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The Importance Of Direct HbA1c Testing Capabilities Using A Clinical Chemistry Analyzer

Diabetes is a global epidemic that affects approximately 271 million people around the world and according to the International Diabetes Federation, it is a figure that is on the rise. Their calculations forecast that diabetes will affect roughly 552 million by the year 2030, highlighting the fundamental need to manage patients with diabetes. India is one of the most prominent countries affected by diabetes when analyzing its prevalence worldwide and affects roughly 30 million Indians, which is expected to increase to 9 percent of India’s total population by 2030.

HbA1c explained further

HbA1c, also known as hemoglobin A1c or glycated hemoglobin, is an important blood test that is able to determine how well diabetes is being controlled. It develops when hemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming glycated. As glycation is irreversible, HbA1c remains in the same state in the red blood cell for 8–12 weeks; this then gives an overall picture of what the average blood sugar level is. This is particularly important as it allows clinicians to monitor the glycaemic control in individuals with diabetes.

What is the HbA1c assay used for?

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 6–8 weeks. It is recommended that HbA1c levels be monitored every 3-4 months. In patients who have recently changed their therapy or in those who have gestational diabetes it may be beneficial to measure HbA1c levels more frequently, at 2–4-week intervals. With HbA1c clinicians are able to monitor blood glucose levels periodically to deliver accurate and quick results that can improve patient care.

Randox offers an automated immunoturbidimetric HbA1c test offering an improved method for the rapid direct measurement of HbA1c in human blood; which is available for use on the RX daytona+, RX imola, and RX modena clinical chemistry analyzers.

Problems with other methods used to test for HbA1c

Alternative available methods that can be used to test for HbA1c include the chromatography-based HPLC assay. With this method the chromatographic assay uses an HPLC instrument and ion exchange or affinity column to separate HbA1c molecules from other hemoglobin molecules. The HbA1c content is calculated on the ratio of HbA1c peak area to the total hemoglobin peak areas. However, problems with this method include interferences such as hemoglobin variants (HbS, HbC, HbD, and HbE), along with non-variant HbF (fetal hemoglobin) and chemically modified derivatives such as LA1c (labile A1C) and CHb (carbamyl-Hb), which cause discrepancies with results. These discrepancies can lead to inaccurate diagnoses and treatment leading to additional costs to the health system.

Key benefits of direct HbA1c testing

Direct HbA1c testing eliminates the need for the sample incubation step which is required on alternative methods; this allows samples to be to run immediately on the RX series clinical chemistry analyzers and provides faster and more accurate results when they are needed. The removal of the offline preparation stage increases the recovery times, allowing laboratories to enhance their workflow and also consolidate testing onto one single clinical chemistry platform.

Additional benefits of using the RX series in conjunction with the Randox HbA1c assay include having one assay instead of two, which enables quicker calibration; saving the user time and making the overall method simple and quick to perform, setting a new standard in HbA1c determination and patient care.

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