WISH (WGM-101)血糖機驗證之評估研究

The Evaluation Study of Verification for WISH (WGM-101) Glucometer

商弘昇(Hung-Sheng Shang)；陳清梅(Ching-Mei Chen)；黃正一(Zheng-Yi Huang)；闕宗熙(Tzong-Shi Chiueh)；張錦標(Jin-Biou Chang)

WISH(WGM-101)血糖機 ； 驗證 ； 糖尿病 ； WISH (WGM-101) glucometer ； verification ； diabetic mellitus ； ISO 15197:2003

中華職業醫學雜誌

21卷2期（2014 / 04 / 25）

111 - 122

繁體中文

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.

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.