Jiri ozi na ọrụ NEJM Group dị njikere ịghọ dọkịta, kpakọba ihe ọmụma, duo otu nlekọta ahụike yana kwalite mmepe ọrụ gị.
Na Jenụwarị 2020, nchịkwa nri na ọgwụ US (FDA) malitere ịtụle nzaghachi US na Covid-19.Na Febụwarị 4, ka anyị kwupụtachara ihe mberede ahụike ọha, anyị malitere inye ikike nyocha iji chọpụta ọrịa na-arụ ọrụ.N'ọnọdụ mberede dị otú ahụ, FDA nwere ike inye ikike iji ihe mberede (EUA) maka ngwaahịa ahụike dabere na nyocha nke akaebe sayensị.Ịnabata ụkpụrụ EUA dị ala, kama ichere nkwado zuru oke iji nweta ihe akaebe sara mbara, nwere ike ime ngwa ngwa nke ịnweta ule ziri ezi.Ka anyị kwuchara okwu asymptomatic, o doro anya na anyị kwesịrị ịmalite usoro ndị ọzọ iji ghọta ezi mgbasa nke SARS-CoV-2 n'ofe obodo ahụ.N'oge ntiwapụ nke nje gara aga, emebeghị nnwale serological (ya bụ, antibody) ma ọ bụ nwee oke ojiji.Agbanyeghị, na nke a, FDA ghọtara na ịgba mbọ hụ na ịnweta nnwale serological ngwa ngwa na zuru oke na United States nwere ike ịkwalite nyocha sayensị na nghọta nke Covid-19, si otú a na-enyere aka ịzaghachi obodo ahụ.
Nnwale serological nwere ike ịchọpụta mmeghachi omume mgbochi nke anụ ahụ maka ọrịa ndị gara aga.Yabụ, naanị nnwale serological enweghị ike ikpebi ma mmadụ bu ọrịa SARS-CoV-2 ugbu a.Na mgbakwunye, ọ bụ ezie na ahụmịhe nke nje ndị ọzọ egosila na ọnụnọ nke ọgwụ mgbochi SARS-CoV-2 nwere ike inye ụfọdụ nchebe megide ịmaliteghachi, anyị amaghị ma enwere ọgwụ mgbochi ọ bụla?Ma ọ bụ ọkwa ụfọdụ nke ọgwụ nje?Ọ pụtara na mmadụ nwere ihe mgbochi iji nwetaghachi ọrịa, ma ọ bụrụ otú ahụ, ogologo oge ole ka mgbochi a ga-adịru?
Iji mee ka ohere ịnweta ule serological n'oge site na ụlọ nyocha na ndị na-ahụ maka ahụike, FDA nyere ụkpụrụ nduzi na March 16. Ntuziaka na-enye ndị mmepe ohere ịkwalite ule ha na-enweghị EUA.Ọ bụrụhaala na ule ahụ gafere nkwenye ahụ, a ga-agwa ha.FDA, na akụkọ nyocha ahụ nwere ozi dị mkpa gbasara mmachi, gụnyere nkwupụta na FDA enyochabeghị ule ahụ na nsonaazụ enweghị ike iji chọpụta ma ọ bụ wepụ ọrịa.1
N'oge ahụ, a naghị ejikarị ule serological na nlekọta ndị ọrịa.Anyị na-emejuputa usoro nchebe ndị ọzọ site na igbochi ojiji ya na ụlọ nyocha nke Medicare na Centre Ọrụ Medicaid kwadoro iji mee ule mgbagwoju anya dị ka Clinical Laboratory Improvement Amendment (CLIA) si dị.Ụlọ nyocha ndị dị otú ahụ nwere ndị ọrụ na-atụle kpọmkwem arụmọrụ ule wee họrọ ule kacha mma maka ebumnuche enyere.Ọfịs ndị nrụpụta chọrọ iji ule serological n'ụlọ ma ọ bụ na saịtị nlekọta (dịka ndị dọkịta) (ọ gwụla ma echekwabara ha site na asambodo CLIA ụlọ nyocha) ka ga-edobe ngwa EUA ma FDA nye ya ikike maka nnwale ha.Anyị na-eme atụmatụ inyocha amụma a ka enyere ikike ọtụtụ ule serological.Agbanyeghị, n'ịtụgharị uche, anyị chọpụtara na amụma ndị akọwapụtara na ntuziaka March 16 anyị nwere ntụpọ.
Ka ọ na-erule ngwụsị March, ndị na-emepụta azụmahịa 37 agwala FDA maka iwebata ule serological na ahịa US.FDA natara arịrịọ EUA maka nnwale serological wee malite inye ikike nnwale mbụ n'April.Agbanyeghị, na mbido Eprel, ndị ọrụ gọọmentị malitere ịkọwapụta nsonaazụ ule ndị a nwere na mmeghe nke akụ na ụba ma nye mkpuchi maka ojiji sayensị na-akwadoghị yana emezughị oke FDA setịpụrụ.N'ihi ya, ahịa na-ejupụta na nyocha serological, ụfọdụ n'ime ha enweghị nsonaazụ na-adịghị mma, ọtụtụ na-erekwa n'ụzọ megidere iwu FDA.Ka ọ na-erule ngwụsị Eprel, ndị na-emepụta azụmahịa 164 agwala FDA na ha emeela nnwale serological.Usoro mmemme a dị iche na ahụmịhe anyị na nyocha nyocha nke azụmaahịa.N'okwu a, a na-enye ule ole na ole n'okpuru ọkwa;ndị na-emepụta ihe na-akwalitekarị ule nke ha kama ịdepụta ngwaahịa ndị ọzọ mere, na-abụkarị ndị na-abụghị ndị US, dị ka ụfọdụ ule serological;nkwuputa ụgha na data Enwere ikpe mmejọ dị ntakịrị.
Na Eprel 17, FDA nyere ndị na-ahụ maka ahụike akwụkwọ ozi na-akọwa na ụfọdụ ndị mmepe ejirila ndepụta ngosi ngwa ule serological mee ihe n'ụzọ na-ezighi ezi na-ekwu na ụlọ ọrụ akwadola ma ọ bụ nyere ikike nyocha ha.2 Ọ bụ ezie na e nwere ihe karịrị 200 serological tests reagent mmepe, na FDA ka afọ ofufo nyefere EUA ma ọ bụ na-ezube idobe EUA, otú FDA gbanwere ya amụma na May 4 ka anyị nwere ike inyocha ndị ọkà mmụta sayensị ndabere nke niile azụmahịa ekesa ule na-atụle irè ya. Mmekọahụ.3 Ka ọnwa Febụwarị 1, 2021, FDA akagbuola nkwekọrịta ahụ.Edepụtara ndepụta ule 225 site na webụsaịtị anyị, enyerela akwụkwọ ozi ịdọ aka ná ntị 15, yana ịdọ aka ná ntị mmebi iwu mbubata nye ụlọ ọrụ 88.
N'otu oge ahụ, kemgbe March, FDA anọwo na-arụkọ ọrụ na National Institute of Health (NIH), Ụlọ Ọrụ Maka Nchịkwa na Mgbochi Ọrịa, na Agency for Advanced Research and Development in Biomedicine iji nyere National Cancer Institute (NCI) aka. guzobe ikike inyocha serology.Iji nyere aka kọwaa mkpebi nchịkwa FDA na ule onye ọ bụla (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - ngwa-nkebi- nkwado).Otu nleba anya nke NCI kpọkọtara nwere 30 oyi kpọnwụrụ SARS-CoV-2 antibody-positive serum na 80 oyi kpọnwụrụ antibody-adịghị mma na anticoagulated citrate glucose usoro usoro A plasma sample.Ahọpụtara nha na nhazi nke otu panel iji mee ka nyocha dabere na ụlọ nyocha yana ịnye atụmatụ ezi uche na oge ntụkwasị obi maka ịrụ ọrụ ule n'okpuru obere nlele nlele.Ọrụ a bụ oge mbụ gọọmentị etiti mere nyocha onwe ya iji gwa FDA ikike.N'ikpeazụ, National Institutes of Health (NIH) jiri mmekọrịta ya na ụlọ akwụkwọ agụmakwụkwọ mee nyocha mbụ nke ebe nlekọta na-ekwe nkwa na ule nyocha ụlọ Covid-19 n'okpuru mmemme RADx (Rapid Diagnostic Acceleration).4
Anyị akọwapụtala ahụmịhe anyị na nnwale nyocha nke Covid-19.5 Eziokwu dị mkpa na ndị sonyere-na omume FDA?Ọnọdụ nyocha nke serological dịkwa iche, ihe mmụta anyị mụtakwara dịkwa iche.
Nke mbụ, ahụmịhe anyị na nnwale serological na-emesi ike ịdị mkpa nke ikike nnwere onwe nke ngwaahịa ọgwụ na ezigbo sayensị, yana anaghị ekwe ka ngwaahịa nnwale na-enweghị ikike ịbanye n'ahịa.N'ịmara ihe anyị maara ugbu a, ọbụlagodi na-enweghị ihe mgbochi anyị nyere na mbụ, anyị agaghị ekwe ka nnwale serological na-enweghị nyocha na ikike FDA.Ọ bụ ezie na ihe ndị ọzọ nwere ike ime ka iju mmiri nke ngwaahịa na-enweghị ikike n'ahịa, iwu March 16 anyị na-enye ohere ka nke a mee.
Nke abụọ, dịka akụkụ nke atụmatụ ntiwapụ ahụ, gọọmentị etiti kwesịrị ịhazi nhazi nke mmemme nyocha ọha na eze na nke onwe iji dozie nsogbu ọrịa na-efe efe metụtara mgbasa ọrịa na mgbochi na mmalite mmalite nke ntiwapụ.Mgbalị siri ike ga-enyere aka hụ na a na-eme nyocha dị mkpa n'oge kwesịrị ekwesị, belata ntugharị nyocha, ma jiri akụ gọọmenti etiti mee ihe n'ụzọ zuru ezu.
Nke atọ, anyị kwesịrị ịmepụta ikike iji nyochaa arụmọrụ ule n'ime gọọmentị etiti ma ọ bụ n'aha gọọmenti etiti tupu ntiwapụ ahụ, ka e wee nwee ike ịme nyocha onwe onye ngwa ngwa n'oge ntiwapụ ahụ.Mmekọrịta anyị na NCI egosila anyị uru usoro a bara.Ejikọtara ya na ikike FDA, atụmatụ a nwere ike ikwe ka nyocha ngwa ngwa na nke onwe ya nke izi ezi nke nchọpụta molecular, antigen na serological tests, ma belata mkpa ọ dị maka ndị mmepe ịchọta ụdị ndị ọrịa ma ọ bụ ihe nlele ụlọ ọgwụ ndị ọzọ iji kwado ule ha, si otú ahụ na-eme ka ojiji nke ziri ezi. a na-emeziwanye nnwale.Gọọmenti etiti etiti kwesịrị ịtụle itinye usoro a n'ọrụ na teknụzụ eji eme ihe na-abụghị ọrịa.Dịka ọmụmaatụ, mmemme RADx NIH nwere ike ịga n'ihu wee gbasaa karịa Covid-19.N'ikpeazụ, anyị chọrọ usoro a na-ahụkarị iji nyochaa nhazi ule na arụmọrụ.
Nke anọ, ndị sayensị na ndị ahụike kwesịrị ịghọta ebumnuche na ojiji ụlọ ọgwụ nke nnwale serological, yana otu esi eji nsonaazụ nnwale ahụ nke ọma iji gwa nlekọta ndị ọrịa n'ozuzu ha.Site na mmepe nke ihe ọmụma sayensị, agụmakwụkwọ na-aga n'ihu dị mkpa na nzaghachi mberede ahụike ọha na eze ọ bụla, karịsịa na-atụle na a na-eji usoro nyocha serological eme ihe n'ụzọ na-ezighị ezi maka nchoputa, na ndị nwere obere ọrịa ọrịa nwere ike iji otu usoro nyocha.A ga-enwe nsonaazụ dị mma na-ezighi ezi yana mgbochi mgbochi ọrịa.Ọ dị mkpa ka usoro nyocha anyị na-emelite mgbe niile ma na-eduzi ya site na sayensị a pụrụ ịdabere na ya.
N'ikpeazụ, ndị niile na-etinye aka na nzaghachi mberede ahụike ọha kwesịrị inweta ozi ka mma ngwa ngwa.Dị nnọọ ka ndị ọkachamara n'ịgwọ ahụike na-agbalị ngwa ngwa ịghọta ka Covid-19 si emetụta ndị ọrịa yana otu esi agwọ ndị ọrịa nke ọma, FDA ga-emeghari na ozi nwere oke ma na-agbanwe agbanwe, ọkachasị n'oge mmalite nke ntiwapụ.Ịmepụta ụda na usoro nhazi nke mba na nke mba ụwa iji nakọta ihe akaebe na ịnakọta, kesaa na ikesa ozi dị mkpa maka ịkwụsị ọrịa na-efe efe ugbu a na ịzaghachi ihe mberede ahụike ọha na eze n'ọdịnihu.
N'ile anya n'ihu, ka ọrịa na-efe efe na-etolite, FDA ga-aga n'ihu na-eme ihe iji hụ na a na-enye nnwale mgbochi nke ziri ezi na nke a pụrụ ịdabere na ya n'oge kwesịrị ekwesị iji gboo mkpa ahụike ọha.
1. Nchịkwa nri na ọgwụ.Amụma maka nyocha nyocha maka ọrịa coronavirus 2019 na mberede ahụike ọha.Maachị 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Nchịkwa nri na ọgwụ.Akwụkwọ ozi e degaara ndị na-ahụ maka ahụike gbasara ozi dị mkpa gbasara iji serology (ọgwụ mgbochi ọrịa) iji chọpụta COVID-19.Eprel 17, 2020 (emelitere na June 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19) -akwụkwọ ozi e degaara onye nlekọta ahụike).
3. Shah A na ShurenJ.Mụtakwuo maka amụma nnwale mgbochi mmadụ nke FDA edegharịrị: butere ohere na izi ezi ụzọ.Silver Spring, MD, Nchịkwa nri na ọgwụ ọjọọ (FDA), Mee 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing- ohere-na -nkenke).
4. Ụlọ ọrụ ahụike mba.Ọsọ diagnostic acceleration (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Covid-19 molekul diagnostic test mụtara ihe.Akwụkwọ akụkọ Bekee 2020;383 (17): e97-e97.
Oge nzipu: Mar-10-2021