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The New Glucose Standard POCT12-A3 Misses the Mark

机译:新的葡萄糖标准POCT12-A3未能实现目标

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摘要

POCT12-A3 is a Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance standards. I have reviewed this standard based on the attributes of an ideal performance standard. POCT12-A3 has tighter limits than its predecessor for 95% of results, the limits widen for 98% of results, and there are no limits for 2% of results. It is hard to fathom that 2% of the results are unspecified and could cause life-threatening results, as glucose meters do not perform this poorly. There should be a specification for unreported results since, by definition, point-of-care-testing assays are time sensitive. POCT12-A3 provides useful advice about the glucose testing procedure but provides evaluation guidance only about analytical performance. Moreover, the recommended protocol to assess meter performance is biased and likely to underestimate the observed performance. The guideline would be improved if its specification were based on an error grid and contained evaluation protocols for user errors.
机译:POCT12-A3是有关医院血糖仪程序和性能标准的医院临床实验室标准协会标准。我已经根据理想性能标准的属性对该标准进行了回顾。 POCT12-A3对于其95%的结果具有比其上一代更严格的限制,对于98%的结果,该限制扩大了,对于2%的结果没有限制。很难理解2%的结果是未指定的,并且可能导致危及生命的结果,因为血糖仪的执行效果不佳。对于未报告的结果,应该有一个规范,因为按照定义,即时检验是对时间敏感的。 POCT12-A3提供了有关葡萄糖测试程序的有用建议,但仅提供了有关分析性能的评估指导。此外,推荐的评估仪表性能的协议存在偏差,并且可能会低估所观察到的性能。如果该指南的规范基于错误网格并包含针对用户错误的评估协议,则该指南将得到改进。

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