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Molecular immunology department
Molecular immunology department owns everal technology platforms including ELISA/ELISpot, reverse dot blot, and time- resolved fluorescence. The product lines developed can be used for TB infection screening, diagnosis and detection of drug resistance. Among them is the tuberculosis T cell immune detection kit with independent intellectual property (patented in China), which has won CFDA clinical approval and production license; the in- development kit for rapid diagnosis of tuberculosis drug sensitivity based on reverse dot blot will help to achieve an all- round and rapid detection of MDR- TB; the in- development tuberculosis molecular diagnostic kit is simple to use and does not require any special equipment, suitable for the needs of tuberculosis prevention and control at all levels of disease control facilities.
Molecular immunology department has taken part in the major projects of the 12th five- year plan and has established a long- term cooperation with Institute of Microbiology of Chinese Academy of Sciences, Peking University, Tsinghua University, Chinese Center for Disease Control and Prevention and Beijing Chest Hospital. The platform established for the conversion of biological reagents ensures sustained innovation of the product lines.

細(xì)胞免疫部
細(xì)胞免疫部建立了成熟穩(wěn)定的流式抗體多色標(biāo)記平臺以及完善的質(zhì)控體系,主要開發(fā)應(yīng)用于流式細(xì)胞儀的熒光單克隆抗體及配套試劑,以及針對免疫評價、艾滋病診斷、白血病分型和免疫細(xì)胞治療等臨床需求而開發(fā)的系列診斷產(chǎn)品。目前已開發(fā)包括凋亡檢測試劑盒、造血干細(xì)胞/間充質(zhì)干細(xì)胞檢測試劑盒、淋巴細(xì)胞亞群檢測試劑盒等千余種單克隆抗體產(chǎn)品,其中淋巴細(xì)胞亞群檢測試劑盒等部分產(chǎn)品已經(jīng)獲得國家食品藥品監(jiān)督管理總局的臨床批文和生產(chǎn)許可,為國內(nèi)首創(chuàng),可用于艾滋病的檢測,具有重大的社會意義和經(jīng)濟(jì)價值。
細(xì)胞免疫部承擔(dān)了國家"十二五"科技重大專項(xiàng),并與包括協(xié)和醫(yī)院、301醫(yī)院、佑安醫(yī)院和中國醫(yī)科大學(xué)等單位建立了長期合作關(guān)系,不斷開發(fā)新產(chǎn)品和新應(yīng)用。

分子診斷部
分子診斷部以microRNA為切入點(diǎn),專注于重大癌癥、艾滋病、結(jié)核病、肝病等microRNA診斷試劑盒的研制,并提供從microRNA表達(dá)譜檢測到功能研究的全套技術(shù)服務(wù)。本平臺采用自主知識產(chǎn)權(quán)發(fā)明專利"三步法qPCR"技術(shù)和獨(dú)特的外源RNA對照設(shè)計(jì),實(shí)現(xiàn)血清、血漿、組織、細(xì)胞、石蠟組織切片中microRNA表達(dá)量的檢測。
艾滋病快速進(jìn)展microRNA標(biāo)志物已申報(bào)獲得5項(xiàng)國家發(fā)明專利,乳腺癌特異性microRNA標(biāo)志物已申報(bào)獲得4項(xiàng)國家發(fā)明專利,乙肝、肝硬化特異性microRNA標(biāo)志物已申報(bào)3項(xiàng)國家發(fā)明專利,肝硬化miRNA診斷試劑盒已啟動注冊申報(bào)程序。

蛋白免疫部
蛋白免疫部借助于化學(xué)發(fā)光免疫分析(CLIA)技術(shù)平臺,研發(fā)出國際首創(chuàng)的K18和K19腫瘤早期篩查輔助診斷試劑盒,及其他11個腫瘤早期篩查輔助診斷系列產(chǎn)品。加上14種甲功、性腺、心肌類臨床輔助診斷產(chǎn)品,全部獲得國家食品藥品監(jiān)督管理總局的臨床批文和生產(chǎn)許可。其研究結(jié)果獲得一項(xiàng)國際專利——用于診斷上皮源性癌癥的血液標(biāo)志物及其單克隆抗體,一項(xiàng)國內(nèi)專利——一種紫杉醇緩釋納米粒、制備方法及其應(yīng)用以及計(jì)算機(jī)軟件著作權(quán)——腫瘤早期篩查風(fēng)險(xiǎn)評估系統(tǒng)。
