目的：对强生Vitros 5600全自动生化免疫分析仪免疫急诊项目进行性能验证，为患者急诊检验项目提供准确和快捷的结果。方法：按照美国临床实验室标准化协会(CLSI)评价标准及美国强生公司提供的验证方案对生化免疫分析仪免疫急诊项目肌红蛋白(Mb)、肌钙蛋白I (TropI)、N端脑利钠钛前体(NTproBNP)及总β人绒毛膜促性腺激素(T-βHCG)等进行精密度、准确度、线性范围、参考区间及携带污染率等检测指标进行验证，以评价其检测性能。结果：生化免疫分析仪检测Mb、TropI、NTproBNP及T-βHCG批内精密度CV值为0.58～2.02%，均＜2.5％，批间CV值为1.43～3.15%，均＜5.0%；正确度相对偏倚为-3.52～4.21%；检测范围内的线性关系良好，r2值在0.9836～0.9998，斜率(a)在0.9865～1.0207；携带污染率为0.096～0.180%；参考区间验证符合率R均≥95%。结论：Vitros 5600全自动生化免疫分析仪检测免疫急诊项目的各项检测指标性能良好，符合急诊免疫检验工作的需求。%Objective:To have the performance verification of Johnson Vitros 5600 fully automatic biochemical analyzer (hereinafter referred to as Vitros 5600 analyzer) emergency immunological parameter is to provide more accurate and more efficient service for the patients in emergency inspection items.Methods: According to the clinical laboratory standards institute (CLSI) evaluation criterion and Johnson validation plan, we verified the precision, accuracy, linear range, reference range, and carry pollution rate detection indexes of Myoglobin, Troponin I (TropI), N-terminal brain natriuretic titanium (NTproBNP) and total beta human chorionic gonadotropin (TβHCG) about the Vitros 5600 analyzer emergency projects evaluated the performance of the analyzer.Results: The batch precision CV of Myoglobin, TropI, NTproBNP and TβHCG tested by Vitros 5600 analyzer is 0.58~2.02%, < 2.5%, and the inter assay CV is 1.43~3.15%, < 5.0%. Accuracy relative bias is -3.52~4.21%. Linearity relationship is good within the scope of testing,r2 is 0.9836~0.9998, and the slope (a) is 0.9865~1.0207. Carry pollution rate is 0.096~0.180%. Reference range verification coincidence rate is R≥95%.Conclusion: The detection index performance of Vitros 5600 analyzer detecting immune emergency projects is good. It can meet the demand of emergency immune inspection work.
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