人絨毛膜促性腺激素（HCG）快速診斷試劑盒再驗(yàn)證

論文編號(hào):HG265   論文字?jǐn)?shù):17092,頁(yè)數(shù):32

摘要
 本論文所研究的是人絨毛膜促性腺激素（HCG）快速診斷試劑盒再驗(yàn)證實(shí)驗(yàn)。是利用高度特異性的抗原抗體反應(yīng)及免疫層析分析技術(shù)，通過(guò)膠體金標(biāo)記的β-HCG單克隆抗體和鼠IgG以及固定于硝基纖維素膜上的抗α-HCG抗體及羊抗鼠IgG抗體 ，特異性的檢測(cè)尿液中HCG。通過(guò)對(duì)組成該試劑盒的各工序及組成部分分別進(jìn)行驗(yàn)證，依次通過(guò)了噴膜機(jī)性能參數(shù)的調(diào)試、噴膜實(shí)驗(yàn)、金子墊的涂布實(shí)驗(yàn)、樣品墊的涂布實(shí)驗(yàn)及組裝環(huán)境實(shí)驗(yàn)等各工序的驗(yàn)證，最后得出結(jié)論：此工藝條件在現(xiàn)有的技術(shù)條件下仍然可行，各個(gè)工藝條件都能夠達(dá)到預(yù)期目的，組裝出來(lái)的產(chǎn)品HCG靈敏度達(dá)到98%以上，特異性達(dá)到99.8%。經(jīng)過(guò)一定周期的生產(chǎn)過(guò)程后，現(xiàn)行各個(gè)工藝條件都能達(dá)到方案的預(yù)期目的，具有可靠性和重現(xiàn)性，可繼續(xù)投入生產(chǎn)，原先驗(yàn)證過(guò)的平衡狀態(tài)并沒(méi)有因?yàn)楣に囘\(yùn)行等因素影響而發(fā)生飄移現(xiàn)象。
 
 
關(guān)鍵詞  人絨毛膜促性腺激素   快速診斷試劑    再驗(yàn)證   

Title HCG re-verification experiment
 Abstract
This paper is the study of the human chorionic gonadotropin (HCG) rapid diagnostic kit for further verification experiment.It is to use a high degree of specificity of the antibody immune response and chromatography analysis technology, marked by colloidal gold β-HCG and mouse monoclonal antibody IgG and fixed in the nitro-cellulose membrane of the anti-α-HCG and sheep anti-mouse antibody IgG Antibody, the specificity of detection in urine HCG. Through the composition of the kits in all processes and components were verified, followed by a jet aircraft performance parameters of the film debugging, sprayed film experiment, the gold coating pad test, the sample pad test and assembly coating of the environment Such as the verification process, finally concluded: This process conditions in the existing technology is still feasible under the conditions of the various process conditions can achieve the desired objectives, assembled by the HCG products reached more than 98% sensitivity and specificity reached 99.8 percent. After a certain period of the production process, the current conditions of the various programmes to achieve the desired objective, reliable and reproducible, can continue to put into production, originally verified the balance and not because of the effect of factors such as running a drift Phenomenon.

 Keyword human chorionic gonadotropin
          fast diagnosis reagent
           again confirmation

 目錄
第一章 文獻(xiàn)綜述 5
1.1試劑檢測(cè)原理 5
1.2再驗(yàn)證目的及再驗(yàn)證周期 5
1.3影響產(chǎn)品質(zhì)量的主要因素 6
1.3.1生物原材料的活性 6
1.3.2非生物原材料的質(zhì)量 6
1.3.3工藝技術(shù)的影響 6
1.3.4匹配的精細(xì)度和全面性也會(huì)影響到產(chǎn)品的質(zhì)量 7
1.3.5中間品干燥過(guò)程中的影響 7
1.3.6生產(chǎn)、貯存的條件 7
1.3.7轉(zhuǎn)移及貯存過(guò)程中引入的影響 7
1.3.8機(jī)器、人為的影響 7
1.4產(chǎn)品常出現(xiàn)的質(zhì)量問(wèn)題及相關(guān)組成材料的作用 8
1.4.1產(chǎn)品常出現(xiàn)的質(zhì)量問(wèn)題及原因 8
1.4.2產(chǎn)品相關(guān)組成材料和試劑的作用 10
1.5應(yīng)用的檢測(cè)技術(shù) 12
1.5.1雙抗體夾心法 12
1.5.2膠體金免疫層析技術(shù) 12
1.5.3膠體金標(biāo)記技術(shù) 13
1.6發(fā)展前景 14
1.6.1體外診斷試劑的前景 14
1.6.2 HCG膠體金快速診斷試劑的發(fā)展前景 14
1.7生產(chǎn)工藝流程圖及環(huán)境要求 15
1.7.1生產(chǎn)條件 15
1.7.2生產(chǎn)工藝流程圖 15
1.8產(chǎn)品介紹 17
1.8.1產(chǎn)品名稱 17
1.8.2包裝規(guī)格 17
1.8.3預(yù)期用途 17
1.8.4檢驗(yàn)原理 17
1.8.5主要組成 17
1.8.6貯存條件及有效期 17
1.8.7適用儀器 18
1.8.8樣本要求 18
1.8.9檢驗(yàn)方法 18
1.8.10檢查結(jié)果及解釋 18
1.8.11檢驗(yàn)方法的局限性 18
1.8.12產(chǎn)品性能指標(biāo) 18
1.8.13注意事項(xiàng) 19
第二章 實(shí)驗(yàn)部分 20
2.1實(shí)驗(yàn)材料與設(shè)備 20
2.1.1實(shí)驗(yàn)材料 20
2.1.2設(shè)備 20
2.2實(shí)驗(yàn)方法 21
2.2.1噴膜機(jī)運(yùn)行及性能確認(rèn) 21
2.2.2包被膜制備工藝驗(yàn)證方法 21
2.2.3膠體金墊制備 22
2.2.4樣品墊實(shí)驗(yàn) 23
2.2.5組裝工序 24
第三章  結(jié)果與討論 26
3.1實(shí)驗(yàn)結(jié)果 26
3.1.1噴膜機(jī)參數(shù)確定 26
3.1.2膜實(shí)驗(yàn)結(jié)果 27
3.1.3金子墊制備實(shí)驗(yàn)結(jié)果 27
3.1.4樣品墊實(shí)驗(yàn)結(jié)果 28
3.1.5組裝環(huán)境影響結(jié)果 28
第四章  結(jié)論 30
致  謝 31
參考文獻(xiàn) 32