Sebelisa lintlha le lits'ebeletso tsa Sehlopha sa NEJM ho itokisetsa ho ba ngaka, ho bokella tsebo, ho etella pele mokhatlo oa tlhokomelo ea bophelo le ho khothaletsa nts'etsopele ea mosebetsi oa hau.
Ka Pherekhong 2020, US Food and Drug Administration (FDA) e ile ea qala ho nahana ka karabelo ea US ho Covid-19.Ka la 4 Hlakola, ka mor'a ho phatlalatsa boemo ba tšohanyetso ba bophelo bo botle ba sechaba, re ile ra qala ho fana ka tumello ea liteko ho bona hore na batho ba tšoaelitsoe joang.Boemong bo joalo ba tšohanyetso, FDA e ka fana ka tumello ea tšebeliso ea tšohanyetso (EUA) bakeng sa lihlahisoa tsa bongaka ho latela tlhahlobo ea bopaki ba mahlale.Ho amohela litekanyetso tse tlase tsa EUA, ho fapana le ho emela tumello e felletseng ho fumana bopaki bo pharaletseng, ho ka potlakisa lebelo la ho fumana liteko tse nepahetseng.Kamora ho tlaleha linyeoe tsa asymptomatic, ho hlakile hore re hloka ho nka maano a mang ho utloisisa phatlalatso ea 'nete ea SARS-CoV-2 naheng ka bophara.Nakong ea ts'oaetso ea vaerase e fetileng, tlhahlobo ea serological (ke hore, antibody) ha e so etsoe kapa e na le ts'ebeliso e fokolang.Leha ho le joalo, ntlheng ena, FDA e hlokomela hore ho netefatsa phihlello e potlakileng le e lekaneng ea tlhahlobo ea serological United States e ka khothaletsa lipatlisiso tsa mahlale le kutloisiso ea Covid-19, ka hona ho thusa ho arabela naha.
Teko ea serological e ka lemoha karabelo ea 'mele ea ho itšireletsa mafung ho ts'oaetso ea nako e fetileng.Ka hona, tlhahlobo ea serological feela e ke ke ea tseba hore na motho ha joale o tšoaelitsoe ke SARS-CoV-2.Ntle le moo, leha boiphihlelo ba livaerase tse ling bo bonts'itse hore boteng ba li-antibodies tsa SARS-CoV-2 bo ka fana ka tšireletso khahlano le ts'oaetso hape, ha re tsebe hore na ho na le li-antibodies?Kapa boemo bo itseng ba li-antibodies?Ho bolela hore motho o na le tšireletso ea 'mele ea ho tšoaetsoa hape,' me haeba ho joalo, tšireletso ee e tla tšoarella nako e kae?
Bakeng sa ho nolofatsa phihlello ea pele ea liteko tsa serological ke lilaboratori le bafani ba tlhokomelo ea bophelo, FDA e fane ka litataiso ka la 16 Hlakubele.Ha feela tlhahlobo e feta netefatso, ba tla tsebisoa.FDA, mme tlaleho ea tlhahlobo e na le tlhahisoleseling ea bohlokoa mabapi le lithibelo, ho kenyelletsa le polelo ea hore tlhahlobo ha e so hlahlojoe ke FDA mme liphetho li ke ke tsa sebelisoa ho hlahloba kapa ho thibela tšoaetso.1
Ka nako eo, tlhahlobo ea serological hangata e ne e sa sebelisoe tlhokomelong ea bakuli.Re kenya ts'ebetsong mehato e meng ea ts'ireletso ka ho thibela tšebeliso ea eona ho lilaboratori tse ngolisitsoeng ka molao ke Medicare le Medicaid Services Centers ho etsa liteko tse rarahaneng haholo ho latela Clinical Laboratory Improvement Amendment (CLIA).Lilaboratori tse joalo li na le basebetsi ba nahanang ka ts'ebetso ea liteko ka ho khetheha mme ba khetha tlhahlobo e ntle ka ho fetisisa bakeng sa morero o itseng.Liofisi tsa ntlafatso tse ikemiselitseng ho sebelisa liteko tsa serological lapeng kapa sebakeng sa tlhokomelo (mohlala, lingaka) (ntle le haeba li sirelelitsoe ke setifikeiti sa laboratori sa CIA) li ntse li tlameha ho fana ka kopo ea EUA le ho fuoa tumello ke FDA bakeng sa tlhahlobo ea bona.Re rera ho hlahloba leano lena ka mor'a hore liteko tse 'maloa tsa serological li lumelloe.Leha ho le joalo, ha re hetla morao, re ile ra hlokomela hore maano a boletsoeng litataisong tsa rona tsa la 16 Hlakubele li ne li fosahetse.
Qetellong ea Hlakubele, baetsi ba khoebo ba 37 ba ne ba tsebisitse FDA ka tlhahiso ea bona ea liteko tsa serological 'marakeng oa US.FDA e amohetse kopo ea EUA ea tlhahlobo ea serological mme ea qala ho fana ka tumello ea tlhahlobo ea pele ka Mmesa.Leha ho le joalo, mathoasong a Mmesa, liofisiri tsa mmuso li ile tsa qala ho hlahisa litlamorao tse ka bang teng tsa liteko tsena ho buleng moruo hape mme ba fana ka inshorense bakeng sa ts'ebeliso e sa tšehetsoeng ke mahlale ebile e sa fihlelle meeli e behiloeng ke FDA.Ka lebaka leo, 'maraka o tletse liteko tsa serological, tseo tse ling tsa tsona li nang le litholoana tse mpe,' me tse ngata li rekisoa ka mekhoa e hananang le maano a FDA.Qetellong ea Mmesa, baetsi ba khoebo ba 164 ba ne ba tsebisitse FDA hore ba entse tlhahlobo ea serological.Letoto lena la liketsahalo le fapane le boiphihlelo ba rona litekong tsa tlhahlobo tsa khoebo.Tabeng ena, liteko tse fokolang li fanoa tlas'a tsebiso;hangata bahlahisi ba khothaletsa liteko tsa bona ho fapana le ho thathamisa lihlahisoa tse entsoeng ke ba bang, hangata bao e seng ba US, joalo ka liteko tse ling tsa serological;litletlebo tsa bohata le data Ho na le linyeoe tse fokolang haholo tsa ho senya.
Ka la 17 Mmesa, FDA e ile ea fana ka lengolo le eang ho bafani ba litšebeletso tsa bongaka le hlalosang hore bahlahisi ba bang ba sebelisitse hampe lethathamo la tsebiso ea tlhahlobo ea serological ho bolela ka bohata hore liteko tsa bona li amohetsoe kapa li lumelletsoe ke setsi.2 Leha ho na le bahlahisi ba fetang 200 ba lisebelisoa tsa tlhahlobo ea serological, FDA e rometse EUA ka boithatelo kapa e rera ho tlisa EUA, kahoo FDA e fetotse pholisi ea eona ka la 4 Mots'eanong e le hore re ka lekola motheo oa mahlale oa liteko tsohle tse phatlalalitsoeng khoebong le ho lekola katleho ea eona. Thobalano.3 Ho tloha ka la 1 Hlakubele 2021, FDA e hlakotse tumellano eo.Lethathamo la liteko tse 225 le thathamisitsoe ho tsoa webosaeteng ea rona, ho ile ha fanoa ka mangolo a lemosang a 15, 'me litemoso tsa tlolo ea molao ea kantle ho naha li ile tsa fuoa lik'hamphani tse 88.
Ka nako e ts'oanang, ho tloha ka March, FDA e 'nile ea sebelisana le Mekhatlo ea Sechaba ea Bophelo (NIH), Litsi tsa Taolo le Thibelo ea Mafu, le Setsi sa Lipatlisiso tse Tsoetseng Pele le Nts'etsopele ea Biomedicine ho thusa National Cancer Institute (NCI) theha bokhoni ba ho lekola serology.Ho thusa ho tsebisa liqeto tsa taolo tsa FDA litekong tsa motho ka mong (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - khits-part-tiiso).Sehlopha sa litlhahlobo se kopantsoeng ke NCI se na le disampole tse 30 tse hatselitsoeng tsa SARS-CoV-2 tsa antibody-negative serum tse 80 tse hatselitsoeng le li-anticoagulated citrate solution solution A lisampole tsa plasma.Boholo le sebopeho sa phanele li ile tsa khethoa ho nolofalletsa tlhahlobo e thehiloeng laboratoring le ho fana ka likhakanyo tse utloahalang le linako tsa boitšepo bakeng sa ts'ebetso ea tlhahlobo tlas'a lisampole tse fokolang tse fumanehang.Mosebetsi ona o tšoaea lekhetlo la pele mmuso oa koporasi o itlhahloba ho tsebisa FDA ka tumello.Kamora moo, Mekhatlo ea Sechaba ea Bophelo bo Botle (NIH) e sebelisitse kamano ea eona le setsi sa thuto ho etsa litlhahlobo tsa pele tsa lintlha tse ts'episang tsa tlhokomelo le liteko tsa tlhahlobo ea Covid-19 ea lapeng tlasa lenaneo la eona la RADx (Rapid Diagnostic Acceleration).4
Re kile ra hlalosa boiphihlelo ba rona litekong tsa tlhahlobo ea Covid-19.5 Lintlha tse nepahetseng le barupeluoa-le liketso tsa FDA?Boemo ba litlhahlobo tsa serological le bona bo fapane, 'me lithuto tseo re ithutileng tsona li fapane.
Ntlha ea pele, phihlelo ea rona ea tlhahlobo ea serological e hatisa bohlokoa ba tumello e ikemetseng ea lihlahisoa tsa bongaka ka mokhoa o utloahalang oa saense, 'me ha e lumelle lihlahisoa tsa liteko tse sa lumelloeng ho kena' marakeng.Ho tseba seo re se tsebang hona joale, le ntle le lithibelo tseo re li behileng qalong, re ne re ke ke ra lumella tlhahlobo ea serological ntle le tlhahlobo le tumello ea FDA.Leha lintlha tse ling li ka baka moroallo oa lihlahisoa tse sa lumelloeng 'marakeng, leano la rona la la 16 Hlakubele le lumella sena ho etsahala.
Ea bobeli, e le karolo ea morero oa ho qhoma, 'muso oa koporasi o lokela ho hokahanya ho lokisoa ha mananeo a lipatlisiso tsa sechaba le tsa poraefete ho rarolla mathata a seoa a amanang le phetiso ea mafu le ho itšireletsa mafung nakong ea pele ea ho qhoma.Boiteko bo kopanetsoeng bo tla thusa ho netefatsa hore lipatlisiso tse hlokahalang li etsoa ka nako e nepahetseng, ho fokotsa ho pheta-pheta ha lipatlisiso, le ho sebelisa lisebelisoa tsa federal ka botlalo.
Taba ea boraro, re lokela ho theha bokhoni ba ho lekola ts'ebetso ea liteko kahare ho mmuso oa koporasi kapa molemong oa mmuso oa koporasi pele ho koluoa, e le hore litlhahlobo tse ikemetseng li ka etsoa kapele nakong ea koluoa.Tšebelisano ea rona le NCI e re bontšitse bohlokoa ba mokhoa ona.E kopantsoe le tumello ea FDA, leano lena le ka lumella tlhahlobo e potlakileng le e ikemetseng ea ho nepahala ha tlhahlobo ea limolek'hule, liteko tsa antigen le tsa serological, le ho fokotsa tlhokahalo ea hore bahlahisi ba fumane mehlala ea mokuli kapa mehlala e meng ea kliniki ho netefatsa liteko tsa bona, ka hona ho potlakisa Ts'ebeliso ea ts'ebeliso e nepahetseng. tlhahlobo ea ntlafatsoa.'Muso oa kopanelo o boetse o lokela ho nahana ka ho sebelisa mokhoa ona ho mahlale a sebelisoang kantle ho seoa sena.Mohlala, lenaneo la NIH la RADx le ka tsoela pele le ho hola ho feta Covid-19.Ha nako e ntse e ea, re hloka mokhoa o tloaelehileng oa ho netefatsa moralo oa tlhahlobo le ts'ebetso.
Ea bone, sechaba sa saense le tsa bongaka se lokela ho utloisisa sepheo le ts'ebeliso ea bongaka ea tlhahlobo ea serological, le mokhoa oa ho sebelisa liphetho tsa liteko ka nepo ho tsebisa tlhokomelo ea bakuli ka kakaretso.Ka nts'etsopele ea tsebo ea mahlale, thuto e tsoelang pele e bohlokoa karabelong efe kapa efe ea tšohanyetso ea bophelo bo botle ba sechaba, haholoholo ha ho nahanoa hore mekhoa ea tlhahlobo ea serological e sebelisoa hampe bakeng sa tlhahlobo, mme batho ba nang le litekanyetso tse tlase tsa ts'oaetso ba ka sebelisa mokhoa o le mong oa tlhahlobo.Ho tla ba le liphello tse ntle tsa bohata le ho bonahala ho itšireletsa mafung.Mekhoa ea rona ea liteko e hloka ho ntlafatsoa khafetsa le ho tataisoa ke mahlale a tšepahalang.
Qetellong, bohle ba amehang karabelong ea tšohanyetso ea bophelo bo botle ba sechaba ba hloka ho fumana leseli le betere kapele.Joalo ka ha litsebi tsa bongaka li leka ka potlako ho utloisisa hore na Covid-19 e ama bakuli joang le hore na e ka phekola bakuli joang, FDA e tlameha ho ikamahanya le tlhaiso-leseling e fokolang le e tsoelang pele, haholo-holo methating ea pele ea koluoa.Ho theoa ha mekhoa e metle le e hokahaneng ea naha le ea machabeng ea ho bokella bopaki le ho bokella, ho arolelana le ho hasanya tlhahisoleseling ho bohlokoa bakeng sa ho felisa seoa sa hona joale le ho arabela maemong a tšohanyetso a bophelo a sechaba a tlang.
Ha re shebile pele, ha seoa sena se ntse se hola, FDA e tla tsoelapele ho nka mehato ea ho netefatsa hore liteko tse nepahetseng le tse tšepahalang tsa antibody li fanoa ka nako e nepahetseng ho fihlela litlhoko tsa bophelo bo botle ba sechaba.
1. Tsamaiso ea Lijo le Lithethefatsi.Leano la liteko tsa tlhahlobo ea lefu la coronavirus la 2019 maemong a tšohanyetso a bophelo ba sechaba.La 16 Hlakubele 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Tsamaiso ea Lijo le Lithethefatsi.Lengolo le eang ho bafani ba tlhokomelo ea bophelo bo botle mabapi le tlhahisoleseling ea bohlokoa mabapi le ts'ebeliso ea serology (lithibela-mafu) ho lemoha COVID-19.La 17 Mmesa, 2020 (e ntlafalitsoe ka la 19 Phuptjane, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 - lengolo le eang ho mofani oa tlhokomelo ea bophelo).
3. Shah A le ShurenJ.Ithute haholoanyane ka leano le ntlafalitsoeng la FDA la tlhahlobo ea li-antibody: Beha phihlello le ho nepahala pele.Silver Spring, MD, Tsamaiso ea Lijo le Lithethefatsi (FDA), la 4 Motšeanong, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy -antibody-tests-prioritizing- phihlello-le -nepahalo).
4. Mekhatlo ea Sechaba ea Bophelo bo Botle.Potlako e Potlakileng ea Tlhahlobo (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Covid-19 teko ea tlhahlobo ea limolek’hule e ithutile thuto.The English Journal of Medicine 2020;383(17): e97-e97.
Nako ea poso: Mar-10-2021