胰岛素定量标记免疫分析试剂盒行业标准的建立和验证

The Establishing and Verification Industry Standard for Insulin Quantitative Labelling Immunoassay kit

目的:建立胰岛素定量标记免疫分析试剂盒的行业标准,并进行试验验证。方法:选择不同方法的8种胰岛素定量标记免疫分析试剂盒,按照拟定行业标准规定,对外观、线性、最低检出限、准确性、精密度和稳定性等项目进行验证。结果:除某些试剂盒的个别指标不能满足要求外,大部分试剂盒均能满足拟定行标中的所有要求。结论:胰岛素定量标记免疫分析试剂盒行业标准制定合理、可操作性强。该标准的制定有助于统一胰岛素定量标记免疫分析试剂盒的质量标准,为其生产、检验、流通及临床应用及其他领域的监管提供依据。

Objective To establish and verify the industry standard for insulin quantitative labelling immunoassay kit.Methods Eight kits of different methods were used.The appearance,linearity,detection limit,accuracy,precision and stability et al.were verified in accordance with industry standard.Results Besides individual kit not matchable for some demand,the others kits could meet all requirements.Conclusion The establishing of the industry standard for insulin quantitative labelling immunoassay kit was reasonable and operable,which would help contribute to the unity insulin quantitative labelling immunoassay kit’s quality,and offer the basis for the administration of its production,examination,circulation,clinical application and other areas.