Test to Aid Doctors Diagnose and Monitor Diabetes

Abbott (Abbott Park, IL, USA) has received CE marking for the ARCHITECT clinical chemistry Hemoglobin A1c (HbA1c) test. The ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative in vitro measurement of the percent hemoglobin A1c or HbA1c fraction in human whole blood and hemolysate on the ARCHITECT c8000 and c4000 Systems.

In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardization processes outlined by the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry (IFCC).

Diabetes can be managed by using diabetes medicines, making important lifestyle changes related to diet and exercise, and monitoring blood glucose and HbA1c levels. For people whose HbA1c test results are normal, doctors may recommend that testing be repeated at least every three years or more frequently depending on a person’s initial results and risk status.

"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," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "With the CE Mark of Abbott's ARCHITECT clinical chemistry HbA1c test, we are pleased to offer this valuable tool to help doctors diagnose diabetes and identify patients at-risk for developing diabetes. Doctors can use this information to improve patient care."

The ARCHITECT clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Africa, and also in Canada pending country registration. Abbott has filed for 510(k) clearance with the US Food and Drug Administration.

Related Links:
Abbott