WGM-101F (WISH)血糖機符合ISO 15197:2013之驗證評估

The ISO 15197:2013 Evaluation Study of Validation for WGM-101F (WISH) Glucometer

陳清梅(Ching-Mei Chen) ； 湯勝輝(Sheng-Hui Tang) ； 商弘昇(Hung-Sheng Shang) ； 林富煌(Fu-Huang Lin) ； 張錦標(Jin-Biou Chang)

《中華職業醫學雜誌》 23卷4期 (2016/10) Pp. 265-276

摘要

目的：WGM-101F (WISH)為新研發之血糖機，上市前進行臨床之驗證，以符合ISO15197：2013之規定，確保血糖機之分析品質，在糖尿病病患的自我血糖監測，可提供準確與可靠的檢驗數據。方法：ISO15197：2013為目前最新的國際認證血糖儀之標準，其驗證包括：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、血球容積比干擾性評估、高海拔評估，結果能符合國際ISO15197:2003之規定。。結果：精確度評估的結果為＜100 mg/dl濃度血糖 SD:1.1-3.2 (SD＜5 mg/dl)，≥ 100mg/dl濃度血糖 CV: 1.2-4.6 % (CV＜5%)。WGM-101F血糖機檢測之within-run SD: 2.0-9.5、within-run CV:2.6-6.1%、between-day CV:1.6-3.9%、total CV: 3.6-6.7%。準確性評估有95%以上都落在誤差範圍±15%內；Mean % Err為2.6-3.9%。Clarke Grid的評估100%落在A區。指尖血與靜脈血相關性評估The Error Index ＜±1。干擾性評估包含20種臨床常用藥物及6種人體產生的干擾來源，結果顯示26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20-600mg/dl。血球容積比干擾性評估95%血糖值檢測結果：容許誤差＜±15%，高海拔評估95% 以上都落在誤差範圍±15%內； Mean % Err為1.1-4.1%。結論：WGM-101F (WISH)血糖機驗證結果，可符合國際ISO15197:2013之要求。

關鍵字

WGM-101F(WISH)血糖機 ； 驗證 ； 糖尿病 ； ISO 15197:2013

並列摘要

Purpose: WGM-101F (WISH) is a new development of glucometer. The pre-marketing clinical validation 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 validated norm for small glucometer in EU countries. validation includes: precision evaluation, accuracy evaluation, comparative correction evaluation, user evaluation, interference evaluation, linear evaluation, interference evaluation of hematocrit, the evaluation of high altitude. Test results could meet international requirements of ISO15197: 2013. Results: The results of the precision are SD 1.1-3.2 (SD＜5.0 mg/dl) when blood glucose concentration is ＜100 mg/dl and CV 1.2-4.6% (CV＜5.0%) when blood glucose concentration is ≥100 mg/dl. The SD and CV are 2.0-9.5% and 2.6-6.1 of within-run、The SD and total CV are 1.6-3.9% and 3.6-6.7% of between-day. There are more than 95% of accuracy within ±15% error range and mean bias is 2.6-3.9%. 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 ±10% and at least 95% results are within error range. The liner range of the evaluation is 20-600mg/dl. The 95% acceptable error of interference evaluation of hematocrit is ＜15%. The 95% error range of high altitude evaluation is within 15%; Mean % Err is 1.1-4.1%. Conclusion: The results of the validation for WGM-101F (WISH) glucometer fulfill International ISO 15197:2013 requirement.

並列關鍵字

WGM-101F (WISH) glucometer ； validation ； diabetic mellitus ； ISO 15197:2013