Assessing the performance of handheld glucose testing for critical care.
Assessing the performance of handheld glucose testing for critical care.
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评估重症监护手持式血糖测试的性能。
DOI：
10.1089/dia.2008.0049
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发表时间：
2008
影响因子：
5.4
通讯作者：
Abad,VictorJ
中科院分区：
文献类型：
--
作者：
Kost,GeraldJ;Tran,NamK;Louie,RichardF;Gentile,NicoleL;Abad,VictorJ
背景：我们使用局部平滑 (LS) 中值绝对差 (MAD) 曲线方法，结合改进的 Bland-Altman 差异图和叠加的国际标准化组织 (ISO) 15197 公差带，评估了具有多任务测试条的护理点 (POC) 血糖仪系统 (GMS) 的性能。我们分析了严格血糖控制 (TGC) 的性能。方法：使用带有多层金、多电极、四孔测试条的改良葡萄糖氧化酶（StatStrip™，NOVA Biomedical，Waltham，MA）。没有试纸校准代码。对 GMS 结果与临床实验室化学分析仪的配对血浆葡萄糖测量结果进行了实用比较。 35 家医院使用 20 种化学分析仪对静脉样本 (n= 1,703) 进行了分析。使用 Bland-Altman 图和 ISO 15197 标准识别出错误结果。对 80–110 mg/dL 的 TGC 区间的差异值进行了分析。 结果：GMS 符合 ISO 15197 指南； 98.6%（416 中的 410）观察结果在葡萄糖 <75 mg/dL 的耐受范围内，而对于 ≥75 mg/dL，100% 在耐受范围内。配对差异（手持式减去参考值）平均值为 –2.2 (SD 9.8) mg/dL；中位数为−1（范围，−96 至 45）mg/dL。 LS MAD 曲线分析显示低于 186 mg/dL 的令人满意的性能；高于 186 mg/dL，未达到建议的误差容限 (5 mg/dL)。没有出现不一致的值。所有点均落在克拉克误差网格区域 A 内。线性回归显示y= 1.018x– 0.716 mg/dL，r2= 0.995。结论：LS MAD 曲线利用了人类视觉辨别表现的能力。 TGC 的 LS MAD 曲线和 ISO 15197 性能是可以接受的。 POC 和参考葡萄糖校准应统一和标准化。
Background:We assessed the performance of a point-of-care (POC) glucose meter system (GMS) with multitasking test strip by using the locally-smoothed (LS) median absolute difference (MAD) curve method in conjunction with a modified Bland-Altman difference plot and superimposed International Organization for Standardization (ISO) 15197 tolerance bands. We analyzed performance for tight glycemic control (TGC).Methods:A modified glucose oxidase enzyme with a multilayer-gold, multielectrode, four-well test strip (StatStrip™, NOVA Biomedical, Waltham, MA) was used. There was no test strip calibration code. Pragmatic comparison was done of GMS results versus paired plasma glucose measurements from chemistry analyzers in clinical laboratories. Venous samples (n= 1,703) were analyzed at 35 hospitals that used 20 types of chemistry analyzers. Erroneous results were identified using the Bland-Altman plot and ISO 15197 criteria. Discrepant values were analyzed for the TGC interval of 80–110 mg/dL.Results:The GMS met ISO 15197 guidelines; 98.6% (410 of 416) of observations were within tolerance for glucose <75 mg/dL, and for ≥75 mg/dL, 100% were within tolerance. Paired differences (handheld minus reference) averaged –2.2 (SD 9.8) mg/dL; the median was −1 (range, −96 to 45) mg/dL. LS MAD curve analysis revealed satisfactory performance below 186 mg/dL; above 186 mg/dL, the recommended error tolerance limit (5 mg/dL) was not met. No discrepant values appeared. All points fell in Clarke Error Grid zone A. Linear regression showedy= 1.018x– 0.716 mg/dL, andr2= 0.995.Conclusions:LS MAD curves draw on human ability to discriminate performance visually. LS MAD curve and ISO 15197 performance were acceptable for TGC. POC and reference glucose calibration should be harmonized and standardized.