| 孙楠,曲守方,于婷,黄杰.人抗甲状腺球蛋白抗体测定试剂盒行业标准的建立与验证[J].中国药事,2020,34(4):454-458 |
| 人抗甲状腺球蛋白抗体测定试剂盒行业标准的建立与验证 |
| The Establishment and Verification of Industry Standards for Anti-Tg Ab Assay kits |
| 投稿时间：2019-06-27 |
| DOI：10.16153/j.1002-7777.2020.04.013 |
| 中文关键词: 人抗甲状腺球蛋白抗体 试剂盒 行业标准 |
| 英文关键词: Anti-Tg Ab kits industry Standards |
| 基金项目:国家高技术研究发展计划（863计划）新型体外诊断试剂质量评价体系和国家参考物质研究项目（编号2011AA02A115） |
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| 中文摘要: |
| 目的：对人抗甲状腺球蛋白抗体测定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、精密度、稳定性等指标符合要求，准确性项目有1批次试剂盒低浓度的测定结果不在±10.0%范围内，不符合拟定的行业标准要求。特异性项目中有1批次试剂盒不符合要求。结论：人抗甲状腺球蛋白抗体测定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试验方法，从而提高此类试剂盒的产品质量，并为其监管提供依据。 |
| 英文摘要: |
| Objective: To verify the feasibility of the industry Standards for Anti-Tg Ab assay kits. Methods: The kits of different immunoassay methods were selected for validation in accordance with industry Standards. Results: The appearance, limit of blank, linearity, accuracy and stability could meet requirements, while the accuracy of the test results of 1 batch of kits with low concentration is not within the range of ±10.0%, which does not meet the proposed industry standards. In the specific project, 1 batch of kits did not meet the requirements. Conclusion: The establishment of reasonable industry standards for Anti-Tg Ab assay kits is helpful to standardize the experimental methods and technical requirements of such kits so as to improve the product quality, and provide a basis for their supervision. |
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