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Glycated haemoglobin assay receives CE mark

Abbott has received CE marking for its new ARCHITECT haemoglobin A1c (HbA1c) assay. The new HbA1c test provides clinicians with important information that may help patients take critical steps to manage the progression of their disease. Measurement of HbA1c reflects a person’s average blood glucose level over the previous three months.

In 2009, an international expert committee recommended that clinicians could use HbA1c testing for the diagnosis of type 2 diabetes – as well as to identify patients at risk of developing diabetes – if the assay meets specific performance criteria, such as certification and standardisation processes outlined by the NGSP (formerly the National Glycohemoglobin Standardization Program) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

"When diabetes is not managed properly, it can lead to damage of important systems in the body, including the heart, kidneys, and eyes, and even cause life-threatening complications," commented Brian Blaser, executive vice president, Diagnostics Products, Abbott. "With the ARCHITECT HbA1c test, we are pleased to offer a valuable tool to help clinicians diagnose diabetes and identify patients at risk."
www.abbott.co.uk

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