How to Increase Laboratory Accuracy with Direct HbA1c Testing !

HbA1c:

Diabetes is a global epidemic affecting in the region of 425 million people according to the International Diabetes Federation. Worryingly, this figure is on the rise with forecasts suggesting diabetes will affect up to 629 million people globally by 2045. Such a dramatic increase highlights the fundamental need for better disease management. When we look at the worldwide prevalence of diabetes, the United States is one of the most prominent countries affected.

HbA1c - an important biomarker for diabetes management and control !

HbA1c, also known as hemoglobin A1c or glycated hemoglobin, is an important blood test used to determine how well diabetes is being controlled. It develops when hemoglobin, a protein within the red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming “glycated.” The concentration of HbA1c in the blood of diabetic patients increases with rising blood glucose levels and is representative of the mean blood glucose level over the preceding six to eight weeks. HbA1c can therefore be described as a long-term indicator of diabetic control, unlike blood glucose which is only a short-term indicator of diabetic control. It is recommended that HbA1c levels are monitored every three to four months.

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Evaluation of Diabetic Marker HbA1c and Anemia in the Context of Kidney Disease

Each year, more than 100,000 people in the United States are diagnosed with kidney failure, the final stage of kidney disease.1 The most common cause is diabetes, accounting for nearly 44 percent of new cases. Often, a consequence of kidney disease is anemia. This occurs when kidneys fail to generate enough erythropoietin hormone to trigger adequate red blood cell production. For decades, clinicians have successfully used the hemoglobin A1c (HbA1c or A1C) assay to monitor long-term blood glucose control for patients with chronic diabetes. More recently, researchers have studied the HbA1c assay’s use as a potential diagnostic marker for diabetes complications such as kidney disease.

The HbA1c test measures average plasma glucose—hemoglobin in a red blood cell that was combined with glucose over the previous eight to 12 weeks. The higher the HbA1c value, the greater the risk that the diabetes patient will develop kidney disease, and perhaps, anemia, a common consequence of renal disease. However, a chemically modified derivative of hemoglobin called carbamylated hemoglobin (CHb) can affect the accuracy of the HbA1c test results. Studies have shown that the formation of CHb due to abnormal urea concentration is linked to both the severity and the duration of renal failure. Research findings have inspired conflicting viewpoints on the efficacy of HbA1c test results in the presence of CHb and on the level of CHb it takes to affect results. This article explores the links between diabetes and renal failure. It discusses what research has discovered about the effect of CHb on HbA1c testing. Finally, it shows how testing technology has improved to ensure HbA1c testing accuracy.

Read more: Evaluation of Diabetic Marker HbA1c and Anemia in the Context of Kidney Disease

Source: MedicalLaboratoryObserver

The Continuing Case for Point-of-Care Testing for HbA1c

There is an ongoing conflict between traditional clinical laboratories and the relative new kid on the block, point-of-care testing (POCT). Of course, the laboratory system will likely always be king. But there is absolutely a place for POCT, especially as the way in which we approach healthcare, especially diagnostics, develops beyond the usual settings.

POCT ensures the rapid provision of diagnostic information, ideally during one consultation, to enable clinical decisions to be made at the earliest opportunity. Such rapid provision of information facilitates optimization of the care process. The potential for any application of POCT can, therefore, be judged in terms of its contribution to decision making and to the process of care.

In the case of the management of diabetes patients, POCT for glycated hemoglobin (HbA1c) may offer a number of advantages—as long as the performance characteristics of the analyzers used are equivalent to those employed in the central laboratory, and can be certified as such.

The use of HbA1c for management of diabetes

Glycated hemoglobin (HbA1c) is well-recognized as a reliable measure for glycemic control.

Read more: The Continuing Case for Point-of-Care Testing for HbA1c

Figure 1. Glycated hemoglobin (HbA1c) explained

Source: mlo-online

Borderline Diabetes: What You Need to Know

The term borderline diabetes refers to a condition called prediabetes. Prediabetes is a condition in which blood sugar levels are higher than normal but not high enough to be classed as type 2 diabetes.

Prediabetes is to be considered a risk factor for type 2 diabetes. It is estimated that 10 to 23 percent of people with prediabetes will go on to develop type 2 diabetes within 5 years.

Prediabetes can be accompanied by other risk factors. It is associated with conditions such as obesity, especially abdominal obesity, high blood pressure, high blood fat levels and low levels of "good" cholesterol.

When these risk factors "cluster" together in a person, there is a higher risk of not just type 2 diabetes but heart disease and stroke as well.

Read more: Borderline Diabetes: What You Need to Know

Source: medicalnewstoday

Blood Test Uncovers Undiagnosed Diabetes In Hospital Patients

Hyperglycemia is a frequent finding that can be related to physiologic stress, illness and medications, including steroids and vasopressors and glycated hemoglobin (HbA1c) correlates with the average blood glucose level over the previous eight to 12 weeks.

Screening of HbA1c levels plays an important role in the diagnosis and management of diabetes mellitus in the outpatient setting but remains underused in the evaluation of hyperglycemia with undiagnosed diabetes in the inpatient setting.

Read more:   Blood Test Uncovers Undiagnosed Diabetes In Hospital Patients

A point-of-care glycated hemoglobin (HbA1C) analyzer.

Source: labmedica

Diabetes Testing on High-Throughput Analyzer Files for FDA Approval

The cobas c513 analyzer has been submitted to the US Food and Drug Administration (FDA) for approval as a dedicated, high-throughput HbA1c testing solution to help laboratories meet increasing testing needs for people with diabetes.

The cobas c513 analyzer from Roche (Basil, Switzerland) is based on the proven, trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT). The HbA1c test is a longer term measurement of blood sugar levels used to determine if a person has or is at risk of developing diabetes. Set to run on the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, the cobas c513 will ensure high-quality results and comply with current guidelines and recommendations for HbA1c testing and measures A1c as defined by the IFCC.

cobas c513 features direct results reporting, thereby minimizing risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This feature will help save valuable time and laboratory resources, while ensuring high-quality results. Furthermore, cobas c513 will provide a higher on-board test capacity, enabling laboratories to load the analyzer with more tests at a time, save lab space, minimize resources, and ensure a smooth workflow.

Read more: Diabetes Testing on High-Throughput Analyzer Files for FDA Approval

The cobas c513 analyzer provides throughput of up to 400 HbA1c patient results/hour, closed

tube sampling (CTS), and is standardized according to IFCC transferable to DCCT/NGSP

Source: Roche