甲状旁腺激素测定试剂盒行业标准的验证
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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。
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.
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.
引文
[1]张萌萌.甲状旁腺素的生物学研究与成骨作用[J].中国骨质疏松杂志,2017,12(23):1648-1653.
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[13]颜海彬,张炳云.联合使用甲状旁腺激素和辛伐他汀对去卵巢大鼠骨质疏松症的治疗有叠加效应[J].中国骨质疏松杂志,2016,3(22):300-303.
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[15]张立永,赵文新,黎世雄,等.甲状腺术后引流液甲状旁腺激素测定的意义探索[J].中华内分泌外科杂志,2017,5(11):395-398.
[16]晏龙强,李富新,章帅,等.甲状腺癌行甲状腺全切除术后甲状旁腺激素水平变化的影响因素分析[J].中国全科医学,2015,29(18):3579-3581.
[17]王晓妹,朱文秀,宋博,等.甲状腺癌全切除术围术期常规化监测甲状旁腺激素的临床价值探讨[J].国际检验医学杂志,2016,13(37):1836-1837.
[18]韩树坤.继发性甲状旁腺功能亢进手术术中快速甲状旁腺激素测定33例临床分析[J].中国实用医药,2015,7(10):59-60.
[19]甘良英.甲状旁腺激素及其检测方法新进展[J].中国血液净化,2016,5(15):266-268.
[20]徐智勇,鲁军,高小坤.体外诊断试剂冷链管理[J].中国医学装备,2018,15(3):110-112.
[21]高尚先,孙彬裕,曲守方,等.关于我国体外诊断试剂监督管理改革的建议[J].药物分析杂志,2006,26(8):1175-1180.
[22]杨海洁,蒋积余,吴永鑫,等.PDCA管理法在医院体外诊断试剂管理中的应用[J].中国医学装备,2017,14(11):129-132.
[2]Souberbielle JC,Roth H,Fouque DP.Parathyroid hormone measurement in CKD[J].Kidney Int,2010,77(2):93-100.
[3]邱丹丹,蒋松.慢性肾脏病甲状旁腺激素代谢异常的研究进展[J].肾脏病与透析肾移植杂志,2017,2(26):174-178.
[4]Takahata M,Awad HA,O′Keefe RJ,et al.Endogenous Tissue Engineering:PTH Therapy for Skeletal Repair[J]Cell Tissue Res,2012,347(3):545-552.
[5]Goettsch C,Iwata H,Aikawa E.Parathyroid hormone:critical bridge between bone metabolism and cardiovascular disease[J].Arterioscler Thromb Vasc Biol,2014,34(7):1333-1335.
[6]朱建明,黄建平.甲状旁腺功能减退症的激素替代治疗进展[J].医药导报,2017,36(A01):59-61.
[7]周晓莉,饶一武,朱梅.甲状腺癌术后血钙及血清甲状旁腺激素检测的临床意义[J].热带医学杂志,2015,2(15):237-240.
[8]陈澎涛.甲状腺全切手术后患者甲状旁腺激素和血钙的水平变化[J].上海医药,2017,38(13):45-47.
[9]周露,陈仁贵,叶婷,等.糖尿病肾病与慢性肾小球肾炎血液透析患者甲状旁腺激素水平研究[J].临床军医杂志,2018,4(46):417-419.
[10]王忻,赵毅,朱悦,等.甲状旁腺激素用于预防脊髓损伤后骨质疏松的实验研究[J].临床和实验医学杂志,2018,3(17):230-234.
[11]谭磊,邢攸军.甲状旁腺激素通过增加血管及骨的形成防治骨质疏松[J].中国骨质疏松杂志,2016,9(22):1112-1115.
[12]刘明,潘薇,陈德才.甲状旁腺激素治疗骨质疏松症的研究进展[J].中华骨质疏松和骨矿盐疾病杂志,2012,2(5):151-156.
[13]颜海彬,张炳云.联合使用甲状旁腺激素和辛伐他汀对去卵巢大鼠骨质疏松症的治疗有叠加效应[J].中国骨质疏松杂志,2016,3(22):300-303.
[14]戴佳奇,张云,严杰,等.术中快速甲状旁腺激素检测在甲状腺手术中的应用研究[J].中华内分泌外科杂志,2017,4(11):330-333.
[15]张立永,赵文新,黎世雄,等.甲状腺术后引流液甲状旁腺激素测定的意义探索[J].中华内分泌外科杂志,2017,5(11):395-398.
[16]晏龙强,李富新,章帅,等.甲状腺癌行甲状腺全切除术后甲状旁腺激素水平变化的影响因素分析[J].中国全科医学,2015,29(18):3579-3581.
[17]王晓妹,朱文秀,宋博,等.甲状腺癌全切除术围术期常规化监测甲状旁腺激素的临床价值探讨[J].国际检验医学杂志,2016,13(37):1836-1837.
[18]韩树坤.继发性甲状旁腺功能亢进手术术中快速甲状旁腺激素测定33例临床分析[J].中国实用医药,2015,7(10):59-60.
[19]甘良英.甲状旁腺激素及其检测方法新进展[J].中国血液净化,2016,5(15):266-268.
[20]徐智勇,鲁军,高小坤.体外诊断试剂冷链管理[J].中国医学装备,2018,15(3):110-112.
[21]高尚先,孙彬裕,曲守方,等.关于我国体外诊断试剂监督管理改革的建议[J].药物分析杂志,2006,26(8):1175-1180.
[22]杨海洁,蒋积余,吴永鑫,等.PDCA管理法在医院体外诊断试剂管理中的应用[J].中国医学装备,2017,14(11):129-132.