Siv NEJM Group cov ntaub ntawv thiab cov kev pabcuam los npaj los ua tus kws kho mob, sau cov kev paub, coj lub koom haum saib xyuas kev noj qab haus huv thiab txhawb nqa koj txoj haujlwm.
Thaum Lub Ib Hlis 2020, US Food and Drug Administration (FDA) tau pib xav txog Asmeskas cov lus teb rau Covid-19.Thaum Lub Ob Hlis 4, tom qab tshaj tawm qhov xwm txheej kev noj qab haus huv rau pej xeem, peb tau pib tso cai rau kev kuaj mob txhawm rau txheeb xyuas cov kab mob nquag.Thaum muaj xwm txheej ceev, FDA tuaj yeem tso cai siv thaum muaj xwm txheej ceev (EUA) rau cov khoom kho mob raws li kev tshuaj xyuas cov pov thawj tshawb fawb.Kev lees txais cov qauv EUA qis dua, tsis yog tos kom pom zoo tag nrho kom tau txais cov pov thawj dav dav, tuaj yeem ua kom tau txais cov kev xeem raug.Tom qab tshaj tawm cov xwm txheej asymptomatic, nws yog qhov tseeb tias peb yuav tsum tau siv lwm cov tswv yim kom nkag siab txog qhov tseeb ntawm kev sib kis ntawm SARS-CoV-2 thoob plaws lub tebchaws.Thaum muaj tus kab mob kis dhau los, kev kuaj serological (piv txwv li, tshuaj tiv thaiv kab mob) tsis tau ua lossis siv tsawg.Txawm li cas los xij, nyob rau hauv rooj plaub no, FDA lees paub tias ua kom muaj kev nkag tau sai thiab tsim nyog rau kev kuaj serological hauv Tebchaws Meskas tuaj yeem txhawb nqa kev tshawb fawb thiab kev nkag siab ntawm Covid-19, yog li pab teb rau lub tebchaws.
Kev ntsuam xyuas serological tuaj yeem kuaj pom lub cev hloov kho lub cev tiv thaiv kab mob rau cov kab mob yav dhau los.Yog li, kev kuaj serological ib leeg tsis tuaj yeem txiav txim siab seb tus neeg puas tau kis tus kabmob SARS-CoV-2 tam sim no.Tsis tas li ntawd, txawm hais tias qhov kev paub ntawm lwm cov kab mob tau pom tias muaj SARS-CoV-2 cov tshuaj tiv thaiv kab mob tuaj yeem ua rau qee qhov kev tiv thaiv rov qab los, peb tsis paub tias puas muaj cov tshuaj tiv thaiv kab mob?Los yog ib theem ntawm cov tshuaj tiv thaiv?Nws txhais tau hais tias ib tug neeg muaj kev tiv thaiv kab mob rov qab, thiab yog tias muaj, qhov kev tiv thaiv no yuav kav ntev npaum li cas?
Txhawm rau kom yooj yim rau kev nkag mus rau qhov kev ntsuam xyuas serological thaum ntxov los ntawm lub chaw soj nstuam thiab cov kws kho mob, FDA tau tshaj tawm cov lus qhia thaum Lub Peb Hlis 16. Cov lus qhia tso cai rau cov neeg tsim khoom txhawb nqa lawv cov kev sim yam tsis muaj EUA.Tsuav qhov kev xeem dhau qhov kev pov thawj, lawv yuav raug ceeb toom.FDA, thiab daim ntawv tshaj tawm kev xeem muaj cov ntaub ntawv tseem ceeb txog kev txwv, suav nrog cov lus hais tias qhov kev sim tsis tau raug tshuaj xyuas los ntawm FDA thiab cov txiaj ntsig tsis tuaj yeem siv los kuaj lossis txiav txim tsis muaj kab mob.1
Thaum lub sij hawm, kev ntsuam xyuas serological feem ntau tsis yog siv hauv kev saib xyuas neeg mob.Peb siv lwm yam kev tiv thaiv los ntawm kev txwv tsis pub siv rau cov chaw kuaj mob uas tau lees paub los ntawm Medicare thiab Medicaid Services Centers los ua qhov kev sim siab nyuaj raws li Kev Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Mob (CLIA).Cov chaw soj nstuam no muaj cov neeg ua haujlwm tshwj xeeb uas xav txog qhov kev xeem ua tau zoo thiab xaiv qhov kev xeem zoo tshaj plaws rau lub hom phiaj.Cov chaw tsim khoom lag luam uas npaj siab yuav siv cov kev ntsuam xyuas serological hauv tsev lossis ntawm qhov chaw saib xyuas (xws li kws kho mob) (tshwj tsis yog tias lawv tau txais kev tiv thaiv los ntawm lub chaw soj nstuam daim ntawv pov thawj CLIA) tseem yuav tsum xa daim ntawv thov EUA thiab tau tso cai los ntawm FDA rau lawv qhov kev sim.Peb npaj yuav tshuaj xyuas txoj cai no tom qab ob peb qhov kev ntsuam xyuas serological tau tso cai.Txawm li cas los xij, hauv kev pom tom qab, peb pom tau tias cov cai teev tseg hauv peb lub Peb Hlis 16 cov lus qhia tsis raug.
Txog thaum kawg ntawm lub Peb Hlis, 37 cov tuam txhab lag luam tau ceeb toom rau FDA ntawm lawv qhov kev qhia txog kev kuaj serological rau hauv Asmeskas kev lag luam.FDA tau txais EUA qhov kev thov rau kev kuaj serological thiab tau pib tso cai thawj zaug rau lub Plaub Hlis.Txawm li cas los xij, thaum pib lub Plaub Hlis, tsoomfwv cov neeg ua haujlwm tau pib tshaj tawm cov txiaj ntsig ntawm cov kev sim no ntawm kev rov qhib kev lag luam thiab muab kev pov hwm rau kev siv uas tsis tau txais kev txhawb nqa los ntawm kev tshawb fawb thiab tsis ua raws li cov kev txwv los ntawm FDA.Raws li qhov tshwm sim, kev ua lag luam raug dej nyab nrog kev ntsuas serological, qee qhov tau txais txiaj ntsig tsis zoo, thiab ntau yam raug muag hauv txoj hauv kev uas cuam tshuam FDA cov cai.Thaum kawg ntawm lub Plaub Hlis, 164 cov tuam txhab lag luam tau ceeb toom rau FDA tias lawv tau ua qhov kev ntsuam xyuas serological.Cov xwm txheej no txawv ntawm peb qhov kev paub dhau los hauv kev lag luam kev kuaj mob.Hauv qhov no, ob peb qhov kev xeem raug muab raws li kev ceeb toom;manufacturers feem ntau txhawb lawv tus kheej cov kev ntsuam xyuas es tsis txhob teev cov khoom ua los ntawm lwm yam, feem ntau tsis yog-US manufacturers, zoo li tej yam serological xeem;Cov ntaub ntawv cuav thiab cov ntaub ntawv muaj tsawg dua ntawm kev cuam tshuam.
Thaum Lub Plaub Hlis 17, FDA tau tshaj tawm tsab ntawv rau cov kws kho mob piav qhia tias qee tus neeg tsim khoom tau ua phem rau daim ntawv ceeb toom cov khoom siv tshuaj ntsuam xyuas kom tsis raug lees tias lawv cov kev sim tau pom zoo lossis tso cai los ntawm lub koom haum.2 Txawm hais tias muaj ntau dua 200 tus neeg tsim tshuaj ntsuam xyuas reagent, FDA tau yeem xa EUA lossis cov phiaj xwm xa EUA, yog li FDA tau hloov nws txoj cai rau lub Tsib Hlis 4 kom peb tuaj yeem soj ntsuam cov hauv paus kev tshawb fawb ntawm txhua qhov kev lag luam xa tawm kev sim thiab ntsuas nws cov txiaj ntsig. Kev sib deev.3 Raws li Lub Ob Hlis 1, 2021, FDA tau tso tseg qhov kev pom zoo.Cov npe ntawm 225 qhov kev xeem tau teev tseg los ntawm peb lub vev xaib, 15 tsab ntawv ceeb toom tau tshaj tawm, thiab cov lus ceeb toom ua txhaum cai raug xa mus rau 88 tuam txhab.
Nyob rau tib lub sijhawm, txij li lub Peb Hlis, FDA tau koom tes nrog National Institutes of Health (NIH), Lub Chaw Tiv Thaiv Kab Mob thiab Tiv Thaiv, thiab Lub Tsev Haujlwm Saib Xyuas Kev Tshawb Fawb thiab Kev Loj Hlob hauv Biomedicine los pab National Cancer Institute (NCI) tsim kom muaj peev xwm ntsuas serology.Txhawm rau pab qhia FDA cov kev txiav txim siab txog kev ntsuas tus kheej (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - kits-part-validation).Pab neeg soj ntsuam sib sau ua ke los ntawm NCI muaj 30 khov SARS-CoV-2 cov qauv tshuaj tiv thaiv kab mob zoo thiab 80 khov tshuaj tiv thaiv kab mob tsis zoo thiab cov tshuaj tiv thaiv coagulated citrate qabzib cov qauv A plasma kuaj.Qhov loj thiab muaj pes tsawg leeg ntawm lub vaj huam sib luag tau raug xaiv los ua kom muaj kev soj ntsuam raws li kev soj ntsuam thiab muab kev kwv yees tsim nyog thiab kev ntseeg siab rau qhov kev sim ua tau zoo raws li qhov muaj cov qauv tsawg.Txoj haujlwm no yog thawj zaug uas tsoomfwv tau ua qhov kev ntsuas tus kheej los qhia rau FDA ntawm kev tso cai.Tom qab ntawd, Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv Hauv Tebchaws (NIH) tau siv nws txoj kev sib raug zoo nrog lub chaw kawm los ua qhov kev ntsuam xyuas ua ntej ntawm kev cog lus ntawm cov ntsiab lus ntawm kev saib xyuas thiab tsev Covid-19 kev kuaj mob nyob rau hauv nws txoj haujlwm RADx (Rapid Diagnostic Acceleration).4
Peb yav dhau los tau hais txog peb qhov kev paub dhau los hauv Covid-19 kev kuaj mob.5 Qhov tseeb thiab cov neeg koom nrog-thiab FDA qhov kev ua?Qhov xwm txheej ntawm kev xeem serological kuj txawv, thiab cov lus qhia peb tau kawm kuj txawv.
Ua ntej, peb cov kev paub dhau los hauv kev kuaj serological qhia txog qhov tseem ceeb ntawm kev tso cai ywj pheej ntawm cov khoom kho mob raws li kev tshawb fawb zoo, thiab tsis tso cai rau cov khoom kuaj tsis raug tso cai nkag mus rau hauv kev ua lag luam.Paub tias peb tam sim no paub dab tsi, txawm tias tsis muaj kev txwv peb thawj zaug, peb yuav tsis tso cai rau kev soj ntsuam serological yam tsis muaj FDA tshuaj xyuas thiab kev tso cai.Txawm hais tias lwm yam yuav ua rau muaj dej nyab ntawm cov khoom tsis raug tso cai rau hauv kev ua lag luam, peb lub Peb Hlis 16 txoj cai tso cai rau qhov no tshwm sim.
Qhov thib ob, raws li ib feem ntawm txoj kev npaj muaj kev sib kis, tsoomfwv yuav tsum koom tes nrog kev npaj cov kev tshawb fawb pej xeem-tsim nyog los daws cov teeb meem kev sib kis uas cuam tshuam txog kev kis tus kabmob thiab kev tiv thaiv kabmob thaum ntxov ntawm kev kis tus kabmob.Kev sib koom ua ke yuav pab kom ntseeg tau tias cov kev tshawb fawb tsim nyog tau ua tiav raws sijhawm, txo qis kev tshawb fawb kom tsawg, thiab siv tag nrho tsoomfwv cov peev txheej.
Thib peb, peb yuav tsum tsim kom muaj peev xwm los ntsuas qhov kev ntsuas kev ua tau zoo hauv tsoomfwv lossis sawv cev ntawm tsoomfwv ua ntej muaj kev sib kis, kom kev soj ntsuam ywj pheej tuaj yeem ua tiav sai thaum muaj kev sib kis.Peb txoj kev koom tes nrog NCI tau qhia peb txog tus nqi ntawm txoj hauv kev no.Ua ke nrog kev tso cai los ntawm FDA, lub tswv yim no tuaj yeem tso cai rau kev soj ntsuam sai thiab ywj pheej ntawm qhov raug ntawm kev kuaj kab mob molecular, kuaj antigen thiab serological, thiab txo qis qhov xav tau rau cov neeg tsim khoom los nrhiav cov neeg mob cov qauv lossis lwm yam kev kuaj mob los kuaj xyuas lawv cov kev sim, yog li ua kom muaj kev siv tau zoo. kuaj tau zoo dua.Tsoomfwv tseem yuav tsum txiav txim siab siv txoj hauv kev no rau cov thev naus laus zis uas siv sab nraud ntawm kev sib kis.Piv txwv li, NIH's RADx program tuaj yeem txuas ntxiv thiab nthuav dav dhau Covid-19.Nyob rau lub sijhawm ntev, peb xav tau ib txoj hauv kev los txheeb xyuas cov qauv tsim thiab kev ua haujlwm.
Plaub, lub zej zog kev tshawb fawb thiab kev kho mob yuav tsum nkag siab txog lub hom phiaj thiab kev siv tshuaj ntsuam xyuas serological, thiab yuav ua li cas siv cov txiaj ntsig kev ntsuas kom tsim nyog los qhia txog kev saib xyuas neeg mob.Nrog rau kev txhim kho kev paub txog kev tshawb fawb, kev kawm tas mus li yog qhov tseem ceeb hauv kev teb rau pej xeem kev noj qab haus huv thaum muaj xwm txheej ceev, tshwj xeeb tshaj yog xav tias cov txheej txheem kuaj serological yog siv tsis raug rau kev kuaj mob, thiab cov neeg uas muaj tus kab mob tsawg yuav siv ib txoj hauv kev sim.Yuav muaj cov txiaj ntsig tsis zoo thiab pom kev tiv thaiv kab mob.Peb txoj kev sim yuav tsum tau hloov kho tas li thiab coj los ntawm kev tshawb fawb ntseeg tau.
Thaum kawg, txhua tus neeg koom nrog hauv cov lus teb rau kev noj qab haus huv rau pej xeem xwm txheej ceev yuav tsum tau txais cov ntaub ntawv zoo dua sai dua.Ib yam li cov kws kho mob tau sim nkag siab sai npaum li cas Covid-19 cuam tshuam rau cov neeg mob thiab yuav ua li cas kho cov neeg mob zoo tshaj plaws, FDA yuav tsum hloov kho kom raug txwv thiab hloov kho cov ntaub ntawv, tshwj xeeb tshaj yog nyob rau theem pib ntawm qhov tshwm sim.Kev tsim lub suab thiab kev sib koom tes hauv lub tebchaws thiab thoob ntiaj teb cov txheej txheem los sau cov pov thawj thiab sau, sib qhia thiab tshaj tawm cov ntaub ntawv yog qhov tseem ceeb rau kev xaus kev sib kis tam sim no thiab teb rau cov xwm txheej kev noj qab haus huv rau pej xeem yav tom ntej.
Saib tom ntej, raws li kev sib kis loj zuj zus tuaj, FDA yuav txuas ntxiv ntsuas los xyuas kom meej tias cov tshuaj tiv thaiv kab mob muaj tseeb thiab txhim khu kev qha tau muab raws sijhawm kom tau raws li cov kev xav tau ntawm pej xeem kev noj qab haus huv.
1. Food and Drug Administration.Txoj cai rau kev kuaj mob rau tus kab mob 2019 tus kab mob coronavirus hauv pej xeem kev noj qab haus huv xwm txheej ceev.Lub Peb Hlis 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Food and Drug Administration.Tsab ntawv rau cov kws kho mob hais txog cov ntaub ntawv tseem ceeb txog kev siv serology (antibodies) txhawm rau txheeb xyuas COVID-19.Lub Plaub Hlis 17, 2020 (hloov kho rau Lub Rau Hli 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19 - tsab ntawv mus rau tus kws kho mob).
3. Shah A and Shuren J.Kawm paub ntxiv txog FDA txoj cai kho cov tshuaj tiv thaiv kab mob: Ua ntej nkag mus thiab raug.Silver Spring, MD, Food and Drug Administration (FDA), Lub Tsib Hlis 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing- access-thiab-accuracy).
4. National Institutes of Health.Rapid Diagnostic Acceleration (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Covid-19 molecular diagnostic test tau kawm ib zaj lus qhia.Phau ntawv Journal of Medicine 2020;383(17): e97-e97 : kuv.
Post lub sij hawm: Mar-10-2021