European Reference Laboratory for Glycohemoglobin Study Reaffirms EKF’s Quo-Test® Meets HbA1c Performance Criteria

EKF Diagnostics has announced that in a newly published paper [1] its Quo-Test® point-of-care (POC) hemoglobin A1c (HbA1c) analyzer has again been confirmed to meet International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance criteria. Using sigma-metrics data modelling, scientists from the European Reference Laboratory for Glycohemoglobin demonstrated that Quo-Test easily met IFCC accepted quality targets of >2 sigma at 10% total allowable error (TAE) at 48 mmol/mol HbA1c. This is essential for the effective monitoring of glycemic control in diabetes patients.

Under strict evaluation conditions, Quo-Test was not only shown to perform extremely well against routine laboratory analyzers, certified as secondary reference measurement procedures (SRMPs), but also when compared to six other POC HbA1c analyzers. The authors explained that in the laboratory, sigma-metrics is a quality management strategy that provides a universal benchmark for analytical performance - effectively placing all analyzers on a level playing field. Using sigma-metrics, analytical characteristics (bias and imprecision) are placed in the form of TAE within a framework of clinical requirements. An IFCC Task Force in 2015 advocated the use of sigma-metrics quality targets for HbA1c to standardize analytical quality at a global level [2].

This latest study [1] follows the release of critical evaluation data by the European Reference Laboratory for Glycohemoglobin published in a white paper in 2016 [3], which also demonstrated Quo-Test’s strong performance. In the white paper Quo-Test’s performance in sigma-metrics was very good. Sigma was shown to be >2 at 48mmol/mol and at an HbA1c value of 75 mmol/mol >4. Examining the CVs of all duplicates, one lot number even had a sigma of >6; this is a class-leading level of performance.

Notably, within the 2016 evaluation study, the boronate affinity fluorescence quenching technology employed by Quo-Test was demonstrated to maintain results consistency due to its ability to minimize the effects of hemoglobin variants. This compared well with laboratory-based HPLC systems. Quo-Test showed no interference of the common Hb-variants HbAS, HbAC, HbAD, HbAE, HBAJ, elevated A2 and HbF<8.6%.

“We are pleased that the European Reference Laboratory for Glycohemoglobin has reaffirmed that Quo-Test fully meets accepted global performance criteria for HbA1c analysis,” said Gavin Jones, Global Diabetes Product Manager, EKF Diagnostics. “We are extremely confident that our Quo-Test is one of the most accurate, easy-to-use and reliable HbA1c POC analyzers available, which is also unaffected by most hemoglobin variants.”

CE-marked for the monitoring of HbA1c in diabetes patients, Quo-Test is specifically designed for use in a POC setting, such as diabetes clinics and doctors’ surgeries. It is fully automated, measuring HbA1c from a 4 µL sample taken from a finger prick or venous whole blood. Results are available in four minutes within a measuring range of 4-15% A1c DCCT, and precision performance with a CV of 2.2% at 6.6% DCCT has been demonstrated [3].