Ortho Clinical Diagnostics announces FDA approval of VITROS Chemistry Products HbA1c Reagent Kit for diagnosis of diabetes

Operational, performance and clinical improvements without having results interfered by common hemoglobin variants demonstrate company commitment to meet evolving customer needs

Ortho Clinical Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the VITROS^® Chemistry Products HbA1c Reagent Kit to be used on the VITROS^® 5600 Integrated System, VITROS^® 4600 Chemistry System, and the VITROS^® 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

“The VITROS^® Chemistry Products HbA1c assay was developed for improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements, as well as to meet the evolving needs of today’s laboratory professionals for enhanced products”

The VITROS^® Chemistry Products HbA1c Reagent Kit offers operational and performance enhancements over the company’s currently marketed VITROS^® Chemistry Products d%A1c Reagent Kit, including higher throughput and simplified calibration. The design of the VITROS^® HbA1c assay allows its use in patients with hemoglobin variants S, C, D, and E traits. The new assay is now available and will replace the VITROS^® Chemistry Products d%A1c Reagent Kit, which will eventually be discontinued.

“The VITROS^® Chemistry Products HbA1c assay was developed for improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements, as well as to meet the evolving needs of today’s laboratory professionals for enhanced products,” said Ted DiMagno, PhD, Principal Scientist, Research and Development who led the development team for the test at Ortho Clinical Diagnostics. “This easier-to-use and faster new assay will enable our customers to more effectively, productively and confidently diagnose and monitor diabetes as the rate of the disease continues to climb in U.S., without having common hemoglobin variants interfere with results.”

A false high or low HbA1c value caused by a clinically silent hemoglobin variant may lead to over or under treatment. The design of the VITROS^® HbA1c assay allows its use in patients with hemoglobin variants S, C, D and E traits. In addition, the method is unaffected by the presence of chemically modified hemoglobin. Approximately 7 percent of the world's population are heterozygous carriers of hemoglobinopathies. Among diabetic patients, more than 12 million worldwide are estimated to have a hemoglobin disorder. In the U.S., the four most common variants are Hb S, C, E, and D. HbE is found primarily in people from Southeast Asia and is now encountered quite commonly in the U.S. HbD Punjab is found most commonly in the Punjab region of India and is also encountered in the U.S.

The percent of glycated hemoglobin (HbA1c) in a person’s blood is the worldwide standard for measuring blood glucose levels to detect and monitor long-term glucose control in individuals with diabetes. The American Diabetes Association now recommends the use of the A1c test to detect and monitor diabetes based on an extensive International Expert Committee review of established and emerging epidemiological evidence. According to the 2014 National Diabetes Statistics report, 29.1 million Americans had diabetes in 2012, with more than 8 million of them undiagnosed. Diabetes remains the seventh leading cause of death in the United States, directly responsible or contributing to more than 234,000 deaths in 2010. People with diabetes are also at high risk for blindness, kidney failure, heart disease, stroke and amputations.

The VITROS^® Chemistry Products HbA1c Reagent Kit 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 or reagent-to-reagent contamination, and to extend on-board reagent stability. Similar to VITROS^® MicroSlide and MicroWell Technologies, this test is performed without the need for water.