Test Achieves CE Mark as Aid in Diabetes Diagnosis

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. Available for use on the company’s DCA systems, including the DCA Vantage® Analyzer, the test kit 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. The benefits of using hemoglobin A1c (HbA1c) testing to measure average blood glucose levels in the management and treatment of patients with confirmed diabetes is well established. More recently, the medical community has recognised 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.³

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 (1µL) 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.