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Quality planning and control strategy for AQT90 flex Radiometer® in point of care testing.
Scandinavian Journal of Clinical and Laboratory Investigation ( IF 1.3 ) Pub Date : 2020-06-01 , DOI: 10.1080/00365513.2020.1768585
Claudio Ilardo 1 , Cecile Reynaud 1 , Regine Bonneton 1 , Joel Barthes 1
Affiliation  

In the context of point of care testing (PoCT) and ISO 22870, internal quality control (IQC) is a crucial part of PoCT accreditation processes. Quality Control materials shall be periodically examined with a frequency that is based on the robustness of the analytical procedure and the risk of harm to the patient from an erroneous result. We propose to apply the statistical quality control (SQC) procedure to develop an individualized QC plan for AQT90 flex instrument used in PoCT. The robustness is determined by the sigma-metric and analytical goal represented by an allowable total error (TEa) is evaluated using a Varela graphic tool. A Sigma-metric SQC run size nomogram for estimating the number of patient samples between IQC events. According to the calculated robustness we can distinguish 3 groups of parameters: HCG and CRP with large sample size per event, D-Dimer and Procalcitonin with an average sample size per event and Myoglobin. NT-proBNP. and Troponin T with a limited sample size per event. In PoCT, the SQC strategy can promote more effective, and not necessarily more frequent, IQC.



中文翻译:

就照护测试而言,AQT90 flexRadiometer®的质量计划和控制策略。

在即时检验(PoCT)和ISO 22870的背景下,内部质量控制(IQC)是PoCT认证过程的关键部分。质量控制材料应定期进行检查,检查频率应基于分析程序的稳健性和错误结果对患者造成伤害的风险。我们建议应用统计质量控制(SQC)程序为PoCT中使用的AQT90 flex仪器制定个性化的质量控制计划。鲁棒性由sigma度量确定,分析目标由可允许的总误差(TEa)表示,使用Varela图形工具进行评估。Sigma-metric SQC运行大小列线图,用于估计IQC事件之间的患者样本数量。根据计算的鲁棒性,我们可以区分3组参数:HCG和CRP每次事件的样本量较大,D-Dimer和降钙素原的每次事件平均样本量和肌红蛋白。NT-proBNP。肌钙蛋白T每次事件的样本量有限。在PoCT中,SQC策略可以促进提高IQC的效率,而不一定提高其频率。

更新日期:2020-06-01
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