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2、蝕肀莆蒀螂袃莂葿羄膈羋蒈蚄羈膄蕆螆膇蒂蕆衿羀莈蒆羈膅芄薅蟻羈膀薄螃膃肆薃裊羆蒅薂蚅節(jié)莁薁螇肄芇薁衿芀膃薀羂肅蒁蕿蟻裊莇蚈螄肁芃蚇袆襖腿蚆薆聿肅蚅螈袂蒄蚅袀膈莀蚄羃羀芆蚃螞膆膂螞螅罿蒁螁袇膄莆螀罿羇節(jié)蝿蠆膂羋莆袁羅膄蒞羃芁蒃莄蚃肄荿莃螅艿芅莃袈肂膁蒂羀裊蒀蒁蝕肀莆蒀螂袃莂葿羄膈羋蒈蚄羈膄蕆螆膇蒂蕆衿羀莈蒆羈膅芄薅蟻羈膀薄螃膃肆薃裊羆蒅時(shí)間分辨熒光免疫分析法乙型肝炎血清標(biāo)志物分析靈敏度的建立與分析Establishmentandanalysisofanalyticsensitivityofhepatit
3、isBvirusserummarkersbyTime-resolvedFluoroimmunoassay譚玉華陳鮮美盧順舵沈?。◤V州市豐華生物工程有限公司,廣東廣州510730)摘要對(duì)乙型肝炎表面抗原和表面抗體定量測(cè)定試劑盒(時(shí)間分辨熒光免疫分析法)的分析靈敏度進(jìn)行建立與分析,以便更好的指導(dǎo)臨床診斷和進(jìn)行流行病學(xué)研究。通過(guò)實(shí)驗(yàn)研究,乙型肝炎病毒表面抗原定量檢測(cè)試劑盒和表面抗體定量檢測(cè)試劑盒的檢測(cè)低限分別為0.0356ng/mL和0.548mIU/mL,生物檢測(cè)限分別為0.200ng/mL和5.00m
4、IU/mL,功能靈敏度分別為0.200ng/mL和5.00mIU/mL,線性范圍分別為0.200ng/mL-300ng/mL和5.00mIU/mL-1200mIU/mL,并達(dá)到中國(guó)藥品生物制品檢定所檢定要求。時(shí)間分辨熒光免疫分析法乙型肝炎病毒定量檢測(cè)試劑盒具有靈敏度高,線性范圍寬,特異性強(qiáng)的特點(diǎn),已能有效應(yīng)用于臨床體外診斷和流行病學(xué)研究。關(guān)鍵詞時(shí)間分辨熒光免疫分析;乙型肝炎;標(biāo)志物;分析靈敏Establishmentandanalysisofanalyticsensitivityofhepatiti
5、sBvirusserummarkersbyTime-resolvedFluoroimmunoassayTANYu-hua,CHENXian-mei,LUShun-duo,etal.GuangzhouFenghuaBio-engineeringCo.,LTD,Guangzhou510730ChinaAbstractToestablishandanalysetheanalyticsensitivityforthequantificationkitsforhepatitisBvirus(HBV)surfa
6、ceantigen(HBsAg)andantibodytoHBsAg(anti-HBs),thekitsweremeasuredbyTime-resolvedFluoroimmunoassay(TRFIA),inordertothebetterinstructionclinicaldiagnosisandconductstheepidemiologyresearch.Throughthestudy,thelowerlimitofdetectionofthequantificationkitsforH
7、BsAgandanti-HBsfor0.0356ng/mLand0.548mIU/mLrespectively,thebiologicallimitofdetectionis0.200ng/mLand5.00mIU/mLrespectively,thefunctionsensitivityis0.200ng/mLand5.00mIU/mLrespectively,thelinearscopeis0.200ng/mL-300ng/mLand5.00mIU/mL-1200mIU/mLrespective
8、ly,andpassedtheexaminationoftheNationalInstituteforControlofPharmaceuticalandBiologicalProducts.ThequantificationkitsforHBVserummarkersbyTRFIA,whichhasthehighsensitivity,thewidelinearscope,thegoodspecificity,couldhavetheeffecttouseinthe