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class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái),熙寧生物專業(yè)大分子生物分析平臺(tái)</p><p><span>***更新：</span>2021-01-19 03:08:02</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="rqnpwik" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">寧波熙寧檢測(cè)技術(shù)有限公司</a></p><p><span>聯(lián)系人：</span>王蒙</p><p><span>郵箱: </span>meng.wang@accurantbio.com</p><p><span>電話: </span>13585708897</p><p><span>傳真: </span>0574_</p><p><span>網(wǎng)址: </span>https://www.accurantbio.com</p><p><span>手機(jī): </span>0574-87878487</p><p><span>地址: </span>浙江省寧波市鄞州區(qū)聚賢路587弄A5幢4樓</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="cfcpmtv" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="azm8ta2" class="box"><p><p style="text-indent:25px">對(duì)鑒別診斷自身免疫性甲狀腺炎有重要價(jià)值，二者聯(lián)合應(yīng)用其診斷符合率可達(dá)98％。橋本氏甲狀腺炎、原發(fā)性甲減及甲亢等免疫性疾病患者血清TMA和TGA高于正常人，尤其橋本氏甲狀腺炎更為突出，血清TMA和TGA是診斷此類疾病的“特異指標(biāo)”，山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)。①甲亢：TGA，山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)，山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)、TMA均強(qiáng)陽(yáng)性，TMA高于TGA，兩種抗體均低于橋本氏甲狀腺炎。部分患者TGA、TMA可轉(zhuǎn)為陰性，但多數(shù)臨床的甲亢患者TGA、TMA長(zhǎng)期測(cè)定弱陽(yáng)性。因此應(yīng)定期復(fù)查甲狀腺功能，以防復(fù)發(fā)。②橋本氏甲狀腺炎、阿狄森氏?。篢GA、TMA均表現(xiàn)強(qiáng)陽(yáng)性，亦有少部分患者TMA強(qiáng)陽(yáng)性，TGA弱陽(yáng)性或陰性。亞甲炎患者兩種抗體明顯高于正常人，低于橋本氏甲狀腺炎。③原發(fā)性甲低癥：TGA、TMA均陽(yáng)性，但繼發(fā)性甲低TGA、TMA陰性，用以鑒別繼發(fā)性甲低。④甲狀腺：TGA增高明顯。⑤孕期自身免疫疾?。篢GA、TMA均可增高。正常的參考值：0～50IU/ml8．抗甲狀腺過(guò)氧化物酶抗體（Anti-TPO，TPOA）TPOA是主要的甲狀腺組織自身抗體，是甲狀腺疾病合成過(guò)程的關(guān)鍵酶，與甲狀腺組織免疫性損傷密切相關(guān)。主要包括甲狀腺刺激性抗體(TS-Ab)和甲狀腺刺激阻滯性抗體(TSB-Ab)。TPOA直接對(duì)抗甲狀腺過(guò)氧化物酶(TPO)。臨床檢驗(yàn)醫(yī)學(xué)是建立在基礎(chǔ)醫(yī)學(xué)與臨床醫(yī)學(xué)之間的橋梁學(xué)科，由血液學(xué)、生物化學(xué)、免疫學(xué)等多基礎(chǔ)學(xué)科所組成。山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái),熙寧生物專業(yè)大分子生物分析平臺(tái)" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637413944405945790/4979901.png"></div><p style="text-indent:25px">為了滿足臨床大批量樣品的測(cè)定需求，涉及抗原、抗體的特異性結(jié)合，這就不可避免地存在交叉反應(yīng)等非特異性問(wèn)題。國(guó)際醫(yī)學(xué)溯源性參考檢測(cè)方法國(guó)際溯源性參考方法—質(zhì)譜檢測(cè)法國(guó)際檢驗(yàn)醫(yī)學(xué)溯源聯(lián)合會(huì)（JCLTM）的主要任務(wù)是通過(guò)實(shí)施參考系統(tǒng)，建立檢驗(yàn)結(jié)果溯源性，改進(jìn)其可比性，從而提高醫(yī)療衛(wèi)生質(zhì)量并降低費(fèi)用。JCTLM設(shè)立工作框架，按照國(guó)際標(biāo)準(zhǔn)(ISO17511，15193，15194)建立參考物質(zhì)和參考測(cè)量程序認(rèn)定步驟。在JCTLM官網(wǎng)上查到檢測(cè)TT3、TT4和FT4的溯源性參考方法均為應(yīng)用質(zhì)譜法檢測(cè)。本文挑選三篇年份較近的溯源性參考方法的信息進(jìn)行簡(jiǎn)單介紹：TT3溯源性液質(zhì)參考方法信息(來(lái)自美國(guó)國(guó)家標(biāo)準(zhǔn)與技術(shù)研究院，NIST)，TT4溯源性液質(zhì)參考方法信息（來(lái)自英國(guó)化學(xué)家實(shí)驗(yàn)室，LGC）FT4溯源性液質(zhì)參考方法信息（來(lái)自比利時(shí)根特大學(xué)，GhentUniversity）國(guó)內(nèi)候選參考方法（質(zhì)譜法）推薦本方法為原國(guó)家衛(wèi)生部臨床檢驗(yàn)中心在2015年發(fā)布的TT4檢測(cè)候選參考方法。山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)精翰生物自主構(gòu)建了NF-AT報(bào)告基因Jurkat穩(wěn)轉(zhuǎn)細(xì)胞系來(lái)替代Blinatumomab生物分析方法中的T細(xì)胞。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái),熙寧生物專業(yè)大分子生物分析平臺(tái)" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637413944524315695/5163016.png"></div><p style="text-indent:25px">在生物藥開(kāi)發(fā)的整個(gè)生命周期中，可以使用不同級(jí)別的方法驗(yàn)證。應(yīng)當(dāng)指出，每一個(gè)級(jí)別都應(yīng)被視為完全**的方法評(píng)估。即使方法的試劑和測(cè)定步驟在研究級(jí)驗(yàn)證中和監(jiān)管級(jí)驗(yàn)證之間沒(méi)有變化，也應(yīng)分別在每個(gè)級(jí)別進(jìn)行相應(yīng)的方法驗(yàn)證。評(píng)價(jià)方法的效能是否可接受的嚴(yán)謹(jǐn)性也隨著驗(yàn)證級(jí)別的增加而增加；如果有必要，應(yīng)當(dāng)重新開(kāi)發(fā)和驗(yàn)證一個(gè)方法，以確保它符合必要的接受標(biāo)準(zhǔn)。這并不是說(shuō)，在不太嚴(yán)謹(jǐn)?shù)募?jí)別使用該方法獲得的經(jīng)驗(yàn)不能應(yīng)用于更嚴(yán)謹(jǐn)級(jí)別的方法開(kāi)發(fā)上；而是，不應(yīng)簡(jiǎn)單地將附加參數(shù)添加到較低級(jí)別的評(píng)估中，因?yàn)槠詈虲V的接受標(biāo)準(zhǔn)可能更嚴(yán)格，對(duì)相關(guān)文檔記錄和期望的流程可重構(gòu)性也會(huì)增加。對(duì)大分子方法效能的評(píng)估，即驗(yàn)證級(jí)別的選擇，應(yīng)當(dāng)強(qiáng)調(diào)，是一個(gè)通過(guò)基于可接受風(fēng)險(xiǎn)水平的決策；這些風(fēng)險(xiǎn)水平是針對(duì)每種情況，例如，在藥物分子分析方法、生物基質(zhì)和物種水平上的風(fēng)險(xiǎn)，進(jìn)行特別的評(píng)估。FDA在其指南草案中暗示使用更靈活的驗(yàn)證工作流程，指出：“對(duì)于需要監(jiān)管機(jī)構(gòu)的行動(dòng)才能獲得批準(zhǔn)的，或者與藥物標(biāo)簽（labeling）相關(guān)的關(guān)鍵研究，如生物等效性（BE）或PK研究，應(yīng)完整地驗(yàn)證生物分析方法。對(duì)用于制藥廠商內(nèi)部決策的探索性方法，較少的驗(yàn)證可能就足夠了”。</p><p style="text-indent:25px">幫助介導(dǎo)這些功能的糖鏈可以具有無(wú)數(shù)種復(fù)雜的結(jié)構(gòu)。N糖譜技術(shù)利于鑒定糖型，以確保藥物產(chǎn)品的一致和穩(wěn)定。N糖譜用于單克隆抗體的糖型結(jié)構(gòu)分析，可鑒定糖型種類和相對(duì)數(shù)量。技術(shù)流程溶液中的分子與芯片表面的分子結(jié)合、解離整個(gè)過(guò)程的變化，獲得動(dòng)力學(xué)和親和力數(shù)據(jù)。由于其具有無(wú)需標(biāo)記、高靈敏度、檢測(cè)快速、并能實(shí)時(shí)定量測(cè)試等優(yōu)勢(shì)，用來(lái)研究蛋白質(zhì)、核酸、多肽、小分子化合物等生物分子的相互作用。技術(shù)流程臨床前DMPK研究過(guò)體內(nèi)體外ADME研究為臨床前藥物篩選、藥物開(kāi)發(fā)、給藥途徑、藥效學(xué)研究、制劑研究及藥物申報(bào)等工作提供指導(dǎo)依據(jù)具體服務(wù)項(xiàng)目如下生物分析通過(guò)液相色譜串聯(lián)質(zhì)譜（LCMS/MS）技術(shù)，對(duì)不同生物樣本（如全血、血清、血漿、尿、組織等）中的原型藥物及其代謝產(chǎn)物進(jìn)行定性和定量分析，為藥物篩選、藥效學(xué)評(píng)價(jià)、生物利用度、組織分布、代謝及排泄途徑、藥物劑型設(shè)計(jì)和開(kāi)發(fā)、藥品注冊(cè)申報(bào)以及臨床研究用藥管理等提供科學(xué)的數(shù)據(jù)支持，熙寧生物專注于大分子生物分析。游離藥物(free drug)檢測(cè)和總藥物(Total drug)檢測(cè)的目的是更真實(shí)測(cè)定出血液樣品中能否發(fā)揮活性作用的藥物。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái),熙寧生物專業(yè)大分子生物分析平臺(tái)" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637413944123728184/5882543.png"></div><p style="text-indent:25px">3.光電管和檢測(cè)系統(tǒng)：經(jīng)熒光染色的細(xì)胞受合適的光激發(fā)后所產(chǎn)生的熒光是通過(guò)光電轉(zhuǎn)換器轉(zhuǎn)變成電信號(hào)而進(jìn)行測(cè)量的。光電倍增管（PMT）常用。4.計(jì)算機(jī)和分析系統(tǒng)：經(jīng)放大后的電信號(hào)被送往計(jì)算機(jī)分析器。流式細(xì)胞檢測(cè)的臨床應(yīng)用1.免疫學(xué)領(lǐng)域：淋巴細(xì)胞亞群檢測(cè)，用以評(píng)估機(jī)體的免疫狀態(tài)、輔助疾病如AIDS/HIV的診斷等，是目前各醫(yī)療單位開(kāi)展和應(yīng)用的項(xiàng)目。2.血液學(xué)領(lǐng)域：血液系統(tǒng)疾病的免疫分型及白血病微小殘留病變(minimalresidualdisease，MRD)監(jiān)測(cè)，用于血液系統(tǒng)疾病的診斷、評(píng)估和復(fù)發(fā)監(jiān)測(cè)。FCM的細(xì)胞免疫分型是國(guó)際公認(rèn)的診斷造血細(xì)胞疾病必不可少的重要標(biāo)準(zhǔn)之一，是目前被接受和認(rèn)可的免疫分型方法。3.臨床：主要是DNA倍體和細(xì)胞周期分析，了解細(xì)胞DNA倍體和增殖能力，異常倍體的出現(xiàn)意味著DNA合成的異常，可能是病變前發(fā)生的重要標(biāo)志。另外，F(xiàn)ACS還可以檢測(cè)分析相關(guān)標(biāo)志物（細(xì)胞的增殖活性標(biāo)志分子、分化標(biāo)志分子、凋亡標(biāo)志分子以及免疫學(xué)標(biāo)志物），用于發(fā)病機(jī)制的研究、個(gè)性化方案的制定以及預(yù)后判斷等。4.臨床細(xì)胞：流式細(xì)胞儀是在細(xì)胞領(lǐng)域的一個(gè)重要的研究和研發(fā)依托。熙寧生物專注于大分子生物檢測(cè)。熙寧生物主要檢測(cè)內(nèi)容包含藥代動(dòng)力學(xué)(PK)，藥效動(dòng)力學(xué)(PD)，抗藥抗體(ADA)，中和抗體(NAb)。山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)</p><p style="text-indent:25px">只有的細(xì)胞亞群可以表達(dá)細(xì)胞因子，靜止的正常淋巴細(xì)胞(T、B、NK)不分泌細(xì)胞因子。山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)</p><p> 2價(jià)），而IgM有10個(gè)抗原結(jié)合位點(diǎn)（10價(jià)）。親和度表示IgG或IgM的，分別對(duì)于2個(gè)或10個(gè)抗原分子，的整體結(jié)合強(qiáng)度（overallstrength）。圖5.競(jìng)爭(zhēng)式ELISA的詳細(xì)原理和流程圖?？乖?jìng)爭(zhēng)式ELISA（a）；抗體競(jìng)爭(zhēng)式ELISA（b）。關(guān)鍵試劑一個(gè)ELISA方法較重要的組成部分是測(cè)試試劑，它決定了ELISA方法的靈敏度、特異性和方法的質(zhì)量。ELISAs常用于藥物開(kāi)發(fā)：在PK評(píng)估中，定量測(cè)定蛋白生物藥的濃度；測(cè)定內(nèi)源性蛋白和生物標(biāo)志物；檢測(cè)抗藥物抗體的存在以進(jìn)行免疫原性評(píng)估，等。LBA方法優(yōu)先的關(guān)鍵試劑是單克隆抗體（MAbs）或多克隆抗體（PAbs），而不是重組靶標(biāo)蛋白。為了產(chǎn)生PAbs或MAbs，需要將生物藥，或生物標(biāo)志物蛋白，及其佐劑或載體，根據(jù)相關(guān)應(yīng)用，給到合適的宿主動(dòng)物物種上進(jìn)行免疫。對(duì)于PAbs，兔子，山羊和綿羊是較常用的宿主物種；因?yàn)樗鼈兊拇篌w型（產(chǎn)生的抗體量也大），容易找到血管和強(qiáng)健的免疫反應(yīng)。用于免疫的每一個(gè)抗原都是高度復(fù)雜的，因此它可以呈現(xiàn)大量的，可以被不同的淋巴細(xì)胞識(shí)別的表位；這些淋巴細(xì)胞隨后被。了的淋巴細(xì)胞增殖，分化成漿細(xì)胞，并分泌出多克隆抗體的混合體。PAb庫(kù)（混合體）了不同抗體的**群體，這些抗體可以識(shí)別抗原的多個(gè)表位(用于ELISA分析)。山東國(guó)標(biāo)熙寧生物專業(yè)大分子生物分析平臺(tái)</p><p style="text-indent:25px">寧波熙寧檢測(cè)技術(shù)有限公司位于外高橋自由貿(mào)易試驗(yàn)區(qū)加楓路8號(hào)503-505/浙江省寧波市鄞州區(qū)聚賢路587弄A5幢4樓，擁有一支專業(yè)的技術(shù)團(tuán)隊(duì)。熙寧是寧波熙寧檢測(cè)技術(shù)有限公司的主營(yíng)品牌，是專業(yè)的一般項(xiàng)目：技術(shù)服務(wù)、技術(shù)開(kāi)發(fā)、技術(shù)咨詢、技術(shù)交流、技術(shù)轉(zhuǎn)讓、技術(shù)推廣；醫(yī)學(xué)研究和試驗(yàn)發(fā)展；實(shí)驗(yàn)分析儀器銷售；儀器儀表銷售（除依法須經(jīng)批準(zhǔn)的項(xiàng)目外，憑營(yíng)業(yè)執(zhí)照依法自主開(kāi)展經(jīng)營(yíng)活動(dòng)）。許可項(xiàng)目：貨物進(jìn)出口，技術(shù)進(jìn)出口，進(jìn)出口代理（依法須經(jīng)批準(zhǔn)的項(xiàng)目，經(jīng)相關(guān)部門批準(zhǔn)后方可開(kāi)展經(jīng)營(yíng)活動(dòng)，具體經(jīng)營(yíng)項(xiàng)目以審批結(jié)果為準(zhǔn)）。公司，擁有自己**的技術(shù)體系。公司不**提供專業(yè)的一般項(xiàng)目：技術(shù)服務(wù)、技術(shù)開(kāi)發(fā)、技術(shù)咨詢、技術(shù)交流、技術(shù)轉(zhuǎn)讓、技術(shù)推廣；醫(yī)學(xué)研究和試驗(yàn)發(fā)展；實(shí)驗(yàn)分析儀器銷售；儀器儀表銷售（除依法須經(jīng)批準(zhǔn)的項(xiàng)目外，憑營(yíng)業(yè)執(zhí)照依法自主開(kāi)展經(jīng)營(yíng)活動(dòng)）。許可項(xiàng)目：貨物進(jìn)出口，技術(shù)進(jìn)出口，進(jìn)出口代理（依法須經(jīng)批準(zhǔn)的項(xiàng)目，經(jīng)相關(guān)部門批準(zhǔn)后方可開(kāi)展經(jīng)營(yíng)活動(dòng)，具體經(jīng)營(yíng)項(xiàng)目以審批結(jié)果為準(zhǔn)）。，同時(shí)還建立了完善的售后服務(wù)體系，為客戶提供良好的產(chǎn)品和服務(wù)。誠(chéng)實(shí)、守信是對(duì)企業(yè)的經(jīng)營(yíng)要求，也是我們做人的基本準(zhǔn)則。公司致力于打造***的生物分析，臨床檢測(cè)，生物藥檢測(cè)，免疫原性檢測(cè)。</p></p><br 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