Full metadata record
DC FieldValueLanguage
dc.contributor.authorWeissenbacher, Sylviaen_US
dc.contributor.authorYang, Chen-Yuen_US
dc.contributor.authorKuan, Tang-Chinen_US
dc.contributor.authorDemircik, Filizen_US
dc.contributor.authorHanna, Minaen_US
dc.contributor.authorPfuetzner, Andreasen_US
dc.date.accessioned2019-10-05T00:08:48Z-
dc.date.available2019-10-05T00:08:48Z-
dc.date.issued1970-01-01en_US
dc.identifier.issn1473-7159en_US
dc.identifier.urihttp://dx.doi.org/10.1080/14737159.2019.1662300en_US
dc.identifier.urihttp://hdl.handle.net/11536/152884-
dc.description.abstractBackground: We evaluated the Wellion Galileo GLU/KET blood and ketone (ss-Hydroxybutyrate, ss-OHB) meter to demonstrate that it meets ISO15107:2015 regulatory approval criteria. Research Design and Methods: A total of 100 subjects (52 female, age: 30 to 84 years, diabetes: 10 type 1/90 type 2) with blood glucose levels distributed over the entire measurement range as required by the ISO15197 protocol were tested (double determinations with 3 strip lots and two devices). A similar test protocol was followed to test ss-OHB strip performance (reference devices: YSI 2300plus for glucose and STANBIO ss-HOB LiquiColor TestKit for ss-OHB). Precision was tested for glucose with 3 blood glucose concentrations (ss-OHB: 2 control solutions). Results: All glucose test-strip lots met the strict ISO acceptance criteria. Mean absolute relative difference (MARD) was 4.9% and all data pairs were in zone A of the consensus error grid. The ss-OHB test-strips also met the pre-defined acceptance criteria. Within-run and between-run precision was calculated to be 2.3% and 0.7% for the glucose strips (3.7%/0.8% for the ketone strips). Conclusions: When tested according to the ISO15197:2015 guideline, the device showed very accurate measurement performance for glucose and ss-OHB testing and fully met regulatory accuracy approval criteria.en_US
dc.language.isoen_USen_US
dc.subjectBlood glucose meteren_US
dc.subjectaccuracyen_US
dc.subjectprecisionen_US
dc.subjectss-hydroxybutyrateen_US
dc.subjectss-OHBen_US
dc.titleSystem accuracy assessments with a blood glucose meter with combined glucose and ss-hydroxybutyrate measurement capabilitiesen_US
dc.typeArticleen_US
dc.identifier.doi10.1080/14737159.2019.1662300en_US
dc.identifier.journalEXPERT REVIEW OF MOLECULAR DIAGNOSTICSen_US
dc.citation.spage0en_US
dc.citation.epage0en_US
dc.contributor.department交大名義發表zh_TW
dc.contributor.departmentNational Chiao Tung Universityen_US
dc.identifier.wosnumberWOS:000484998800001en_US
dc.citation.woscount0en_US
Appears in Collections:Articles