Study Reaffirms HbA1c Analyzer Meets Performance Standards

In a newly published paper, a point-of-care (POC) hemoglobin A1c (HbA1c) analyzer has again been confirmed to meet the performance criteria of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

Using sigma-metrics data modeling, scientists from the European Reference Laboratory for Glycohemoglobin demonstrated that the Quo-Test HbA1c analyzer from EKF Diagnostics easily met IFCC accepted quality targets of >2 sigma at 10% total allowable error (TAE) at 48 mmol/mol HbA1c. This is essential for 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 6 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.

This latest study follows the release of critical evaluation data by the European Reference Laboratory for Glycohemoglobin published in a white paper in 2016, which also demonstrated Quo-Test’s excellent performance. In the white paper Quo-Test’s performance in sigma-metrics was also very good. 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 common Hb-variants.

“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,”said Gavin Jones, Global Diabetes Product Manager, EKF Diagnostics. CE-marked for the monitoring of HbA1c in diabetes patients, Quo-Test is automated and specifically designed for use in POC settings such as diabetes clinics and doctors’ surgeries, measuring HbA1c from a 4 µL sample taken from a finger prick or venous whole blood. Results are available in 4 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.

The study, by Lenters-Westra E & English E, was published in the March 2017 issue of the journal Clinics in Laboratory Medicine.