Arens S, Moons V, Meuleman P, Struyf F, Zaman Z
Centraal Klinisch Laboratorium, Universitaire Ziekenhuizen Leuven, Belgium.
Clin Chem Lab Med. 1998 Jan;36(1):47-52. doi: 10.1515/CCLM.1998.009.
The performance and practicability of 2 blood glucose meters (Glucocard Memory 2 and Accutrend sensor) were evaluated. Both glucose meters produced acceptably precise results in the hyper- and normoglycaemic concentration ranges. In the hypoglycaemic concentration range, the imprecision of Accutrend sensor was much higher than recommended by the American Diabetes Association. Within-run coefficients of variation for Glucocard Memory 2 were 6.3%, 3.9% and 2.4% at glucose concentrations of 1.7 mmol/l, 5.8 mmol/l and 11.7 mmol/l, respectively: for Accutrend sensor these were 15.2%, 5.0% and 1.2% at respective concentrations of 0.9 mmol/l, 4.2 mmol/l and 19.6 mmol/l. Between-day coefficients of variation for Glucocard Memory 2 were 4.8% and 3.5% at glucose concentrations of 3.9 mmol/l and 17.2 mmol/l, respectively and for Accutrend sensor they were 3.8% and 2.9% at glucose concentrations of 3.8 mmol/l and 18.7 mmol/l, respectively. Results were linear over a range of 1.6 mmol/l -29.7 mmol/l for Glucocard Memory 2 and 1.6 mmol/l -33.3 mmol/l for Accutrend sensor. Results of both blood glucose meters correlated closely with the hexokinase/glucose-6-phosphate dehydrogenase laboratory method. Ninety-eight percent of both Glucocard Memory 2 and Accutrend sensor results were within 20% of the comparison method values. Ninety-three percent of the Glucocard Memory 2 and 96% of the Accutrend sensor results were within 15% of the comparison method results. An inverse relation between the glucose readings and haematocrit values was observed for both blood glucose meters in the hyperglycaemic range and this effect was more pronounced for Accutrend sensor. In the normo- and hypoglycaemic ranges the effect was insignificant and absent, respectively. Minimum sample volume for Glucocard Memory 2 was 3 microliters and for Accutrend sensor it was 9 microliters. Lower sample volumes gave erroneous results. Presenting more than the required volume had no effect on results.
对两款血糖仪（Glucocard Memory 2和Accutrend传感器）的性能和实用性进行了评估。在高血糖和正常血糖浓度范围内，两款血糖仪均产生了可接受的精确结果。在低血糖浓度范围内，Accutrend传感器的不精密度远高于美国糖尿病协会的推荐值。Glucocard Memory 2在葡萄糖浓度为1.7 mmol/l、5.8 mmol/l和11.7 mmol/l时的批内变异系数分别为6.3%、3.9%和2.4%；Accutrend传感器在相应浓度0.9 mmol/l、4.2 mmol/l和19.6 mmol/l时的批内变异系数分别为15.2%、5.0%和1.2%。Glucocard Memory 2在葡萄糖浓度为3.9 mmol/l和17.2 mmol/l时的日间变异系数分别为4.8%和3.5%；Accutrend传感器在葡萄糖浓度为3.8 mmol/l和18.7 mmol/l时的日间变异系数分别为3.8%和2.9%。Glucocard Memory 2在1.6 mmol/l - 29.7 mmol/l范围内结果呈线性，Accutrend传感器在1.6 mmol/l - 33.3 mmol/l范围内结果呈线性。两款血糖仪的结果与己糖激酶/葡萄糖-6-磷酸脱氢酶实验室方法密切相关。Glucocard Memory 2和Accutrend传感器的结果分别有98%在比较方法值的20%以内。Glucocard Memory 2的结果有93%、Accutrend传感器的结果有96%在比较方法结果的15%以内。在高血糖范围内，两款血糖仪的血糖读数与血细胞比容值之间均观察到负相关关系，且这种效应在Accutrend传感器上更为明显。在正常血糖和低血糖范围内，这种效应分别不显著和不存在。Glucocard Memory 2的最小样本体积为3微升，Accutrend传感器的最小样本体积为9微升。样本体积过小会得出错误结果。使用超过所需体积的样本对结果没有影响。
