Study Reaffirms HbA1c Analyzer Meets Performance Standards
By Labmedica International staff writersIn 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).
Posted on 10 Mar 2017
Posted on 10 Mar 2017
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.