Analytical Performance and Quality Control of a Glucose Monitor System

سال انتشار: 1390
محل انتشار: فصلنامه آسیب شناسی ایران، دوره: 6، شماره: 1
کد COI اختصاصی: JR_IJP-6-1_002
زبان مقاله: انگلیسی
تعداد مشاهده: 950

نویسندگان

Dept. of Pathology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Dept. of Genetics, Tehran University of Medical Sciences, Tehran, Iran

چکیده

Background and Objective: The reliability and validity of monitors for self-monitoring of blood glucose are debated. We evaluated the analytical performance of Accu-check Active (BoehringerMannheim, Roche) which is one of the most commonly used monitors in Iran. Material and Methods: We compared the monitor readings with the reference values by percentage of values within certain intervals of the reference method, regression analysis, anddifference plot. We used operational process specification charts to determine the probability that different QC rules would detect an analytical error. In addition, we assessed the quality on thesigma scale. Results: This meter met International Organization for Standardization’s criteria but notthe American Diabetes Association’s stringent criteria. The monitor produced precise readings throughout the concentration range and results correlated closely with the reference method. The measured total error was 6.39% (less than allowable total error of 10%). The method reached6 sigma at glucose levels of 6.66 and 18.87 mmol/L and a sigma of 3 to 4 at glucose level of 2.49. Repeatability and intermediate precision were acceptable. Discussion: We concluded that the overall performance of this instrument is reasonable but in hypoglycemic range, multiple control rules and control materials are required to assure the desired quality is achieved.

کلیدواژه ها

Blood Glucose Self Monitoring, Diabetes Mellitus, Point of Care Systems

مقالات مرتبط جدید

اطلاعات بیشتر در مورد COI

COI مخفف عبارت CIVILICA Object Identifier به معنی شناسه سیویلیکا برای اسناد است. COI کدی است که مطابق محل انتشار، به مقالات کنفرانسها و ژورنالهای داخل کشور به هنگام نمایه سازی بر روی پایگاه استنادی سیویلیکا اختصاص می یابد.

کد COI به مفهوم کد ملی اسناد نمایه شده در سیویلیکا است و کدی یکتا و ثابت است و به همین دلیل همواره قابلیت استناد و پیگیری دارد.