The verification of industry standard for growth hormone quantitative labeling immunoassay kit
10.3969/J.ISSN.1672-8270.2017.02.006
- VernacularTitle:生长激素定量标记免疫分析试剂盒行业标准的验证
- Author:
Ting YU
;
Shoufang QU
;
Jie HUANG
- Keywords:
Growth hormone;
Reagent kit;
Industry standard;
Chemiluminescence;
Verification
- From:
China Medical Equipment
2017;14(2):18-22
- CountryChina
- Language:Chinese
-
Abstract:
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 verified the 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 anticipative remand (relative deviation couldn't be more than ±10%).Conclusion: According to the verification 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.
