Performance Evaluation of Fully Automated Chemiluminescent Platform Detection System
Objective:Application of chemiluminescence assay to performance evaluation of detection systems for chemiluminescence platforms.Methods:The performance of the fully automated chemiluminescent assay using AutoLumo A2000 Plus was evaluated in terms of precision,correctness,recovery experiments,detection limits,linearity intervals and analytical specificity in accordance with the guidelines for laboratory accreditation and the document performance evaluation of in vitro diagnostic testing systems.Results:Repeatability variation(CV)is<1/4TEa and precision variation(CV)is<1/3TEa,which meet the specified requirements;The test results of 11 tumour marker items using this device to participate in the last 5 inter-room quality assessment by Shanghai Clinical Laboratory Quality Control Centre were all within the permitted range,and the 95%confidence interval(93.91-100.35ng/mL)including the specified value of 100ng/mL in the correctness evaluation with patient samples was verified and passed;The results of the recovery test,detection limit,linear range and analytical specificity were all within the limits stated by the manufacturer.Conclusion:The performance evaluation results of the fully automated chemiluminescence platform detection system in terms of precision,correctness,recovery test,detection limit,linearity interval and analytical specificity are all in line with the manufacturer's declaration of the requirements of the indicators,and the analytical performance of the detection system meets the detection and clinical requirements.
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