EKF Diagnostics has developed Quo-Test, for easy and reliable measurement of glycated haemoglobin (HbA1c) used in the detection and management of diabetes. The device, which is awaiting FDA clearance with a launch expected early in 2013, will be sold in North, Central and South America by Stanbio Laboratory, a Texas based specialist distributor of IVD products and clinical chemistry manufacturer. Stanbio was acquired by EKF Diagnostics in May 2011.
Quo-Test enables clinicians to make a rapid determination of diabetes management , thereby improving patients’ experience, thanks to the fast and accurate results obtained from the machine in just four minutes from 4μl of blood from finger prick or venous sample. The user-friendly device has a multi-lingual menu and allows for efficient data handling, with a barcode reader and storage of up to 7,000 results, which can be downloaded to a computer via a USB port.
Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT): a simple, fast and accurate method, based on the well-documented boronate affinity for glycated haemoglobin, which is not affected by haemoglobin variants. Although Quo-Test has been developed to be used in a point of care setting, it is a professional product providing laboratory level accuracy, reporting its results in IFCC and DCCT standards (Mono S & JDS reporting are also available). The CE marked analyser has been approved by China's SFDA for the monitoring of HbA1c in diabetes patients and is manufactured in the UK by EKF Diagnostics Group company Quotient Diagnostics Ltd (ISO13485:2003 certified).