 women, age 32–94 years. Patients were assigned into two groups based on HbA1c values; Group 1: HbA1c ≤ 7% (good glycemic control) and Group 2: HbA1c > 7% (poor glycemic control). We analyzed the concentration of glucose, HbA1c, and lipid profile including total cholesterol levels, triglycerides (TAG), low-density lipoproteins (LDL), and high-density lipoproteins (HDL). Results: Significantly lower values of glucose concentration, TAG and the ratio TAG/HDLc were obtained in the group of patients with good glycemic control. (p 0.005) Our study revealed a significant positive correlation between HbA1c and triglyceride level (r = 0.375; p = 0.003) and HbA1c and ratio triglyceride/HDLc (r = 0.335; p = 0.009). Conclusion: HbA1c can also be used as a predictor of dyslipidemia in type 2 diabetics in addition to as a glycemic control parameter

Evaluation of tumor marker HE4 assay on the Elecsys 2010 analyzer

Introduction: Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer. The measured HE4 values may depend on the testing procedure used. The aim of this study was to evaluate the Methods: We evaluated a HE4 method on Elecsys 2010 analyzer. The method for quantitative determination of HE4 is direct, competitive chemiluminescent immunoassay. For quality control we use Elecsys PreciControl HE4 1 and 2. HE4 was measure on sera obtained from 56 women ( 20 healthy and 36 with epithelial ovarian cancer). Results: The Roche HE4 assays showed a good linearity (r=0.99) and precision (intrassayed total CV<5%). The median HE4 serum concentrations was significantly higher among EOC patients than healthy females (p<0,05). Elevated levels HE4 were found in 78 % patients with epithelial ovarian cancer. Conclusions: The presented results of the analytical evaluation methods for the determination of HE4 on the Elecsys 2010 analyzer showed an acceptable accuracy and precision

Evaluation of high sensitivity C-reactive protein assay in cerebrospinal fluid on the Dimension RxL analyzer

<strong>Introduction</strong>: Low sensitivity and specificity in traditional laboratory tests became insufficient for accurate diagnostics and initiation of proper treatment of patients infected with bacterial meningitis. High sensitivity C reactive protein (hsCRP) may be an appropriate supplement for rapid diagnosis of bacterial meningitis. The subject of our investigation was the determination of C- reactive protein in cerebrospinal fluid (CSF) during<br />acute bacterial meningitis.<br /><strong>Methods:</strong> HsCRP was analysed by a sensitive immunoturbidimetric assay using the Dimension RxL analyser (Siemens). Cerebrospinal fluid concentrations of C-reactive protein have been measured in 20 patients<br />(age range,1 to 50 years) presenting with acute bacterial meningitis and also in a non-infected, non-inflamed control group (n=25).<br /><strong>Results:</strong> The accuracy and precision of the method proved to be satisfactory. Repeatability of serial sampling for hsCRP described by coefficient of variation were CV=2.1-4.5%. This assay hsCRP in cerebrospinal fluid demonstrates adequate performance characteristics for routine clinical use. Elevated levels of CRP were found in 95% patients with bacterial meningitis. The mean CRP value in 25 uninfected control group was 0.25 mg/L (range 0.10-0.55). The mean CRP for patients with bacterial meningitis was 21.4 mg/L (range 0.40-100).<br /><strong>Conclusions:</strong> A sensitive assay for CRP in CSF would be an useful adjunct to conventional investigation of acute infective meningitis

Comparison of Hemoglobin A1c assay performance on two different commercial systems

Introduction: Glycated hemoglobin (HbA1c) is formed by non-enzymatic binding of glucose to the free amino group of the N-terminal end of the ß-chain of hemoglobin A. HbA1c is representative of the mean blood glucose level over three months. The aim of the study was to evaluate the Hemoglobin A1c immunoturbidimetric assay performance on two different commercial systems. Methods: We evaluated the precision and trueness for determination of HbA1c in whole blood. Concentrations of total hemoglobin and HbA1c were evaluated on Dimension Xpand (Siemens) and Cobas 501 (Roche) analyzers. HbA1c was measured in a latex agglutination inhibition test. Commercial controls Liquichek Diabetes Control Level 1 and Liquichek Diabetes Control Level 2 (Bio Rad) at two levels were used for quality control. Analytical validation of HbA1c included: within-run imprecision, between-day imprecision, inaccuracy and comparison determination on the human samples on 2 systems: Dimension Xpand and Cobas 501 analyzers. Results: Within-run imprecision on the commercially controls for Level 1 is 4.5% and Level 2 is 3.2% between-day imprecision on commercially controls is 6.1% Level 1 and 5.1% Level 2 for respectively inac- curacy on commercially controls for Level 1 is 1.8% and Level 2 is 4.8%. Method comparison on human samples shows the correlation coefficient of 0.99. Conclusion: The presented results of the analytical evaluation methods for the determination of HbA1c showed an acceptable accuracy and precision

Clinical aspects and importance of nutrition in homeostasis of the bone tissue

Substantial changes have occurred in the nutritional management of many diseases in the last twenty years. Introduction of standards, clinical review and implementation of evidence based practice led to re-evaluation of some established dietary interventions. The most common form of osteoporosis is the primary osteoporosis, which is the result of the bone loss and deterioration of bone structure, as people age. Bone loss and osteoporosis can be prevented through adequate nutrition, physical activity, and, if necessary, appropriate treatment. This review will focus on nutritional and clinical aspects of bone tissue homeostasis, with references to physiological and pathophysiological processes. 

Blood iron stores reduction affects lipoprotein status – a potential benefit of blood donation

Aim To determine the lipoprotein proile of voluntary blood donors, and on the basis of parameters to evaluate the risk of atherosclerosis. Methods The study included voluntary blood donors of both sexes. Participants were divided into two groups. The irst group of subjects consisted of men and women in menopause (BD1). Thesecond group consisted of women in reproductive age (BD2). Analysisof concentration of lipoproteins was performed by direct determination of total cholesterol, LDL-C and HDL-C. From the totalserum cholesterol and concentration of lipoproteins ratios of totalcholesterol/ HDL-C ratio and LDL-C/HDL-C were calculated. Results Signiicantly higher concentration of LDL-C was obtained in the serum of BD 1, compared to LDL-C in the serum of BD 2, within the reference range. Mean concentration of HDL-C in the serum of BD 2 group was higher than the values measured in the BD group 1, without signiicant difference. The ratio of total cholesterol / HDL-C showed signiicantly higher values in the BD 1 group compared with results in the BD 2 group. Signiicantly higher values in the BD group 1 were observed for the ratio of LDL-C/HDL-C. Obtained results showed that all voluntary blood donors had a concentration of individual lipoprotein fractions in a lower risk range for atherosclerosis development. Conclusion Female voluntary blood donors in reproductive age have a more favorable lipid status in relation to the voluntary blood donors, men and women in menopause, indicating that this population of women is exposed to lower risk of developing atherosclerosis