总IgE定量标记免疫分析试剂盒行业标准的验证

The verification of industry standard for total IgE quantitative labelling immunoassay kit

目的对总IgE定量标记免疫分析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、准确度、精密度、稳定性等指标符合要求,特异性项目中有个别试剂盒对IgM、IgG的测定结果高于行业标准要求。结论总IgE定量标记免疫分析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实验方法,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 industry standard for total IgE quantitative labelling immunoassay kit .Methods Different methods of kits were used and were verified in accordance with industry standard .Results The appearance ,limit of blank ,linearity , accuracy ,precision and stability could meet requirements ,while specificity of individual kits was just partly qualified .Conclusion The establishing of the industry standard for total IgE quantitative labelling immunoassay kit was reasonable ,which could help to standardized the experimental methods and technical requirements and promoted the improvement of quality ,and offer the basis for the admistration .