Skeie Svein, Thue Geir, Nerhus Kari, Sandberg Sverre
NOKLUS, Norwegian Center for Quality Improvement of Primary Care Laboratories, Division of General Practice, Department of Public Health and Primary Care, Ulriksdal 8c, University of Bergen, N-5009 Bergen, Norway.
Clin Chem. 2002 Jul;48(7):994-1003.
Instruments for self-monitoring of blood glucose (SMBG) are increasingly used by patients with diabetes. The analytical quality of meters in routine use is poorly characterized.
We compared SMBG performance achieved by patients and by a medical laboratory technician. Imprecision was calculated from duplicate measurements, and deviation as the difference between the first measurement and the mean of duplicate laboratory-method results (calibrated with NIST material). Analytical quality for five groups of SMBG instruments was compared with quality specifications for BG measurements. All participants completed a questionnaire assessing both SMBG training and use of the meters.
We recruited 159 SMBG users from a hospital outpatient clinic and 263 others from 65 randomly selected general practices (total of 422). Most (two thirds) used insulin. CVs for the five meter types were 7%, 11%, 18%, 18%, and 20% in the hands of patients and 2.5-5.9% for the technician. For three of five meter types, patients' BG measurements had larger deviations from the laboratory results than did the technician's results. The technician's performance could not predict the patients'. No instrument when used by patients (but two operated by the technician) met published quality specifications. The analytical quality of patients' results was not related to whether they had chosen the instruments on advice from healthcare personnel (one-third of patients), were only self-educated in SMBG (50%), or performed SMBG fewer than seven times/week (62%).
The analytical quality of SMBG among patients was poorer than, and could not be predicted from, the performance of the meters in the hands of a technician. We suggest that new instruments be tested in the hands of patients who are trained on meter use in a routine way.
血糖自我监测（SMBG）仪器越来越多地被糖尿病患者使用。日常使用的血糖仪的分析质量特征尚不明确。
我们比较了患者和医学实验室技术人员的SMBG检测性能。不精密度通过重复测量计算得出，偏差为首次测量值与重复实验室方法结果的平均值（用美国国家标准与技术研究院的材料校准）之间的差值。将五组SMBG仪器的分析质量与血糖测量的质量规范进行比较。所有参与者都完成了一份评估SMBG培训和血糖仪使用情况的问卷。
我们从医院门诊招募了159名SMBG使用者，从65个随机选择的普通诊所招募了263名使用者（共422名）。大多数（三分之二）使用胰岛素。五种血糖仪类型在患者手中的变异系数分别为7%、11%、18%、18%和20%，技术人员操作时为2.5 - 5.9%。对于五种血糖仪类型中的三种，患者的血糖测量结果与实验室结果的偏差大于技术人员的结果。技术人员的表现无法预测患者的表现。患者使用时没有一台仪器（但技术人员操作的两台仪器）符合公布的质量规范。患者检测结果的分析质量与他们是否根据医护人员的建议选择仪器（三分之一的患者）、是否仅接受过SMBG自我教育（50%）或每周进行SMBG少于7次（62%）无关。
患者的SMBG分析质量比技术人员操作血糖仪的性能差，且无法根据技术人员的表现进行预测。我们建议新仪器应由以常规方式接受过血糖仪使用培训的患者进行测试。
