Meeting HBA1c performance criteria

EKF Diagnostics, a global in vitro diagnostics company, has announced that, in a recently published paper (Lenters-Westra E, English, E. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med 2017; 37: 57–71.) its Quo-Test point-of-care (POC) haemoglobin A1c (HbA1c) analyser has been confirmed as meeting 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 glycaemic control in diabetes patients.

Under strict evaluation conditions, Quo-Test was shown to perform well against routine laboratory analysers, certified as secondary reference measurement procedures (SRMPs), but also when compared to six other POC HbA1c analysers. The authors explained that sigma-metrics is a quality management strategy that provides a universal benchmark for analytical performance, effectively placing all analysers 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 standardise 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 strong performance. In the White Paper, Quo-Test’s performance in sigma-metrics was very good. Sigma was shown to be >2 at 48 mmol/mol and >4 at an HbA1c value of 75 mmol/mol. Examining the coefficients of variation (CVs) of all duplicates, one lot number showed sigma >6.

www.ekfdiagnostics.com

 

Other news

Visualise No Malaria

Upcoming Events

Clinical and Laboratory Haemostasis 2019

The Atrium Conference Centre, Sheffield Hallam University
5-6 June 2019

Ist International Blizard/QMUL Tuberculosis Symposium

Bearsted Lecture Theatre, Alexandra Wing, Queen Mary University of London - Whitechapel
26-27 June 2019

The Oxford Haematology in Obstetrics Postgraduate Course

St Edmund Hall, Queen's Lane, Oxford OX1 4AR
9-11 September 2019

IBMS Biomedical Science Congress

ICC, Birmingham
22-25 September 2019

Latest Issue

Pathology In Practice

Pathology In Practice

Apr 2019

Reducing exposure to antimicrobial agents

Register now to apply for regular copies of Pathology In Practice and free access to premium content, as well as our regular newsletters.