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Peer-Reviewed Publication
Expert Rev Med Devices2025;22(3):253-260.March 1, 2025Journal Article

Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety.

Claudio Burrini1, Beatrice Morrocchi1, Nicola Giorgetti2, Beate Saeger3
1Manfredo Fanfani-Lifenet Healthcare group, Laboratory of Clinical Chemistry, Florence, Italy.
2ARKRAY Italia S.R.L, Vimercate, MB, Italy.
3ARKRAY Europe B.V, Scientific Affairs Division, Amstelveen, The Netherlands.

Abstract

INTRODUCTION: Abnormal HCT levels and medications can cause inaccurate readings with blood glucose meters (BGM) in routine practice. The GLUCOCARD S onyx (ARKRAY Inc.) BGM was evaluated over a wide HCT range (20-70%) and its interaction with 27 common drug interferences, as per ISO15197:2013/EN ISO15197:2015, compared to clinical laboratory reference methods. METHODS: Pooled venous blood samples…

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