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)(wai)診斷試(shi)劑(ji)(ji)是指可單獨使(shi)(shi)用(yong)或與儀器(qi)、器(qi)具、設備或系統組合(he)使(shi)(shi)用(yong)，在疾病的(de)(de)(de)(de)(de)預(yu)防、診斷、治療(liao)監測、預(yu)后觀察、健康狀態評價以及(ji)遺傳性(xing)疾病的(de)(de)(de)(de)(de)預(yu)測過程中(zhong)，用(yong)于對人(ren)體(ti)(ti)樣本（各種體(ti)(ti)液、細胞(bao)、組織樣本等）進行體(ti)(ti)外(wai)(wai)(wai)檢測的(de)(de)(de)(de)(de)試(shi)劑(ji)(ji)、試(shi)劑(ji)(ji)盒、校(xiao)準品(pin)(pin)（物）、質控品(pin)(pin)（物）等。在我國，大多數體(ti)(ti)外(wai)(wai)(wai)診斷試(shi)劑(ji)(ji)是按(an)照(zhao)醫療(liao)器(qi)械(xie)管理(li)(li)的(de)(de)(de)(de)(de)，也有部(bu)分體(ti)(ti)外(wai)(wai)(wai)診斷試(shi)劑(ji)(ji)是按(an)照(zhao)藥(yao)品(pin)(pin)管理(li)(li)的(de)(de)(de)(de)(de)，按(an)照(zhao)藥(yao)品(pin)(pin)管理(li)(li)的(de)(de)(de)(de)(de)主要(yao)是用(yong)于血源篩查的(de)(de)(de)(de)(de)體(ti)(ti)外(wai)(wai)(wai)診斷試(shi)劑(ji)(ji)和(he)采用(yong)放射性(xing)核素標記(ji)的(de)(de)(de)(de)(de)體(ti)(ti)外(wai)(wai)(wai)診斷試(shi)劑(ji)(ji)，這些產品(pin)(pin)都不屬于醫療(liao)器(qi)械(xie)，其他的(de)(de)(de)(de)(de)屬于醫療(liao)器(qi)械(xie)，根據情況，體(ti)(ti)外(wai)(wai)(wai)診斷試(shi)劑(ji)(ji)在二類(lei)和(he)三類(lei)醫療(liao)器(qi)械(xie)中(zhong)都有包含。
三、體外診斷試劑研發流程
1、立項(xiang)準備階(jie)段(duan)(duan)(duan)(duan)(duan)：包(bao)(bao)括(kuo)立項(xiang)調(diao)研(yan)(yan)、立項(xiang)評估、設(she)計輸入(ru)(ru)等(deng)。首先需(xu)要確(que)(que)定(ding)立項(xiang)的(de)方(fang)向(xiang)，包(bao)(bao)括(kuo)待測靶標(biao)、預期(qi)用(yong)(yong)途(tu)、應用(yong)(yong)場景等(deng)。其(qi)次(ci)是(shi)明(ming)確(que)(que)市(shi)場容量(liang)和應用(yong)(yong)前(qian)(qian)景，包(bao)(bao)括(kuo)相(xiang)應疾病的(de)發(fa)(fa)(fa)病率，以及(ji)(ji)市(shi)場上(shang)是(shi)否(fou)具有同類產(chan)(chan)品上(shang)市(shi)即(ji)(ji)(ji)競品情況分(fen)析。確(que)(que)定(ding)好(hao)方(fang)向(xiang)后(hou)(hou)，需(xu)要查閱大量(liang)文獻及(ji)(ji)行(xing)業報(bao)(bao)(bao)(bao)道，做到充分(fen)了解靶標(biao)研(yan)(yan)究進(jin)展和應用(yong)(yong)，確(que)(que)認(ren)檢(jian)(jian)(jian)測方(fang)法(fa)和技術的(de)可(ke)行(xing)性，以及(ji)(ji)確(que)(que)認(ren)設(she)備環境條件(jian)、項(xiang)目開發(fa)(fa)(fa)人(ren)員職能和組成(cheng)(cheng)(cheng)等(deng)。2、產(chan)(chan)品研(yan)(yan)制(zhi)(zhi)階(jie)段(duan)(duan)(duan)(duan)(duan)：完(wan)成(cheng)(cheng)(cheng)立項(xiang)后(hou)(hou)，即(ji)(ji)(ji)可(ke)啟動體(ti)外診斷試(shi)(shi)劑的(de)研(yan)(yan)制(zhi)(zhi)階(jie)段(duan)(duan)(duan)(duan)(duan)。研(yan)(yan)制(zhi)(zhi)前(qian)(qian)期(qi)包(bao)(bao)括(kuo)原材料(liao)(liao)的(de)篩選(xuan)、主要生產(chan)(chan)工(gong)藝(yi)及(ji)(ji)反應體(ti)系的(de)研(yan)(yan)究和產(chan)(chan)品驗(yan)(yan)(yan)(yan)證(zheng)(zheng)研(yan)(yan)究階(jie)段(duan)(duan)(duan)(duan)(duan)。3、注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)階(jie)段(duan)(duan)(duan)(duan)(duan)：上(shang)述階(jie)段(duan)(duan)(duan)(duan)(duan)完(wan)成(cheng)(cheng)(cheng)后(hou)(hou)，即(ji)(ji)(ji)可(ke)進(jin)入(ru)(ru)注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)階(jie)段(duan)(duan)(duan)(duan)(duan)，用(yong)(yong)GMP廠房連續生產(chan)(chan)的(de)3批次(ci)試(shi)(shi)劑盒(he)進(jin)行(xing)注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)抽樣申(shen)請(qing)，然后(hou)(hou)進(jin)行(xing)注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)的(de)檢(jian)(jian)(jian)定(ding)。這個階(jie)段(duan)(duan)(duan)(duan)(duan)的(de)資(zi)料(liao)(liao)將匯總成(cheng)(cheng)(cheng)產(chan)(chan)品注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)(bao)(bao)時(shi)的(de)文件(jian)，即(ji)(ji)(ji)《注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)測報(bao)(bao)(bao)(bao)告(gao)(gao)》。4、臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)段(duan)(duan)(duan)(duan)(duan)：拿到注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)檢(jian)(jian)(jian)驗(yan)(yan)(yan)(yan)報(bao)(bao)(bao)(bao)告(gao)(gao)后(hou)(hou)，即(ji)(ji)(ji)可(ke)啟動臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)段(duan)(duan)(duan)(duan)(duan)。臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)階(jie)段(duan)(duan)(duan)(duan)(duan)包(bao)(bao)括(kuo)臨(lin)(lin)(lin)床(chuang)(chuang)前(qian)(qian)準備、制(zhi)(zhi)定(ding)臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)方(fang)案(an)(an)、過(guo)倫理(li)臨(lin)(lin)(lin)床(chuang)(chuang)協議簽署、臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)備案(an)(an)、臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)實施、臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)總結等(deng)。這個階(jie)段(duan)(duan)(duan)(duan)(duan)的(de)資(zi)料(liao)(liao)將匯總成(cheng)(cheng)(cheng)產(chan)(chan)品注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)(bao)(bao)時(shi)的(de)文件(jian)，即(ji)(ji)(ji)《臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)方(fang)案(an)(an)》、《臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)報(bao)(bao)(bao)(bao)告(gao)(gao)》。5、注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)審(shen)(shen)核(he)階(jie)段(duan)(duan)(duan)(duan)(duan)：臨(lin)(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)(yan)(yan)(yan)完(wan)成(cheng)(cheng)(cheng)后(hou)(hou)進(jin)入(ru)(ru)的(de)注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)審(shen)(shen)核(he)階(jie)段(duan)(duan)(duan)(duan)(duan)，是(shi)國家藥品監督管理(li)局(ju)根(gen)據注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)申(shen)請(qing)人(ren)的(de)申(shen)請(qing)，依照相(xiang)應法(fa)定(ding)程序，對其(qi)擬上(shang)市(shi)的(de)IVD試(shi)(shi)劑的(de)安全(quan)性、有效性研(yan)(yan)究及(ji)(ji)其(qi)結果進(jin)行(xing)系統評價，以決定(ding)是(shi)否(fou)同意其(qi)申(shen)請(qing)的(de)過(guo)程。此階(jie)段(duan)(duan)(duan)(duan)(duan)包(bao)(bao)括(kuo)撰寫提(ti)交IVD注(zhu)(zhu)冊(ce)(ce)(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)(bao)(bao)資(zi)料(liao)(liao)、體(ti)系考核(he)、根(gen)據發(fa)(fa)(fa)補(bu)通(tong)知(zhi)單進(jin)行(xing)相(xiang)應發(fa)(fa)(fa)補(bu)工(gong)作、發(fa)(fa)(fa)補(bu)資(zi)料(liao)(liao)提(ti)交。以上(shang)所有審(shen)(shen)核(he)通(tong)過(guo)后(hou)(hou)，即(ji)(ji)(ji)可(ke)獲(huo)證(zheng)(zheng)。
四、體外診斷試劑包括哪些
1、第一類(lei)體(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)：包括(kuo)微(wei)生(sheng)物(wu)(wu)(wu)培養(yang)基（不用(yong)(yong)(yong)于(yu)(yu)微(wei)生(sheng)物(wu)(wu)(wu)鑒別(bie)和藥(yao)敏試(shi)(shi)(shi)(shi)(shi)(shi)(shi)驗）。 和樣本(ben)處理用(yong)(yong)(yong)產品(pin)，如溶血劑(ji)(ji)(ji)(ji)(ji)、稀釋液、染色液等(deng)(deng)。2、第二(er)類(lei)體(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)：包括(kuo)用(yong)(yong)(yong)于(yu)(yu)蛋(dan)白質檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)糖類(lei)檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)激素檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)酶類(lei)檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)酯(zhi)類(lei)檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)維(wei)生(sheng)素檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)無機(ji)離子檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)藥(yao)物(wu)(wu)(wu)及(ji)藥(yao)物(wu)(wu)(wu)代謝物(wu)(wu)(wu)檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)自身抗(kang)體(ti)(ti)檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)微(wei)生(sheng)物(wu)(wu)(wu)鑒別(bie)或藥(yao)敏試(shi)(shi)(shi)(shi)(shi)(shi)(shi)驗的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；用(yong)(yong)(yong)于(yu)(yu)其(qi)他生(sheng)理、生(sheng)化或免疫(yi)功(gong)能指標檢(jian)(jian)(jian)測(ce)(ce)(ce)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)。3、第三類(lei)體(ti)(ti)外診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)：包括(kuo)與(yu)(yu)致病性(xing)病原體(ti)(ti)抗(kang)原、抗(kang)體(ti)(ti)以及(ji)核酸等(deng)(deng)檢(jian)(jian)(jian)測(ce)(ce)(ce)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)血型(xing)、組織(zhi)配型(xing)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)人類(lei)基因檢(jian)(jian)(jian)測(ce)(ce)(ce)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)遺傳性(xing)疾病相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)麻醉藥(yao)品(pin)、精神(shen)藥(yao)品(pin)、醫療用(yong)(yong)(yong)毒性(xing)藥(yao)品(pin)檢(jian)(jian)(jian)測(ce)(ce)(ce)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)治療藥(yao)物(wu)(wu)(wu)作用(yong)(yong)(yong)靶(ba)點檢(jian)(jian)(jian)測(ce)(ce)(ce)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)腫瘤標志物(wu)(wu)(wu)檢(jian)(jian)(jian)測(ce)(ce)(ce)相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)；與(yu)(yu)變態(tai)反應（過敏原）相(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)。
肯帝亞
美爾固
格蘭
龍勝
鵬鴻
板川
歐肯
頂上
萬嘉
科凡
