Abbott Launches First-ever Rapid Point-of-Care HbA1c Test to Aid in the Diagnosis of Diabetes


2019-06-18 07:46:00 PR Newswire


Abbott (ABT) today announced that its Afinion™ HbA1c Dx assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition. The Afinion HbA1c Dx meets FDA's stringent requirements for performance testing for diagnostic use claims. The test delivers accurate and precise1,2 glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor's office visit. The Afinion HbA1c Dx assay (approved for monitoring and diagnosis) complements the Afinion HbA1c assay (approved for monitoring only), the number one point-of-care HbA1c test in the U.S. for monitoring long-term glycemic control in diabetes.3  "As diagnostics continue to move to point-of-care settings such as physician office labs, the Afinion HbA1c Dx rapid assay shows how Abbott is once again setting new standards for innovation in the diagnosis and monitoring of diabetes," said Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Rapid Diagnostics, Abbott. "In addition to giving physicians the certainty of diagnosis they need to make informed decisions during a patient visit, the HbA1c Dx assay gives people living with diabetes near real-time results, so that in consultation with their doctor they can make adjustments to their lifestyle and better manage their condition." "Rapid, reliable diabetes screening at the point of care enables healthcare providers to immediately link patients to comprehensive care that can help prevent the serious consequences of the disease," said Richard Kahn, Ph.D., former chief scientific and medical officer of the American Diabetes Association. "In addition, point-of-care diagnosis can enhance clinical efficiencies for busy practices and, at a population level, help stem the massive economic and societal impacts of diabetes in the U.S."
Abbott ( ABT )今天宣布,其 Afinion ™ HbA1c Dx 分析方法现在可用于 Afinion 2分析仪以及 Afinion AS100分析仪。Afinion HbA1c Dx 分析是美国食品药品监督管理局(Food and Drug Administration)( FDA )批准的第一个也是唯一的快速点护理测试,目的是帮助医疗保健专业人员诊断糖尿病和评估患者病情发展的风险。 Afinion HbA1c Dx 符合 FDA 对诊断使用声称的性能测试的严格要求,该测试仅在3分钟内提供准确和精确的1,2份糖化血红蛋白( HbA1c )结果,使临床医生能够诊断患者,并帮助他们在单个医生的就诊期间制定个性化的护理计划。Afinion HbA1c Dx 检测(批准用于监测和诊断)补充了 Afinion HbA1c 检测(仅批准用于监测),这是美国用于监测糖尿病长期血糖控制的第一个护理点 HbA1c 检测。3. 雅培公司快速诊断部门副总裁 Elizabeth Balthrop 说:“随着诊断技术不断转向诸如医生办公室实验室之类的护理领域, Afinion HbA1c Dx 快速分析显示雅培(Abbott)公司是如何再次制定糖尿病诊断和监测创新标准的。”HbA1c Dx 分析不仅为医生提供了在病人就诊时做出明智决定所需的诊断的确定性,而且还使糖尿病患者获得了近乎实时的结果,以便与医生协商,调整他们的生活方式,更好地管理他们的病情。 美国糖尿病协会前首席科学和医学官员理查德·卡恩博士说:“在医疗护理领域快速、可靠的糖尿病筛查使医疗服务提供者能够立即将患者与全面护理联系起来,从而帮助预防疾病的严重后果。”此外,护理点诊断可以提高繁忙实践的临床效率,并在人口层面帮助遏制糖尿病在美国的巨大经济和社会影响。