Florkowski Christopher, Budgen Christopher, Kendall Deborah, Lunt Helen, Moore M Peter
Diabetes Centre, Christchurch Hospital, Christchurch, New Zealand.
Ann Clin Biochem. 2009 Jul;46(Pt 4):302-5. doi: 10.1258/acb.2009.008193. Epub 2009 May 19.
To assess the accuracy and precision of the Roche Performa and Medisense Optium Xceed (5 and 10 s reading) blood glucose meters.
Capillary blood samples were taken from 100 patients attending a diabetes centre and blood glucose measured on Roche Performa (n = 4) and Medisense Optium Xceed 5 s (n = 2) and 10 s reading (n = 2) meters. Venous plasma glucose from samples taken simultaneously was measured by the laboratory hexokinase method as reference standard. Imprecision was determined on the meters by replicate analysis (n = 20) of control solutions provided by the manufacturers and also patient venous whole-blood samples. Accuracy was assessed relative to the reference method by Bland-Altman plots, Passing and Bablok regression analysis, and both Clarke and consensus error grid analysis. Coefficients of variation (CVs) were calculated to determine imprecision.
Bland-Altman and Passing-Bablok analysis confirmed significant systematic bias for all meters, with relative under-reading of higher glucose concentrations. Error grid analysis showed that <5% readings exceeded +/-20% (or +/-0.83 mmol/L for readings <4 mmol/L) deviation from the reference method (1%, 2% and 4% for the Roche, Optium 5 and 10 s meters, respectively). CVs were all <4% for the control solutions and <6% for patient samples.
Both Roche Performa and Medisense Optium glucose meters (5 and 10 s readings) perform satisfactorily and are acceptable for operational use.
评估罗氏Performa血糖仪和雅培Optium Xceed血糖仪(5秒和10秒读数)的准确性和精密度。
从一家糖尿病中心的100名患者采集毛细血管血样,使用罗氏Performa血糖仪(n = 4)、雅培Optium Xceed 5秒读数血糖仪(n = 2)和10秒读数血糖仪(n = 2)测量血糖。同时采集的样本的静脉血浆葡萄糖通过实验室己糖激酶法测量作为参考标准。通过对制造商提供的对照溶液以及患者静脉全血样本进行重复分析(n = 20)来确定血糖仪的不精密度。通过Bland-Altman图、Passing和Bablok回归分析以及Clarke和一致性误差网格分析相对于参考方法评估准确性。计算变异系数(CV)以确定不精密度。
Bland-Altman和Passing-Bablok分析证实所有血糖仪均存在显著的系统偏差,对较高葡萄糖浓度存在相对读数偏低的情况。误差网格分析显示,<5%的读数超出与参考方法偏差的+/-20%(对于读数<4 mmol/L为+/-0.83 mmol/L)(罗氏血糖仪、Optium 5秒读数血糖仪和10秒读数血糖仪分别为1%、2%和4%)。对照溶液的CV均<4%,患者样本的CV<6%。
罗氏Performa血糖仪和雅培Optium血糖仪(5秒和10秒读数)性能均令人满意,可接受用于实际操作。