生长激素定量标记免疫分析试剂盒行业标准的验证

The verification of industry standard for growth hormone quantitative labeling immunoassay kit

目的:制订生长激素(GH)定量标记免疫分析试剂盒行业标准,并采用该标准适用的化学发光标记、时间分辨荧光标记方法进行验证。方法:选择GH磁微粒化学发光法、电化学发光法、化学发光法和时间分辨荧光分析法试剂盒,按照拟定的行业标准规定,对空白限、线性、准确度、精密度、特异性和稳定性项目进行验证。结果:除部分试剂盒的准确度结果不能满足预期要求的±10%外,其余验证结果均能满足拟定行业标准中的要求。结论:根据验证情况,将准确度要求调整至±15%,其余项目要求不变,最终确定GH定量标记免疫分析试剂盒行业标准。该标准的制定,有助于统一GH定量标记免疫分析试剂盒的质量标准,为该类产品的研制、检验及上市后的监督管理提供依据。

Objective: To establish the industry standard for growth hormone quantitative labelling immunoassay kit, and to validate it by chemiluminescence labeling and time-resolved fluorescence labeling method which are suitable for the standard. Methods: Different assay method kits, including magnetic particle chemiluminescent assay, electrochemiluminescence assay, chemiluminescence assay and time-resolved fluorescent assay, were used to verifiedthe blank limitation, linearity, accuracy, precision, specificity and stability in accordance with protocol industry standard. Results: Other verification results could meet requirements of the protocol industry standard besides accuracy in part of kits couldn't achieve to anticipativere mand (relative deviation couldn't be more than ±10%).Conclusion: According to theverification results, the accuracy requirements was adjusted to ±15%. The other items of industry standard were maintained. The industry standard for growth hormone quantitative labeling immunoassay kit is ultimately established. The standard would contribute to unity quality standard of growth hormone quantitative labeling immunoassay kit, and provide the basis for the supervision and administration of its production, examination, circulation, clinical application and other areas.