Ortho Clinical Diagnostics Receives CE Mark for VITROS® Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay

Ortho Clinical Diagnostics Receives CE Mark for VITROS® Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay

Oct 17, 2014

Raritan, NJ, October 17, 2014 – Ortho-Clinical Diagnostics, Inc. today announced that it obtained CE Mark (Conformité Européenne) 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 determines the percentage of glycated hemoglobin (HbA1c) in human whole blood. It is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. Measurements are effective in monitoring long-term glucose control in individuals with diabetes. The product will be available in the European Economic Area and several other countries in November 2014.  


Using patented VITROS® MicroTip Technology, the new assay runs on the Ortho Clinical Diagnostics VITROS® Chemistry and Integrated systems and provides operational, performance and clinical improvements compared to the company’s existing assay. The improved VITROS® Chemistry Products HbA1c assay can be used to aid in the diagnosis and identification of patients at risk for developing diabetes. It also offers higher throughput, simplified calibration and improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements. The purpose of the NGSP is to standardize HbA1c test results to those of the Diabetes Control and Complications Trial (DCCT)[1] and United Kingdom Prospective Diabetes Study (UKPDS)[2], which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.


The percent of glycated hemoglobin (HbA1c) in a person’s blood is the worldwide standard for measuring blood glucose levels to detect and monitor diabetes. According to the World Health Organization, 347 million people around the globe have diabetes. The disease, a leading cause of blindness, amputation and kidney failure, is predicted to become the seventh leading cause of death in the world by the year 2030.[3]


“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,” said Robert Yates, Chief Operating Officer, Ortho Clinical Diagnostics. “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: the 5,1 FS Chemistry System, the 4600 Chemistry System and the 5600 Integrated System. The assay uses VITROS® MicroTip Technology, which offers a special chemistry menu and user-defined assays in a cost-effective, easily implemented format. It utilizes single-use disposable tips and closed reagent packs to eliminate the risk of sample carryover, reagent-to-reagent contamination and extend on-board reagent stability. Similar to VITROS® MicroSlide and MicroWell Technologies, this is performed without the need for water.


About VITROS® Systems

Ortho Clinical Diagnostics pioneered the VITROS® series of systems in 1978 and continues to expand and evolve these sophisticated laboratory systems to reduce the probability of human error, improve operational efficiencies and increase uptime in clinical labs. The VITROS® series of systems includes automated, integrated and compact analyzers that offer immunoassay and chemistry detection with standardized reagents and results across all platforms. The introduction of the exclusive VITROS® MicroSlide Technology revolutionized chemistry and immunoassay testing by offering the first and only dry slide technology, eliminating the need for a water supply. VITROS® MicroSlide Technology is one of the five enabling technologies, which also include VITROS® MicroTip Technology, VITROS® MicroWell Technology, VITROS® MicroSensor Technology and VITROS® IntelliCheck® Technology. These technologies power the transformational performance in labs around the world by delivering confidence in results, productivity and financial predictability as well as environmental benefits.

In addition, the Ortho Clinical Diagnostics broad menu of more than 125 VITROS® assays offers all of the most important clinical chemistry tests, covering major disease states including heart disease, cancer, endocrine disease, infectious disease, thyroid disease, metabolic conditions and anemia.


About Ortho-Clinical Diagnostics, Inc. 

Ortho-Clinical Diagnostics, Inc. delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.





The VITROS® Chemistry Products HbA1c Reagent Kit, VITROS® 5,1 FS, VITROS® 4600, VITROS® 5600, VITROS® MicroSlide, VITROS®MicroTip, VITROS® MicroWell, VITROS® MicroSensor, VITROS® IntelliCheck® and the VITROS® logo are trademarks of Ortho-Clinical Diagnostics, Inc.




[1] The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329 (14): 977–86.

[2] King P, Peacock I, Donnelly R. The UK Prospective Diabetes Study (UKPDS): Clinical and therapeutic implications for type 2 diabetes.  Br J Clin Pharmacol. 1999; 48(5):643-648.

[3] World Health Organization. Diabetes fact sheet (October 2013).  Available at: http://www.who.int/mediacentre/factsheets/fs312/en/  Accessed September 19, 2014.