Sebenzisa ulwazi kunye neenkonzo zeQela le-NEJM ukulungiselela ukuba ngugqirha, ukuqokelela ulwazi, ukukhokela umbutho wezempilo kunye nokukhuthaza uphuhliso lwakho lomsebenzi.
NgoJanuwari ka-2020, i-US Food and Drug Administration (FDA) yaqala ukujonga impendulo yase-US kwi-Covid-19.Nge-4 kaFebruwari, emva kokubhengeza imeko engxamisekileyo yezempilo yoluntu, saqala ukugunyazisa iimvavanyo zokufumanisa usulelo olusebenzayo.Kwimeko engxamisekileyo enjalo, i-FDA inokunika ugunyaziso lokusetyenziswa olungxamisekileyo (EUA) kwiimveliso zonyango ngokusekelwe kuhlaziyo lobungqina besayensi.Ukwamkela imigangatho esezantsi ye-EUA, kunokulinda imvume epheleleyo ukuze ufumane ubungqina obubanzi, kunokukhawulezisa isantya sokufumana iimvavanyo ezichanekileyo.Emva kokuxela iimeko ze-asymptomatic, kucacile ukuba kufuneka samkele ezinye iindlela zokuqonda ukusasazeka kwe-SARS-CoV-2 kwilizwe liphela.Ngexesha lokuqhambuka kwentsholongwane yangaphambili, uvavanyo lwe-serological (oko kukuthi, isilwa-mzimba) alwenziwanga okanye lunosetyenziso olulinganiselweyo.Nangona kunjalo, kule meko, i-FDA iyaqonda ukuba ukuqinisekiswa kokufikelela okukhawulezayo nokwaneleyo kuvavanyo lwe-serological e-United States kunokukhuthaza uphando lwesayensi kunye nokuqonda kwe-Covid-19, ngaloo ndlela inceda ekuphenduleni ilizwe.
Uvavanyo lwe-serological lunokubona impendulo yomzimba eguqukayo kwizifo ezidlulileyo.Ke ngoko, uvavanyo lwe-serological lulodwa alukwazi ukubona ukuba umntu wosulelwe ngoku yi-SARS-CoV-2.Ukongeza, nangona amava ezinye iintsholongwane ebonise ukuba ubukho bee-antibodies ze-SARS-CoV-2 bunokuthi bunike ukhuseleko oluthile ngokuchasene nokwasulelwa kwakhona, asazi nokuba kukho naziphi na ii-antibodies?Okanye inqanaba elithile le-antibodies?Kuthetha ukuba umntu unamandla okuzikhusela ekuphinde asuleleke kwakhona, kwaye ukuba kunjalo, iya kuhlala ixesha elingakanani le nto?
Ukuze kuququzelelwe ukufikelela kwangoko kuvavanyo lwe-serological ngamalabhoratri kunye nababoneleli bezempilo, i-FDA ikhuphe izikhokelo ngoMatshi 16. Izikhokelo zivumela abaphuhlisi ukuba bakhuthaze iimvavanyo zabo ngaphandle kwe-EUA.Ngethuba nje uvavanyo luphumelela ukuqinisekiswa, baya kwaziswa.I-FDA, kunye nengxelo yovavanyo iqulethe ulwazi olubalulekileyo malunga nezithintelo, kubandakanywa ingxelo yokuba uvavanyo aluzange luhlaziywe yi-FDA kwaye iziphumo azikwazi ukusetyenziselwa ukuxilonga okanye ukukhupha izifo.1
Ngelo xesha, uvavanyo lwe-serological lwalungasetyenziswanga kukhathalelo lwesigulane.Sisebenzisa ezinye iindlela zokukhusela ngokukhawulela ukusetyenziswa kwayo kwiibhubhoratri ezivunywe yi-Medicare kunye ne-Medicaid Services Centres ukwenza uvavanyo olunzima kakhulu ngokuhambelana ne-Clinical Laboratory Improvement Amendment (CLIA).Iilabhoratri ezinjalo zinabasebenzi abaqwalasela ngokuthe ngqo ukusebenza kovavanyo kwaye bakhethe olona vavanyo lungcono ukulungiselela injongo ethile.Ii-ofisi zabaphuhlisi ezinenjongo zokusebenzisa uvavanyo lwe-serological ekhaya okanye kwindawo yokhathalelo (umz. oogqirha) (ngaphandle kokuba zikhuselwe sisiqinisekiso se-CLIA selabhoratri) kusafuneka zingenise isicelo se-EUA kwaye zigunyaziswe yi-FDA kuvavanyo lwazo.Siceba ukuphonononga lo mgaqo-nkqubo emva kokuba iimvavanyo ezininzi ze-serological zigunyazisiwe.Nangona kunjalo, xa sijonga emva, siye safumanisa ukuba imigaqo-nkqubo echazwe kwimigaqo yethu ye-16 kaMatshi yayineziphene.
Ekupheleni kuka-Matshi, abavelisi bezorhwebo abangama-37 baye bazisa i-FDA ngokwazisa kwabo uvavanyo lwe-serological kwimarike yaseMelika.I-FDA ifumene isicelo se-EUA sovavanyo lweserological kwaye yaqala ukugunyazisa uvavanyo lokuqala ngo-Epreli.Nangona kunjalo, ekuqaleni kuka-Epreli, amagosa karhulumente aqala ukukhupha iziphumo ezinokuthi zenzeke kolu vavanyo ekuvulweni kwakhona koqoqosho kwaye abonelele nge-inshurensi yokusetyenziswa okungaxhaswanga yisayensi kwaye engahlangabezani nemida ebekwe yi-FDA.Ngenxa yoko, imakethi izaliswe ziimvavanyo ze-serological, ezinye zazo ezineziphumo ezibi, kwaye ezininzi zithengiswa ngeendlela eziphikisana nemigaqo-nkqubo ye-FDA.Ekupheleni kuka-Epreli, abavelisi bezorhwebo abali-164 baye bazisa i-FDA ukuba benze uvavanyo lwe-serological.Olu chungechunge lweziganeko luhluke kumava ethu kwiimvavanyo zokuxilonga ezithengiswayo.Kule meko, iimvavanyo ezimbalwa zinikezelwa phantsi kwesaziso;abavelisi bahlala bekhuthaza iimvavanyo zabo endaweni yokudwelisa iimveliso ezenziwe ngabanye, abadla ngokuba ngabavelisi abangengabo abase-US, njengovavanyo oluthile lweserological;amabango obuxoki kunye nedatha Kukho iimeko ezimbalwa kakhulu zokuphazamisa.
Ngomhla we-17 ku-Epreli, i-FDA yakhupha ileta eya kubaboneleli beenkonzo zonyango echaza ukuba abanye abaphuhlisi balusebenzise kakubi uluhlu lwesaziso sesethi ye-serological ukubanga ngobuxoki ukuba iimvavanyo zabo zivunyiwe okanye zigunyaziswe yi-arhente.2 Nangona kukho ngaphezu kwama-200 abaphuhlisi be-reagent yovavanyo lwe-serological, i-FDA ingenise ngokuzithandela i-EUA okanye iceba ukungenisa i-EUA, ngoko ke i-FDA yatshintsha umgaqo-nkqubo wayo nge-4 kaMeyi ukuze sikwazi ukuvavanya isiseko senzululwazi salo lonke uvavanyo olusasazwe lwezorhwebo kwaye sivavanye ukusebenza kwayo. Ukwabelana ngesondo.3 Ukusukela nge-1 kaFebruwari 2021, i-FDA isirhoxisile isivumelwano.Uluhlu lweemvavanyo ezingama-225 lwadweliswa kwiwebhusayithi yethu, iileta ezili-15 ezilumkisayo zakhutshwa, kwaye izilumkiso zokwaphulwa kwemithetho yokungenisa elizweni zakhutshwa kwiinkampani ezingama-88.
Ngexesha elifanayo, ukususela ngo-Matshi, i-FDA ibambisene neZiko leSizwe lezeMpilo (NIH), amaZiko oLawulo lweSifo kunye noThintelo, kunye ne-Arhente yoPhando oluPhambili kunye noPhuhliso kwi-Biomedicine ukunceda i-National Cancer Institute (NCI) misela isakhono sokuvavanya iserology.Ukunceda ukwazisa izigqibo zolawulo lwe-FDA kuvavanyo lomntu ngamnye (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - iikhithi-inxalenye-ukuqinisekiswa).Iqela lovavanyo elihlanganiswe yi-NCI libandakanya ama-30 eesampuli ze-SARS-CoV-2 ezikhenkcezisiweyo ze-antibody-positive serum kunye ne-80 ekhenkceziweyo ye-antibody-negative serum kunye ne-anticoagulated citrate yesisombululo se-glucose ifomula A iisampulu zeplasma.Ubungakanani kunye nokwakhiwa kwephaneli kukhethwe ukwenza uvavanyo olusekwe kwilabhoratri kunye nokubonelela ngoqikelelo olufanelekileyo kunye namaxesha okuzithemba ekusebenzeni kovavanyo phantsi kokufumaneka kwesampulu encinci.Lo msebenzi uphawula okokuqala ukuba urhulumente wesigqeba wenze ukuzivavanya ukwazisa i-FDA yesigunyaziso.Emva koko, iNational Institutes of Health (NIH) yasebenzisa ubudlelwane bayo neziko lezemfundo ukwenza uvavanyo lokuqala lwamanqaku athembisayo ononophelo kunye neemvavanyo zokuxilonga ze-Covid-19 phantsi kwenkqubo yayo yeRADx (Rapid Diagnostic Acceleration).4
Sikhe sachaza amava ethu kuvavanyo loxilongo lwe-Covid-19.5 Iinyani ezifanelekileyo kunye nabathathi-nxaxheba-kunye nezenzo ze-FDA?Imeko yeemviwo ze-serological nayo yahlukile, kwaye izifundo esizifundileyo zahlukile.
Okokuqala, amava ethu kuvavanyo lwe-serological agxininisa ukubaluleka kogunyaziso oluzimeleyo lweemveliso zonyango kwisiseko esivakalayo sesayensi, kwaye ayivumeli iimveliso zokuvavanya ezingagunyaziswanga ukuba zingene kwimarike.Ukwazi into esiyaziyo ngoku, nangaphandle kwezithintelo ebesizibekile ekuqaleni, ngekhe sivumele uvavanyo lwe-serological ngaphandle kokuphononongwa kunye nogunyaziso lwe-FDA.Nangona ezinye izinto zinokubangela ukuphuphuma kweemveliso ezingagunyaziswanga emarikeni, umgaqo-nkqubo wethu we-16 kaMatshi uyakuvumela oku ukuba kwenzeke.
Okwesibini, njengenxalenye yesicwangciso sokuqhambuka, urhulumente wobumbano kufuneka alungelelanise ulungiselelo lweenkqubo zophando zoluntu-zabucala ukujongana nemiba ye-epidemiological enxulumene nokusasazeka kwezifo kunye nokungakhuseleki kwinqanaba lokuqala lokuqhambuka.Umgudu odibeneyo uya kunceda ukuqinisekisa ukuba uphando oluyimfuneko lwenziwa ngexesha elifanelekileyo, ukunciphisa ukuphindaphinda kophando, kunye nokusebenzisa ngokupheleleyo izibonelelo ze-federal.
Okwesithathu, kufuneka siseke amandla okuvavanya ukusebenza kovavanyo kurhulumente womanyano okanye egameni likarhulumente womanyano ngaphambi kokuqhambuka, ukuze uvavanyo oluzimeleyo luqhutywe ngokukhawuleza ngexesha lokuqhambuka.Intsebenziswano yethu ne-NCI isibonise ukubaluleka kwale ndlela.Idityaniswe nesigunyaziso se-FDA, esi sicwangciso sinokuvumela uvavanyo olukhawulezayo noluzimeleyo lokuchaneka kwe-molecular diagnostics, i-antigen kunye ne-serological tests, kunye nokunciphisa imfuno yokuba abaphuhlisi bafumane imizekelo yesigulane okanye ezinye iisampuli zekliniki ukuqinisekisa iimvavanyo zabo, ngaloo ndlela ukukhawuleza uvavanyo luphuculwe.Urhulumente womdibaniso kufuneka kwakhona aqwalasele ukusebenzisa le ndlela kubuchwephesha obusetyenziswa ngaphandle kobhubhane.Umzekelo, inkqubo ye-RADx ye-NIH inokuqhubeka kwaye yandise ngaphaya kwe-Covid-19.Ekuhambeni kwexesha, sifuna indlela eqhelekileyo yokuqinisekisa uyilo lovavanyo kunye nokusebenza.
Okwesine, inzululwazi kunye noluntu lwezonyango kufuneka luqonde injongo kunye nokusetyenziswa kweklinikhi yovavanyo lwe-serological, kunye nendlela yokusebenzisa iziphumo zovavanyo ngokufanelekileyo ukwazisa ukhathalelo lwesigulane ngokubanzi.Ngophuhliso lolwazi lwesayensi, imfundo eqhubekayo ibalulekile kuyo nayiphi na impendulo kaxakeka yezempilo yoluntu, ngakumbi kuthathelwa ingqalelo ukuba iindlela zovavanyo lwe-serological zisetyenziselwa ukuxilongwa, kwaye abantu abanamazinga asezantsi osulelo banokusebenzisa indlela enye yovavanyo.Kuya kubakho iziphumo zobuxoki kunye nokungakhuseleki kwintsholongwane.Iindlela zethu zokuvavanya kufuneka zihlaziywe rhoqo kwaye zikhokelwe yisayensi ethembekileyo.
Okokugqibela, onke amaqela abandakanyekayo kwimpendulo yongxamiseko yezempilo yoluntu kufuneka afumane ulwazi olungcono ngokukhawuleza.Kanye njengokuba iingcali zonyango zizama ngokukhawuleza ukuqonda ukuba i-Covid-19 ibachaphazela njani abaguli kunye nendlela yokunyanga abaguli, i-FDA kufuneka iziqhelanise nolwazi olulinganiselweyo noluvelayo, ngakumbi kumanqanaba okuqala okuqhambuka.Ukusekwa kweendlela ezivakalayo nezilungelelanisiweyo zesizwe nezamazwe ngamazwe zokuqokelela ubungqina kunye nokuqokelela, ukwabelana kunye nokusasaza ulwazi kubalulekile ekupheliseni ubhubhane wangoku kunye nokusabela kwiimeko ezingxamisekileyo zempilo yoluntu.
Ukujonga phambili, njengoko ubhubhane ukhula, i-FDA iya kuqhubeka nokuthatha amanyathelo okuqinisekisa ukuba uvavanyo lwe-antibody oluchanekileyo noluthembekileyo lunikezelwa ngexesha elifanelekileyo ukuhlangabezana neemfuno zempilo yoluntu.
1. Ulawulo lokutya kunye neziyobisi.Umgaqo-nkqubo wovavanyo loxilongo lwesifo se-coronavirus ka-2019 kwiimeko zikaxakeka zempilo yoluntu.Nge-16 kaMatshi, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Ulawulo lokutya kunye neziyobisi.Ileta eya kubaboneleli bezempilo malunga nolwazi olubalulekileyo malunga nokusetyenziswa kwe-serology (i-antibodies) ukufumanisa i-COVID-19.Nge-17 ka-Epreli, 2020 (uhlaziywe ngoJuni 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 -ileta eya kumboneleli wezempilo).
3. UShah A noShurenJ.Funda ngakumbi malunga nomgaqo-nkqubo wovavanyo we-antibody ohlaziyiweyo we-FDA: Beka phambili ufikelelo kunye nokuchaneka.Silver Spring, MD, uLawulo lokuTya kunye neDrugs (FDA), nge-4 kaMeyi, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy -antibody-tests-prioritizing- ukufikelela-kunye -nokuchaneka).
4. AmaZiko eSizwe ezeMpilo.Ukukhawulezisa uDiagnostic ngokukhawuleza (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. UShuren J, uStenzel T. Covid-19 uvavanyo lwemolekyuli yokuxilonga bafunde isifundo.Ijenali yesiNgesi yezoNyango ngo-2020;383(17): e97-e97.
Ixesha lokuposa: Mar-10-2021