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CE mark for Allegro analyzer

May 1, 2017Nova Biomedical received CE mark certification for its Allegro capillary blood analyzer for point-of-care testing in primary care settings. Allegro and its StatStrip A companion meter provide 14 clinically important tests to monitor glycemic control, assess cardiac risk with a full lipids panel, and assess kidney function.

All Allegro tests use capillary fingerstick sampling and disposable test cartridges or strips. To monitor glycemic control, Allegro provides HbA1c, glucose, and estimated average glucose tests. To assess cardiac risk, the analyzer provides total, HDL, non-HDL, and LDL cholesterol tests, cholesterol/HDL ratio, and triglycerides tests, and to assess kidney function, it provides urine creatinine, urine albumin, and urine albumin/creatinine ratio, and blood creatinine with eGFR tests.

Allegro is the only analyzer that can measure HbA1c, lipids, glucose, and creatinine from a capillary sample, according to a company statement. Its design is composed of dual measurement bays, which offer the ability to measure two cartridges simultaneously, doubling throughput and improving efficiency.

The companion meter wirelessly transmits results to the analyzer, where they combine with all cartridge test results for one patient report. Results can be transmitted to electronic medical records for providers to review with patients during the visit.

“We at Nova Biomedical are extremely excited to obtain CE mark certification to launch Allegro in CE regulated countries, and we continue our clinical studies with an eye toward FDA clearance in the coming months. Allegro provides a solution to a clear and fast-growing market need for point-of-care testing to support the management of diabetes and related comorbidities, such as kidney and cardiovascular diseases, in primary care settings,” Douglas Curley, Allegro product manager at Nova, said in a statement. “As chronic disease management continues to shift to primary care settings, clinicians need fast, accurate results during the patient visit for early detection and ongoing monitoring, and to make therapy changes. We are confident that Allegro will meet this need.”

Allegro’s HbA1c accuracy is certified by the National Glycohemoglobin Standardization program and total cholesterol and HDL cholesterol are certified by the CDC Cholesterol Reference Method Laboratory Network.

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