摘要
目的:对人抗甲状腺球蛋白抗体测定试剂盒行业标准可行性进行验证。方法:按照拟定行业标准的要求,选择不同免疫分析方法的试剂盒进行验证。结果:外观、空白限、线性、精密度、稳定性等指标符合要求,准确性项目有1批次试剂盒低浓度的测定结果不在±10.0%范围内,不符合拟定的行业标准要求。特异性项目中有1批次试剂盒不符合要求。结论:人抗甲状腺球蛋白抗体测定试剂盒行业标准制定合理,有助于规范此类试剂盒的技术要求和试验方法,从而提高此类试剂盒的产品质量,并为其监管提供依据。
Objective:To verify the feasibility of the industry Standards for Anti-Tg Ab assay kits.Methods:The kits of different immunoassay methods were selected for validation in accordance with industry Standards.Results:The appearance,limit of blank,linearity,accuracy and stability could meet requirements,while the accuracy of the test results of 1 batch of kits with low concentration is not within the range of±10.0%,which does not meet the proposed industry standards.In the specific project,1 batch of kits did not meet the requirements.Conclusion:The establishment of reasonable industry standards for Anti-Tg Ab assay kits is helpful to standardize the experimental methods and technical requirements of such kits so as to improve the product quality,and provide a basis for their supervision.
作者
孙楠
曲守方
于婷
黄杰
Sun Nan;Qu Shou-fang;Yu Ting;Huang Jie(National Institutes for Food and Drug Control,The Key Laboratory of Biotechnology Product Test Method and Its Standardization of The Ministry of Health,Beijing 100050,China)
出处
《中国药事》
CAS
2020年第4期454-458,共5页
Chinese Pharmaceutical Affairs
基金
国家高技术研究发展计划(863计划)新型体外诊断试剂质量评价体系和国家参考物质研究项目(编号2011AA02A115)。
