scholarly journals Unexpected Detection of Abnormal Hemoglobin Variants During Routine HbA1c Analysis by HPLC Technique: Challenges and Opportunities in HbA1c Testing

2021 ◽  
Vol 9 (1) ◽  
pp. 15-21
Author(s):  
Neelam Narsingrao Sreedevi ◽  
Guduru Vijay Kumar ◽  
Boda Chendar ◽  
Madrol Vijaya Bhaskar ◽  
Kompella Sree Satya Sai Baba ◽  
...  
Keyword(s):  
Hemoglobin A1c ◽  
Glycated Hemoglobin ◽  
Incidental Finding ◽  
Diabetic Patients ◽  
Hb E ◽  
Challenges And Opportunities ◽  
Abnormal Hemoglobin ◽  
Diabetic Population ◽  
Hemoglobin Variants

Background: Glycated Hemoglobin A1c (HbA1c) assay is most widely used in diabetic patients for assessing long-term control of glycemia. The presence of hemoglobin variants may be an incidental finding and can interfere with HbA1c measurements. The aim of the present study is to investigate the prevalence and impact of interference of different abnormal hemoglobin variants on HbA1c measurements during routine HbA1c testing. Methods: A total of 12,092 HbA1c samples were collected from January to August 2018. HbA1c quantification was carried out on a Variant II Bio-Rad’s HPLC analyzer. Abnormal chromatograms were further analyzed using the extended-run high-pressure liquid chromatography (HPLC) analysis in the A2/F mode. Results: The samples were examined for presence of abnormal variants. Samples producing abnormal chromatograms were further analyzed in A2/F mode to characterize hemoglobin variants. Abnormal variants were identified in 126 (1%) samples, and 74 (0.59%) sickle cell traits (SCT) were the most common variant in our findings. Moreover, 30 (0.24%) cases were eluted in the variant window in A1c mode, which on further analysis were found to be Hb E & Hb D traits. Furthermore, 3 (0.02%) cases were eluted at a RT <1 min as (unknown) and identified as Hb H. Also,19 (0.15%) samples were eluted in the P3 window at different retention times. Conclusion: Observing each chromatograph after the analysis can help us in identifying silent hemoglobin variants in routine HbA1c testing. Knowledge and awareness of common hemoglobin variants affecting measurement of HbA1c is imperative to avoid reporting of falsely low HbA1c values in diabetic population.

Evaluation of a Fully Automated High-Performance Liquid Chromatography Assay for Hemoglobin A1c

1999 ◽  
Vol 123 (9) ◽  
pp. 763-767 ◽  
Author(s):  
Hanh M. Khuu ◽  
C. Andrew Robinson ◽  
Kathy Goolsby ◽  
Robert W. Hardy ◽  
Robert J. Konrad
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hemoglobin A1c ◽  
Blood Glucose Control ◽  
Objective Measure ◽  
Hplc Method ◽  
Diabetic Patients ◽  
Abnormal Hemoglobin ◽  
Hemoglobin Variants

Abstract Introduction.—Measurement of hemoglobin A1c (HbA1c) is used as an objective measure of long-term blood glucose control in diabetic patients. Recent improvements in automation combined with new recommendations for precision and accuracy have caused us to reevaluate our methods for measuring HbA1c. Objective.—We evaluated a newly automated high-performance liquid chromatography (HPLC) instrument for measurement of HbA1c (Tosoh A1c 2.2 Plus Glycohemoglobin Analyzer, Tosoh Medics, Foster City, Calif) and compared the results obtained by HPLC to those obtained with an immunoassay (Hitachi 911, Boehringer Mannheim Corporation, Indianapolis, Ind). Results.—The Tosoh analyzer was found to be linear in a range of 5.3% to 17% and had a throughput of 20 samples per hour. HbA1c results for 102 patient samples by the 2 techniques showed good correlation, with a slope of 0.87 and an intercept at 1.27% ± 0.15%. Both the total and within-run coefficients of variation were consistently lower for the HPLC method compared with the immunoassay method. The HPLC method produces a chromatogram that shows the different hemoglobin fractions, allowing identification of abnormal hemoglobin variants. In heterozygous individuals, HbA1c measurements are made with no interference from the hemoglobin variant. In the case of homozygous or doubly heterozygous hemoglobin variants, the Tosoh HPLC identifies the hemoglobin variants as such and correctly does not report a HbA1c value in the presence of a markedly decreased amount of hemoglobin A. Conclusions.—The Tosoh HPLC provides adequate throughput and improved precision, and the method is traceable to the Diabetes Control and Complications Trial.

scholarly journals Challenges in Hemoglobin A1C Measurement in 183 Patients with Diabetes having Hemoglobin Variants and Chemically Modified Derivatives

2021 ◽  
Vol 2 (4) ◽  
pp. 7
Author(s):  
Dilshad Ahmed Khan ◽  
Sumbal Nida
Keyword(s):  
Hemoglobin A1c ◽  
Clinical Chemistry ◽  
Glycosylated Hemoglobin ◽  
Diabetic Patients ◽  
Chemically Modified ◽  
Patients With Diabetes ◽  
Hemoglobin Variants ◽  
Selection Of

Diabetes is considered as one of the most common metabolic disorder. It has challenged in terms of diagnosis,monitoring and management in the patients with type-2 diabetes. Glycosylated Hemoglobin (HbA1c) hasrecently been validated for the diagnosis diabetes in non-fasting condition, long term blood glycose monitoringand also predicting its complications in the patients. National Glycohemoglobin Standardization Program andInternational Federation of Clinical chemistry have been collaborating for the harmonization of HbA1cmethods and directing the laboratories to maintain strict quality goals. However, standardization of variousHbA1c methods being used worldwide still needs consideration especially in diabetic patients havinghemoglobin variants. The main objectives are to review HbA1c methods and address challenges in itsmeasurement methodology for the patients with diabetes mellitus having hemoglobin variants or chemicallymodified derivatives. Thus, to provide guidance to the clinical pathologist for selection of appropriate methodfor their laboratories.

scholarly journals Are dipeptidyl peptidase-4 inhibitors effective and safe in long term when added to ongoing therapies of diabetics? a real-life study in tertiary referral center

2019 ◽  
Vol 6 (2) ◽  
pp. 264
Author(s):  
Deniz Avci ◽  
Ali Cetinkaya
Keyword(s):  
Hemoglobin A1c ◽  
Real Life ◽  
Dipeptidyl Peptidase ◽  
Diabetic Patients ◽  
Mean Values ◽  
Tertiary Referral Center ◽  
Dipeptidyl Peptidase 4 ◽  
Dipeptidyl Peptidase 4 Inhibitors

Background: The aim of this study was to determine how HbA1c, lipid, renal functions and such parameters were affected in the long term by adding dipeptidyl peptidase-4 inhibitors to the ongoing treatment regimens of patients with Type 2 diabetes mellitus.Methods: The study was conducted in diabetes mellitus outpatient clinic of Kayseri Training and Research Hospital between February 2012 and May 2017, with patients who did not achieve the sufficient success in diabetes their controls at the time of admission. From these patients, those who added (dipeptidyl peptidase-4 inhibitors) to their treatments were selected. Patients were followed up as long as they continued to these new treatments and the parameters at the baseline were compared with final values.Results: A total of 80 diabetic patients were followed in the study. The median age of the patients was 56.08±9.71 years. During this follow-up, an average decrease of 1.03% was noted when patients were compared with 9.53±1.87% of the initial hemoglobin A1c, and 8.50±1.48% of the Hemoglobin A1c values at the end of follow-up. This decrease was statistically significant (p <0.001). However, differences in the initial and final values of the lipid parameters of the patients were not statistically significant.Conclusions: Addition of dipeptidyl peptidase-4 inhibitors to patients' treatments causes significant decreases in Hemoglobin A1c mean values. This decline is long lasting. However, there are no positive or negative effects on biochemical parameters such as lipids, kidney and liver functions.

scholarly journals Effects of Telemetric Interventions on Maternal and Fetal or Neonatal Outcomes in Gestational Diabetes: Systematic Meta-Review

JMIR Diabetes ◽  
10.2196/24284 ◽  
2021 ◽  
Vol 6 (3) ◽  
pp. e24284
Author(s):  
Claudia Eberle ◽  
Stefanie Stichling
Keyword(s):  
Glycemic Control ◽  
Systematic Reviews ◽  
Hemoglobin A1c ◽  
Glycated Hemoglobin ◽  
Neonatal Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Meta Analyses

Background In 2019, 1 of 6 births was affected by gestational diabetes mellitus (GDM) globally. GDM results in adverse maternal, fetal, and neonatal outcomes in the short and long term, such as pregnancy and birth complications, type 2 diabetes, metabolic syndrome, and cardiovascular disease. In the context of “transgenerational programming,” diabetes mellitus during pregnancy can contribute to “programming” errors and long-term consequences for the child. Therefore, early therapy strategies are required to improve the clinical management of GDM. The interest in digital therapy approaches, such as telemetry, has increased because they are promising, innovative, and sustainable. Objective This study aimed to assess the current evidence regarding the clinical effectiveness of telemetric interventions in the management of GDM, addressing maternal glycemic control, scheduled and unscheduled visits, satisfaction, diabetes self-efficacy, compliance, maternal complications in pregnancy and childbirth, as well as fetal and neonatal outcomes. Methods Medline via PubMed, Web of Science Core Collection, Embase, Cochrane Library, and CINAHL databases were systematically searched from January 2008 to April 2020. We included randomized controlled trials, systematic reviews, meta-analyses, and clinical trials in English and German. Study quality was assessed using “A MeaSurement Tool to Assess systematic Reviews” and “Effective Public Health Practice Project.” Results Our search identified 1116 unique studies. Finally, we included 11 suitable studies (including a total of 563 patients and 2779 patient cases): 4 systematic reviews or meta-analyses (1 of high quality and 3 of moderate quality), 6 randomized controlled trials (2 of high quality and 4 of moderate quality), and 1 low-quality nonrandomized controlled trial. We classified 4 “asynchronous interventions” and 3 “asynchronous and real-time interventions.” Our findings indicate that telemetric therapy clearly improves glycemic control and effectively reduces glycated hemoglobin A1c levels. Furthermore, in 1 study, telemetry proved to be a significant predictor for a better glycemic control (hazard ratio=1.71, 95% CI 1.11-2.65; P=.02), significantly fewer insulin titrations were required (P=.04), and glycemic control was achieved earlier. Telemetric therapy significantly reduced scheduled and unscheduled clinic visits effectively, and women were highly satisfied with the treatment (P<.05). From fetal and neonatal short-term outcomes, some improving tendencies in favor of telemetry were determined. No long-term outcomes were detected. Conclusions Telemetric interventions clearly improved glycemic control, notably glycated hemoglobin A1c levels, and reduced scheduled and unscheduled clinic visits effectively, which reinforces this digital approach in the treatment of GDM.

HB Puerta del Sol [HBA1:c.148A>C], HB Valdecilla [HBA2:c.3G>T], HB Gran Vía [HBA2:c.98T>G], HB Macarena [HBA2:c.358C>T] and HB El Retiro [HBA2:c.364_366dupGTG]: description of five new hemoglobinopathies

2016 ◽  
Vol 54 (4) ◽  
Author(s):  
Félix de la Fuente-Gonzalo ◽  
Jorge M. Nieto ◽  
Diego Velasco ◽  
Elena Cela ◽  
Germán Pérez ◽  
...  
Keyword(s):  
Glycated Hemoglobin ◽  
Clinical Impact ◽  
Analytical Determination ◽  
Diabetic Patients ◽  
Post Translational Modifications ◽  
Hba1 C ◽  
Abnormal Hemoglobin ◽  
Unstable Hemoglobin ◽  
Hbh Disease

AbstractStructural hemoglobinopathies do not usually have a clinical impact, but they can interfere with the analytical determination of some parameters, such as the glycated hemoglobin in diabetic patients. Thalassemias represent a serious health problem in areas where their incidence is high. The defects in the post-translational modifications produce hyper-unstable hemoglobin that is not detected by most of electrophoretic or chromatographic methods that are available so far.We studied seven patients who belong to six unrelated families. The first two families were studied because they had peak abnormal hemoglobin (Hb) during routine analytical assays. The other four families were studied because they had microcytosis and hypochromia with normal HbAThe Hb Puerta del Sol presents electrophoretic mobility and elution in HPLC that is different from HbA and similar to HbS. The electrophoretic and chromatographic profiles of the four other variants are normal and do not show any anomalies, and their identification was only possible with sequencing.Some variants, such as Hb Valdecilla, Hb Gran Vía, Hb Macarena and Hb El Retiro, have significant clinical impact when they are associated with other forms of α-thalassemia, which could lead to more serious forms of this group of pathologies as for HbH disease. Therefore, it is important to maintain an adequate program for screening these diseases in countries where the prevalence is high to prevent the occurrence of severe forms.

scholarly journals Changes in Salivary Amylase and Glucose in Diabetes: A Scoping Review

Diagnostics ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 453
Author(s):  
Pilar Pérez-Ros ◽  
Emmanuel Navarro-Flores ◽  
Ivan Julián-Rochina ◽  
Francisco Miguel Martínez-Arnau ◽  
Omar Cauli
Keyword(s):  
Glycemic Control ◽  
Glucose Concentration ◽  
Diabetic Patients ◽  
Clinical Settings ◽  
Salivary Amylase ◽  
Glucose Levels ◽  
Non Invasive ◽  
Diabetic Population ◽  
Saliva Collection

Background and Objective: Diabetes mellitus (DM) is a common long-term disease which can be related with salivary amylase levels. DM has recently been associated with salivary amylase diagnostics that could further impair diagnoses in the diabetic population, as well as being an interesting alternative to traditional methods of determine glucose levels. The main advantage of this method is related to the fact that it is a fast diagnostic method. The DM population experiences changes to their metabolism which affects their salivary parameters, making this an alternative procedure for diagnosis and follow-up of the illness due to the non-invasive nature of salivary analyzes. The objective of this review is to summarize the evidence regarding the changes in salivary amylase and glucose levels, and their relationship with blood markers of glycemic control used in clinical settings such as blood glucose and glycated hemoglobin. The differences in salivary amylase levels depending on the method of saliva collection under fasting or non-fasting conditions. The changes in salivary amylase depends on the type of diabetes, the type of insulin treatment or the quality of glycemic control. Conclusions: Salivary amylase concentration is increased in diabetic patients in most of the studies and salivary glucose concentration in all studies in both fasting and non-fasting (post-prandial) conditions. Salivary amylase and glucose concentration represent potential non-invasive biomarkers to evaluate glycemic control and clinical management of diabetic patients, although it is necessary to evaluate the influence of potential modulating factors such as age, duration diseases, sex and the effects of pharmacological treatments in these outcomes which remained to be elucidated.

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