游离β-HCG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 of Industry Standard for Free β-HCG Quantitative Labelling Immunoassay kit

目的:建立游离人绒毛膜促性腺激素β亚单位(freeβ-HCG)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7种freeβ-HCG定量标记免疫分析试剂盒,按照拟定行业标准规定,对外观、空白限、线性、准确度、精密度、特异性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:freeβ-HCG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freeβ-HCG定量标记免疫分析试剂盒的质量标准,为其生产、检验、流通及临床应用等领域的监管提供依据。

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