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首页> 外文期刊>Clinical chemistry and laboratory medicine: CCLM >Critical evaluation of connectivity-based point of care testing systems of glucose in a hospital environment.
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Critical evaluation of connectivity-based point of care testing systems of glucose in a hospital environment.

机译：对医院环境中基于连通性的葡萄糖即时检测系统的关键评估。

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BACKGROUND: In recent years a number of point of care testing (POCT) glucometers were introduced on the market. We investigated the analytical variability (lot-to-lot variation, calibration error, inter-instrument and inter-operator variability) of glucose POCT systems in a university hospital environment and compared these results with the analytical needs required for tight glucose monitoring. METHODS: The reference hexokinase method was compared to different POCT systems based on glucose oxidase (blood gas instruments) or glucose dehydrogenase (handheld glucometers). Based upon daily internal quality control data, total errors were calculated for the various glucose methods and the analytical variability of the glucometers was estimated. RESULTS: The total error of the glucometers exceeded by far the desirable analytical specifications (based on a biological variability model). Lot-to-lot variation, inter-instrument variation and inter-operator variability contributed approximately equally to total variance. As in a hospital environment, distribution of hematocrit values is broad, converting blood glucose into plasma values using a fixed factor further increases variance. The percentage of outliers exceeded the ISO 15197 criteria in a broad glucose concentration range. CONCLUSIONS: Total analytical variation of handheld glucometers is larger than expected. Clinicians should be aware that the variability of glucose measurements obtained by blood gas instruments is lower than results obtained with handheld glucometers on capillary blood.
机译：背景：近年来，市场上推出了许多即时检验（POCT）血糖仪。我们研究了大学医院环境中葡萄糖POCT系统的分析变异性（批次间差异，校准误差，仪器间和操作员之间的变异性），并将这些结果与严格的葡萄糖监测所需的分析需求进行了比较。方法：将己糖激酶参考方法与基于葡萄糖氧化酶（气体仪器）或葡萄糖脱氢酶（手持式血糖仪）的不同POCT系统进行了比较。根据每日内部质量控制数据，计算出各种葡萄糖方法的总误差，并估算了血糖仪的分析变异性。结果：血糖仪的总误差远远超过了所需的分析指标（基于生物变异性模型）。批间差异，仪表间差异和操作员间差异对总方差的贡献大致相等。如在医院环境中，血细胞比容值的分布很宽，使用固定因子将血糖转换为血浆值会进一步增加差异。在广泛的葡萄糖浓度范围内，异常值百分比超出了ISO 15197标准。结论：手持式血糖仪的总分析变化大于预期。临床医生应该意识到，通过血气仪器获得的葡萄糖测量结果的变异性低于使用手持式血糖仪在毛细管血液上获得的结果。

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