Department of Pathology, Singapore General Hospital, Outram Road, Republic of Singapore.
Diabetes Technol Ther. 2010 Nov;12(11):889-93. doi: 10.1089/dia.2010.0095. Epub 2010 Sep 30.
Maltose interference is a concern with blood glucose testing at point-of-care. We evaluated a maltose interference-free test strip (with a modified recombinant glucose dehydrogenase-pyrroloquinoline quinone system) for the Accu-Chek(®) Performa glucose meter (Roche Diagnostics, Mannheim, Germany).
Blood specimens (n = 120) sent for clinical laboratory glucose testing were used in assessing performance characteristics, including imprecision, linearity, clinical impact analysis, and method comparison, of the test strips. To evaluate sugar interference, two heparinized blood specimens were spiked with maltose, xylose, and galactose (up to 500 mg/dL) followed by testing with modified Performa, Accutrend(®) (Roche Diagnostics), and Advantage II (Roche Diagnostics) test strips and by the laboratory method.
Test strips demonstrated total laboratory coefficients of variation of <7%; within-run coefficients of variation were 2.7-5.4% for blood glucose at 2.5-19.7 mmol/L. Clarke Error Grid analysis of the 120 results (0.8-27.6 mmol/L) showed all values to be within critical clinical limits. Comparison with laboratory results gave 0.960 correlation (Spearman's r(2)) with a Deming regression y (Performa) = 0.95x (laboratory) - 0.11 mmol/L (SEy|x0.06 mmol/L). A slight negative bias (-0.5 mmol/L) was demonstrated with the Bland-Altman difference plot. Maltose (up to 13.9 mmol/L) and xylose (33.3 mmol/L) had no effect, but galactose (2.2 mmol/L) showed interference. The sugars also affected test strips for Advantage II but not Accutrend glucose meters. With International Organization for Standardization ISO 15197:2003 criteria, 99% of the 120 results determined by the test strips were within the minimal acceptable performance; only one of 106 (5.9 mmol/L) was >20% from the laboratory result.
The modified and improved Performa test strips were not affected by maltose and xylose. They meet ISO 15197:2003 requirements with a slight bias (-0.5 mmol/L) compared to the laboratory method.
在即时检测点进行血糖检测时，麦芽糖干扰是一个关注点。我们评估了一种麦芽糖无干扰测试条（采用改良的重组葡萄糖脱氢酶-吡咯喹啉醌系统），用于 Accu-Chek®Performa 血糖仪（罗氏诊断公司，德国曼海姆）。
使用 120 份送往临床实验室进行葡萄糖检测的血液标本，评估测试条的性能特征，包括不精密度、线性、临床影响分析和方法比较。为了评估糖干扰，将 2 份肝素化血液标本分别混入麦芽糖、木糖和半乳糖（最高 500mg/dL），然后用改良的 Performa、Accutrend®（罗氏诊断公司）和 Advantage II（罗氏诊断公司）测试条以及实验室方法进行检测。
测试条的总实验室变异系数<7%；血糖在 2.5-19.7mmol/L 时，批内变异系数为 2.7-5.4%。对 120 个结果（0.8-27.6mmol/L）的 Clarke 误差网格分析显示，所有值均在临界临床限度内。与实验室结果的比较得出 0.960 的相关性（Spearman r²），Deming 回归 y（Performa）=0.95x（实验室）-0.11mmol/L（SEy|x0.06mmol/L）。Bland-Altman 差值图显示出轻微的负偏倚（-0.5mmol/L）。麦芽糖（最高 13.9mmol/L）和木糖（33.3mmol/L）无影响，但半乳糖（2.2mmol/L）显示出干扰。这些糖还影响 Advantage II 的测试条，但不影响 Accutrend 血糖仪。根据国际标准化组织 ISO 15197:2003 标准，测试条测定的 120 个结果中，99%符合最小可接受性能；仅 106 个（5.9mmol/L）结果与实验室结果相差>20%。
改良和改进的 Performa 测试条不受麦芽糖和木糖的影响。与实验室方法相比，它们符合 ISO 15197:2003 要求，仅有轻微偏差（-0.5mmol/L）。
