Ascensia Elite XL (Bayer)

Description:

The Ascensia Elite XL (Bayer) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has failed a clinical validation.

Validation Publications:

Ho HT, Yeung WK, Young BW. Evaluation of "point of care" devices in the measurement of low blood glucose in neonatal practice. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F356-359. doi: 10.1136/adc.2003.033548. PMID: 15210675. Available from: PMC1721720.

ADA:1994 - Fail Neonates (n = 44) (Note: Error < 10 %: 38.1 %)

CLSI:1994 - Fail Neonates (n = 44) (Note: Error ≤ 0.83 mmol/L: 85.7% (< 95 %))

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.

15197:2011 - Fail Neonates

15197:2003 - Fail Neonates

Relevant Publications:

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.