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Abbott glycated hemoglobin assay wins CE mark

Abbott has received CE mark approval for Architect HbA1c assay, designed to monitor treatment efficacy for diabetes patients.

The chemiluminescent microparticle Architect HbA1c assay, which is designed for the quantitative determination of percent hemoglobin A1c (HbA1c), uses human whole blood on the Architect i immunoassay systems and provides results in just 36 minutes.

Abbott diagnostics products executive vice president Brian Blaser said the company’s automated Architect HbA1c (IA) assay allows for consistent and accurate testing of HbA1c, a glycated hemoglobin used primarily to monitor long-term diabetes control.

"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," Blaser added.

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