全自动酶联免疫平台传染病八项报告自动审核系统的建立和优化
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Establishment and optimization of automatic review system for eight report items of infectious disease based on fully automated enzyme immunoassay analyzers
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    摘要:目的 构建全自动酶联免疫平台传染病八项报告自动审核系统,提升审核效能。方法 依据CLSI AUTO-15文件及WS/T 616—2018行业标准,整合中间件(infinity)与实验室信息系统(LIS),建立六维规则体系,包括质量控制联动、标本状态监控、仪器报警响应、灰区动态优化、血清学模式复检、历史数据比对,通过三阶段验证(收集17 828例标本建立规则、收集6 743例标本验证优化规则、收集12 335例标本评估效能),经人机比对优化审核规则。结果 建立了基于全自动酶联免疫平台的自动审核系统,经优化后其敏感性与特异性分别为98.9%与95.4%,阳性预测值与阴性预测值分别为72.4%与99.8%;自动审核通过率经优化由规则建立初期的77.1%提升至85.2%,标本周转时间(TAT)中位数缩短23.1%(由216 min下降至166 min);审核人力减少50%。结论 基于全自动酶联免疫平台的传染病八项自动审核系统通过多规则智能整合,简单易行,可操作性强,可减轻审核人员的工作强度,缩短TAT,显著提升审核效率与准确性。

    Abstract:

    Abstract: Objective To establish and optimize an automatic review system for eight report-items of infectious disease markers based on fully automated enzyme immunoassay analyzers and improve the review efficiency. MethodsFolowing CISI AUTO-15 and WS/T 616-2018 standards,a six-dimensional rule system was developed by integrating the infinity and Laboratory Information System,includingqualitycontrollinkage,specimenstatusmonitoring,instrumentalarmresponse,dynamic grayzoneoptimization,serologicalpattern interpretation, and historical data comparison. The system underwent three-phase validation(rule establishment: 17 828 samples,rule verification and optimization:6 743 samples,efficacy evaluation: 12 335 samples),with rules and thresholds refined through human-machine comparison. ResultsAn automated review rule system based on the fully automated enzyme immunoassay platform was established. The optimized system achieved sensitivity and specificity of 98.9% and 95.4%,respectively,with positive and negative predictive values of 72.4%and 99.8%,respectively.The autoverification rate was optimized to increase froman initial 77.1% to 85.2,median turnaround time (TAT)was reduced by 23.1% (from 216 minutes to 166 minutes),and manual review stafing requirements decreased by 5O%. ConclusionThe autoverification system for the eight items of infectious disease panel on automated enzyme immunoassay platfomm employs multi-rule intelligent integration. It is simple, user-friendly, practical, and highly operable,capable of reducing reviewer workload,shortening TAT, and significantly enhancing review efficiency and accuracy.

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蒋玉娥,王传琼,杨蕊,石琼,夏全松.全自动酶联免疫平台传染病八项报告自动审核系统的建立和优化[J].临床检验杂志,2026,44(06):455-460

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  • 收稿日期:2025-09-16
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  • 在线发布日期: 2026-08-11
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