Objective To analyze the performance characteristics of dry biochemistry module of the Vitros 5600 Biochemistry immunity analyzer. Methods According to the project provided by John & John Corporation, we evaluated and identified the precision, accuracy, linear range and clinical reference range from 18 test items. Results The accuracy of 18 test items was found to meet our laboratory requirements well. The within-batch precision of 18 test items was lower than 2.5% and the total precision are lower than 5.0%. The linearity of 18 test items was good in the linear range (r2>0.95). The reference range of the 18 test items cited by John & John Corporation was satisfied. Conclusion The function of dry biochemistry module of the Vitros 5600 Biochemistry immunity analyzer is accorded with the declaration of the corporation, and the performance meets the emergency laboratory requirements well.%目的 对Vitros 5600全自动生化免疫分析仪干生化模块的检测性能进行验证.方法 参照强生公司提供的验证方法,对该仪器干生化模块包括肝肾功能电解质共18个检测项目进行准确度、精密度的测定,并对其检测线性和参考区间进行验证,以评价其检测性能.结果 Vitros 5600全自动生化免疫分析仪干生化模块的准确度达到要求,精密度批内CV＜2.5％、批间CV＜5.0％,检测范围内的线性关系良好(r2＞0.95),参考区间验证符合率≥95％,各项目可借鉴厂商提供的参考区间.结论 Vitros 5600分析仪干生化模块的检测性能良好,符合我室急诊生化检验工作的需求.
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