摘要
目的对自制的总前列腺特异性抗原(total prostate specific antigen,t PSA)定量测定试剂盒(化学发光免疫分析法)进行性能验证,判断自制试剂盒是否满足产品行业标准要求。方法参照产品行业标准要求,对自制试剂盒的准确度、最低检测限、线性、重复性、批间差、稳定性、配对抗体等克分子反应性进行考察。结果自制试剂盒的最低检测限为0.0022 ng/m L,线性相关系数r=0.9998,重复性为2.82%和1.96%,批间差为5.55%,配对抗体等克分子反应小于15%,均符合产品标准的要求。对刚过12个月有效期的产品进行以上项目检测,也符合产品标准要求,说明效期内试剂质量稳定。结论自制试剂盒的各项性能指标符合行业标准要求,在线性、最低检测限和检测范围方面比临床常用的罗氏t PSA电化学发光试剂盒更优,可替代国外昂贵试剂应用于临床检测。
Objective To verify the performance of total prostate specific antigen （tPSA） quantitative diagnostic kit （CLIA） in order to know whether the kit is fit for industrial standard. Methods Refering to tPSA quantitative diagnostic kit （CLIA） industrial standard, the kit accuracy, sensitivity, linearity, repeatability, precision between different assays, stability and equal gram molecular reaction of matching antibodies were studied. Results The sensitivity of the kit was 0.0022 ng/mL. The linear coefficient （r） was 0.9998. Repeatability were 2.82% and 1.96%. And the precision between different assays was 5.55%. Equal gram molecular reaction of matching antibodies was less than 15%. All results were in line with the requirements of industrial standard. The same analysis was performed with the kits which were one month over the expiration date and all the analysis results were in line with industrial standard. Conclusion All analytic performance results of the kit meet industrial standard.The detection index of linearity, detection limit, detection range are better than that of the tPSA kit from Roche, which can replace foreign expensive reagent for clinical testing and basic medical researh.
出处
《分子诊断与治疗杂志》
2015年第5期323-327,共5页
Journal of Molecular Diagnostics and Therapy
基金
国家高技术研究发展计划(863计划)2011AA02A101
