Ascensia Elite XL (Bayer)
The technology used in the Ascensia Elite XL (Bayer), to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.
|Medaval||Not recommended||This device failed clinical validation.|
Diaw CS, Piol N, Urfer J, Werner D, Roth-Kleiner M. Prospective evaluation of three point of care devices for glycemia measurement in a neonatal intensive care unit. Clin Chim Acta. 2013 Oct 21;425:104-8. Epub: 2013 Jul 29. doi: 10.1016/j.cca.2013.07.021. PMID: 23906797.
- Fail Neonates
15197:2003 - Fail Neonates
Roth-Kleiner M, Stadelmann Diaw C, Urfer J, Ruffieux C, Werner D. Evaluation of different POCT devices for glucose measurement in a clinical neonatal setting. Eur J Pediatr. 2010 Nov;169(11):1387-95. Epub: 2010 Jun 24. doi: 10.1007/s00431-010-1243-2. PMID: 20574734.
Retrospective study with ISO 15197:2003 criteria applied to results, on neonates, recorded over 1 year. The authors claim that the device tended to overestimate glycaemia values; however the application of protocol criteria is dependent on the protocol procedure being followed precisely.