HbA1c Analysis Research Articles

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.

Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association of Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (Hb A1c) in the blood. Glycemic control is monitored by the people with diabetes measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring (CGM) devices and also by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.

Numerous laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in patients with diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments in the full version of the guideline). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association of Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (Hb A1c) in the blood. Glycemic control is monitored by the patients measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring devices and also by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring; genetic testing; and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.

Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association for Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c) in the blood. Glycemic control is monitored by the people with diabetes measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring (CGM) devices and also by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.

Numerous laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in patients with diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments in the full version of the guideline). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association for Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c) in the blood. Glycemic control is monitored by the patients measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring devices and also by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring; genetic testing; and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Remote HbA1c testing via microsampling: fit forpurpose?

The collection of capillary blood microsamples via finger-prick has several advantages over traditional blood collection. It is considered convenient and more patient-centric, enabling collection of the sample by the patient at her/his home with subsequent analysis in the lab following postal shipment. Determination of the diabetes biomarker HbA1c in self-collected microsamples to remotely monitor diabetes patients seems to be a very promising option which could eventually lead to better treatment adaptations and disease control. This is especially convenient/relevant for patients living in areas where venipuncture is impractical, or to support virtual consultations using telemedicine. Over the years, a substantial numbers of reports on HbA1c and microsampling have been published. However, the heterogeneity of the applied study designs and data evaluation is remarkable. This review provides a general and critical overview of these papers, along with specific points of attention that should be dealt with when aiming at implementing microsampling for reliable HbA1c determination. We focus on the used (dried) blood microsampling techniques, collection conditions, stability of the microsamples, sample extraction, analytical methods, method validation, correlation studies with conventional venous blood samples and patient satisfaction. Lastly, the possibility of using liquid instead of dried blood microsamples is discussed. Liquid blood microsampling is expected to have similar advantages as dried blood microsampling and several studies suggest it to be a suitable approach to collect samples remotely for subsequent HbA1c analysis in the lab.

Semaglutide versus tirzepatide for people with type 2 diabetes: cost of glycemic control in Austria, the Netherlands, Lithuania, and the United Arab Emirates

Objectives The glucagon-like peptide-1 agonist semaglutide and the dual glucose-dependent insulinotropic polypeptide tirzepatide have proven to significantly reduce glucose levels in people with type 2 diabetes. However, the costs needed to achieve a sustained decrease in HbA1c level and disease control with semaglutide and tirzepatide, respectively, are unclear. Therefore, this study aimed to compare the cost of treatment with semaglutide with the cost of treatment with tirzepatide for type 2 diabetes in Austria, the Netherlands, Lithuania, and the United Arab Emirates in order to determine their respective value for money. Methods The primary outcome of this analysis was the cost in euros needed to achieve disease control in one person with type 2 diabetes based on the composite endpoint of HbA1c <7%, ≥5% weight loss, and no hypoglycemic events. In addition, analyses regarding the cost needed to reach relevant HbA1c endpoints were performed. Clinical data were obtained from the SURPASS 2 trial, registered at clinicaltrials.gov (NCT03987919), and drug cost was based on wholesale acquisition cost or pharmacy purchase prices from public domains obtained in Q1 of 2023. Results The cost needed to achieve disease control in one person with type 2 diabetes (HbA1c <7%, ≥5% weight loss, and no hypoglycemic events) was up to three times lower using semaglutide compared with all three doses of tirzepatide in most markets. In the HbA1c analyses, semaglutide was also found to be the least expensive treatment option. Conclusion Semaglutide provides better value for money than tirzepatide for HbA1c-lowering endpoints.

Incidental finding of rare hemoglobin: hemoglobin Bari in northeast Spain

Abstract Objectives Cation exchange high-performance liquid chromatography (HPLC) is one of the techniques available for determining glycated hemoglobin (HbA1c) and also the method of choice for structural hemoglobinopathies screening. The objective of this case is to show how in a routine HbA1c test it is possible to incidentally find a hemoglobinopathy. Case presentation In a routine blood analysis, an abnormal value for the hemoglobin A2 (HbA2) was obtained during the study of HbA1c with HPLC on the ADAMS™ A1c HA-8180T. After suspecting it could be due to the presence of a hemoglobinopathy, the study of possible variants was expanded using electrophoresis and HPLC on the Hydrasys and Variant II analysers, respectively. Since it could not be identified by these conventional methods, a genetic study was also carried out using Sanger sequencing. The patient presented a low HbA2 (1.3 %) and a 24.9 % variant with a retention time of 1.95 min, compatible with alpha-globin chain variant. In the genetic study, the pathogenic variant c.138C&gt;G was detected in the HbA 2 gene in heterozygosis, which resulted in the expression of the structural hemoglobinopathy known as hemoglobin Bari. Conclusions The initial screening for structural hemoglobinopathies allows its identification or suspicion especially when it was performed with HbA1c analysis, requiring subsequent confirmation and diagnosis by other techniques.

Outcomes and experiences of families with children with type 1 diabetes on insulin pumps through subsidised pump access programs in Western Australia.

In Australia, access to insulin pump therapy for children with type 1 diabetes (T1D) is predominantly restricted to families with private health insurance. In an attempt to improve equity, additional subsidised pathways exist which provide pumps to families with reduced financial resources. We aimed to describe the outcomes and experiences of families with children commenced on pumps through these subsidised pathways in Western Australia (WA). Children with T1D in WA who did not have private health insurance and received pumps from the subsidised pump programs between January 2016 and December 2020 were included. Study 1 was designed to review glycaemic outcome. A retrospective analysis of HbA1c was conducted in the whole cohort and in children who commenced pump after the first year of diagnosis to exclude the impact of the partial clinical remission phase following diagnosis. HbA1c at baseline, and six, 12, 18 and 24 months after pump initiation were collected. Study 2 was designed to review experiences of families commenced on pumps through subsidised pathway. A questionnaire designed by the clinical team was distributed to parents via an online secure platform to capture their experiences. Of the 61 children with mean (SD) age 9.0 (4.9) years who commenced pump therapy through subsidised pump programs, 34 children commenced pump therapy after one year of diagnosis of T1D. The median (IQR) HbA1c (%) in 34 children at baseline was 8.3 (1.3), with no statistically significant change from baseline at six months [7.9 (1.4)], 12 months [8.0 (1.5)], 18 months [8.0 (1.3)] or 24 months [8.0 (1.3)]. The questionnaire response rate was 56%. 83% reported intention to continue pump therapy, however 58% of these families did not have avenue to acquire private health insurance. Families expressed inability to procure private health insurance due to low income and unreliable employment and remained largely unsure about the pathway to obtain the next pump. Children with T1D who commenced insulin pump therapy on subsidised pathways maintained glycaemic control for two years, and families favored pumps as a management option. However, financial limitations persist as a significant barrier to procure and continue pump therapy. Pathways for access need to be assessed and advocated.

Correlation analysis of HbA1c versus random, fasting, and postprandial glucose levels as predictors of glycemic control in type 2 diabetes patients

Background: Glycated Hemoglobin (HbA1c) is used for assessing glycemic control over the past 8–12 weeks. This is critical for determining the efficacy of diabetes treatment and predicting the progression of microvascular complications. However, in health-care situations where tests for HbA1c are either unavailable or unfeasible for any reason, clinicians rely only on plasma glucose values for assessing the glycemic control of the patient. Aims and Objectives: The purpose of this study was to determine the relationship between HbA1c and fasting, postprandial, and random plasma glucose levels. Materials and Methods: Routine blood samples obtained from the laboratory to measure HbA1c and plasma glucose (fasting/postprandial/random) were used for study. A total of 207 samples were used to investigate the relationship between HbA1c and fasting and postprandial glucose (PPG/PP). The correlation of HbA1c with random glucose values was investigated using 112 samples. HbA1c was estimated by immunoturbidimetry and glucose was estimated by hexokinase method. Pearson’s correlation analysis was done by SPSS version 20 software. Results: The Pearson correlation coefficient (r) with regard to PPG/PP and HbA1c was 0.75 (P=0.01, 95% CI), fasting glucose and HbA1c was 0.73 (P=0.01, 95% CI), and random glucose and HbA1c was 0.59 (P=0.01, 95% CI). Conclusion: PPG/PP correlates with HbA1c better than fasting or random glucose. When it is impossible to perform HbA1c measurements, PPG measurements should be used instead.

Relation between sleep quality and glycemic control among type 2 diabetic patients

Abstract Objective: To investigate the relation between sleep quality and glycemic control among type 2 diabetic patients. Methods: Across sectional descriptive design was used; the study sample including 125 diabetic patients was recruited at diabetic clinics in Zagazig University hospitals. The interview questionnaire sheet consists of 4 parts: (1) demographic data, (2) medical history, (3) an Arabic version of the Pittsburgh sleep quality index (PSQI), and (4) glycated hemoglobin A1c (HbA1c) analysis test. Results: The mean of sleep duration was the highest score of PSQI components, 96.8% of diabetic patients had poor sleep quality, and 90.4% of diabetic patients had poor glycemic control. A highly statistically significant relationship was found between HbA1c and sleep quality. Moreover, income, duration of disease and smoking were independent positive predictors of HbA1c level, while the female gender was a statistically significant negative predictor. Additionally, female gender and income were statistically significant independent positive predictors of PSQI score. Conclusions: Poor sleep quality and poor glycemic control were very common among type 2 diabetic patients. There was a highly significant relation between sleep quality and glycemic control.

Evaluation of local hemoglobinopathy prevalence and promotion of accurate hemoglobin A1c testing using historical data retrieval

ObjectivesHeterozygous hemoglobin variants are known to cause method- and variant-specific interference with hemoglobin A1c (HbA1c) quantitation. Less attention has been paid to the role of other hemoglobin variants in confounding HbA1c testing. Here we evaluated the frequency with which enzymatic (ENZ) and immunoassay (IA) HbA1c quantitation methods, i.e., those unable to routinely detect the presence of hemoglobin variants, were used within our healthcare system for HbA1c analysis in patients with elevated fetal hemoglobin as well as compound heterozygous and homozygous variants. Design & MethodsThis analysis was enabled by automated review of HbA1c result history, implemented to promote detection of variants prior to HbA1c result reporting. ResultsDuring a 54-week period, 319,290 HbA1c analyses were performed. We observed 110 unique patient cases (0.03% problem identification rate) in which HbA1c testing was ordered in the presence of either a homozygous or compound heterozygous hemoglobin variant or elevated hemoglobin F beyond the tolerance of the method. Among the 110 cases identified, 55 (50%) showed a compound heterozygous or homozygous hemoglobin variant while 55 (50%) showed elevated hemoglobin F. Of those cases involving a compound heterozygous or homozygous variant, 8/55 (15%) involved patients who had one or more ENZ or IA HbA1c results reported previously within our system. Of the 55 total compound heterozygous or homozygous variants identified, 37 (67%) were hemoglobin E, 10 (18%) hemoglobin S/C, 4 (7%) hemoglobin S, 2 (4%) hemoglobin C, 1 (2%) hemoglobin Camden, and 1 (2%) unidentified variant. ConclusionsExclusive use of methods unable to routinely detect the presence of hemoglobin variants may lead to reporting of HbA1c results that are not clinically meaningful.

High Sensitivity C-Reactive Protein as a Prognostic Indicator of Cardiovascular Disease in Severe Non-Diabetic COVID-19 Patients.

The long-term extrapulmonary sequelae of COVID-19 after recovery from the critical stage at the intensive care unit (ICU) are still unclear. Some post-COVID symptoms are prevalent even after a one-year follow-up. To explore the relationship between high sensitivity C-reactive protein (hs-CRP) and hyperglycemia with cardiovascular diseases in non-diabetic COVID-19 patients. To determine whether increased fasting blood sugar (FBS) levels are associated with elevated hs-CRP and to explore whether hs-CRP can serve as a prognostic indicator to predict cardiovascular outcome. FBS and hs-CRP values of 26 non-diabetic COVID-19 patients were collected from their medical records at JIPMER hospital. In one-year follow-up of these 26 patients, 2mL of blood sample was collected for the analysis of FBS, HbA1c, and hs-CRP. hs-CRP increased in 23% of follow-up patients who were at high risk, and 42.3% of participants were at average risk for cardiovascular disease. High and average-risk groups of survivors showed a positive correlation of hs-CRP with FBS and HbA1c levels, and these patients should be carefully monitored. ICU survivors with elevated hs-CRP need periodic check-ups for cardiovascular diseases. We suggest that hs-CRP could be used as an early prognostic indicator of cardiovascular diseases and can reduce the risk.

An Assessment of the Utility of Serum Fructosamine in the Diagnosis and Monitoring of Diabetes Mellitus.

Fructosamine (FA) has gained importance as a new biomarker for hyperglycemia in the past decade and may be of indispensable use in certain conditions where hemoglobin A1c (HbA1c) falls short of utility such as disorders of red blood cells, patients with rapid glycemic excursions requiring more short-term monitoring, pregnancy, chronic kidney disease, etc. Methods: The present study was a hospital-based observational cross-sectional study conducted in the Department of Biochemistry, All India Institute of Medical Sciences (AIIMS), Nagpur, India. Serum HbA1c, FA, albumin-corrected fructosamine (AlbF), total protein-corrected FA (PrF), hemoglobin (Hb), and hematocrit (Hct) were estimated in 32 controls (Group I) and 32 cases of diabetes mellitus (DM) (Group II). The clinical data and lab results were presented as mean±SD/±standard error (SE) of the mean. Student's t-test and ANOVAwere used to compare various parameters between the groups. Pearson correlation analysis was performed to assess the correlation between different diagnostic parameters. The receiver operating characteristic (ROC) curve was plotted to assess the diagnostic significance and cut-off value for FA, AlbF, and PrF. The controls and cases were matched for age and gender distribution. Serum HbA1c (p<0.0001), serum FA (p<0.0001), fasting blood sugar (p=0.001), postprandial blood sugar (p<0.0001), random blood sugar (p=0.001), hematocrit (p=0.002), AlbF (p<0.0001), and PrF (p<0.0001) were found to be significantly higher in known diabetic subjects compared to controls. The casegroup was further subdivided into pre-diabetic and diabetic groups. On correlation analysis of HbA1c with various parameters, a moderate correlation of HbA1c was noted with FA (r=0.522, p<0.0001) and AlbF (r=0.375, p=0.002) in all subjects. Additionally, a moderate correlation of FA (r=0.479, p=0.033), AlbF (r=0.444, p=0.050), and PrF (r=0.441, p=0.065) with HbA1c was also found in subjects with diabetic range glycemia. No such correlation was noted in the pre-diabetic group. No significant correlation was noted between FA and its corrected values in any range of glycemia. None of the parameters assessing glycemia were found to be significantly affected by hemoglobin status. On ROC curve analysis, HbA1c was found to be the best parameter (area under the curve (AUC) =83%, p<0.0001) followed by AlbF (AUC= 80.5%, p<0.0001) and uncorrected FA (AUC=80.5%, p<0.0001) to diagnose DM. Serum FA should be considered a valid diagnostic biomarker and of indispensable use in special populations where HbA1c falls short of utility such aspatients with red blood cell disorders or those showing rapid glycemic excursions such as those on corticosteroid therapy or insulin therapy, etc. It exhibits additional advantages over HbA1c with respect to lower reagent cost and easy automation on any conventional laboratory instruments based on simple colorimetry.

Comparison of Point-of-Care and Laboratory Glycated Hemoglobin A1c and Its Relationship to Time-in-Range and Glucose Variability: A Real-World Study.

Introduction The main objective of the current study was to perform a comparison of point-of-care testing for hemoglobin A1c (POCT-HbA1c) versus the standard laboratory method (Lab HbA1c) and their relationship to time-in-range (TIR) and glucose variability (GV) among patients with diabetes mellitus (DM) presented to the outpatient diabetes clinics. Methods This single-center cross-sectional study was carried out on diabetic patients (aged ≥14 years of both genders) who undergo routine follow-up at our institution and whose physicians ordered HbA1c analysis for routine care. The included patients were those using the intermittently scanned continuous glucose monitoring (isCGM) Abbott's FreeStyle Libre system for at least three months and regular CGM users with at least 70% use. Results We included 97 diabetic patients (41 female and 56 male), with a median age of 25 years (Interquartile range= 18) and a mean DM duration of 10.33±5.48 years. The mean values of Lab-HbA1c and POCT HbA1c were 8.82%±0.85% and 8.53%±0.89%, respectively. The TIR, time below range, and time above range were 33.47±14.38 minutes (47.78%±14.32%), 5.44±2.58 minutes (8.41%±4.42%), and 28.8±8.27 minutes (43.81%±13.22%), respectively. According to the Bland-Altman plot analysis, the POCT-HbA1c values are consistent with the standard Lab-HbA1c values (SD of bias= 0.55, and 95% CI= -0.78 to 1.4). The univariate linear regression analysis showed a statistically significant relationship between laboratory HbA1c and POCT HbA1c (R2= 0.637,p<0.001), TIR (R2= 0.406,p<0.001), and GV (R2= 0.048,p= 0.032). After adjusting for age, gender, disease duration, diabetes type, and percentage of sensor data in a multivariable linear regression model, the linear associations remained significant (allp< 0.05). Conclusion The current findings show that TIR and GV can be used as endpoints and valuable parameters for the therapy of DM.

A Statistical Simulation to Evaluate the Robustness of Hb A1c Measurement in the Presence of Quantitative Error.

The performance requirements for hemoglobin (Hb) A1c analysis have been questioned as analytic methods have improved. We developed a statistical simulation that relates error to the clinical utility of an oft-used laboratory test, as a means of assessing test performance expectations. Finite mixture modeling of the Centers for Disease Control and Prevention-National Health and Nutrition Examination Survey (NHANES) 2017-2020 Hb A1c data in conjunction with Monte Carlo sampling were used to model and simulate a population prior to the introduction of error into the results. The impact of error on clinical utility was assessed by categorizing the results using the American Diabetes Association (ADA) diagnostic criteria and assessing the sensitivity and specificity of Hb A1c under various degrees of error (bias and imprecision). With the current allowable total error threshold of 6% for Hb A1c measurement, the simulation estimated a worst case between 50% and 60% for both test sensitivity and specificity for the non-diabetic category. Similarly, sensitivity and specificity estimates for the pre-diabetic category were 30% to 40% and 60% to 70%, respectively. Finally, estimates for the diabetic category yielded values of 80% to 90% for sensitivity and >90% for specificity. Bias and imprecision greatly affect the clinical utility of Hb A1c for all patient groups. The simulated error demonstrated in this modeling impacts 3 critical applications of the Hb A1c in diabetes management: the capacity to reliably screen, diagnostic accuracy, and utility in diabetes monitoring.

Effects of hepatitis C virus genotypes and viral load on glucose and lipid metabolism after sustained virological response with direct-acting antivirals.

The objective of this study, carried out at the university hospital of the Federal University of Rio Grande, was to assess whether the treatment of chronic hepatitis C with direct-acting antivirals and the sustained virological response will affect the metabolic influences of the hepatitis C virus and whether these effects will vary according to genotypes and virus load. This is an intervention pre-post study, carried out from March 2018 to December 2019, evaluating 273 hepatitis C virus patients treated with direct-acting antivirals. Inclusion criteria included being monoinfected with hepatitis C virus and achieving sustained virological response . Exclusion criteria included the presence of decompensated cirrhosis or co-infected with hepatitis B virus or human immunodeficiency virus. Genotypes, genotype 1 subtypes, and hepatitis C virus viral load were analyzed. Glucose metabolism was evaluated by the Homeostasis Model Assessment-insulin resistance indices: Homeostasis Model Assessment-β, TyG, and HbA1c, measured at the beginning of treatment and in sustained virological response. Statistical analysis with a T test by paired comparison of the means of the variables in the pretreatment and in the sustained virological response. Homeostasis Model Assessment-insulin resistance analysis: there were no significant differences between pretreatment and sustained virological response. Homeostasis Model Assessment-β analysis: significant increase in genotype 1 patients (p<0.028). TyG index analysis: significant increase in genotype 1b (p<0.017), genotype 3 (p<0.024), and genotype non-1 with low viral load (p<0.039). HbA1c analysis: significant decrease in genotype 3 (p<0.001) and genotype non-1 patients with low viral load (p<0.005). We detected significant metabolic influences after sustained virological response: impairment in lipid profile and improvements in the glucose metabolism. We found significant differences in genotype dependence, genotype 1 subtypes, and viral load.

Serological and oncoinformatic analysis of HbA1c as a prognostic biomarker in screening the risks of different cancers among the male T2D patients of Bangladesh

Hemoglobin A1C (HBA1c) represents the average serological sugar status of T2D patients of the past three months, considered a clinically standard method of studying sugar metabolism. Overexpressing HbA1 can metabolically forecast the risk of different cancers among T2D patients. Based on this, the study aimed to analyze the impact of sugar metabolism in cancer development considering the overexpression of HbA1 as the prognostic biomarker of screening the risks of eight different cancers among the chronic male T2D patients of Bangladesh. Serological analysis of the concentrations of FBS, THABF, creatinine, SC, STGs, HDLC, and LDLC of the T2D patients was conducted in response to their individual HbA1c concentration. Afterward, HbA1 overexpression and promotor-methylation responsible for BLCA, BRCA, CHOL, COAD, LUAD, LUSC, PAAD, and PRAD cancers in the male T2D patients were profiled as the oncoinformatic screening, where the sample types used, individual cancer stages, racial-footprints, gender, age, nodal metastasis, p53-methylations, pancreatitis, diabetes status, smoking behaviors, and survivability status were studied. Finally, the genetic involvement of a group of genes responsible for genetic co-expression of HbA1, endophytic vesicle regulation, antioxidant regulation, and reactive oxygen species based-metabolic regulation in T2D males was identified and comprehensively discussed. The research revealed a significant correlation between BMI and FBS in both the patient and the control groups (p&lt;0.0001). Besides, FBS, THABF, and creatinine were found significantly regulated with their respective HbA1c concentrations (p&lt;0.0001) for each group. The SC, STGs, HDLC, and LDLC regulated ardently and equally for both groups (p&lt;0.0001), while HbA1c ranged from 3.8-5.8% and 5.11-15.8%, for the controls and patients respectively. HbA1 was found interactive with diversified cancer-causing genes, while HbA1 was mostly downregulating with the progressing metastasis. To receive maximum benefits from using HbA1c in clinical profiling of cancer risks among chronic-male T2D patients in minimal time and expense further studies can be needed with a larger sample size.

Comparison of NGSP Certified Methods and their Cost Analysis for Estimation of HbA1c- A Cross-sectional Study

Introduction: Diabetes Mellitus (DM) is a major non communicable disease that adversely impacts the health of the global community, contributing significantly to mortality. Estimation of glycated haemoglobin (HbA1c) is an integral component of diagnosis, treatment and follow-up of cases of DM as the various protocols have included it for therapy. In order to regularise the estimation of HbA1c, it is mandated by American Diabetes Association (ADA) to perform the test on NGSP certified methods only. Aim: To compare the results of HbA1c analysis by SIEMENS DIMENSION EXL 200 and BIORAD D-10 (NGSP certified methods). Materials and Methods: This was a cross-sectional observational study done in Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, a tertiary care center. One hundred and twenty blood samples in EDTA tubes for haemoglobin variant analysis, received from patients with unexplained anaemia or screening for antenatal care were included in the study. The tests for HbA1c were performed by HPLC based BIORAD D10 and enzymatic based method, SIEMENS DIMENSION EXL 200 analyser. Cost analysis of both the methods was also performed. Students paired t-test was done to look for any significant statistical difference. Kappa coefficient was also calculated to analyse for agreement between values. Results: HbA1c estimation by SIEMENS DIMENSION EXL200 and BIORAD D-10 (both NGSP certified) showed marginally different results, but it was not significant enough to make a clinical difference (5.308% on BIORAD D10 and 5.211% on SIEMENS DIMENSION EXL 200). On performing the cost analysis, there was a significant difference observed with a figure of Rs 476.05/- per test on the SIEMENS DIMENSION EXL200, while it was significantly cheaper at Rs 266/- per test on the BIORAD D10. Conclusion: Estimation of HbA1c on SIEMENS DIMENSION EXL200 and BIORAD D10 was not clinically significant. As per cost analysis, BIORAD D10 is a cheaper alternative and suitable for tertiary care or large volume centres.

Assessment of lipid profile with HbA1c in type 2 diabetic Iraqi patients

Insulin-induced hyperglycemia is the hallmark of diabetes mellitus (DM), including various metabolic disorders. Diabetic people are more likely to develop dyslipidemia, hypertension, and obesity. Type 2 diabetes ‎(T2DM), the most common illness, is generally asymptomatic in its early stages and can go misdiagnosed for years. Diabetes screening may be beneficial in some cases since early identification and treatment can lessen the burden of diabetes and its consequences.‎ This study aimed to find the relationship between Glycated hemoglobin (HbA1c) ‎and lipid profile components in T2DM‎ patients. Methods: This descriptive-analytical and cross-sectional study was performed on the control group and T2DM patients in ‎Medical City in Baghdad between March and June 2021‎. A total of 90 patients with T2DM and ‎‎45 healthy control were included in this study. In the control group, healthy volunteer individuals participated. For all subjects, HbA1c, fasting blood sugar/FBS, and lipid profile (Total Cholesterol/TC, Triglyceride/TG, High-density Lipoprotein/HDL, Low-density Lipoprotein/LDL, and Very Low-density Lipoprotein/VLDL) were assessed. Among T2DM patients, 62.22% (n= 56) were male, and 37.78% (n= ‎‎34) were female. Mean ± SD levels of HbA1c, TC, TG, LDL, VLDL, HDL, and FBS were 7.33±0.56 ‎‎% (168.21±9.23, 146.10±9.64, 137.23±8.32, 41.05±5.86, 43.85±6.17, and ‎‎208.81±52.1) mg/dl respectively in the T2DM group. In the control group, ‎the Mean ± SD results of the same parameters were 4.91±0.27%, ‎‎(171.20±3.57, 116.60±8.25, 105.05±2.11, 41.83±4.92, 44.04±5.54, ‎‎96.20±7.8) mg/dl respectively. Results demonstrated statistically significant ‎‎differences between T2DM patients and control groups in HbA1c ‎‎(p equal to 0.0025), TG ‎(p equal to 0.015), LDL ‎ ‎(p=0.0029),‎ and FBS ‎(p=0.02‎). Pearson correlation analysis of HbA1c with other variables showed a significant ‎positive correlation with serum TC, TG, LDL, and ‎FBS ‎(r=0.573, P&lt;0.01; ‎r=0.655, P &lt;0.001; r=0.498, P&lt;0.05‎; r=0.691, ‎P&lt;‎0.001‎; ‎‏respectively). At the same time, the data showed a negative connection between HbA1c and HDL (r= - 0.562, P&lt;0.01). The findings of this study reveal that diabetic people do not have a satisfactory HbA1c level. Furthermore, HbA1c shows a significant correlation with TC, TG, LDL, and VLDL, whereas it has a significant negative correlation with HDL. The study's findings showed that HbA1c might be a useful marker for predicting dyslipidemia in T2DM patients. Keywords: T2DM, Lipid profile, HbA1c.

The Effect of Storage at -20°C and -80°C on HbA1c Measurements in Whole Blood Samples Analysed Using Bio-Rad D-10

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 HbA1c (mean±SD) was 6.6±2.2%. At -20°C of storage, the HbA1c levels decreased with a mean difference of 0.1% and 0.3% on days 15 and 30, respectively. Storage at -80°C resulted in a mean difference of 0.1% on day 15 whilst no change was noted on day 30. The number of samples that showed clinically significant HbA1c change (defined as a change of &gt;0.5%) was less for the samples stored at -80°C (4.5%) as compared to -20°C (23%). Conclusion: HbA1c concentration is affected by temperature and duration of sample storage. In instances where prolonged storage of HbA1c samples is expected, storage at -80°C is preferable.