From the Department of Pediatrics, University of Saskatchewan, Saskatoon, Saskatchewan, Canada (Inman).
The Department of Pathology & Laboratory Medicine, Division of Clinical Biochemistry, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada (AW Lyon, ME Lyon).
Arch Pathol Lab Med. 2020 Oct 1;144(10):1204-1208. doi: 10.5858/arpa.2020-0101-RA.
CONTEXT.—: Glycemic control requires accurate blood glucose testing. The extent of hematocrit interference is difficult to assess to assure quality patient care.
OBJECTIVE.—: To predict the effect of patient hematocrit on the performance of a glucose meter and its corresponding impact on insulin-dosing error.
DESIGN.—: Multilevel mixed regression was conducted to assess the extent that patient hematocrit influences Roche Accu-Chek Inform II glucose meters, using the Radiometer ABL 837 as a reference method collected during validation of 35 new meters. Regression coefficients of fixed effects for reference glucose, hematocrit, an interaction term, and random error were applied to 4 months of patient reference method results extracted from the laboratory information system. A hospital inpatient insulin dose algorithm was used to determine the frequency of insulin dose error between reference glucose and meter glucose results.
RESULTS.—: Fixed effects regression for method and hematocrit predicted biases to glucose meter results that met the "95% within ±12%" for the US Food and Drug Administration goal, but combinations of fixed and random effects exceeded that target in emergency and hospital inpatient units. Insulin dose errors were predicted from the meter results. Twenty-eight percent of intensive care unit, 20.8% of hospital inpatient, and 17.7% of emergency department results were predicted to trigger a ±1 insulin dose error by fixed and random effects.
CONCLUSIONS.—: The current extent of hematocrit interference on glucose meter performance is anticipated to cause insulin error by 1-dose category, which is likely associated with low patient risk.
血糖控制需要准确的血糖检测。由于难以评估血细胞比容的干扰程度，因此难以确保患者得到高质量的护理。
预测患者血细胞比容对血糖仪性能的影响及其对胰岛素剂量误差的影响。
使用 Radiometer ABL 837 作为参考方法，在对 35 台新血糖仪进行验证期间收集数据，采用多级混合回归来评估患者血细胞比容对罗氏 Accu-Chek Inform II 血糖仪的影响。使用参考葡萄糖、血细胞比容、交互项和随机误差的固定效应回归系数，对从实验室信息系统中提取的 4 个月的患者参考方法结果进行应用。使用医院住院胰岛素剂量算法来确定参考葡萄糖和血糖仪结果之间胰岛素剂量误差的频率。
方法和血细胞比容的固定效应回归预测了血糖仪结果的偏差，符合美国食品和药物管理局（FDA）“95%在±12%范围内”的目标，但固定和随机效应的组合超出了该目标。从血糖仪结果预测胰岛素剂量误差。固定和随机效应预测 28%的重症监护病房、20.8%的住院病房和 17.7%的急诊病房结果可能会导致胰岛素剂量误差增加 1 个类别，这可能与患者风险较低有关。
目前血细胞比容对血糖仪性能的干扰程度预计会导致 1 个剂量类别出现胰岛素误差，这可能与患者的低风险有关。
