采用IntraSpect™技术的智能质量管理2用于GEM® Premier™ 5000血气分析仪的质量控制——患者样本作为自身对照的新应用。

Intelligent Quality Management 2 with IntraSpect™ technology for quality control of GEM® Premier™ 5000 blood gas analyzers- A novel application of the patient sample as its own control.

作者信息

Westgard James O, Cervera Jose

机构信息

Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medical and Public Health, Madison, WI, USA.

President, Westgard QC, Inc., Madison, WI, 53717, USA.

出版信息

Pract Lab Med. 2022 Apr 8;30:e00273. doi: 10.1016/j.plabm.2022.e00273. eCollection 2022 May.

DOI:10.1016/j.plabm.2022.e00273

PMID:35465622

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9027344/

Abstract

BACKGROUND

Quality control (QC) in point-of-care (POC) testing has been greatly improved by automatic control processes, such as the Intelligent Quality Management (iQM®) technology found in GEM Premier blood gas analyzers (Werfen, Bedford, MA). The 2nd generation technology, iQM2, provides additional capabilities, notably the incorporation of IntraSpect software that monitors the response curves of individual tests to detect transient errors caused by micro-clots, micro-bubbles or any event that disturbs the sensor response during sample data acquisition. IntraSpect is a novel form of patient-based, real-time quality control (PBRTQC).

METHODS

IntraSpect pattern recognition software monitors the last 15 measurements of each patient-response curve. Control limits for slope coefficients have been established from theoretical models and empirical data. Abnormal measurement behavior is flagged to identify transient errors that invalidate test results. Results from 1,013,391 patient samples were collected on 4,985 GEM Premier 5000 cartridges and 2,765 instruments in clinical use worldwide.

RESULTS AND CONCLUSIONS

Total pre-analytic and transient errors detected by IntraSpect were 1.91% worldwide. iQM2 with IntraSpect technology provides a unique control function detecting transient errors that would otherwise go undetected with traditional QC. Together with the statistical QC technology in iQM2, pre-analytic, analytic, and transient analytic errors are detected much faster-seconds versus hours-than by traditional statistical QC.

摘要

背景

即时检验（POC）中的质量控制（QC）已通过自动控制流程得到了极大改善，例如在GEM Premier血气分析仪（Werfen，贝德福德，马萨诸塞州）中发现的智能质量管理（iQM®）技术。第二代技术iQM2提供了更多功能，特别是集成了IntraSpect软件，该软件可监测各个测试的响应曲线，以检测由微凝块、微气泡或在样本数据采集期间干扰传感器响应的任何事件引起的瞬时误差。IntraSpect是一种基于患者的新型实时质量控制（PBRTQC）。

方法

IntraSpect模式识别软件监测每个患者响应曲线的最后15次测量。已根据理论模型和经验数据确定了斜率系数的控制限。标记异常测量行为以识别使测试结果无效的瞬时误差。在全球临床使用的4985个GEM Premier 5000试剂盒和2765台仪器上收集了1013391份患者样本的结果。

结果与结论

全球范围内，IntraSpect检测到的总分析前和瞬时误差为1.91%。具有IntraSpect技术的iQM2提供了一种独特的控制功能，可检测传统质量控制方法无法检测到的瞬时误差。与iQM2中的统计质量控制技术一起，分析前、分析中和瞬时分析误差的检测速度比传统统计质量控制快得多——从几秒钟到几小时不等。