評估市售連線型快速血糖儀效能

Evaluation of the Performance of Three Portable Blood Glucose Meters

邱素琴(Su-Chin Chiu) ； 施勇綸(Yung-Luen Shih) ； 黃韶顏(Shau-Yen Huang) ； 倪維亞(Wei-Ya Ni) ； 陳媛孃(Yung-Liang Chen) ； 侯心宇(Hsin-Yu Hou) ； 莊穎瑩(Ying-Ying Chuang) ； 呂旭峰(Hsu-Feng Lu) ； 李明哲(Ming-Zhe Lee) ； 廖年捷(Nien-Chieh Liao)

《檢驗及品保雜誌》 7卷2期 (2018/04) Pp. 68-78

https://doi.org/10.6573/JTQA.201804_7(2).03

摘要

糖尿病患經常以掌上型快速血糖儀自我檢測血糖濃度，但欲獲得正確的血糖值檢驗結果端賴可靠的品管監控，才能進行營養調整與藥物劑量修正。本研究評估市售三種廠牌連線型快速血糖儀Accu-Check Inform II system（羅氏，德國）、GM700 Pro（瑞特，台灣）及Fora TD-4258（泰博，台灣）之效能，包括精密度(precision)、準確性(accuracy)與干擾性(interference)。結果指出於高濃度條件下Accu-Check Inform II system、GM700 Pro及Fora TD-4258的總精密度(total precision)分別為2.37、4.32與8.01 mg/dL，CV值分別為＜1.6%、＜4%及＜2.8%。就準確性而論，以Beckman DXC大型生化分析儀為標準，三台機器的準確性皆100%。因此精密度及準確性符合ISO 15197規範（亦即當血糖值＜100 mg/dL時，實驗數據之差距必需±15 mg/dL以內，當血糖值≥100 mg/dL 時，檢查數值不可超過±15%）。再就麥芽糖及血容比對血糖儀的干擾性而言，本實驗發現無論體外或人體試驗（腹膜透析液含麥芽糖），以及以血容比24%、42%與62%三種差異極大的模擬檢體測試均證實三種廠牌分析儀皆不受到干擾。總之，實驗研究證實三種廠牌分析儀無論精密度或準確性，其性能皆遠超過ISO 15197:2013的規範。唯有高品質分析儀，才能產出準確報告並正確管理血糖，因此本研究的評估結果可提供醫院或居家病患購置血糖儀的參考。

關鍵字

糖尿病 ； 精密度 ； 準確性 ； 麥芽糖 ； 血容比

並列摘要

Patients with diabetes usually use blood glucose results obtained with portable blood glucose meters (BGMs) to make critical decisions for their treatments. It is therefore imperative that results generated by BGMs be accurate and reliable. In this study, the performances of three portable BGMs were evaluated, including the Accu-Check Inform II system, GM700 Pro, and Fora TD-4258. They were assessed for precision, accuracy, and interference according to the ISO 15197:2013 criteria, which require that 95% of blood glucose results reach the following standard: within ± 15 mg/dl of laboratory results at concentrations under 100 mg/dL and within ± 15% of laboratory results at concentrations greater than 100 mg/dL. Precision values of these three BGMs for samples with high glucose concentration (≥100 mg/dL) were found to be 2.37, 4.32, and 8.01 mg/dL, and coefficient values were ＜1.6%, ＜4%, and ＜2.8%, respectively. Compared with the results generated by Beckman DXC, all 3 BGMs had an accuracy of 100%. Al though the presence of maltose in peritoneal dialysate has been shown to interfere with glucose measurement, no such interference was found in this study with any of the three devices. Furthermore, all 3 BGMs showed stable performance at 3 different hematocrit levels (24%, 42% and 62%). Therefore, these three BGMs exceeded ISO 15197:2013 accuracy and precision criteria. Our findings will aid patients in the selection of BGMs for self-monitoring of glucose levels.

並列關鍵字

Diabetes ； precision ； accuracy ； maltose ； hematocrit