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1、新生儿促甲状腺素的时间分辨荧光免疫分析及其试剂盒研制谭玉华，冯健明，卢顺舵，罗建安，李建国，季涛，李贵情（广州市丰华生物工程有限公司，广州510730）摘要：目的利用时间分辨荧光免疫分析（TrFIA）技术，建立新生儿促甲状腺素（NeonatalTSH）微量检测法，并研制其检测试剂盒。方法采用了一株TSH单克隆抗体用于固相包被，另一株TSH单克隆抗体用于标记铕（Eu3+），固相双抗体夹心时间分辨荧光免疫分析法检测NeonatalTSH。结果自建的NeonatalhTSHTrFIA法灵敏度高可达2.28µU/ml，且在测量范围
2、内，自制试剂盒剂量-反应曲线的相关系数r达0.9987。与hLH、hFSH、HCG无明显交叉反应。分析内或分析间质控结果在靶值±25%内，室内低质控、高质控分析内和分析间变异系数(CV)分别为7.12%和6.09%，7.82%和7.03%。与DELFIA®NeonatalTSH试剂标准品进行准确性比对实测值与标示效价比平均值为1.05。与DELFIA®NeonatalTSH试剂比对试验符合率一致，相关性系数r可达0.9822。试剂盒室间质评能力比对成绩100%。结论自建的NeonatalTSHTrFIA法具有灵敏度高，特异
3、性强，准确度高，精密性好和非放射性等优点，具有良好的临床应用价值。关键词：新生儿；促甲状腺素；时间分辨荧光免疫分析Time-resolvedFluoroimmunoassayofNeonatalHypothyropinandPreparationofIt’sTestReagentTanYu-hua,FengJian-ming,LuShun-duo,LuoJian-an,LiJian-guo,JiTao,LiGui-qing(GuangzhouFenghuaBio-engineeringCo.,LTD,Guangzhou51
4、0730China)Abstract:ObjectiveToestablishamethodofTime-resolvedFluoroimmunoassay(TrFIA)forthequantitativedeterminationofhumanthyroidstimulatinghormone(hTSH)inbloodspecimensdiredonfilterpaperasanaidinscreeningnewbornsforneonatalhypothyroidism,andtoprepareit’stestreag
5、ent.MethodsThemethodbasedonsolidphasesandwichTrFIAforNeonatalHypothyropin(Neo-hTSH),whichusedtwoanti-TSHmonoclonalantibody-onewascoatedonmicroplatesandanotherwaslabeledbyEuropium.ResultsTheassaysensitivityofthemethodwas2.28µU/ml.Thecorrelationcoefficientofselfmade
6、kit’scurvewas0.9987.Therewasnoobviouscross-reactiontohumanluteinizinghormone(hLH),humanfolliclestimulating(hFSH)andhumanchorionicgonadotropin(HCG).Theintra-assayandtheinter-assaymeasuredvaluesofcontrolswerenotmorethan25%differencefromtheirlabeledvalues,stilltheiri
7、ntra-assayandtheinter-assaycoefficientsofvariation(CV)oflowandhighcontrolswere7.12%and6.09%,7.82%and7.03%,respectively.ThecorrelationcoefficientofselfmadeKitandDELFIA®NeonatalTSHkitwas0.9822,andtheresultsofselfmadeKitandDELFIA®NeonatalTSHkitwereshowingnodifference
8、.Thelab’sproficiencytestingwasexcellent.ConclusionsTheNeonatalTSHTrFIAestablishedwhichhasseveraladvantagesincludinghighsensitivity,strongspecificity,goo
