Nova Biomedical, Waltham, Mass, has received the CE mark for Allegro, a 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 results are ready during the patient visit, with an aim to simplify clinic workflow and produce cost savings for providers.

All Allegro tests use easy capillary fingerstick sampling and disposable test cartridges or strips. To monitor glycemic control, Allegro provides estimated average glucose tests, glucose, and HbA1c. To assess cardiac risk, Allegro provides high-density lipoprotein (HDL), low-density lipoprotein, non-HDL, and total cholesterol tests, cholesterol/HDL ratio, and triglycerides tests. To assess kidney function, Allegro provides blood creatinine with estimated glomerular filtration rate, urine albumin, urine creatinine, and urine a1bumin/creatinine ratio.

Allegro can measure creatinine, HbAlc, glucose, and lipids from a capillary sample. Its design comprises dual measurement bays, which offers the ability to measure two cartridges simultaneously, doubling throughput and improving efficiency.

Allegro’s companion meter wirelessly transmits results to the analyzer, where they combine with all cartridge test results for one patient report. All results can be transmitted to electronic medical records for providers to review with patients during the visit. Having immediate results during the patient visit reduces clinic follow-up calls, letters, and patient revisits, and can improve patient satisfaction, compliance with care plans, and outcomes.

Douglas Curley, Nova Biomedical.

Douglas Curley, Nova Biomedical.

“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,” says Douglas Curley, Allegro product manager at Nova. “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.”

Curley adds, “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 US Centers for Disease Control and Prevention cholesterol reference method laboratory network.

For more information, visit Nova Biomedical.