Gwiritsani ntchito zidziwitso ndi ntchito za NEJM Gulu kukonzekera kukhala dokotala, kudzikundikira chidziwitso, kutsogolera bungwe lazaumoyo ndikulimbikitsa chitukuko cha ntchito yanu.
Mu Januware 2020, US Food and Drug Administration (FDA) idayamba kuganizira momwe US yayankhira Covid-19.Pa february 4, titalengeza za ngozi yapagulu, tidayamba kuloleza kuyezetsa kuti tipeze matenda omwe ali ndi matenda.Pazidzidzi zotere, a FDA atha kupereka chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) pazinthu zachipatala kutengera kuwunika kwaumboni wasayansi.Kutengera miyezo yotsika ya EUA, m'malo modikirira chivomerezo chonse kuti mupeze umboni wokulirapo, kumatha kufulumizitsa liwiro lopeza mayeso olondola.Pambuyo popereka lipoti la milandu ya asymptomatic, zikuwonekeratu kuti tikuyenera kutengera njira zina kuti timvetsetse kufalikira kwenikweni kwa SARS-CoV-2 m'dziko lonselo.M'zaka zam'mbuyomu za kachilomboka, kuyezetsa kwa serological (ie, antibody) sikunachitike kapena kumagwiritsidwa ntchito pang'ono.Komabe, pamenepa, a FDA amazindikira kuti kuwonetsetsa kuti apezeke mwachangu komanso moyenera kuyezetsa ma serological ku United States kumatha kulimbikitsa kafukufuku wasayansi ndi kumvetsetsa kwa Covid-19, potero kuthandizira kuyankha dzikolo.
Kuyeza kwa serological kumatha kuzindikira momwe thupi limayankhira ku matenda am'mbuyomu.Chifukwa chake, kuyesa kwa serological kokha sikungadziwe ngati munthu ali ndi kachilombo ka SARS-CoV-2.Kuphatikiza apo, ngakhale zokumana nazo ma virus ena zawonetsa kuti kupezeka kwa ma antibodies a SARS-CoV-2 kumatha kupereka chitetezo kuti asatengedwenso, sitikudziwa ngati pali ma antibodies?Kapena mlingo wina wa ma antibodies?Zikutanthauza kuti munthu ali ndi chitetezo chokwanira kuti atengedwenso, ndipo ngati ndi choncho, chitetezochi chikhala nthawi yayitali bwanji?
Pofuna kupititsa patsogolo kuyesedwa koyambirira kwa serological kuyezetsa ndi ma laboratories ndi othandizira azaumoyo, a FDA adapereka malangizo pa Marichi 16. Malangizowa amalola opanga kulimbikitsa mayeso awo popanda EUA.Malingana ngati mayeso adutsa chitsimikiziro, adzadziwitsidwa.FDA, ndipo lipoti la mayeso lili ndi chidziwitso chofunikira chokhudza zoletsa, kuphatikiza mawu oti mayesowo sanawunikidwe ndi a FDA ndipo zotsatira zake sizingagwiritsidwe ntchito kuzindikira kapena kuletsa matenda.1
Panthawiyo, kuyesa kwa serological sikunali kugwiritsidwa ntchito posamalira odwala.Timagwiritsa ntchito njira zina zodzitetezera poletsa kugwiritsidwa ntchito kwake kuma laboratories ovomerezeka ndi Medicare ndi Medicaid Services Centers kuti ayesetse movutikira kwambiri malinga ndi Clinical Laboratory Improvement Amendment (CLIA).Ma laboratories oterowo ali ndi ogwira ntchito omwe amaganizira makamaka momwe mayeso amagwirira ntchito ndikusankha mayeso abwino kwambiri pazifukwa zomwe zaperekedwa.Maofesi a Madivelopa omwe akufuna kugwiritsa ntchito mayeso a serological kunyumba kapena kumalo osamalira (monga madotolo) (pokhapokha atatetezedwa ndi satifiketi ya labotale ya CIA) ayenera kutumizabe fomu yofunsira ku EUA ndikuvomerezedwa ndi FDA kuti ayesedwe.Tikukonzekera kuwunikanso ndondomekoyi pambuyo povomerezedwa ndi mayeso angapo a serological.Komabe, poyang'ana m'mbuyo, tidazindikira kuti ndondomeko zomwe zafotokozedwa m'mawu athu a Marichi 16 zinali zolakwika.
Pofika kumapeto kwa Marichi, opanga malonda 37 adadziwitsa a FDA za kuyambitsa kwawo mayeso a serological pamsika waku US.A FDA adalandira pempho la EUA loyesa serological ndipo adayamba kuvomereza kuyesa koyamba mu Epulo.Komabe, koyambirira kwa Epulo, akuluakulu aboma adayamba kuwonetsa zomwe zingachitike chifukwa cha mayesowa pakutsegulanso chuma ndikupereka inshuwaransi pazogwiritsa ntchito zomwe sizikuthandizidwa ndi sayansi komanso zomwe sizikukwaniritsa malire omwe a FDA adakhazikitsa.Zotsatira zake, msika wadzaza ndi mayeso a serological, ena omwe ali ndi zotsatira zoyipa, ndipo ambiri amagulitsidwa m'njira zotsutsana ndi mfundo za FDA.Pofika kumapeto kwa Epulo, opanga malonda 164 adadziwitsa a FDA kuti adayesa mayeso a serological.Zochitika zotsatizanazi ndizosiyana ndi zomwe takumana nazo muzoyesa zamalonda zamalonda.Pankhaniyi, mayesero ochepa amaperekedwa pansi pa chidziwitso;opanga nthawi zambiri amalimbikitsa kuyesa kwawo m'malo molemba zinthu zopangidwa ndi ena, nthawi zambiri omwe si a US, monga mayeso ena a serological;zonena zabodza ndi deta Pali milandu yocheperako yosokoneza.
Pa Epulo 17, a FDA adalemba kalata kwa opereka chithandizo chamankhwala kufotokoza kuti otukula ena adagwiritsa ntchito molakwika mndandanda wazidziwitso za serological test kit kunena zabodza kuti mayeso awo adavomerezedwa kapena kuvomerezedwa ndi bungwe.2 Ngakhale pali oposa 200 opanga ma serological test reagent, a FDA apereka mwakufuna kwawo EUA kapena akufuna kutumiza EUA, kotero a FDA adasintha mfundo zake pa Meyi 4 kuti tithe kuunika maziko asayansi pazoyesa zonse zomwe zafalitsidwa ndikuwunika momwe zimagwirira ntchito. Kugonana.3 Pofika pa febulo 1, 2021, a FDA adaletsa mgwirizanowo.Mndandanda wa mayeso 225 adalembedwa patsamba lathu, makalata 15 ochenjeza adaperekedwa, ndipo machenjezo ophwanya malamulo akunja adaperekedwa kumakampani 88.
Panthawi imodzimodziyo, kuyambira March, FDA yakhala ikugwirizana ndi National Institutes of Health (NIH), Centers for Disease Control and Prevention, ndi Agency for Advanced Research and Development in Biomedicine kuthandiza National Cancer Institute (NCI) kukhazikitsa luso lowunika serology.Kuthandizira kudziwitsa zisankho zamalamulo a FDA pamayeso amunthu payekha (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - zida-gawo-kutsimikizira).Gulu lowunika lomwe laphatikizidwa ndi NCI lili ndi zitsanzo 30 zoziziritsidwa za SARS-CoV-2 zokhala ndi ma antibody-positive seramu ndi 80 zoziziritsa za antibody-negative seramu ndi anticoagulated citrate glucose solution formula A plasma zitsanzo.Kukula ndi kapangidwe ka gululo zidasankhidwa kuti zithandizire kuwunika kochokera ku labotale ndikupereka kuyerekezera koyenera komanso nthawi yodalirika pakuyesa mayeso pansi pa kupezeka kwa zitsanzo zochepa.Ntchitoyi ndi nthawi yoyamba yomwe boma la federal limadziyesa kuti lidziwitse a FDA chilolezo.Pambuyo pake, National Institutes of Health (NIH) idagwiritsa ntchito ubale wake ndi likulu la maphunziro kuti liwunikire koyambirira kwa malo osamalirira komanso mayeso apakhomo a Covid-19 pansi pa pulogalamu yake ya RADx (Rapid Diagnostic Acceleration).4
Tafotokoza kale zomwe takumana nazo poyezetsa matenda a Covid-19.5 Zowona zoyenera ndi omwe atenga nawo mbali-ndi zochita za FDA?Mkhalidwe wa mayeso a serological nawonso ndi wosiyana, ndipo maphunziro omwe taphunzira nawonso ndi osiyana.
Choyamba, zomwe takumana nazo pakuyezetsa serological zimagogomezera kufunikira kwa chilolezo chodziyimira pawokha chamankhwala azachipatala pamaziko omveka asayansi, ndipo salola kuti zinthu zoyesa zosaloleka zilowe pamsika.Podziwa zomwe tikudziwa tsopano, ngakhale popanda zoletsa zomwe tidakhazikitsa poyamba, sitingalole kuyesa kwa serological popanda kuwunikira ndi kuvomerezedwa ndi FDA.Ngakhale zinthu zina zingayambitse kuchuluka kwa zinthu zosaloledwa pamsika, mfundo zathu za Marichi 16 zimalola kuti izi zichitike.
Chachiwiri, monga gawo la ndondomeko ya mliriwu, boma la federal liyenera kugwirizanitsa kukonzekera mapulogalamu a kafukufuku wa anthu wamba kuti athetse vuto la miliri yokhudzana ndi kufalikira kwa matenda ndi chitetezo cha mthupi kumayambiriro kwa mliri.Kuyesayesa kogwirizana kudzathandiza kuonetsetsa kuti kafukufuku wofunikira akuchitidwa panthawi yake, kuchepetsa kubwerezabwereza kafukufuku, ndikugwiritsa ntchito mokwanira chuma cha federal.
Chachitatu, tiyenera kukhazikitsa kuthekera koyesa mayeso mkati mwa boma la feduro kapena m'malo mwa boma zisanachitike, kuti kuwunika kodziyimira pawokha kuchitidwe mwachangu panthawi yomwe yayamba.Mgwirizano wathu ndi NCI watiwonetsa phindu la njirayi.Kuphatikizidwa ndi chilolezo cha FDA, njirayi ikhoza kulola kuwunika mwachangu komanso kodziyimira pawokha kulondola kwa kuyezetsa kwa maselo, kuyesa kwa antigen ndi serological, ndikuchepetsa kufunikira kwa otukula kuti apeze zitsanzo za odwala kapena zitsanzo zina zachipatala kuti zitsimikizire mayeso awo, potero kufulumizitsa Kugwiritsa ntchito molondola. kuyezetsa bwino.Boma liyeneranso kuganizira zogwiritsa ntchito njira imeneyi pa matekinoloje omwe amagwiritsidwa ntchito kunja kwa mliriwu.Mwachitsanzo, pulogalamu ya NIH ya RADx ikhoza kupitilira ndikukulira kupitilira Covid-19.M'kupita kwanthawi, timafunikira njira yofananira yotsimikizira kapangidwe ka mayeso ndi magwiridwe antchito.
Chachinayi, gulu la asayansi ndi azachipatala liyenera kumvetsetsa cholinga ndi kagwiritsidwe ntchito kachipatala poyesa mayeso a serological, komanso momwe angagwiritsire ntchito zotsatira zoyezetsa moyenera kuti adziwitse chisamaliro cha odwala nthawi zonse.Ndi chitukuko cha chidziwitso cha sayansi, maphunziro osalekeza ndi ofunikira pakuyankha kwadzidzidzi kulikonse kwaumoyo wa anthu, makamaka poganizira kuti njira zoyesera za serological zimagwiritsidwa ntchito molakwika pozindikira, ndipo anthu omwe ali ndi matenda otsika amatha kugwiritsa ntchito njira imodzi yoyesera.Padzakhala zotsatira zabwino zabodza komanso chitetezo chokwanira ku matenda.Njira zathu zoyesera ziyenera kusinthidwa nthawi zonse ndikutsogoleredwa ndi sayansi yodalirika.
Pomaliza, maphwando onse omwe akukhudzidwa ndi chithandizo chadzidzidzi cha anthu ayenera kudziwa zambiri mwachangu.Monga momwe akatswiri azachipatala akuyesa kumvetsetsa momwe Covid-19 imakhudzira odwala komanso momwe angathandizire odwala, a FDA akuyenera kusinthira ku chidziwitso chochepa komanso chosinthika, makamaka kumayambiriro kwa mliri.Kukhazikitsa njira zomveka bwino komanso zogwirizana zamayiko ndi mayiko kuti asonkhanitse umboni ndikusonkhanitsa, kugawana ndi kufalitsa zidziwitso ndikofunikira kuti athetse mliri womwe ulipo komanso kuthana ndi ngozi zadzidzidzi zamtsogolo.
Kuyang'ana m'tsogolo, pamene mliri ukukula, a FDA apitiliza kuchitapo kanthu kuti awonetsetse kuti mayeso olondola komanso odalirika a antibody akuperekedwa munthawi yake kuti akwaniritse zosowa zapagulu.
1. Food and Drug Administration.Ndondomeko yoyezetsa matenda a matenda a coronavirus a 2019 pazidzidzi zadzidzidzi.Marichi 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Food and Drug Administration.Kalata yopita kwa othandizira azaumoyo zokhudzana ndi chidziwitso chofunikira chokhudza kagwiritsidwe ntchito ka serology (ma antibodies) kuti azindikire COVID-19.Epulo 17, 2020 (zosinthidwa pa Juni 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 -kalata yopita kwa azaumoyo).
3. Shah A ndi ShurenJ.Phunzirani zambiri za malamulo owunikiridwa a FDA oyesa antibody: Ikani patsogolo mwayi wopezeka ndi kulondola.Silver Spring, MD, Food and Drug Administration (FDA), Meyi 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy -antibody-tests-prioritizing- kupeza-ndi -kulondola).
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 kuyezetsa matenda a maselo aphunzirapo kanthu.The English Journal of Medicine 2020;383 (17): e97-e97.
Nthawi yotumiza: Mar-10-2021