CE Mark for Haemoglobin A1c Test Announced

Abbott has received CE marking for its new ARCHITECT® Haemoglobin A1c (HbA1c) assay, a simple blood test designed to aid the diagnosis and monitoring of diabetes. The new ARCHITECT HbA1c test provides physicians with important information that may help patients take critical steps to manage the progression of this serious disease.

Measurement of HbA1c reflects a person’s average blood glucose level over the past three months. In 2009, an international expert committee recommended that physicians could use HbA1c testing for the diagnosis of type 2 diabetes – as well as to identify patients at risk for 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 doctors diagnose diabetes and identify patients at risk, helping to improve patient care."

The ARCHITECT clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Canada and Africa, pending country registration.