基于EP09-A3方案的IGF-1检测一致性评价:化学发光免疫分析法与电化学发光免疫分析法OA

Objective To evaluate the consistency of insulin-like growth factor 1(IGF-1)test results between the new MAGLUM X8 fully automated chemiluminescence immunoassay analyzer(chemiluminescence method)and the Roche E601 fully automated electrochemiluminescence immunoassay analyzer(electrochemiluminescence method),so as to provide a ba-sis for clinical test result recognition.Methods According to the Clinical Laboratory Standards Institute(CLSI)EP09-A3 protocol,80 fresh serum samples were collected from patients in the Department of Pediatrics at the People's Hospital of He-chi from July to November 2023.Two instruments were used to test the same sample twice on the same day,and consistency evaluation was performed using methods such as Passing-Bablok regression analysis,Bland-Altman plot,and medical deci-sion level bias assessment.Results The Passing-Bablok regression equation was y=0.954+1.007x.The 95%confidence interval(CI)for the slope(0.985,1.023)included 1,and the 95%CI for the intercept(-1.884,2.945)included 0,indicating no significant system atic or proportional bias between the two systems.Bland Altman analysis showed that the 95%consistency limit(LoAs)of the percentage difference between the two systems ranged from-9.22%to10.24%,both within the clinically acceptable range of±12.5%,and 97.50%(78/80)of the sample values were within the LoAs range;the expected bias at the IGF-1 reference interval threshold for minors in China was within a clinically acceptable range of±12.5%.Conclusion The results of testing IGF-1 using MAGLUM X8 and Roche E601 in the new industry are highly con-sistent,which can meet clinical testing needs and provide reliable support for diagnosis and treatment decisions.