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題名 | WISH (WGM-101)血糖機驗證之評估研究=The Evaluation Study of Verification for WISH (WGM-101) Glucometer |
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作者 | 商弘昇; 陳清梅; 黃正一; 闕宗熙; 張錦標; | 書刊名 | 中華職業醫學雜誌 |
卷期 | 21:2 2014.04[民103.04] |
頁次 | 頁111-122 |
分類號 | 410.025 |
關鍵詞 | WISH(WGM-101)血糖機; 驗證; 糖尿病; WISH (WGM-101) glucometer; Verification; Diabetic mellitus; ISO 15197:2003; |
語文 | 中文(Chinese) |
中文摘要 | 目的:WISH(WGM-101)為新研發之血糖機,上市前進行臨床之驗證,以確保血糖機之分析品質,在糖尿病病患的自我血糖監測中,提供準確與可靠的數據。方法:ISO 15197:2003為歐盟國家針對小型血糖機驗證之規範,驗證包括:精確度評估、準確性評估、相關性比對評估、使用者評估、干擾性評估、線性評估,結果能符合國際ISO15197:2003之規定。結果:精確度評估的結果為<75mg/dL濃度血糖SD 0.6-2.1(SD<5 mg/dL),≥75mg/dL 濃度血糖 CV 2.2-4.8%(CV<5%)。血糖機檢測Within-run的SD為1.2-2.9及CV為0.3-4.8%、Between-day的CV為0.8-3.3%、Total CV為0.8-5.8%。準確性評估有95%以上都落在誤差範圍±20%內;平均偏差mean bias為12.81mg/dL。Clarke Grid的評估98%~100%落在A區,0%~2%落在B區。相關性評估100%落在A區、使用者評估98%落在A區,2%落在B區。干擾性評估包含6種臨床常用藥物及2種人體產生的干擾來源。結果顯示8種干擾源造成的誤差值都小於±10%,且至少95%落在誤差範圍內。線性評估範圍為40-563mg/dL。結論:WISH(WGM-101)血糖機驗證結果,可符合國際ISO 15197:2003之規定。 |
英文摘要 | Purpose: WISH (WGM-101) 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 and provide accurate and reliable data.Method: ISO 15197:2003 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. Test results could meet international ISO15197: 2003 requirements.Results: The results of the precision is SD 0.6-2.1 (SD<5.0 mg/dL) when blood glucose concentration is <75 mg/dL and CV 2.2-4.8% (CV<5.0%) when blood glucose concentration is ≥75 mg/dL. The SD and CV are 0.3-4.8% and 1.2-2.9 of Within-run、The SD and total CV are 0.8-3.3% and 0.8-5.8% of Between-day. There are more than 95% of accuracy within ±20% error range and mean bias is 12.81mg/dL. There are 98%~100% in zone A for Clarke Grid evaluation and 0%~2% in zone B. The evaluation of comparative correction is 100% in zone A. There are 98% of users evaluation in zone A and 2% in zone B. Interference evaluation includes 6 common drugs in clinical practice and 2 sources of interference produced by body. The results show that 8 interferences caused by the error are less than ±10% and at least 95% results are within error range. The liner range of the evaluation is 40-563mg/d.Conclusion: The results of the verification for WISH (WGM-101) glucometer fulfill International ISO 15197:2003 requirement. |
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