Scientific Affairs Liaison, Diabetes Care, Bayer HealthCare LLC, Sunnyvale, CA 94085, USA.
Postgrad Med. 2013 May;125(3):91-8. doi: 10.3810/pgm.2013.05.2664.
Point-of-care testing (POCT) is widely used to measure blood glucose levels in people with diabetes, although its use in measuring glycated hemoglobin (HbA1c) levels is less common, perhaps due to perceived performance issues and access to the technology.
Forty blood samples were analyzed in duplicate using Bayer's A1CNow + ® Multi-Test A1C system (A1CNow + ) with 3 different reagent lots; HbA1c levels of the samples spanned the clinically relevant range of 4% to 10%. Corresponding samples were sent to a National Glycohemoglobin Standardization Program (NGSP) secondary reference laboratory (University of Missouri Secondary Reference Laboratory #9), which analyzed the samples with a Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (Tosoh G8; Tosoh Bioscience, Inc).
Glycated hemoglobin levels measured with the A1CNow + aligned with measurements obtained using the laboratory method, with correlation coefficients of 0.985, 0.987, and 0.989 for the 3 lots, respectively. The 95% CIs for the differences between the A1CNow + levels and the mean HbA1c levels were within -0.55% to +0.50% for the 3 reagent lots, which is well within the currently acceptable limits of ±0.75% HbA1c required by the NGSP. Results were further analyzed per the new tighter NGSP performance criteria effective September 1, 2012, requiring that 37 of 40 results be within ±7% (relative bias) of the NGSP reference laboratory measures. All 3 lots met the tighter NGSP criteria.
The A1CNow + provides accuracy and precision when performing POCT of HbA1c as an aid in diabetes management. Ongoing improvements in this and other HbA1c POCT devices may lead to a greater global acceptance of the role of POCT of HbA1c in diabetes management.
即时检验（POCT）被广泛用于测量糖尿病患者的血糖水平，尽管其在测量糖化血红蛋白（HbA1c）水平方面的应用较少，这可能是由于性能问题和对技术的认识。
使用 Bayer 的 A1CNow + ® Multi-Test A1C 系统（A1CNow + ）对 40 份血样进行了双份分析，该系统使用了 3 种不同的试剂批；样本的 HbA1c 水平跨越了 4%至 10%的临床相关范围。相应的样本被送到国家糖化血红蛋白标准化计划（NGSP）二级参考实验室（密苏里大学二级参考实验室 #9），该实验室使用 Tosoh 自动化糖化血红蛋白分析仪 HLC-723G8（Tosoh G8；Tosoh Bioscience，Inc.）对样本进行分析。
A1CNow + 测量的糖化血红蛋白水平与实验室方法的测量结果相吻合，分别为 3 个试剂批的相关系数为 0.985、0.987 和 0.989。A1CNow + 水平与平均 HbA1c 水平之间的差异 95%CI 在 3 个试剂批的-0.55%至+0.50%之间，这在 NGSP 要求的±0.75%HbA1c 的可接受范围内。根据 2012 年 9 月 1 日生效的新的更严格的 NGSP 性能标准，进一步对结果进行了分析，要求 40 个结果中的 37 个结果的相对偏差（相对偏差）在 NGSP 参考实验室测量值的±7%以内。所有 3 个试剂批都符合更严格的 NGSP 标准。
A1CNow + 在作为糖尿病管理辅助手段进行即时 POCT 的 HbA1c 时具有准确性和精密度。这种和其他 HbA1c POCT 设备的不断改进可能会导致全球更广泛地接受 POCT 的 HbA1c 在糖尿病管理中的作用。
