一、什么是體外診斷
體外診斷,又稱IVD(In Vitro Diagnosis),是指在人體之外,通過對人體樣本(血液、體液、組織等)進行檢測而獲取臨床診斷信息,進而判斷疾病或機體功能的產品和服務。在現代醫學領域,體外診斷廣泛應用于體檢、慢病管理、重疾監測等領域,已成為人類疾病預防、診斷、治療日益重要的組成部分,也是保障人類健康與構建和諧社會日益重要的組成部分。如果您有體外診斷相關的需求,可以先來了解一下體外診斷十大品牌。
二、體外診斷試劑屬于幾類醫療器械
體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji)是(shi)指可單獨使(shi)用(yong)或與(yu)儀器、器具(ju)、設備或系統組合使(shi)用(yong),在疾(ji)病(bing)(bing)的(de)預防、診(zhen)(zhen)(zhen)(zhen)斷、治療監測(ce)、預后觀(guan)察、健康狀態評價以及遺傳性(xing)疾(ji)病(bing)(bing)的(de)預測(ce)過程中,用(yong)于(yu)對人體(ti)(ti)樣(yang)本(ben)(各種體(ti)(ti)液、細(xi)胞、組織樣(yang)本(ben)等(deng)(deng))進(jin)行體(ti)(ti)外(wai)(wai)檢測(ce)的(de)試(shi)(shi)劑(ji)(ji)(ji)、試(shi)(shi)劑(ji)(ji)(ji)盒、校準品(物)、質控(kong)品(物)等(deng)(deng)。在我國,大多數體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji)是(shi)按(an)(an)照(zhao)醫(yi)療器械(xie)(xie)管理(li)的(de),也有(you)部分體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji)是(shi)按(an)(an)照(zhao)藥品管理(li)的(de),按(an)(an)照(zhao)藥品管理(li)的(de)主(zhu)要是(shi)用(yong)于(yu)血源篩查的(de)體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji)和采用(yong)放射(she)性(xing)核(he)素標記的(de)體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji),這些產品都(dou)不(bu)屬于(yu)醫(yi)療器械(xie)(xie),其(qi)他的(de)屬于(yu)醫(yi)療器械(xie)(xie),根據(ju)情況,體(ti)(ti)外(wai)(wai)診(zhen)(zhen)(zhen)(zhen)斷試(shi)(shi)劑(ji)(ji)(ji)在二類和三(san)類醫(yi)療器械(xie)(xie)中都(dou)有(you)包含。
三、體外診斷試劑研發流程
1、立(li)項準備(bei)階(jie)(jie)段:包(bao)括立(li)項調研(yan)、立(li)項評估、設計輸入(ru)等(deng)(deng)。首先(xian)需(xu)要(yao)確定(ding)(ding)(ding)立(li)項的(de)(de)(de)方向,包(bao)括待測靶標、預期用(yong)途、應(ying)(ying)用(yong)場(chang)景等(deng)(deng)。其(qi)次是(shi)明確市場(chang)容(rong)量和(he)應(ying)(ying)用(yong)前(qian)景,包(bao)括相應(ying)(ying)疾(ji)病的(de)(de)(de)發(fa)病率(lv),以及(ji)市場(chang)上(shang)(shang)是(shi)否(fou)具有(you)同(tong)類(lei)產品(pin)上(shang)(shang)市即競品(pin)情況分析。確定(ding)(ding)(ding)好方向后(hou),需(xu)要(yao)查閱大量文獻及(ji)行業報(bao)(bao)道,做到(dao)充分了(le)解靶標研(yan)究進(jin)展和(he)應(ying)(ying)用(yong),確認檢(jian)(jian)測方法和(he)技術(shu)的(de)(de)(de)可(ke)(ke)行性,以及(ji)確認設備(bei)環境條件(jian)、項目開(kai)發(fa)人員職(zhi)能(neng)和(he)組成(cheng)等(deng)(deng)。2、產品(pin)研(yan)制(zhi)階(jie)(jie)段:完成(cheng)立(li)項后(hou),即可(ke)(ke)啟(qi)動(dong)體外診(zhen)斷(duan)試(shi)(shi)劑(ji)的(de)(de)(de)研(yan)制(zhi)階(jie)(jie)段。研(yan)制(zhi)前(qian)期包(bao)括原材料的(de)(de)(de)篩(shai)選、主(zhu)要(yao)生產工(gong)藝及(ji)反應(ying)(ying)體系(xi)(xi)的(de)(de)(de)研(yan)究和(he)產品(pin)驗(yan)(yan)(yan)(yan)證研(yan)究階(jie)(jie)段。3、注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)階(jie)(jie)段:上(shang)(shang)述階(jie)(jie)段完成(cheng)后(hou),即可(ke)(ke)進(jin)入(ru)注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)階(jie)(jie)段,用(yong)GMP廠(chang)房連續生產的(de)(de)(de)3批(pi)次試(shi)(shi)劑(ji)盒進(jin)行注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)抽樣申(shen)(shen)請,然后(hou)進(jin)行注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)的(de)(de)(de)檢(jian)(jian)定(ding)(ding)(ding)。這個階(jie)(jie)段的(de)(de)(de)資(zi)料將匯總成(cheng)產品(pin)注(zhu)(zhu)冊(ce)(ce)申(shen)(shen)報(bao)(bao)時(shi)的(de)(de)(de)文件(jian),即《注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)測報(bao)(bao)告》。4、臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)(jie)段:拿(na)到(dao)注(zhu)(zhu)冊(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)報(bao)(bao)告后(hou),即可(ke)(ke)啟(qi)動(dong)臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)(jie)段。臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)(jie)段包(bao)括臨床(chuang)(chuang)(chuang)前(qian)準備(bei)、制(zhi)定(ding)(ding)(ding)臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)方案、過(guo)倫理臨床(chuang)(chuang)(chuang)協議簽署、臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)備(bei)案、臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)實施(shi)、臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)總結(jie)等(deng)(deng)。這個階(jie)(jie)段的(de)(de)(de)資(zi)料將匯總成(cheng)產品(pin)注(zhu)(zhu)冊(ce)(ce)申(shen)(shen)報(bao)(bao)時(shi)的(de)(de)(de)文件(jian),即《臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)方案》、《臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)報(bao)(bao)告》。5、注(zhu)(zhu)冊(ce)(ce)審核階(jie)(jie)段:臨床(chuang)(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)完成(cheng)后(hou)進(jin)入(ru)的(de)(de)(de)注(zhu)(zhu)冊(ce)(ce)審核階(jie)(jie)段,是(shi)國家藥品(pin)監(jian)督管理局根(gen)據注(zhu)(zhu)冊(ce)(ce)申(shen)(shen)請人的(de)(de)(de)申(shen)(shen)請,依照相應(ying)(ying)法定(ding)(ding)(ding)程序,對其(qi)擬(ni)上(shang)(shang)市的(de)(de)(de)IVD試(shi)(shi)劑(ji)的(de)(de)(de)安全性、有(you)效性研(yan)究及(ji)其(qi)結(jie)果(guo)進(jin)行系(xi)(xi)統評價,以決定(ding)(ding)(ding)是(shi)否(fou)同(tong)意其(qi)申(shen)(shen)請的(de)(de)(de)過(guo)程。此(ci)階(jie)(jie)段包(bao)括撰(zhuan)寫提交(jiao)IVD注(zhu)(zhu)冊(ce)(ce)申(shen)(shen)報(bao)(bao)資(zi)料、體系(xi)(xi)考(kao)核、根(gen)據發(fa)補通(tong)知單(dan)進(jin)行相應(ying)(ying)發(fa)補工(gong)作、發(fa)補資(zi)料提交(jiao)。以上(shang)(shang)所有(you)審核通(tong)過(guo)后(hou),即可(ke)(ke)獲證。
四、體外診斷試劑包括哪些
1、第(di)一類體外(wai)診斷試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括(kuo)微(wei)生(sheng)(sheng)(sheng)物(wu)(wu)培養基(不(bu)用(yong)(yong)(yong)(yong)于微(wei)生(sheng)(sheng)(sheng)物(wu)(wu)鑒別(bie)和藥(yao)(yao)敏(min)試(shi)(shi)(shi)(shi)驗(yan))。 和樣本(ben)處理(li)用(yong)(yong)(yong)(yong)產品(pin),如溶血劑(ji)(ji)(ji)、稀釋液、染色液等。2、第(di)二類體外(wai)診斷試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括(kuo)用(yong)(yong)(yong)(yong)于蛋白質檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于糖(tang)類檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于激素檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于酶類檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于酯類檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于維生(sheng)(sheng)(sheng)素檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于無機離子(zi)檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于藥(yao)(yao)物(wu)(wu)及藥(yao)(yao)物(wu)(wu)代謝物(wu)(wu)檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于自身抗體檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于微(wei)生(sheng)(sheng)(sheng)物(wu)(wu)鑒別(bie)或(huo)藥(yao)(yao)敏(min)試(shi)(shi)(shi)(shi)驗(yan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)于其他生(sheng)(sheng)(sheng)理(li)、生(sheng)(sheng)(sheng)化或(huo)免疫(yi)功能指標檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)。3、第(di)三類體外(wai)診斷試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括(kuo)與(yu)(yu)致病性病原(yuan)(yuan)體抗原(yuan)(yuan)、抗體以(yi)及核酸等檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)血型、組(zu)織配型相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)人類基因(yin)檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)遺傳(chuan)性疾病相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)麻醉(zui)藥(yao)(yao)品(pin)、精神藥(yao)(yao)品(pin)、醫療用(yong)(yong)(yong)(yong)毒(du)性藥(yao)(yao)品(pin)檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)治療藥(yao)(yao)物(wu)(wu)作用(yong)(yong)(yong)(yong)靶(ba)點檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)腫瘤(liu)標志物(wu)(wu)檢(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)變態反應(過敏(min)原(yuan)(yuan))相(xiang)(xiang)關(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)。