患者预分类实时质量控制联合室内质量控制在急诊生化检验中的应用
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苏州市智慧+重大疾病生物标志物研究与转化重点实验室项目(SZS2024029)


Application of patient-based pre-classified real-time quality control combined with internal quality control in emergency biochemical testing
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    摘要:

    摘要:目的 评估基于患者预分类的实时质量控制(PCRTQC)联合传统实验室内质量控制(IQC)在急诊生化检测中的实施效果。方法 基于苏州市立医院检验医学中心2024年11月至2025年2月期间的急诊患者检测数据(建模样本量n=68 953),构建并验证PCRTQC模型。自2025年3月起,将该模型应用于钾离子(K+)、碱性磷酸酶(ALP)、天门冬氨酸氨基转移酶(AST)、总蛋白(TP)及尿酸(UA)等急诊生化项目的实时监控,并建立IQC与PCRTQC联合质量控制流程。结果 建立了具有仪器及项目特异性的PCRTQC模型,并与IQC整合形成实验室联合质量控制体系。初步应用验证显示:当ALP检测中IQC出现连续性偏移时,PCRTQC未提示异常,经排查最终确认为质控品问题;PCRTQC有效预警了因参比液装载异常引起的K+检测系统性偏差。结论 PCRTQC与IQC联合质量控制流程能够实现对急诊生化检测系统状态的实时、连续监测,动态识别分析过程中的误差并及时预警,有效提升急诊生化检验的质量,保障检测结果的时效性与准确性,具有一定的临床应用价值。

    Abstract:

    Abstract: ObjectiveTo evaluate the implementation effectiveness of patient pre-classified-based real-time quality control (PCRTQC) combined with conventional intemal quality control (IQC) in emergency biochemistry testing. MethodsBased on emergency patient testing data (modeling sample size n= 68 953) from the Laboratory Medicine Center,Suzhou Municipal Hospital, between November 2024 and February 2025, a PCRTQC model was constructed and validated. Since March 2025, this model was applied to real-time monitoring of emergency biochemistry analytes,including potassium(K*),alkaline phosphatase (ALP),aspartate amin-otransferase (AST),total protein (TP),and uric acid (UA). A combined quality control workflow integrating IQC and PCRTQC was established. ResultsInstrument- and analyte-specific PCRTQC models were established and integrated with IQC to form a combined laboratory quality control system. Preliminary verification demonstrated that when a continuous shift occurred in IQC results for ALP testing, PCRTQC showed no abnormality,and the shift was subsequently confirmed to be caused by a QC material issue. Additionally,PCRTQC effectively provided early warning of systematic bias in K* testing due to improper loading of the reference solution. ConclusionThe combined PCRTQC and IQC workflow allows for real-time and continuous monitoring for the system performance of emergency biochemistry testing,dynamically identifies the errors during analytical process,and provides timely alerts. This approach efectively enhances the quality of emergency biochemistry testing,ensures the timelinessand accuracy of test results,and holds certain clinical applicability.

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徐正超,黄宝丽,魏衍财,杜建钢,许秋芳,吴健,杨依骏.患者预分类实时质量控制联合室内质量控制在急诊生化检验中的应用[J].临床检验杂志,2026,44(05):369-373

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  • 收稿日期:2025-06-12
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  • 在线发布日期: 2026-07-06
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