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歷年稿件內容

*類別：	C組-生化、血清免疫
* 姓名：	陳清梅
投稿種類：	壁報
*中文投稿標題：	WGM-101F (WISH) 血糖機驗證之評估研究
*中文作者姓名列：	陳清梅*、湯勝輝、商弘昇、張錦標#
*中文服務單位：	國防醫學中心三軍總醫院臨床病理科
*英文投稿標題：	The ISO 15197:2013 Evaluation Study of Verification for WGM-101F (WISH) Glucometer
*英文作者姓名列：	Ching-Mei Chen、Sheng-Hui Tang、Hung-Sheng Shang、Jin-Biou Chang*
*英文服務單位：	Department of Pathology, National Defense Medical Center, Division of Clinical Pathology, Tri-Service General Hospital, Taipei, Taiwan; R.O.C
* 投稿摘要：	The ISO 15197:2013 Evaluation Study of Verification for WGM-101F (WISH) Glucometer Ching-Mei Chen、Sheng-Hui Tang、Hung-Sheng Shang、Jin-Biou Chang* Department of Pathology, National Defense Medical Center, Division of Clinical Pathology, Tri-Service General Hospital, Taipei, Taiwan; R.O.C Purpose: WGM-101F (WISH) is a new development of glucometer. The pre-marketing clinical verification of glucometer could ensure the quality in diabetic patients when self-monitoring of blood glucose to provide accurate and reliable data. Method: ISO 15197:2013 is a verified norm for small glucometer in EU countries. Verification includes: precision evaluation, accuracy evaluation, comparative correction evaluation, users evaluation, interference evaluation, linear evaluation, interference evaluation of hematocrit Hct, the evaluation of high altitude. Test results could meet international requirements of ISO15197: 2013. Results: The results of the precision is SD 1.3-2.8 (SD<5.0 mg/dL) when blood glucose concentration is <100 mg/dL and CV 1.2-3.5% (CV<5.0%) when blood glucose concentration is ≥100 mg/dL. The SD and CV are 1.9-9.4% and 2.5-6.4 of Within-run、The SD and total CV are 1.3-4.6% and 3.2-7.0% of Between-day. There are more than 95% of accuracy within ±15% error range and mean bias is 3.9%. There are 100% in zone A for Clarke Grid evaluation. The error index of correction evaluation of finger glucose and venous blood glucose is <1 Interference evaluation includes 20 common drugs in clinical practice and 6 sources of interference produced by body. The results show that 26 interferences caused by the error are less than ±15% and at least 95% results are within error range. The liner range of the evaluation is 10-550mg/dl. The 95% acceptable error of interference evaluation of hematocrit Hct is <15%. The 95% error range of high altitude evaluation is within 15%. The results fulfill the international requirements of ISO15197:2013. Conclusion: The results of the verification for WGM-101F (WISH) glucometer fulfill International ISO 15197:2013 requirement.
*關鍵字1 ：	WGM-101F (WISH) glucometer
*關鍵字2 ：	verification
*關鍵字3 ：	diabetic mellitus
*關鍵字4 ：	ISO 15197:2013
*關鍵字5 ：	interference evaluation of hematocrit
* 服務機關：
* 第一作者：	陳清梅
* 身分字號：	*****72076
其他投稿作者：	湯勝輝
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其他投稿作者：	商弘昇
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審查委員意見：	OK
審查委員意見：	同意
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