Application and insights on patient-based real-time quality control: detecting undetected errors in internal quality control through daily antibody positivity rate analysis.

IF 1.8
Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI:10.11613/BM.2025.020801
Chaochao Ma, Qi Zhang, Yingying Hu, Wenyi Ding, Liangyu Xia, Ling Qiu
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Abstract

Introduction: Traditional internal quality control (IQC) has limitations in detecting systematic errors in clinical laboratories. Patient-Based Real-Time Quality Control (PBRTQC) has emerged as a complementary method, offering new approaches for quality monitoring. Among these, monitoring daily positivity rates provides meaningful insights into laboratory performance.

Materials and methods: This study highlights a case in which PBRTQC was implemented to detect and address a reagent batch issue in thyroid peroxidase antibody (TPO-Ab) testing. Over one year (July 2023 to July 2024), daily positivity rates and their fluctuations were retrospectively analyzed and daily positivity rate alarm limits were established for monitoring.

Results: A notable increase in the TPO-Ab positivity rate was identified starting in June 2024. For outpatients and inpatients, the positivity rates in June and July 2024 were 46.1% ± 7.8% (N = 9039) and 61.4% ± 12.0% (N = 8735), respectively. For the physical examination population, the positivity rates during the same months were 30.0% ± 11.7% (N = 4754) and 52.5% ± 18.1% (N = 5726), respectively. These rates were significantly higher than the pre-June 2024 average monthly positivity rates of 30.0% ± 2.9% (N = 9070 per month) for patients and 11.0% ± 2.4% (N = 4663 per month) for the physical examination population.

Conclusions: PBRTQC, particularly monitoring daily positivity rates, is a valuable tool for early detection of systematic errors. Establishing PBRTQC systems can supplement traditional IQC to improve laboratory test quality.

基于患者的实时质量控制的应用与见解:通过每日抗体阳性率分析发现内部质量控制中未被发现的错误。
传统的内部质量控制(IQC)在检测临床实验室系统错误方面存在局限性。基于患者的实时质量控制(PBRTQC)作为一种补充方法出现,为质量监测提供了新的途径。其中,监测每日阳性率提供了对实验室性能有意义的见解。材料和方法:本研究重点介绍了一个应用PBRTQC检测和解决甲状腺过氧化物酶抗体(TPO-Ab)检测中试剂批次问题的案例。回顾性分析一年内(2023年7月至2024年7月)的日阳性率及其波动情况,建立日阳性率报警限进行监测。结果:从2024年6月开始,TPO-Ab阳性率显著升高。2024年6月和7月门诊和住院患者阳性率分别为46.1%±7.8% (N = 9039)和61.4%±12.0% (N = 8735)。同期体检人群检出率分别为30.0%±11.7% (N = 4754)和52.5%±18.1% (N = 5726)。这些检出率明显高于2024年6月前患者的月平均检出率30.0%±2.9% (N = 9070 /月)和体检人群的月平均检出率11.0%±2.4% (N = 4663 /月)。结论:PBRTQC,特别是监测每日阳性率,是早期发现系统性错误的有价值的工具。建立PBRTQC体系可以作为传统IQC的补充,提高实验室检测质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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