曲守方 于婷 孙楠 黄杰

    [摘要] 目的 制定甲状旁腺激素测定试剂盒行业标准，采用标准适用的化学发光法试剂盒进行验证，评价标准的适用性。 方法 采用磁微粒化学发光法、化学发光微粒子免疫检测法等5种不同厂家的试剂盒，按照拟定行业标准的要求和试验方法，对检出限、线性、准确度、精密度、特异性等项目进行验证。 结果 试剂盒的检出限不高于13.7 pg/mL;准确度、线性、精密度和特异性等其他项目均能满足拟定甲状旁腺激素测定试剂盒行业标准的要求。 结论 制订甲状旁腺激素测定试剂盒行业标准能够规范甲状旁腺激素测定试剂盒的技术要求，为甲状旁腺激素的检测工作及上市后的监督管理提供依据。

    [关键词] 甲状旁腺激素;行业标准;化学发光;检出限;线性;准确度;精密度;特异性

    [中图分类号] R446.6? ? ? ? ? [文献标识码] A? ? ? ? ? [文章编号] 1673-7210(2019)01(c)-0105-04

    [Abstract] Objective To establish the industry standard of parathyroid hormone assay kit， and to validate the standard by chemiluminescence detection kit， and to evaluate the applicability of the standard. Methods The detection limits， linearity， accuracy， precision and specificity of five kinds of kits from different manufacturers were verified by magnetic particle chemiluminescence and chemiluminescent particle immunoassay according to the requirements and test methods of formulating industry standards. Results The detection limit of the kit was not higher than 13.7 pg/mL ......