Product News: Siemens Aids in Diabetes Diagnosis as HbA1c Test Achieves CE Mark

18 Sep 2012

The Siemens Healthcare Diagnostics DCA HbA1c test kit*, already used to monitor diabetes patients’ HbA1c levels, has achieved the CE mark as an aid to diagnose diabetes and identify patients at risk for developing the disease. The kit is available for use on the company’s DCA systems, including the DCA Vantage® Analyzer, and now provides clinicians with a streamlined solution that delivers fast, actionable results for the diagnosis and management of diabetes in environments ranging from physicians offices to hospitals and clinics.

Diabetes currently affects more than 55 million people throughout Europe and the benefits of using hemoglobin A1c (HbA1c) testing in the management and treatment of patients with confirmed diabetes is well established. More recently, the medical community has recognized the clinical utility of HbA1c testing in the disease’s diagnosis. Notably, in 2009, several major diabetes associations, including the International Diabetes Federation (IDF), American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), were part of an International Expert Committee that accepted the HbA1c test for diabetes diagnosis based on several advantages when compared with the traditional method of measuring blood glucose levels.

Convenience was cited as a significant advantage of HbA1c testing since it can be conducted at any time and requires no preparation by the patient, unlike fasting plasma glucose (FPG) measurements, where fasting must occur at least eight hours prior to testing. Also, HbA1c testing only requires a single measurement as opposed to blood glucose testing that involves serial blood draws over several hours.

With the Siemens DCA HbA1c test, only a small (1 µL) whole blood finger stick sample is needed, enabling clinicians to identify at-risk patients within minutes, review test results and discuss early intervention and disease management options during the same office visit. By reducing the need for follow-up visits, in-office testing of HbA1c with the Siemens DCA HbA1c kit not only helps consolidate operations, but also contributes to improved patient care through a simple-to-use tool.

“When not diagnosed or managed properly, diabetes can have devastating health consequences,” said David Stein, Ph.D., CEO, Point of Care Business Unit, Siemens Healthcare Diagnostics. “Siemens is committed to equipping clinicians with a highly precise and accurate method to aid in diagnosing diabetes to help them intervene early in the management of at-risk patients.”

Diabetes should be diagnosed when HbA1c values are greater than or equal to 6.5 percent, per guidelines from the International Expert Committee. Also, according to the 2012 “Standards of Medical Care in Diabetes,” the ADA reports that HbA1c values between 5.7 and 6.4 percent may identify individuals with high risk for future diabetes, a state that may be referred to as prediabetes.

Since 1991, the Siemens DCA HbA1c test has been used for monitoring diabetes patients’ HbA1c levels, and its effectiveness is documented in over 140 publications. Siemens plans to make its dual-purpose DCA HbA1c test kit available in Europe for the diagnosis and monitoring of diabetes during the second quarter of 2013.

More information about the DCA HbA1c test kit’s expanded claim will be available at Siemens booth #474B during the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD), Berlin, German, October 1 – 5.

* Not all product offerings are available in all countries. Not available for sale in the U.S. Kit #: 10698915