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 <75 mg/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 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。

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 usres 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.