强生VITROS 4600全自动干式生化仪性能验证

Performance verification of Johnson VITROS 4600 automatic dry type biochemistry analyzer

目的验证强生VITROS 4600全自动干式生化仪的系统性能,确定该检测系统是否准确、稳定、可靠。方法参照美国临床实验室改进修正案1988(CLIA′88)制定的能力比对检验分析质量要求及相关参考资料,从精密度、准确度、携带污染率、线性范围及参考区间等方面对强生VITROS 4600全自动干式生化仪开展的12个检测项目进行性能验证。结果强生VITROS 4600全自动干式生化仪精密度、准确度、携带污染率、线性范围及参考区间均通过验证。结论强生VITROS 4600全自动干式生化仪精密度较高,准确度较好,携带污染率较低,相关系数较好,参考范围较为准确,其性能能够满足临床要求。

Objective To verify the systematic performance of Johnson VITROS 4600 automatic dry type biochemistry analyzer for determining whether the detection system is accurate,stable and reliable.Methods According to performance verification documents of American Clinical Laboratory Improvement Amendments 1988(CLIA′88)and related literature,the performance of Johnson VITROS 4600 automatic dry type biochemistry analyzer was evaluated from precision,accuracy,contamination rate,linearity and reference range of 12 test items.Results The precision,accuracy,contamination rate,linearity and reference range of Johnson VITROS 4600 automatic dry type biochemistry analyzer all passed the test.Conclusion Johnson VITROS 4600 automatic dry type biochemistry analyzer is a detection system with higher precision,better accuracy,lower contamination rate,better correlation coefficient and more accurate reference range,and its performance can satisfy the clinical requirement.