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

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【关键词】EP09-A3;胰岛素样生长因子1;化学发光免疫分析法;电化学发光免疫分析法；一致性 中图分类号：R446.62 文献标志码：A DOI：10.3969/j.issn.1003-1383.2026.02.007

Consistency evaluation of IGF-1 measurements based on EPO9-A3 protocol： chemiluminescence immunoassay and electrochemiluminescence immunoassay

WU Hongtao，SUN Yingying，LAN Chen，WEI Shuai，CHEN Gao，QIN Meng （Department of Clinical Laboratory，Hechi Hospital Affliated to Youjiang Medical University for Nationalities-thePeople's Hospital ofHechi，Hechi 547OOO，Guangxi，China）

【Abstract】ObjectiveToevaluate theconsistencyof insulin-likegrowth factor1（IGF-1）testresultsbetween thenew MAGLUM X8 full automated chemiluminescence immunoassay analyzer （chemiluminescence method）and the Roche E601 fullyautomated electrochemiluminescenceimmunoassayanalyzer（electrochemiluminescencemethod），soastoprovideabasisforclinical testresultrecognition.MethodsAccordingtotheClinicalLaboratory Standards Institute（CLSI）EP09-A3 protocol，8Ofreshserumsamples werecollected frompatients inthe DepartmentofPediatricsatthePeople'sHospitalof Hechi from July to November 2O23.Two instruments wereused to test thesame sample twice on thesame day，andconsistency evaluation was performedusing methodssuchas Passing-Bablok regresionanalysis，Bland-Altmanplot，and medical decision level bias assessment. ResultsThe Passing-Bablok regression equation was y=0.954+1.007x .The 95% confidence interval （ CI ）for the slope（0.985，1.023）included1，and the 95% CI for the intercept（-1.884，2.945）included 0 ！ indicating no significantsystematicorproportional biasbetween thetwosystems.BlandAltmananalysisshowedthatthe 95% consistency limit（LoAs）of the percentage difference between the two systems ranged from -9.22% to 10.24% ，both within the clinically acceptable range of ± 12.5% ， and 97. 50% （78/80）of the sample values were within the LoAs range;theexpectedbiasattheIGF-1referenceintervalthresholdforminors inChina was withinaclinicallacceptablerangeof ± 12.5%.ConclusionTheresults of testing IGF-1using MAGLUM X8 and Roche E60lin the new industry are highly consistent，which can meet clinical testing needsand provide reliable support for diagnosis and treatment decisions.

【Keywords】EPO9-A3；insulin-likegrowth factor1（IGF-1）；chemiluminescence immunoassay；electrochemiluminescence immunoassay；consistency

胰岛素样生长因子（insulin-likegrowthfactors，IGFs）是一类多功能细胞增殖调控因子，在细胞分化、增殖及个体生长发育中具有重要促进作用。（剩余9034字）