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)斷試(shi)劑(ji)是(shi)(shi)(shi)指可單(dan)獨使用(yong)或與儀器(qi)、器(qi)具、設備或系統組合使用(yong),在(zai)疾病(bing)的(de)預防、診(zhen)斷、治療(liao)(liao)監測、預后觀察、健康狀(zhuang)態評價以及遺傳性疾病(bing)的(de)預測過程中,用(yong)于(yu)(yu)對人體(ti)(ti)樣本(各種體(ti)(ti)液(ye)、細胞、組織樣本等(deng))進行體(ti)(ti)外(wai)(wai)檢(jian)測的(de)試(shi)劑(ji)、試(shi)劑(ji)盒、校準(zhun)品(pin)(pin)(物)、質控品(pin)(pin)(物)等(deng)。在(zai)我(wo)國,大多數體(ti)(ti)外(wai)(wai)診(zhen)斷試(shi)劑(ji)是(shi)(shi)(shi)按(an)照醫療(liao)(liao)器(qi)械管理的(de),也有部分體(ti)(ti)外(wai)(wai)診(zhen)斷試(shi)劑(ji)是(shi)(shi)(shi)按(an)照藥(yao)品(pin)(pin)管理的(de),按(an)照藥(yao)品(pin)(pin)管理的(de)主要是(shi)(shi)(shi)用(yong)于(yu)(yu)血源篩查的(de)體(ti)(ti)外(wai)(wai)診(zhen)斷試(shi)劑(ji)和采用(yong)放射性核素標記的(de)體(ti)(ti)外(wai)(wai)診(zhen)斷試(shi)劑(ji),這些(xie)產(chan)品(pin)(pin)都不屬于(yu)(yu)醫療(liao)(liao)器(qi)械,其他(ta)的(de)屬于(yu)(yu)醫療(liao)(liao)器(qi)械,根(gen)據情況,體(ti)(ti)外(wai)(wai)診(zhen)斷試(shi)劑(ji)在(zai)二(er)類和三類醫療(liao)(liao)器(qi)械中都有包(bao)含。
三、體外診斷試劑研發流程
1、立項準備(bei)階(jie)(jie)段(duan)(duan)(duan)(duan):包(bao)括立項調研(yan)、立項評(ping)估、設計(ji)輸入(ru)等。首(shou)先需要(yao)確(que)定(ding)立項的(de)(de)(de)(de)(de)方向,包(bao)括待測靶(ba)標、預期用(yong)途(tu)、應(ying)用(yong)場景(jing)等。其次(ci)是(shi)(shi)明確(que)市(shi)場容(rong)量和(he)應(ying)用(yong)前景(jing),包(bao)括相(xiang)應(ying)疾(ji)病的(de)(de)(de)(de)(de)發(fa)(fa)病率,以(yi)及(ji)市(shi)場上(shang)(shang)是(shi)(shi)否具有同類產(chan)品(pin)(pin)上(shang)(shang)市(shi)即(ji)(ji)競品(pin)(pin)情況分析。確(que)定(ding)好方向后(hou),需要(yao)查閱大量文獻及(ji)行業報(bao)(bao)道,做(zuo)到充分了解(jie)靶(ba)標研(yan)究進(jin)展和(he)應(ying)用(yong),確(que)認檢(jian)測方法和(he)技術的(de)(de)(de)(de)(de)可行性(xing),以(yi)及(ji)確(que)認設備(bei)環(huan)境條(tiao)件、項目(mu)開發(fa)(fa)人(ren)員職能和(he)組成(cheng)(cheng)等。2、產(chan)品(pin)(pin)研(yan)制階(jie)(jie)段(duan)(duan)(duan)(duan):完成(cheng)(cheng)立項后(hou),即(ji)(ji)可啟動(dong)體(ti)外診斷(duan)試劑(ji)的(de)(de)(de)(de)(de)研(yan)制階(jie)(jie)段(duan)(duan)(duan)(duan)。研(yan)制前期包(bao)括原材料(liao)(liao)的(de)(de)(de)(de)(de)篩選(xuan)、主要(yao)生(sheng)產(chan)工藝及(ji)反(fan)應(ying)體(ti)系(xi)的(de)(de)(de)(de)(de)研(yan)究和(he)產(chan)品(pin)(pin)驗(yan)(yan)證研(yan)究階(jie)(jie)段(duan)(duan)(duan)(duan)。3、注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)驗(yan)(yan)階(jie)(jie)段(duan)(duan)(duan)(duan):上(shang)(shang)述階(jie)(jie)段(duan)(duan)(duan)(duan)完成(cheng)(cheng)后(hou),即(ji)(ji)可進(jin)入(ru)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)驗(yan)(yan)階(jie)(jie)段(duan)(duan)(duan)(duan),用(yong)GMP廠房連續生(sheng)產(chan)的(de)(de)(de)(de)(de)3批次(ci)試劑(ji)盒(he)進(jin)行注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)驗(yan)(yan)抽樣(yang)申(shen)請(qing)(qing),然后(hou)進(jin)行注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)的(de)(de)(de)(de)(de)檢(jian)定(ding)。這個階(jie)(jie)段(duan)(duan)(duan)(duan)的(de)(de)(de)(de)(de)資(zi)料(liao)(liao)將匯(hui)(hui)總成(cheng)(cheng)產(chan)品(pin)(pin)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)時的(de)(de)(de)(de)(de)文件,即(ji)(ji)《注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)測報(bao)(bao)告》。4、臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)階(jie)(jie)段(duan)(duan)(duan)(duan):拿到注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)檢(jian)驗(yan)(yan)報(bao)(bao)告后(hou),即(ji)(ji)可啟動(dong)臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)階(jie)(jie)段(duan)(duan)(duan)(duan)。臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)階(jie)(jie)段(duan)(duan)(duan)(duan)包(bao)括臨(lin)(lin)(lin)床(chuang)(chuang)前準備(bei)、制定(ding)臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)方案、過(guo)(guo)倫理臨(lin)(lin)(lin)床(chuang)(chuang)協議(yi)簽(qian)署、臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)備(bei)案、臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)實施、臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)總結等。這個階(jie)(jie)段(duan)(duan)(duan)(duan)的(de)(de)(de)(de)(de)資(zi)料(liao)(liao)將匯(hui)(hui)總成(cheng)(cheng)產(chan)品(pin)(pin)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)時的(de)(de)(de)(de)(de)文件,即(ji)(ji)《臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)方案》、《臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)報(bao)(bao)告》。5、注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)審(shen)核(he)階(jie)(jie)段(duan)(duan)(duan)(duan):臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)(yan)完成(cheng)(cheng)后(hou)進(jin)入(ru)的(de)(de)(de)(de)(de)注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)審(shen)核(he)階(jie)(jie)段(duan)(duan)(duan)(duan),是(shi)(shi)國家藥品(pin)(pin)監(jian)督管理局根據注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)申(shen)請(qing)(qing)人(ren)的(de)(de)(de)(de)(de)申(shen)請(qing)(qing),依照(zhao)相(xiang)應(ying)法定(ding)程(cheng)序,對(dui)其擬上(shang)(shang)市(shi)的(de)(de)(de)(de)(de)IVD試劑(ji)的(de)(de)(de)(de)(de)安全性(xing)、有效性(xing)研(yan)究及(ji)其結果進(jin)行系(xi)統評(ping)價,以(yi)決定(ding)是(shi)(shi)否同意其申(shen)請(qing)(qing)的(de)(de)(de)(de)(de)過(guo)(guo)程(cheng)。此階(jie)(jie)段(duan)(duan)(duan)(duan)包(bao)括撰寫提交IVD注(zhu)(zhu)(zhu)冊(ce)(ce)(ce)(ce)申(shen)報(bao)(bao)資(zi)料(liao)(liao)、體(ti)系(xi)考核(he)、根據發(fa)(fa)補(bu)(bu)(bu)通知(zhi)單進(jin)行相(xiang)應(ying)發(fa)(fa)補(bu)(bu)(bu)工作、發(fa)(fa)補(bu)(bu)(bu)資(zi)料(liao)(liao)提交。以(yi)上(shang)(shang)所有審(shen)核(he)通過(guo)(guo)后(hou),即(ji)(ji)可獲證。
四、體外診斷試劑包括哪些
1、第一類(lei)體(ti)外(wai)診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji):包(bao)(bao)(bao)括微生(sheng)物(wu)(wu)培養基(不用(yong)(yong)(yong)于(yu)(yu)微生(sheng)物(wu)(wu)鑒別和(he)藥敏(min)試(shi)(shi)(shi)(shi)(shi)(shi)驗(yan)(yan))。 和(he)樣本處理用(yong)(yong)(yong)產品,如溶血(xue)劑(ji)(ji)(ji)(ji)(ji)、稀釋液(ye)、染色液(ye)等(deng)。2、第二類(lei)體(ti)外(wai)診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji):包(bao)(bao)(bao)括用(yong)(yong)(yong)于(yu)(yu)蛋(dan)白質(zhi)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(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)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(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)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(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)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(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)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)維生(sheng)素檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)無機離子檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)藥物(wu)(wu)及藥物(wu)(wu)代謝物(wu)(wu)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)自身抗體(ti)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)微生(sheng)物(wu)(wu)鑒別或藥敏(min)試(shi)(shi)(shi)(shi)(shi)(shi)驗(yan)(yan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);用(yong)(yong)(yong)于(yu)(yu)其他生(sheng)理、生(sheng)化或免疫(yi)功能指標檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)。3、第三類(lei)體(ti)外(wai)診斷(duan)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji):包(bao)(bao)(bao)括與(yu)(yu)致病性(xing)病原體(ti)抗原、抗體(ti)以及核酸(suan)等(deng)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)血(xue)型、組織配型相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)人(ren)類(lei)基因(yin)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(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)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)麻醉藥品、精神藥品、醫(yi)療(liao)(liao)用(yong)(yong)(yong)毒性(xing)藥品檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)治療(liao)(liao)藥物(wu)(wu)作用(yong)(yong)(yong)靶點檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)腫(zhong)瘤標志物(wu)(wu)檢(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)測(ce)(ce)(ce)(ce)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji);與(yu)(yu)變態(tai)反應(過敏(min)原)相(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)關(guan)(guan)的(de)(de)(de)(de)(de)試(shi)(shi)(shi)(shi)(shi)(shi)劑(ji)(ji)(ji)(ji)(ji)。