EKF Diagnostics, the global in-vitro diagnostics company, announces the release of a significant critical evaluation of the Quo-Test analyzer carried out by the European Reference Laboratory for Gylcohemoglobin.
This new evaluation represents the culmination of several years’ cooperation between EKF Diagnostics and the European Reference Laboratory to produce a world class Point-of-Care-Testing (POCT) HbA1c analyzer.
Following CLSI (Clinical & Laboratory Standards Institute) guidelines and NGSP (National Glycohemoglobin Standardization Program) criteria for precision the Quo-Test HbA1c analyzer was found to have class-leading level of performance for precision with a CV (coefficient of variation) of 2.2% at 6.6% DCCT. According to the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) and the NGSP an HbA1c value of 6.5% DCCT indicates a patient can be considered to be diabetic.
This new evaluation also demonstrates that the unique boronate affinity fluorescence quenching technology employed by the Quo-Test helps to keep results consistent by minimising the effect of hemoglobin variants, showing very little difference compared to the market-leading HPLC lab systems. The Quo-Test showed no interference of the common Hb-variants HbAS, HbAC, HbAD, HbAE, HbAJ, elevated A2 (thallasemia) and HbF <8.6%.
“We are very happy with the results of this evaluation” said Global Diabetes Product Manager, Gavin Jones. “Following several disappointing evaluations produced by the European Reference Laboratory we decided to listen carefully to the advice they had to offer and incorporate that advice into our product development programme. What you are seeing in this evaluation is the result of that programme and we feel that we now have one of the most robust, accurate and precise POCT HbA1c analyzers on the market.”
The Quo-Test HbA1c analyzer has been designed for easy and reliable HbA1c measurement for the monitoring and management of diabetes in a point of care setting such as diabetes clinics and doctors’ surgeries.
The Quo-Test HbA1c is a fully automated hemoglobin A1c analyzer that uses patented boronate fluorescence quenching technology to measure glycated hemoglobin from a 4 μl sample taken from a finger prick or venous whole blood.