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, and other items such as accuracy, linearity, precision and specificity could meet the requirements of drafting the industry standard of parathyroid hormone detection kit. Conclusion The formulation of industry standard for parathyroid hormone detection kit can standardize the technical requirements of parathyroid hormone detection kit, and provide the basis for the detection of parathyroid hormone and the supervision and management after the listing.
曲守方 于婷 孙楠 黄杰. 甲状旁腺激素测定试剂盒行业标准的验证[J]. 中国医药导报, 2019, 16(3): 105-108.
QU Shoufang YU Ting SUN Nan HUANG Jie. Verification of the industry standard for parathyroid hormone detection kits. 中国医药导报, 2019, 16(3): 105-108.