HbA1c analyser receives CE Mark approval

Published: 18-Jul-2012

Diagnostic device offers low-cost POC technology for detection and management of diabetes

In-vitro diagnostics device manufacturer, EKF Diagnostics Holdings, has announced that its new Quo-Lab point-of-care (POC) HbA1c analyser has received its CE Mark, allowing the product to be formally launched in the UK and Europe.

Quo-Lab is a semi-automated HbA1c analyser which provides highly-accurate, low-cost and easy-to-use technology for GP surgeries, diabetes clinics and laboratories.

HbA1c monitoring is increasingly used in the detection and management of diabetes, and Quo-Lab has been specifically designed to meet the needs of economies where diabetes is an increasingly common public health issue and where resources are limited.

The new analyser is manufactured by EKF subsidiary, Quotient Diagnostics, and uses the unique Boronate Affinity Florescence method perfected in its Quo-Test HbA1c analyser. Requiring just 4µL of venous or fingerprick blood, the small and lightweight device delivers lab-accurate results within four minutes (CV < 3% at 7% A1c). Its simple 4-Step procedure also requires minimal training, with on-screen instructions available in a variety of user-selectable languages.

Commenting on the approval, Julian Baines, chief executive of EKF Diagnostics Holdings, said: “We believe Quo-Lab will have a very positive reception in the near patient testing market for HbA1c. It provides lab-accurate, low-cost testing that is incredibly easy to use and minimises the opportunity for user error or contamination of the sample. But, most importantly, it has specific benefits to emerging markets where diabetes is on the increase.

“By utilising the methodology that we perfected for Quo-Test we know we have a device that delivers the accuracy and precision that practitioners demand, together with a user experience that is unrivalled in its sector.”

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