化学发光法超高值样本自动稀释检测的质量风险分析与防控策略  

An Analysis of Quality Risks and Prevention Strategies for AutomaticDilution Detection of Ultra-high Value Samplesby Chemiluminescence

作　　者：肖光军[1] 刘艳婷[1] 胡娟 陈姝[1] 赵思涵 李春红 XIAO Guangjun;LIU Yanting;HU Juan;CHEN Shu;ZHAO Sihan;LI Chunhong(Department of Clinical Laboratory and Basic Laboratory,Suining Central Hospital,Suining 629000,China;Department of Oncology,Suining Central Hospital,Suining 629000,China)

机构地区：[1]遂宁市中心医院检验科,四川遂宁629000 [2]遂宁市中心医院肿瘤科,四川遂宁629000

出　　处：《标记免疫分析与临床》2024年第11期2114-2119,共6页Labeled Immunoassays and Clinical Medicine

基　　金：四川省医学科研课题计划(编号:S22045)。

摘　　要：目的探讨化学发光法检测系统中超高值样本自动稀释检测的质量风险,并提出相应的防控策略,以期为临床实验室的质量改进提供科学依据。方法本研究以1例β-人绒毛膜促性腺激素(β-human chorionic gonadotropin,β-hCG)超高值样本化学发光法检测结果假性降低为例,通过事件调查、结果分析和实验验证等方法,分析导致检测结果假性降低的原因,识别出超高值样本自动稀释检测的质量风险,并提出相应的防控策略。结果经调查,检测系统更换新批号试剂后,共有34份超高值样本的β-hCG检测结果出现假性降低,与试剂校准生成的工作曲线异常有关。重新校准后,超高值样本复测结果显著升高(t=6.465,P<0.001),与临床反馈相符,且校准后未自动稀释时复测结果的相对发光单位(RLUs)值与第一次检测时的RLUs值差异无统计学意义(t=0.577,P=0.566),验证了原工作曲线异常是导致检测结果假性降低的主要原因。此外,在室内质控在控、试剂间新鲜患者样本比对通过的情况下,仍发生了该不良事件,表明临床实验室现有质量控制程序在监测超高值样本检测稳定性方面存在不足。结论临床实验室应加强对超高值样本自动稀释检测的质量控制,通过优化校准流程、自制超高值质控品、加强仪器间和试剂批号间比对等措施,提高检测结果的准确性和可靠性,降低患者安全风险。Objective To investigate the quality risks in automatic dilution detection of ultra-high value samples in chemiluminescence systems and to propose optimized strategies for improvement,so as to provide a scientific basis for quality enhancement in clinical laboratories.Methods A case of falsely lowβ-human chorionic gonadotropin(β-hCG)results in an ultra-high value sample detected by chemiluminescence was analyzed.Through multi-steps of event investigation,result analysis,and experimental verification,the potential causes of false results were identified,risks in automatic dilution detection were assessed,and an optimized preventive strategy was proposed.Results After switching to a new reagent batch,34 ultra-high value samples exhibited falsely lowβ-hCG results due to abnormalities in the calibration curve.Recalibration process significantly increased retest results(t=6.465,P<0.001),consistent with clinical feedbacks.However,the relative light units(RLUs)in retests post-calibration without dilution showed no significant difference from initial test results(t=0.577,P=0.566),confirming the calibration curve anomaly as the primary cause of false results.The incident,despite adequate quality control,highlighted existing deficiencies in current standard procedures for ensuring stability in ultra-high value sample detections.Conclusion Clinical laboratories should enhance the quality control procedure for ultra-high value sample detections.Strategies,such as optimizing calibration,developing in-house ultra-high value controls,and improving inter-instrument and reagent batch comparisons,can be essential to ensure the test accuracy and reduce patient safety risks.

关 键 词：化学发光法 分析测量范围 自动稀释 质量控制 Β-HCG 

分 类 号：R-331[医药卫生]