Roche's Accu-Chek® Inform II Hospital Blood Glucose System now approved by Health Canada for Intensive Care Use
The Accu-Chek® Inform II system (ACI II) supports Point of Care coordinators, physicians, nurses, IT experts and infection control managers to optimize their complex workflow. The Accu-Chek® Inform II solution has brought and continues to bring high-end laboratory standards to bedside glucose testing and helps ensure safety for patients.
With this new claim for Critically ill Care Use, healthcare professionals using the Accu-Chek® Inform II Hospital Blood Glucose (HBG) System can continue to deliver accurate and reliable blood glucose measurements that are compliant with the performance requirements of ISO 15197:2013.
“Critically ill patients may be affected by hypoxemia, poor capillary perfusion, or tissue edema and are at increased risk of poor outcomes should they develop either hypo- or hyperglycemia. Ensuring accurate blood glucose monitoring is necessary to improve outcomes. Health Canada approval for this particular indication is a recognition that the Accu-Chek® Inform II System achieves the highest accuracy by aligning with the industry's most stringent standards”, said Michele D’Elia, Medical and Scientific Affairs Director, Roche Diagnostics Canada.
The Accu-Chek® Inform II System can help professionals to ensure highest patient’s safety
Now more than ever, hospital environments, in particular medical and surgical Intensive Care Units, require simplified processes and tools to respond to complex and uncertain times. They require the highest level of accuracy and responsiveness from the technologies and medical solutions they use for blood glucose management so they deliver highly accurate results, elevating the safety and efficacy of insulin delivery and glucose control to patients.
The ACI II HBG system has continually delivered on these important criteria. Roche’s comprehensive and flexible hospital blood glucose system remains the Canadian and Worldwide market leader and preferred solution supported by a highest level of accuracy, premium service and support and fully integrated digital solution across Canada and the globe.1 Our HBG solution continues to be the solution of choice that healthcare professionals can count on.
Roche’s interference testing studies eliminate ambiguities and provide confidence
Potential interfering substances can affect blood glucose results in hospital settings and have an impact on the patient’s safety with insulin dosing treatment. This is why Roche’s ACI II solution is designed, tested and proven to deliver highly accurate results despite the presence of over 240 interfering substances. This superior quality performance delivers best risk management by healthcare professionals.
Furthermore, Roche’s ACI II solution has been thoroughly evaluated with potential interfering substances that were tested at concentrations described by the Clinical Lab Standard Institute in documents EP07: Interference Testing in Clinical Chemistry, 3rd edition and EP37: Supplemental Tables for Interference Testing in Clinical Chemistry, 1st edition. Testing was conducted according to the ISO 15197:2013/EN ISO 15197:2015 standard and the FDA’s Blood Glucose Monitoring Test Systems for Prescription POC Use Draft Guidance, issued November 30, 2018. Many of the endogenous and exogenous compounds were evaluated at concentrations three times or more the therapeutic plasma concentrations. Each medication and metabolite was evaluated at three target glucose levels to ensure accuracy. Finally, accuracy for whole blood glucose measurements were compared to plasma central laboratories and demonstrated excellent correlation to reference methods.2
Test results indicate that the ACI II adheres to CLSI EP07=A3 and ISO 15197-2013 guidelines3,4,5 and provides reliable and accurate blood glucose measurements in the presence of the substances tested, generally well beyond the therapeutic or physiologic range. According to laboratory reference methods, our solution fulfills the most stringent guideline criteria. 6,7
Roche is committed to innovations in Point of Care
Roche embraces its role as a trusted partner to provide fully integrated POC solutions that will enable the highest level of patient care while ensuring effective resource optimization, risk mitigation, compliance and high medical value. Roche invests in technology and solutions that enable users to make informed and clear decisions when and where it is needed most. Roche remains committed to hospital blood glucose and will continue to provide the same high quality and market leading solutions that meet and exceed hospital blood glucose needs, today and in the future1. Roche helps transform healthcare every day while constantly leveraging its purpose: "Doing now what patients need next".
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. For more information, please visit roche.com and rochecanada.com.
1. Boston Biomedical Consultants (BBC), Canada Market Book 2019.
2. Internal Studies, data on file with manufacturer, Evaluation Report: Accu-Chek Inform II test Strips.
3. Clinical and Laboratory Standards Institute (2018). CLSI Guideline EP07: Interference Testing in Clinical Chemistry; Approved Guideline. Third Edition. Available at www.clsi.org.
4. ISO 15197:2013. In vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Available from: https://www.iso.org/standard/54976.html.
5. Clinical and Laboratory Standards Institute (2018). CLSI EP37 Supplemental Tables for Interference Testing in Clinical Chemistry. First Edition. Available at www.clsi.org.
6. Gijzen K, Moolenaar DLJ, Pluim HJ, Demir AY. Evaluation of four hospital use point-of-care glucose meters in an intensive care unit. Clin Chem Lab Med 2011; 49:S677.
7. Gijzen K, Moolenaar D, Pluim E, Demir AY. Evaluation of four hospital use point-of-care glucose meters in an intensive care unit. Turk J Biochem 2010; 35.
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