FDA recently granted premarket notification (510(k)) clearance to Ortho-Clinical Diagnostics, Raritan, NJ, for its Vitros Chemistry Products HbA1c reagent kit, to be used on the Vitros 5600 integrated system, Vitros 4600 chemistry system, and Vitros 5,1 FS chemistry system.

The test can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c 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 monitoring long-term blood glucose control in individuals with diabetes mellitus.

The newly cleared HbA1c kit offers operational and performance enhancements over the company’s currently marketed 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 older kit, which will eventually be discontinued.


Ted DiMagno, PhD, Ortho-Clinical Diagnostics.

“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,” says Ted DiMagno, PhD, principal research and development scientist at Ortho-Clinical Diagnostics, who led the development team for the test. “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 the United States, without having common hemoglobin variants interfere with results.”

Ortho-Clinical Diagnostics pioneered the Vitros series of laboratory systems in 1978, and continues to expand and evolve them 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 operate with standardized reagents and results across all platforms.

In addition, 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 cardiac disease, cancer, reproductive endocrine disease, infectious disease, thyroid disease, metabolic conditions, and anemia.

A false high or low HbA1c value caused by a clinically silent hemoglobin variant may lead to over- or under-treatment.1 The new Vitros HbA1c assay is unaffected by the presence of chemically modified hemoglobin.2 In addition, the design of the assay allows its use in patients with hemoglobin variants S, C, D, and E traits.

Approximately 7% 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.3 In the United States, 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 United States. HbD Punjab is found most commonly in the Punjab region of India and is also encountered in the United States.3

The percent of glycated hemoglobin (HbA1c) in a person’s blood is the worldwide standard for measuring blood glucose levels and monitoring long-term glucose control in individuals with diabetes. In accord with an extensive international expert committee review of established and emerging epidemiological evidence, the American Diabetes Association now recommends use of the A1c test to detect and monitor diabetes.4

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.5

The Vitros HbA1c 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 onboard reagent stability. Similar to Vitros MicroSlide and MicroWell technologies, this test is performed without the need for water.

For more information, visit Ortho-Clinical Diagnostics.


  1. Nasir N, Thevarajah M, Yean CY. Hemoglobin variants detected by hemoglobin A1c (HbA1c) analysis and the effects on HbA1c measurements. Int J Diabetes Dev Ctries. 2010;30(2):86–90. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2878696.
  1. Vitros Chemistry Products HbA1c Reagent Kit Instructions for Use.
  1. Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol. 2009;3(3):446–451.
  1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014;37(S1):S81–S90; doi: 10.2337/dc14-so81.
  1. American Diabetes Association. Statistics about diabetes. Available at: www.diabetes.org/diabetes-basics/statistics. Accessed June 24, 2015.