Abstract
The new ISO15197:2013 norm, defining more stringent system accuracy quality standards, was published in Europe in May 2013. After enforcement of this new regulation, all new meters for patient self-monitoring of blood glucose (SMBG) need to show deviations from a reference method of less than ±15 mg/dl (±0.83 mmol/l) for values below or equal to 100 mg/dl (5.6 mmol/l) and ±15% for values above 100 mg/dl in 95% of the cases as assessed by a standardized clinical protocol requiring 3 strip lots to be tested. 1 A transition period of 3 years has been granted to all SMBG manufacturers prior to implementing the new accuracy criteria as essential and mandatory part of the conformity process required to obtain the CE mark for new devices.
The GlucoMen LX Plus meter (A. Menarini Diagnostics) is a self-testing device that measures glucose and ß-hydroxybutyrate in capillary blood and has already been introduced in Europe in 2011. Previous clinical and laboratory evaluations with this system have shown excellent accuracy and stability against hematocrit interference.2-4 The system is employing an amperometric glucose-oxidase-based technology with integrated correction algorithms, and is specifically designed for measurement in whole blood samples Purpose of our clinical study was to identify the number of blood glucose results falling within the range of the new ISO criteria. The study was performed in January/February 2013 at the laboratories that today belong to Pfützner Science & Health Institute, Mainz, Germany, in compliance with the German Medical Device Act and approved by the responsible Ethics Committee and the Federal Institute of Drugs and Medical Devices. The protocol was designed in compliance with the system accuracy procedure set forth in the ISO15197:2013 norm, in particular with respect to glucose ranges and number of devices and tests strip lots (100 subjects, 3 strip lots, 6 meters). The tested materials including the meters, the control solutions, and strip lots 3211269249 (exp 9/30/2013), 3211325249 (exp 11/30/2013), and 3211334249 (exp 11/30/2013) were provided by the manufacturer. A YSI 2300 STAT Plus glucose analyzer (Yellow Springs Instruments, Yellow Springs, OH, USA) served as reference method for this analysis. Statistical analyses were performed as defined in the ISO guidelines. 1
All 3 strip lots were successfully tested demonstrating compliance with the new ISO criteria as shown in Table 1. The combined system accuracy results for the strip lots tested were falling within 97% to 99% of the ISO criteria. Clinical accuracy was evaluated by means of the Parkes’s consensus error grid.5,6 The overall vast majority of data pairs (628/630, 99.7%) of all values were within zone A of the CGA indicating “clinical accurate measurements with no effect on clinical action”, and 2/630 (0.3%) were in zone B (“altered clinical action with little or no effect on clinical outcome”). No values were seen in the zones C, D, or E, which represent clinically inacceptable values. 5
Accuracy Results for the GlucoMen LX Plus System.
In conclusion, all 3 lots of the GlucoMen LX Plus glucose meter system were compliant with ISO1597:2013 accuracy criteria.
Footnotes
Abbreviations
BG, blood glucose; CE, Conformité Européene; ISO, International Organization for Standardization; SMBG, self-monitoring of blood glucose.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: APF received research grants, speaker fees, and consultancy fees from Abbott, A. Menarini Diagnostics, Bayer, LifeScan, NovaBiomedical, Roche Diagnostics, and Sanofi. FB, CS, and FV are employees of A. Menarini Diagnostics. The other authors have no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The research leading to this article was funded by A. Menatrini Diagnostics.