CE Mark for HbA1c Diabetes Diagnosis Test Achieved

The Siemens Healthcare Diagnostics DCA HbA1c test kit, already widely used to monitor diabetes patients’ HbA1c levels, has achieved the CE mark as an aid to diagnose diabetes and identify patients at risk from developing the disease. Available for use on Siemens’ DCA systems, including the DCA Vantage® Analyser, the test kit now provides clinicians with a streamlined solution that delivers fast, accurate results in a range of environments from doctor surgeries to hospitals and clinics.

With diabetes currently affecting more than 55 million people across Europe, the benefits of using haemoglobin A1c (HbA1c) testing to measure average blood glucose levels in the management and treatment of patients with confirmed diabetes is well established. Recently, the medical community has recognised the clinical utility of HbA1c testing in the disease’s diagnosis.

With the Siemens Healthcare Diagnostics 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 patient visit. This reduces the need for follow-up visits and improves patient care through a simple-to-use tool.

“When not diagnosed or managed properly, diabetes can have devastating health consequences,” stated Hilda Crockett, Business Manager, Point of Care at Siemens Healthcare Diagnostics. “Siemens is committed to equipping clinicians with a highly precise and accurate method to aid 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%, 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% may identify individuals with high risk for future diabetes, a state that may be referred to as prediabetes.

Since 1991, the Siemens Healthcare Diagnostics DCA HbA1c test has been used for monitoring diabetes patients’ HbA1c levels, and its effectiveness is documented in over 140 publications. It is aimed that the dual purpose DCA HbA1c test kit will be available in Europe for the diagnosis and monitoring of diabetes during the second quarter of 2013.