Yi amfani da bayanan ƙungiyar NEJM da sabis don shirya don zama likita, tara ilimi, jagoranci ƙungiyar kiwon lafiya da haɓaka haɓaka aikinku.
A cikin Janairu 2020, Hukumar Abinci da Magunguna ta Amurka (FDA) ta fara yin la'akari da martanin Amurka ga Covid-19.A ranar 4 ga Fabrairu, bayan sanar da gaggawar lafiyar jama'a, mun fara ba da izinin gwaje-gwaje don gano cututtukan da ke aiki.A cikin irin wannan gaggawar, FDA na iya ba da izinin yin amfani da gaggawa (EUA) don samfuran likita bisa nazarin shaidar kimiyya.Yarda da ƙananan ƙa'idodin EUA, maimakon jiran cikakken izini don samun ƙarin shaida, na iya hanzarta saurin samun ingantattun gwaje-gwaje.Bayan bayar da rahoton maganganun asymptomatic, a bayyane yake cewa muna buƙatar ɗaukar wasu dabaru don fahimtar gaskiyar yaduwar SARS-CoV-2 a duk faɗin ƙasar.A lokacin barkewar kwayar cutar da ta gabata, ba a yi gwajin serological (watau antibody) ba ko amfani da iyaka.Koyaya, a wannan yanayin, FDA ta fahimci cewa tabbatar da saurin isashen damar yin gwajin jini a cikin Amurka na iya haɓaka binciken kimiyya da fahimtar Covid-19, ta haka yana taimakawa wajen ba da amsa ga ƙasar.
Gwajin serological na iya gano martanin da ya dace na rigakafi na jiki ga cututtukan da suka gabata.Don haka, gwajin serological kadai ba zai iya tantance ko a halin yanzu mutum yana kamuwa da SARS-CoV-2 ba.Bugu da ƙari, kodayake ƙwarewar wasu ƙwayoyin cuta ta nuna cewa kasancewar ƙwayoyin rigakafin SARS-CoV-2 na iya ba da wasu kariya daga sake kamuwa da cuta, ba mu san ko akwai wasu ƙwayoyin rigakafi ba?Ko wani matakin antibodies?Yana nufin cewa mutum yana da rigakafi don sake kamuwa da cutar, kuma idan haka ne, har yaushe wannan rigakafin zai kasance?
Don sauƙaƙe samun damar yin gwajin jini da wuri ta dakunan gwaje-gwaje da masu ba da kiwon lafiya, FDA ta ba da jagororin a ranar 16 ga Maris. Sharuɗɗan sun ba da damar masu haɓakawa don haɓaka gwajin su ba tare da EUA ba.Muddin gwajin ya wuce tabbatarwa, za a sanar da su.FDA, da rahoton gwajin ya ƙunshi mahimman bayanai game da hane-hane, gami da sanarwa cewa FDA ba ta sake nazarin gwajin ba kuma ba za a iya amfani da sakamakon don tantance ko kawar da cututtuka ba.1
A lokacin, ba a saba amfani da gwajin serological a kulawar haƙuri ba.Muna aiwatar da wasu matakan kariya ta hanyar hana amfani da shi zuwa dakunan gwaje-gwaje da Cibiyoyin Sabis na Medicare da Medicaid suka amince da su don yin gwaje-gwaje masu yawa daidai da Canjin Inganta Ayyukan Lafiya na Clinical (CLIA).Irin waɗannan dakunan gwaje-gwaje suna da ma'aikata waɗanda ke yin la'akari da aikin gwaji na musamman kuma suna zaɓar mafi kyawun gwaji don wata manufa.Ofisoshin masu haɓaka waɗanda ke da niyyar yin amfani da gwaje-gwajen serological a gida ko wurin kulawa (misali likitoci) (sai dai idan an kiyaye su da takardar shaidar CLIA na dakin gwaje-gwaje) dole ne har yanzu gabatar da aikace-aikacen EUA kuma FDA ta ba su izini don gwajin su.Muna shirin yin bitar wannan manufar bayan an ba da izinin gwaje-gwajen serological da yawa.Koyaya, idan muka duba, mun fahimci cewa manufofin da aka zayyana a cikin jagororinmu na Maris 16 suna da kurakurai.
A ƙarshen Maris, masana'antun kasuwanci 37 sun sanar da FDA game da ƙaddamar da gwajin jini a cikin kasuwar Amurka.FDA ta karɓi buƙatar EUA don gwajin serological kuma ta fara ba da izinin gwajin farko a cikin Afrilu.Koyaya, a farkon Afrilu, jami'an gwamnati sun fara yin la'akari da yuwuwar tasirin waɗannan gwaje-gwajen kan sake buɗe tattalin arziƙin tare da ba da inshora don amfani waɗanda ba su da tallafin kimiyya kuma ba su cika iyakokin da FDA ta gindaya ba.Sakamakon haka, kasuwar ta cika da gwaje-gwajen serological, wasu daga cikinsu suna da sakamako mara kyau, kuma ana siyar da da yawa ta hanyoyin da suka saba wa manufofin FDA.A ƙarshen Afrilu, masana'antun kasuwanci 164 sun sanar da FDA cewa sun yi gwajin serological.Wannan jerin abubuwan da suka faru sun bambanta da kwarewarmu a cikin gwaje-gwajen bincike na kasuwanci.A wannan yanayin, an ba da ƴan gwaje-gwaje a ƙarƙashin sanarwa;masana'antun yawanci suna haɓaka nasu gwaje-gwaje maimakon lissafin samfuran da wasu ke yi, galibi waɗanda ba na Amurka ba, kamar wasu gwaje-gwajen serological;da'awar karya da bayanai Akwai ƙananan lokuta na lalatawa.
A ranar 17 ga Afrilu, FDA ta ba da wasiƙa ga masu ba da sabis na kiwon lafiya da ke yin bayanin cewa wasu masu haɓakawa sun yi amfani da jerin abubuwan faɗakarwa na gwajin serological don da'awar ƙarya cewa hukumar ta amince ko ba da izini.2 Ko da yake akwai fiye da 200 serological gwajin reagent Developers, da FDA ta son rai sallama EU ko da tsare-tsaren don mika EUA, don haka da FDA canza ta manufofin a kan Mayu 4 domin mu iya kimanta kimiyya tushen duk kasuwanci rarraba gwajin da kimanta ta tasiri. Jima'i3 Tun daga Fabrairu 1, 2021, FDA ta soke yarjejeniyar.An jera jerin gwaje-gwaje 225 daga gidan yanar gizon mu, an ba da wasiƙun gargaɗi 15, an kuma ba da gargaɗin cin zarafin shigo da kaya ga kamfanoni 88.
A lokaci guda kuma, tun daga Maris, FDA ta kasance tare da Cibiyar Kula da Lafiya ta Kasa (NIH), Cibiyoyin Kula da Cututtuka da Rigakafin Cututtuka, da Hukumar Bincike da Ci gaba a Biomedicine don taimakawa Cibiyar Ciwon daji ta Kasa (NCI) kafa ikon kimanta serology.Don taimakawa sanar da hukunce-hukuncen tsari na FDA akan gwaje-gwajen mutum ɗaya (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - kits-bangare-tabbatacce).Tawagar kimantawa da NCI ta tattara ta ƙunshi samfuran SARS-CoV-2 daskararre 30 da samfuran antibody-tabbatacce da 80 daskararre antibody-negative serum da anticoagulated citrate glucose dabaran samfurin plasma.An zaɓi girman da abun da ke cikin kwamitin don ba da damar kimanta tushen dakin gwaje-gwaje da kuma samar da ƙididdiga masu ma'ana da tazarar amincewa don aikin gwaji a ƙarƙashin ƙarancin samuwan samfurin.Wannan aikin shine karo na farko da gwamnatin tarayya ta gudanar da kima don sanar da FDA na izini.Daga baya, Cibiyar Kiwon Lafiya ta Kasa (NIH) ta yi amfani da alakar ta da cibiyar ilimi don gudanar da kimantawa na farko na abubuwan da suka dace na kulawa da gwajin gwajin gida na Covid-19 a karkashin shirinta na RADx (Rapid Diagnostic Acceleration).4
Mun riga mun zayyana kwarewarmu a gwaje-gwajen gwajin Covid-19.5 Abubuwan da suka dace da mahalarta-da ayyukan FDA?Hakanan yanayin gwajin jini ya bambanta, kuma darussan da muka koya ma sun bambanta.
Na farko, ƙwarewarmu a gwajin serological yana jaddada mahimmancin izini mai zaman kansa na samfuran likita bisa ingantaccen tushen kimiyya, kuma baya barin samfuran gwaji marasa izini shiga kasuwa.Sanin abin da muka sani yanzu, ko da ba tare da hane-hane da muka sanya a farko ba, ba za mu ƙyale gwajin serological ba tare da bita da izini na FDA ba.Kodayake wasu dalilai na iya haifar da ambaliya na samfuran da ba a ba da izini ba a cikin kasuwa, manufofinmu na Maris 16 suna ba da damar hakan ya faru.
Na biyu, a wani bangare na shirin barkewar cutar, ya kamata gwamnatin tarayya ta hada kai da shirye-shiryen gudanar da bincike na jama’a da masu zaman kansu domin magance matsalolin da suka shafi yaduwar cututtuka da rigakafi a farkon barkewar cutar.Ƙoƙari na haɗin gwiwa zai taimaka wajen tabbatar da cewa an gudanar da bincike mai mahimmanci a kan lokaci, rage yawan kwafin bincike, da yin cikakken amfani da albarkatun tarayya.
Na uku, ya kamata mu kafa ikon tantance aikin gwaji a cikin gwamnatin tarayya ko a madadin gwamnatin tarayya kafin barkewar cutar, ta yadda za a iya gudanar da tantance masu zaman kansu cikin gaggawa yayin barkewar cutar.Haɗin gwiwar da muka yi da NCI ya nuna mana ƙimar wannan tsarin.Haɗe tare da izini na FDA, wannan dabarar na iya ba da izinin kimanta sauri da zaman kanta na daidaiton ƙwayoyin cuta, antigen da gwaje-gwajen serological, da rage buƙatar masu haɓakawa don nemo samfuran marasa lafiya ko wasu samfuran asibiti don inganta gwaje-gwajen su, don haka haɓaka amfani da ingantaccen amfani. an inganta gwaji.Ya kamata gwamnatin tarayya ta kuma yi la'akari da yin amfani da wannan hanya ga fasahohin da ake amfani da su a wajen annobar.Misali, shirin RADx na NIH na iya ci gaba da fadada sama da Covid-19.A cikin dogon lokaci, muna buƙatar hanyar gama gari don tabbatar da ƙirar gwaji da aiki.
Na hudu, ya kamata al'ummar kimiyya da likitanci su fahimci manufar da amfani da asibiti na gwajin jini, da kuma yadda ake amfani da sakamakon gwajin yadda ya kamata don sanar da kula da marasa lafiya gaba daya.Tare da haɓaka ilimin kimiyya, ci gaba da ilimi yana da mahimmanci a kowane martanin gaggawa na lafiyar jama'a, musamman la'akari da cewa ana amfani da hanyoyin gwajin serological don ganewar asali, kuma mutanen da ke da ƙarancin kamuwa da cuta na iya amfani da hanyar gwaji ɗaya.Za a sami sakamako mai kyau na ƙarya da kuma tsinkayen rigakafi ga kamuwa da cuta.Hanyoyin gwajin mu na buƙatar sabuntawa akai-akai da kuma jagoranci ta hanyar ingantaccen kimiyya.
A ƙarshe, duk ɓangarorin da ke da hannu a cikin matakan gaggawa na lafiyar jama'a suna buƙatar samun ingantattun bayanai cikin sauri.Kamar yadda ƙwararrun likitocin ke ƙoƙarin fahimtar yadda Covid-19 ke shafar marasa lafiya da kuma yadda za a fi kula da marasa lafiya, dole ne FDA ta dace da ƙayyadaddun bayanai da haɓakawa, musamman a farkon matakan fashewa.Ƙirƙirar ingantattun hanyoyin haɗin kai na ƙasa da ƙasa don tattara shaida da tattarawa, rabawa da yada bayanai yana da mahimmanci don kawo ƙarshen cutar ta yanzu da kuma ba da amsa ga gaggawar lafiyar jama'a a nan gaba.
Ana sa ran gaba, yayin da cutar ta bulla, FDA za ta ci gaba da daukar matakai don tabbatar da cewa an samar da ingantattun gwaje-gwajen rigakafin cutar kan lokaci don biyan bukatun lafiyar jama'a.
1. Gudanar da Abinci da Magunguna.Manufar gwajin gwajin cutar coronavirus na 2019 a cikin gaggawar lafiyar jama'a.Maris 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Gudanar da Abinci da Magunguna.Wasika zuwa ga masu ba da lafiya game da mahimman bayanai game da amfani da serology (maganin rigakafi) don gano COVID-19.Afrilu 17, 2020 (an sabunta ta Yuni 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19) -wasika zuwa ga mai kula da lafiya).
3. Shah A dan ShurenJ.Ƙara koyo game da manufofin gwajin rigakafin mutum da FDA ta sake fasalin: Ba da fifiko ga isa da daidaito.Silver Spring, MD, Hukumar Abinci da Magunguna (FDA), Mayu 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing- isa-da-daidai).
4. Cibiyoyin Lafiya na Kasa.Rapid Diagnostic Acceleration (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Gwajin gano kwayoyin cutar Covid-19 ya koyi darasi.Jaridar Turanci ta Magunguna 2020;383 (17): e97-e97.
Lokacin aikawa: Maris-10-2021