摘要：目的 建立促甲状腺素（TSH）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 选择酶标记、化学发光标记、时间分辨荧光标记三种不同标记方法的TSH定量标记免疫分析试剂盒，按照拟定行业标准规定，对外观和物理检查、最低检出量、准确性、线性、精密度、质控品测定值、特异性和稳定性进行验证。结果 除酶标记试剂盒的线性范围不满足要求外，大部分试剂盒均能满足拟定行标中的所有要求。结论 TSH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TSH定量标记免疫分析试剂盒的质量标准，为此类产品的研制、生产、检验及临床应用等领域的监管提供依据。

Abstract: Objective To establish and verify the industry standard for Thyroid-Stimulating Hormone (TSH) quantitative immunoassay kit. Methods Three types of TSH immunoassay kits of including enzyme, chemiluminescent and time resolved fluorescence labeled immunoassay were used. The appearance and physical examination, the minimum detectable amount, accuracy, linearity, precision, value of quality control, specificity, and stability of immunoassay kits were verified in accordance with industry standard. Results Except the enzyme kit couldn’t meet the demand of linearity range, the others kits could meet all requirements. Conclusion The establishing of the industry standard for Thyroid-Stimulating Hormone quantitative immunoassay kit was reasonable and operable, which would help contribute to the unity Thyroid-Stimulating Hormone quantitative immunoassay kit’s quality, and offer the basis for the administration of its production, examination, circulation, clinical application and other areas.