全自动荧光免疫分析仪GSPTM检测新生儿血斑G6PD性能验证

Verification of Genetic Screening Processor (GSPTM) for G6PD tests of neonatal blood

目的对全自动荧光免疫分析仪GSPTM检测新生儿血斑G6PD的性能进行评估。方法参考《中华人民共和国卫生行业标准》WS/T 420-2013中临床实验室对商品定量试剂盒分析性能的验证,依据CLIA88要求,通过检测试剂盒自带标准品B/C/E三个浓度、试剂盒自带高水平质控品、低水平质控品和试剂盒自带的B-F五个浓度的标准品,分析GSPTM系统的精密度、正确度和线性范围。结果GSPTM筛查系统检测B/C/E中G6PD批内变异系数为1.53%~1.76%,小于厂家声明的3.4%;批间变异系数为1.96%~2.15%,小于厂家声明的3.9%。GSPTM系统检测的低、高质控品浓度平均值分别为15.90U/dL和53.01U/dL,都在试剂盒声明的允许范围之内。线性标本的检测值和理论值的线性方程为y=1.0414x-1.4594,相关系数的平方R2=0.9993,符合厂家声明的线性范围(R2≥0.995)要求。结论GSPTM检测系统参与验证的精密度、准确度及线性范围等主要性能在本实验室均达到了相关标准的要求,可用于新生儿血斑G6PD的检测。

Objective:The performance evaluation of G6PD tests of neonatal blood in Genetic Screening Processor(GSPTM).Methods:According to the CLIA88 requirements of the Health industry standard of the People′s Republic of China(WS/T 420-2013)which is about performance verification test towards Commercialized quantitative kit,standards of B/C/E,low/high controls and five standards of B to F from the kits were tested to analyse precision,correctness and accuracy of GSPTM.Results:The intraassay coefficient of variation of GSP G6PD test of B/C/E detection was between 1.53%and 1.76%which was less than it in manufacturer claims(3.4%).The interassay coefficient of variation was between 1.96 and 2.15%which was less than it in manufacturer claims(3.9%).The average levels of Low and high controls were 15.90 U/dL and 53.01 U/dL,and those were both within the allowable range in claims.The linear equation of detected and theoretical value of linear samples was y=1.0414x-1.4594,and the Correlation coefficient R2=0.9993.And it met the requirements of linear range in manufacturer claims(R2≥0.995).Conclusion:Requirements of related standards toward analyse precision,correctness and accuracy of GSPTM were met in this laboratory,and GSPTM can be used on G6PD tests of neonatal blood.