14 Revolutionary Practices To Stay Clear Of Amiloride Dilemmas
In fact, studies have repeatedly shown that individual test strip lots of available systems do not comply with ISO 15197 accuracy criteria.2-5 In this study, 3 CE-marked SMBG systems (CareSens N, CareSens N POP, alphacheck professional) with 3 different test strip lots each were procured by the manufacturer (i-SENS, Inc, Korea) to assess compliance to accuracy criteria stipulated in ISO 15197:2003. In addition, more stringent criteria of its revision, ISO 15197:2013,6 were applied. The study was performed at the Institut f��r Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universit?t Ulm, Ulm, Germany in compliance with the German Medical Devices Amiloride Act. The study protocol was approved by the Ethics Committee and the Federal Institute for Drugs and Medical Devices. Each system was tested on 100 capillary blood samples from different subjects (��18 years, diabetes type 1 or type 2 or no diabetes) following procedures described in ISO 15197:2003. Comparison measurements were performed on capillary plasma with a glucose oxidase laboratory method (YSI 2300 STAT Plus? glucose analyser, YSI Incorporated, Yellow Springs, OH, USA). To confirm trueness and precision of the comparison method, regular internal and selleckchem external quality control measures were performed. Each of the tested systems fulfilled with all 3 tested lots accuracy criteria of ISO 15197:2003 with 99.5% to 100% of measurement results within ��15 mg/dl of the comparison measurement at glucose concentrations selleck revision ISO 15197:2013, the systems showed 98% to 100% of measurement results within ��15 mg/dl of the comparison measurement at glucose concentrations