標題: | System accuracy assessments with a blood glucose meter with combined glucose and ss-hydroxybutyrate measurement capabilities |
作者: | Weissenbacher, Sylvia Yang, Chen-Yu Kuan, Tang-Chin Demircik, Filiz Hanna, Mina Pfuetzner, Andreas 交大名義發表 National Chiao Tung University |
關鍵字: | Blood glucose meter;accuracy;precision;ss-hydroxybutyrate;ss-OHB |
公開日期: | 1-Jan-1970 |
摘要: | Background: 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. |
URI: | http://dx.doi.org/10.1080/14737159.2019.1662300 http://hdl.handle.net/11536/152884 |
ISSN: | 1473-7159 |
DOI: | 10.1080/14737159.2019.1662300 |
期刊: | EXPERT REVIEW OF MOLECULAR DIAGNOSTICS |
起始頁: | 0 |
結束頁: | 0 |
Appears in Collections: | Articles |