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)斷(duan)試(shi)劑是(shi)指(zhi)可單獨使用(yong)(yong)或(huo)與(yu)儀(yi)器(qi)(qi)、器(qi)(qi)具、設備或(huo)系統組合使用(yong)(yong),在(zai)(zai)疾(ji)病的(de)(de)(de)(de)預防(fang)、診(zhen)(zhen)斷(duan)、治療(liao)(liao)監測(ce)、預后觀(guan)察、健康狀態評價以及遺傳性疾(ji)病的(de)(de)(de)(de)預測(ce)過程中(zhong),用(yong)(yong)于(yu)對人體(ti)(ti)樣(yang)本(各(ge)種體(ti)(ti)液、細胞、組織樣(yang)本等)進(jin)行(xing)體(ti)(ti)外(wai)(wai)檢測(ce)的(de)(de)(de)(de)試(shi)劑、試(shi)劑盒、校(xiao)準品(物)、質控(kong)品(物)等。在(zai)(zai)我國,大多數體(ti)(ti)外(wai)(wai)診(zhen)(zhen)斷(duan)試(shi)劑是(shi)按(an)照(zhao)(zhao)醫療(liao)(liao)器(qi)(qi)械(xie)管(guan)(guan)理的(de)(de)(de)(de),也(ye)有(you)部(bu)分(fen)體(ti)(ti)外(wai)(wai)診(zhen)(zhen)斷(duan)試(shi)劑是(shi)按(an)照(zhao)(zhao)藥品管(guan)(guan)理的(de)(de)(de)(de),按(an)照(zhao)(zhao)藥品管(guan)(guan)理的(de)(de)(de)(de)主要(yao)是(shi)用(yong)(yong)于(yu)血源篩查(cha)的(de)(de)(de)(de)體(ti)(ti)外(wai)(wai)診(zhen)(zhen)斷(duan)試(shi)劑和(he)采(cai)用(yong)(yong)放射性核素標(biao)記的(de)(de)(de)(de)體(ti)(ti)外(wai)(wai)診(zhen)(zhen)斷(duan)試(shi)劑,這些產品都(dou)不屬(shu)于(yu)醫療(liao)(liao)器(qi)(qi)械(xie),其他的(de)(de)(de)(de)屬(shu)于(yu)醫療(liao)(liao)器(qi)(qi)械(xie),根據(ju)情況,體(ti)(ti)外(wai)(wai)診(zhen)(zhen)斷(duan)試(shi)劑在(zai)(zai)二類(lei)和(he)三類(lei)醫療(liao)(liao)器(qi)(qi)械(xie)中(zhong)都(dou)有(you)包含。
三、體外診斷試劑研發流程
1、立項(xiang)(xiang)準(zhun)備階(jie)(jie)段(duan):包(bao)(bao)括(kuo)(kuo)立項(xiang)(xiang)調研(yan)(yan)(yan)、立項(xiang)(xiang)評估、設(she)計輸入等(deng)。首先需要確定立項(xiang)(xiang)的(de)方(fang)向,包(bao)(bao)括(kuo)(kuo)待(dai)測靶標、預期用途、應用場(chang)景等(deng)。其(qi)次(ci)是(shi)明確市場(chang)容量和(he)應用前(qian)景,包(bao)(bao)括(kuo)(kuo)相應疾(ji)病(bing)的(de)發(fa)病(bing)率,以(yi)(yi)及(ji)(ji)市場(chang)上(shang)是(shi)否具有(you)同(tong)類(lei)產(chan)品(pin)上(shang)市即競品(pin)情況分(fen)析(xi)。確定好方(fang)向后(hou)(hou),需要查閱(yue)大量文(wen)獻(xian)及(ji)(ji)行(xing)業報(bao)道,做到充分(fen)了解靶標研(yan)(yan)(yan)究(jiu)進(jin)(jin)展(zhan)和(he)應用,確認檢(jian)(jian)測方(fang)法和(he)技術的(de)可(ke)(ke)行(xing)性(xing),以(yi)(yi)及(ji)(ji)確認設(she)備環境條件(jian)、項(xiang)(xiang)目開發(fa)人員職能(neng)和(he)組成(cheng)(cheng)等(deng)。2、產(chan)品(pin)研(yan)(yan)(yan)制(zhi)階(jie)(jie)段(duan):完成(cheng)(cheng)立項(xiang)(xiang)后(hou)(hou),即可(ke)(ke)啟動體(ti)外診斷試(shi)(shi)劑的(de)研(yan)(yan)(yan)制(zhi)階(jie)(jie)段(duan)。研(yan)(yan)(yan)制(zhi)前(qian)期包(bao)(bao)括(kuo)(kuo)原材料的(de)篩選、主要生產(chan)工藝及(ji)(ji)反(fan)應體(ti)系的(de)研(yan)(yan)(yan)究(jiu)和(he)產(chan)品(pin)驗(yan)(yan)(yan)(yan)(yan)證研(yan)(yan)(yan)究(jiu)階(jie)(jie)段(duan)。3、注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)階(jie)(jie)段(duan):上(shang)述階(jie)(jie)段(duan)完成(cheng)(cheng)后(hou)(hou),即可(ke)(ke)進(jin)(jin)入注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)階(jie)(jie)段(duan),用GMP廠(chang)房連續生產(chan)的(de)3批(pi)次(ci)試(shi)(shi)劑盒進(jin)(jin)行(xing)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)抽樣申(shen)請(qing),然后(hou)(hou)進(jin)(jin)行(xing)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)的(de)檢(jian)(jian)定。這(zhe)個(ge)階(jie)(jie)段(duan)的(de)資(zi)料將(jiang)匯總成(cheng)(cheng)產(chan)品(pin)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)申(shen)報(bao)時的(de)文(wen)件(jian),即《注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)測報(bao)告(gao)》。4、臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)階(jie)(jie)段(duan):拿到注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)檢(jian)(jian)驗(yan)(yan)(yan)(yan)(yan)報(bao)告(gao)后(hou)(hou),即可(ke)(ke)啟動臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)階(jie)(jie)段(duan)。臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)階(jie)(jie)段(duan)包(bao)(bao)括(kuo)(kuo)臨(lin)(lin)(lin)(lin)床(chuang)(chuang)前(qian)準(zhun)備、制(zhi)定臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)方(fang)案、過倫理臨(lin)(lin)(lin)(lin)床(chuang)(chuang)協議簽署、臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)備案、臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)實(shi)施、臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)總結等(deng)。這(zhe)個(ge)階(jie)(jie)段(duan)的(de)資(zi)料將(jiang)匯總成(cheng)(cheng)產(chan)品(pin)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)申(shen)報(bao)時的(de)文(wen)件(jian),即《臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)方(fang)案》、《臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)報(bao)告(gao)》。5、注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)審(shen)核階(jie)(jie)段(duan):臨(lin)(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)完成(cheng)(cheng)后(hou)(hou)進(jin)(jin)入的(de)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)審(shen)核階(jie)(jie)段(duan),是(shi)國家(jia)藥品(pin)監督管(guan)理局根據(ju)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)申(shen)請(qing)人的(de)申(shen)請(qing),依照(zhao)相應法定程序(xu),對其(qi)擬上(shang)市的(de)IVD試(shi)(shi)劑的(de)安全(quan)性(xing)、有(you)效性(xing)研(yan)(yan)(yan)究(jiu)及(ji)(ji)其(qi)結果進(jin)(jin)行(xing)系統評價,以(yi)(yi)決定是(shi)否同(tong)意其(qi)申(shen)請(qing)的(de)過程。此階(jie)(jie)段(duan)包(bao)(bao)括(kuo)(kuo)撰寫提(ti)交IVD注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)申(shen)報(bao)資(zi)料、體(ti)系考(kao)核、根據(ju)發(fa)補通(tong)知單(dan)進(jin)(jin)行(xing)相應發(fa)補工作、發(fa)補資(zi)料提(ti)交。以(yi)(yi)上(shang)所(suo)有(you)審(shen)核通(tong)過后(hou)(hou),即可(ke)(ke)獲證。
四、體外診斷試劑包括哪些
1、第一類(lei)體(ti)(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括微生(sheng)(sheng)物培養基(ji)(不用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)微生(sheng)(sheng)物鑒(jian)別和藥敏(min)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)驗)。 和樣本處理(li)(li)用(yong)(yong)(yong)(yong)(yong)產品(pin)(pin),如溶血(xue)劑(ji)(ji)(ji)、稀釋液、染色液等(deng)。2、第二類(lei)體(ti)(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)蛋白質檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)糖類(lei)檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)激素檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)酶類(lei)檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)酯類(lei)檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)維生(sheng)(sheng)素檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)無機(ji)離(li)子檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)藥物及(ji)藥物代謝物檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)自身抗體(ti)(ti)(ti)檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)微生(sheng)(sheng)物鑒(jian)別或(huo)藥敏(min)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)驗的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)(yu)其他生(sheng)(sheng)理(li)(li)、生(sheng)(sheng)化(hua)或(huo)免疫功能指標(biao)檢(jian)測(ce)(ce)(ce)(ce)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)。3、第三(san)類(lei)體(ti)(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji):包括與(yu)(yu)致病(bing)性病(bing)原(yuan)體(ti)(ti)(ti)抗原(yuan)、抗體(ti)(ti)(ti)以及(ji)核酸等(deng)檢(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)血(xue)型、組織(zhi)配型相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)人(ren)類(lei)基(ji)因(yin)檢(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)遺傳(chuan)性疾病(bing)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)麻醉藥品(pin)(pin)、精(jing)神(shen)藥品(pin)(pin)、醫療(liao)用(yong)(yong)(yong)(yong)(yong)毒性藥品(pin)(pin)檢(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)治療(liao)藥物作用(yong)(yong)(yong)(yong)(yong)靶點檢(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)腫瘤標(biao)志物檢(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji);與(yu)(yu)變態反(fan)應(ying)(過敏(min)原(yuan))相(xiang)(xiang)關(guan)(guan)的試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)。