Siemens Healthcare Diagnostics achieves CE mark for DCA HbA1c
8 November 2012
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.
Notably, in 2009, several major diabetes associations, including
the International Diabetes Federation (IDF), European Association
for the Study of Diabetes (EASD) and the American Diabetes
Association, were part of an international expert committee that
accepted the HbA1c test for diabetes diagnosis. This acceptance was
based on several advantages that were evident when compared against
the traditional method of measuring blood glucose levels3.
Convenience was cited as a significant advantage of HbA1c testing
as 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. HbA1c
testing also only requires a single measurement as opposed to blood
glucose testing that involves serial blood draws over several hours.
With the Siemens Healthcare Diagnostics 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 patient visit. This reduces the need for
follow-up visits and improves patient care through a simple-to-use
“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 cent, 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 per cent may identify individuals with high risk for future
diabetes, a state that may be referred to as prediabetes4.
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. This product demonstrates Siemens’ continued
innovation leadership, a goal of the recently launched Siemens
Agenda 2013 program.
For more information about Siemens’ diabetes testing options,