CE Marking for Abbott's Fully Automated HbA1c Assay

Abbott has announced that it has received CE Marking (Conformite Europeenne) for the Abbott ARCHITECT HbA1c (IA) Assay. The test is designed to help physicians appropriately monitor treatment efficacy for diabetic patients.

Glycated hemoglobin, also known as HbA1c, is a form of hemoglobin used primarily to monitor long-term diabetes control. This helps physicians understand how well the patient's diabetes is being managed from a treatment or dosing perspective. The HbA1c test differs from a patient-administered blood glucose test, which takes a snapshot of a patient's blood sugar level at a moment in time. The HbA1c test must be performed on a laboratory instrument.

Laboratories are seeing an increase of HbA1c testing volumes worldwide due to the rise in patients with diabetes. The Abbott ARCHITECT HbA1c assay is a fully automated chemiluminescent immunoassay to help laboratories manage the increased demand and offer rapid results to physicians. With a simple blood test, the Abbott ARCHITECT HbA1c (IA) Assay provides a result to the physician in just 36 minutes. It also demonstrates a good correlation to the gold standard (high performance liquid chromatography), which provides confidence in the accuracy and reproducibility of patient results. The assay is designed for use on the ARCHITECT i System.

"Abbott's ARCHITECT HbA1c (IA) Assay allows for consistent and accurate testing of HbA1c," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "We are pleased to offer an important tool to address the need for a fully automated glycated hemoglobin assay which can meet the demands of increased testing volumes.

With this test, health care providers can now confidently measure their patients' management of diabetes and use this information to potentially improve treatment decisions."

The new assay is performed on the ARCHITECT immunoassay systems and is available in several European countries, Asia Pacific, Latin America, Japan, Africa, Middle East and India, pending country registration.