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美国兽医临床病理学家协会指南:生物化学的允许总误差指南

ASVCP guidelines: allowable total error guidelines for biochemistry.

作者信息

Harr Kendal E, Flatland Bente, Nabity Mary, Freeman Kathleen P

机构信息

URIKA, LLC, Mukilteo, WA, USA.

出版信息

Vet Clin Pathol. 2013 Dec;42(4):424-36. doi: 10.1111/vcp.12101.

Abstract

As all laboratory equipment ages and contains components that may degrade with time, initial and periodically scheduled performance assessment is required to verify accurate and precise results over the life of the instrument. As veterinary patients may present to general practitioners and then to referral hospitals (both of which may each perform in-clinic laboratory analyses using different instruments), and given that general practitioners may send samples to reference laboratories, there is a need for comparability of results across instruments and methods. Allowable total error (TEa ) is a simple comparative quality concept used to define acceptable analytical performance. These guidelines are recommendations for determination and interpretation of TEa for commonly measured biochemical analytes in cats, dogs, and horses for equipment commonly used in veterinary diagnostic medicine. TEa values recommended herein are aimed at all veterinary settings, both private in-clinic laboratories using point-of-care analyzers and larger reference laboratories using more complex equipment. They represent the largest TEa possible without generating laboratory variation that would impact clinical decision making. TEa can be used for (1) assessment of an individual instrument's analytical performance, which is of benefit if one uses this information during instrument selection or assessment of in-clinic instrument performance, (2) Quality Control validation, and (3) as a measure of agreement or comparability of results from different laboratories (eg, between the in-clinic analyzer and the reference laboratory). These guidelines define a straightforward approach to assessment of instrument analytical performance.

摘要

由于所有实验室设备都会随着时间推移而老化,其部件也可能随时间退化,因此需要进行初始和定期的性能评估,以验证仪器在其使用寿命内能够产生准确和精确的结果。由于兽医患者可能先就诊于普通执业兽医,然后转诊至专科医院(这两类机构都可能各自使用不同仪器进行临床实验室分析),而且普通执业兽医可能会将样本送至参考实验室,因此需要确保不同仪器和方法所得结果具有可比性。允许总误差(TEa)是一个用于定义可接受分析性能的简单比较质量概念。本指南是关于在兽医诊断医学中常用设备对猫、狗和马常见测量生化分析物的TEa测定和解释的建议。本文推荐的TEa值适用于所有兽医环境,包括使用即时检验分析仪的私立临床实验室和使用更复杂设备的大型参考实验室。它们代表了在不产生会影响临床决策的实验室差异的情况下可能出现的最大TEa。TEa可用于:(1)评估单个仪器的分析性能,如果在仪器选择或临床仪器性能评估期间使用此信息将很有帮助;(2)质量控制验证;以及(3)作为不同实验室(例如,临床分析仪与参考实验室之间)结果一致性或可比性的衡量标准。这些指南定义了一种评估仪器分析性能的直接方法。

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