發(fā)布時間：2018-03-14 12:15

  本文選題：腸道病毒型　切入點：抗原　出處：《微生物學免疫學進展》2016年01期 　論文類型：期刊論文

【摘要】：目的建立腸道病毒71型(EV71)抗原ELISA定量檢測方法,用于EV71疫苗生產(chǎn)工藝中抗原定量檢測。方法選取抗EV71單克隆抗體作為包被抗體,HRP標記抗EV71多克隆抗體作為酶標二抗,建立EV71抗原ELISA定量檢測方法。該方法經(jīng)系統(tǒng)驗證后,應(yīng)用于定量檢測2BS及Vero細胞基質(zhì)EV71疫苗生產(chǎn)工藝過程樣品的抗原含量。結(jié)果驗證結(jié)果顯示,該方法的線性范圍為3.125~50.000 U/m L,樣品回收率為92.0%~110.0%,變異系數(shù)小于8.8%;孵育時間及溫度在一定范圍內(nèi)偏差的樣品回收率為100.8%~113.8%;檢測其他腸道病毒中抗原其A值均小于cut-off值;試劑于37℃孵育3 d后的檢測樣品回收率為101.4%~112.4%;2BS及Vero細胞基質(zhì)EV71疫苗生產(chǎn)工藝過程樣品的適用性檢測中,抗原回收率為92.1%~114.9%。結(jié)論建立并驗證EV71抗原ELISA定量檢測方法,其準確度、精密度、耐用性均優(yōu)良,特異性強、穩(wěn)定性好,適用于不同細胞基質(zhì)的EV71疫苗及多價手足口病疫苗生產(chǎn)工藝過程的質(zhì)量控制。
[Abstract]:Objective to establish a quantitative detection method for ELISA of enterovirus 71 EV71) antigen in the production process of EV71 vaccine. Methods Anti EV71 monoclonal antibody was selected as the anti EV71 polyclonal antibody labeled with anti EV71 polyclonal antibody as enzyme labeled second antibody. A method for quantitative detection of EV71 antigen ELISA was established. The method was used to quantitatively detect the antigen content of 2BS and Vero cell matrix EV71 vaccine samples after systematic verification. The linear range of this method is 3.125 ~ 50.000 UmL, the sample recovery rate is 92.0 and 110.0, the coefficient of variation is less than 8.8, the recovery rate of sample with the deviation of incubation time and temperature is 100.8 ~ 113.8.The A value of antigen in other enterovirus is less than cut-off. After incubated at 37 鈩，

本文編號：1611160