We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

EKF Diagnostics

Manufactures analysers for the measurement of glucose, lactate, hemoglobin, hematocrit and HbA1c for GP surgeries, ph... read more Featured Products: More products

Download Mobile App




Study Reaffirms HbA1c Analyzer Meets Performance Standards

By LabMedica International staff writers
Posted on 10 Mar 2017
Print article
Image: The Quo-Test analyzer (Photo courtesy of EKF Diagnostics).
Image: The Quo-Test analyzer (Photo courtesy of EKF Diagnostics).
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.

Gold Member
Serological Pipet Controller
PIPETBOY GENIUS
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Unstirred Waterbath
HumAqua 5
New
Calprotectin Assay
Fecal Calprotectin ELISA

Print article

Channels

Molecular Diagnostics

view channel
Image: Health Canada has approved SPINEstat, a first-in-class diagnostic blood test for axSpA, as a Class II medical device (Photo courtesy of Augurex)

First-in-Class Diagnostic Blood Test Detects Axial Spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory autoimmune condition that typically affects individuals during their most productive years, with symptoms often emerging before the age of 45.... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Technology

view channel
Image: The new algorithms can help predict which patients have undiagnosed cancer (Photo courtesy of Adobe Stock)

Advanced Predictive Algorithms Identify Patients Having Undiagnosed Cancer

Two newly developed advanced predictive algorithms leverage a person’s health conditions and basic blood test results to accurately predict the likelihood of having an undiagnosed cancer, including ch... Read more

Industry

view channel
Image: The collaboration aims to leverage Oxford Nanopore\'s sequencing platform and Cepheid\'s GeneXpert system to advance the field of sequencing for infectious diseases (Photo courtesy of Cepheid)

Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions

Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.