An Analysis of Quality Risks and Prevention Strategies for Automatic Dilution Detection of Ultra-high Value Samples by Chemiluminescence
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 low β-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 low β-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.
万方数据
维普
