US-based Ortho-Clinical Diagnostics has received CE Mark for the Vitros chemistry products HbA1c reagent kit, an enhanced assay to detect and monitor blood glucose levels over time in diabetes patients.
The assay helps to find the percentage of glycated haemoglobin (HbA1c) in human whole blood, and is also designed as an aid in the diagnosis of diabetes. It can also help to identify patients who may be at risk of developing diabetes.
The company intends to launch the product in the European Economic Area and several other countries in November this year.
Using Vitros MicroTip technology, the new assay runs on the company's Vitros chemistry and integrated systems and offers operational, performance and clinical improvements compared to the existing assay.
The enhanced Vitros chemistry products HbA1c assay can be used to aid in the diagnosis and identification of patients at risk of developing diabetes.
The assay provides higher throughput, simplified calibration and improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements.
NGSP standardises HbA1c test results to those of the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.
Ortho Clinical Diagnostics chief operating officer Robert Yates said: "Ortho Clinical Diagnostics is demonstrating our deep commitment to meet the challenges of today's lab professional by continuing our investment in bringing new and enhanced products like the Vitros chemistry products HbA1c assay to market.
"This new assay will enable our customers to more effectively and productively diagnose and monitor diabetes as the rate of the disease continues to climb around the world."
The new Vitros chemistry products HbA1c kit can run on three different Vitros platforms including the 5,1 FS chemistry system, the 4600 chemistry system and the 5600 integrated system.
In order to eliminate the risk of sample carryover, reagent-to-reagent contamination and extend on-board reagent stability, the assay uses single-use disposable tips and closed reagent packs.