Sebenzisa ulwazi nezinsizakalo ze-NEJM Group ukuze uzilungiselele ukuba udokotela, uqongelele ulwazi, uhole inhlangano yokunakekelwa kwezempilo futhi ukhuthaze ukuthuthukiswa komsebenzi wakho.
NgoJanuwari 2020, i-US Food and Drug Administration (FDA) yaqala ukubheka impendulo yase-US ku-Covid-19.Ngomhla zi-4 kuFebhuwari, ngemva kokumemezela isimo esiphuthumayo sezempilo yomphakathi, saqala ukugunyaza ukuhlolwa ukuze kutholakale izifo ezikhona.Esimeni esiphuthumayo esinjalo, i-FDA inganikeza ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo (i-EUA) ngemikhiqizo yezokwelapha ngokusekelwe ekubuyekezweni kobufakazi besayensi.Ukwamukela izindinganiso eziphansi ze-EUA, kunokulinda ukugunyazwa okuphelele ukuze uthole ubufakazi obuningi, kungasheshisa isivinini sokuthola izivivinyo ezinembile.Ngemuva kokubika amacala asymptomatic, kuyacaca ukuthi sidinga ukusebenzisa amanye amasu ukuqonda ukusabalala kweqiniso kwe-SARS-CoV-2 ezweni lonke.Ngesikhathi sokuqubuka kwegciwane kwangaphambilini, ukuhlolwa kwe-serological (okungukuthi, amasosha omzimba) akwenziwanga noma kunokusetshenziswa okulinganiselwe.Kodwa-ke, kulokhu, i-FDA iyabona ukuthi ukuqinisekisa ukufinyelela okusheshayo nokwanele kokuhlolwa kwe-serological e-United States kungakhuthaza ucwaningo lwesayensi nokuqonda kwe-Covid-19, ngaleyo ndlela kusize ukuphendula izwe.
Ukuhlolwa kwe-serological kungathola ukusabela komzimba okuguquguqukayo kwezifo ezidlule.Ngakho-ke, ukuhlolwa kwe-serological kukodwa akukwazi ukunquma ukuthi umuntu okwamanje utheleleke nge-SARS-CoV-2.Ngaphezu kwalokho, yize ulwazi lwamanye amagciwane lukhombisile ukuthi ukuba khona kwamasosha omzimba akwa-SARS-CoV-2 kunganikeza isivikelo esithile ekuthelelekeni kabusha, asazi noma akhona yini amasosha omzimba?Noma izinga elithile lamasosha omzimba?Kusho ukuthi umuntu unamandla okugomela ukuthi angaphinde atheleleke, futhi uma kunjalo, lokhu kuzivikela kuzohlala isikhathi esingakanani?
Ukuze kube lula ukufinyelela kwangaphambi kwesikhathi ekuhlolweni kwe-serological ngamalabhorethri nabahlinzeki bezempilo, i-FDA yakhipha imihlahlandlela ngoMashi 16. Imihlahlandlela ivumela onjiniyela ukuthi baphromothe ukuhlolwa kwabo ngaphandle kwe-EUA.Inqobo nje uma ukuhlolwa kuphumelele ukuqinisekiswa, bazokwaziswa.I-FDA, kanye nombiko wokuhlola uqukethe ulwazi olubalulekile mayelana nemikhawulo, okuhlanganisa nesitatimende sokuthi ukuhlolwa akuzange kubuyekezwe yi-FDA futhi imiphumela ayikwazi ukusetshenziselwa ukuxilonga noma ukukhipha izifo.1
Ngaleso sikhathi, ukuhlolwa kwe-serological kwakungavamile ukusetshenziswa ekunakekelweni kwesiguli.Sisebenzisa ezinye izindlela zokuvikela ngokukhawulela ukusetshenziswa kwayo kumalabhorethri agunyazwe i-Medicare and Medicaid Services Centers ukwenza ukuhlola okuyinkimbinkimbi ngokuhambisana ne-Clinical Laboratory Improvement Amendment (CLIA).Amalabhorethri anjalo anezisebenzi ezicabangela ngokukhethekile ukusebenza kokuhlolwa bese zikhetha ukuhlolwa okungcono kakhulu kwenjongo ethile.Amahhovisi onjiniyela ahlose ukusebenzisa ukuhlolwa kwe-serological ekhaya noma endaweni yokunakekela (isb. odokotela) (ngaphandle uma evikelwe yisitifiketi se-CLIA zelabhorethri) kusafanele athumele isicelo se-EUA futhi agunyazwe yi-FDA ukuze ahlolwe.Sihlela ukubuyekeza le nqubomgomo ngemva kokugunyazwa kokuhlolwa okumbalwa kwe-serological.Kodwa-ke, uma sibheka emuva, sibonile ukuthi izinqubomgomo ezivezwe kuzinkombandlela zethu zangoMashi 16 zazinamaphutha.
Ekupheleni kukaMashi, abakhiqizi bezentengiselwano abangama-37 base bebikele i-FDA ngokwethula kwabo izivivinyo ze-serological emakethe yaseMelika.I-FDA ithole isicelo se-EUA sokuhlolwa kwe-serological futhi yaqala ukugunyaza ukuhlolwa kokuqala ngo-Ephreli.Kodwa-ke, ekuqaleni kuka-Ephreli, izikhulu zikahulumeni zaqala ukuveza imiphumela engaba khona yalezi zivivinyo ekuvulweni kabusha komnotho futhi zanikeza umshwalense wokusetshenziswa okungasekelwe yisayensi futhi ongahlangabezani nemikhawulo ebekwe yi-FDA.Ngenxa yalokho, imakethe igcwele izivivinyo ze-serological, ezinye zazo ezinemiphumela emibi, futhi eziningi zithengiswa ngezindlela ezingqubuzana nezinqubomgomo ze-FDA.Ekupheleni kuka-Ephreli, abakhiqizi bezentengiselwano abayi-164 base bazise i-FDA ukuthi benze ukuhlolwa kwe-serological.Lolu chungechunge lwemicimbi luhlukile kulokho esikwenzayo ekuhloleni okudayiswayo kokuxilonga.Kulokhu, ukuhlolwa okumbalwa okunikezwa ngaphansi kwesaziso;abakhiqizi bavamise ukuphromotha okwabo ukuhlola esikhundleni sokufakwa ohlwini kwemikhiqizo eyenziwe ngabanye, ngokuvamile abakhiqizi abangebona abase-US, njengokuhlola okuthile kwe-serological;izimangalo ezingelona iqiniso kanye nedatha Mancane kakhulu amacala okuphazamisa.
Ngomhlaka-17 Ephreli, i-FDA yakhipha incwadi eya kubahlinzeki benkonzo yezokwelapha ichaza ukuthi abanye onjiniyela basebenzise kabi uhlu lwezaziso zekhithi yokuhlolwa kwe-serological ukuze bamangalele ukuthi ukuhlolwa kwabo kugunyazwe noma kugunyazwe yi-ejensi.2 Nakuba kunabathuthukisi bezinto zokuhlola i-serological ezingaphezu kuka-200, i-FDA ithumele ngokuzithandela i-EUA noma ihlela ukuthumela i-EUA, ngakho i-FDA yashintsha inqubomgomo yayo ngoMeyi 4 ukuze sikwazi ukuhlola isisekelo sesayensi sakho konke ukuhlola okusatshalaliswe ngokwezentengiso futhi sihlole ukusebenza kwayo. Ucansi.3 Kusukela ngoFebhuwari 1, 2021, i-FDA isikhansele isivumelwano.Uhlu lwezivivinyo ezingu-225 lwafakwa ohlwini olusuka kuwebhusayithi yethu, izincwadi eziyisixwayiso ezingu-15 zakhishwa, futhi izixwayiso zokwephulwa kokungenisa zikhishwe ezinkampanini ezingu-88.
Ngaso leso sikhathi, kusukela ngoMashi, i-FDA ibisebenzisana neNational Institutes of Health (NIH), iCenters for Disease Control and Prevention, kanye ne-Agency for Advanced Research and Development in Biomedicine ukusiza iNational Cancer Institute (NCI) sungula ikhono lokuhlola i-serology.Ukusiza ukwazisa izinqumo zokulawula ze-FDA ekuhlolweni ngakunye (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - amakhithi-ingxenye-ukuqinisekisa).Ithimba lokuhlola elihlanganiswe yi-NCI liqukethe amasampula e-SARS-CoV-2 eqandisiwe e-antibody-positive serum kanye ne-80 eqandisiwe ye-antibody-negative serum kanye ne-anticoagulated citrate solution solution A amasampuli e-plasma.Usayizi nokwakheka kwephaneli kukhethiwe ukuze kunikwe amandla ukuhlola okusekelwe elabhorethri kanye nokunikeza izilinganiso ezinengqondo nezikhawu zokuqiniseka zokusebenza kokuhlolwa ngaphansi kokutholakala kwesampula okulinganiselwe.Lo msebenzi umaka okokuqala uhulumeni wobumbano enze ukuzihlola ukuze azise i-FDA ngokugunyazwa.Kamuva, i-National Institutes of Health (NIH) yasebenzisa ubudlelwano bayo nesikhungo sezemfundo ukwenza ukuhlolwa kokuqala kwezindawo zokunakekelwa okuthembisayo kanye nokuhlolwa kwe-Covid-19 yasekhaya ngaphansi kohlelo lwayo lwe-RADx (Rapid Diagnostic Acceleration).4
Ngaphambilini sike sachaza ulwazi lwethu ekuhlolweni kokuxilonga i-Covid-19.5 Amaqiniso afanelekile nabahlanganyeli-kanye nezenzo ze-FDA?Isimo sokuhlolwa kwe-serological naso sihlukile, futhi izifundo esizifundile nazo zihlukile.
Okokuqala, okuhlangenwe nakho kwethu ekuhlolweni kwe-serological kugcizelela ukubaluleka kokugunyazwa okuzimele kwemikhiqizo yezokwelapha ngesisekelo esizwakalayo sesayensi, futhi akuvumeli imikhiqizo yokuhlola engagunyaziwe ukuthi ingene emakethe.Ukwazi esikwaziyo manje, nangaphandle kwemikhawulo ebesiyibeka ekuqaleni, ngeke sivumele ukuhlolwa kwe-serological ngaphandle kokubuyekezwa nokugunyazwa kwe-FDA.Nakuba ezinye izici zingase zibangele inqwaba yemikhiqizo engagunyaziwe emakethe, inqubomgomo yethu yangomhla ziyi-16 kuNdasa iyakuvumela lokhu ukuthi kwenzeke.
Okwesibili, njengengxenye yohlelo lokuqubuka, uhulumeni wobumbano kufanele axhumanise ukulungiselelwa kwezinhlelo zocwaningo ezizimele nezikahulumeni ukuze kubhekwane nezinkinga zesifo esiwumshayabhuqe ezihlobene nokudluliswa kwezifo nokuvikeleka ezigabeni zokuqala zokuqubuka.Umzamo obumbene uzosiza ekuqinisekiseni ukuthi ucwaningo oludingekayo lwenziwa ngesikhathi, kuncishiswe ukuphindwaphindwa kocwaningo, futhi kusetshenziswe ngokugcwele izinsiza zikahulumeni.
Okwesithathu, kufanele sithole amandla okuhlola ukusebenza kokuhlolwa kuhulumeni wobumbano noma egameni likahulumeni wobumbano ngaphambi kokugqashuka, ukuze ukuhlolwa okuzimele kwenziwe ngokushesha ngesikhathi sokuqubuka.Ukusebenzisana kwethu ne-NCI kusibonise ukubaluleka kwale ndlela.Kuhlanganiswe nokugunyazwa kwe-FDA, leli su lingavumela ukuhlolwa okusheshayo nokuzimele kokunemba kokuxilongwa kwamangqamuzana, ukuhlolwa kwe-antigen kanye ne-serological, futhi kunciphise isidingo sabathuthukisi sokuthola izibonelo zesiguli noma amanye amasampula omtholampilo ukuze kuqinisekiswe ukuhlolwa kwabo, ngaleyo ndlela kusheshiswe Ukusebenziseka kokunembile. ukuhlolwa kuyathuthukiswa.Uhulumeni wobumbano kufanele futhi ucabangele ukusebenzisa le ndlela kubuchwepheshe obusetshenziswa ngaphandle kwalolu bhubhane.Isibonelo, uhlelo lwe-NIH lwe-RADx lungaqhubeka futhi lunwebe ngale kwe-Covid-19.Ngokuhamba kwesikhathi, sidinga indlela evamile yokuqinisekisa umklamo wokuhlola nokusebenza.
Okwesine, umphakathi wesayensi nowezokwelapha kufanele uqonde inhloso kanye nokusetshenziswa komtholampilo kokuhlolwa kwe-serological, kanye nendlela yokusebenzisa imiphumela yokuhlolwa ngendlela efanele ukwazisa ukunakekelwa kwesiguli ngokuvamile.Ngokuthuthuka kolwazi lwesayensi, imfundo eqhubekayo ibalulekile kunoma iyiphi impendulo ephuthumayo yezempilo yomphakathi, ikakhulukazi uma kucatshangelwa ukuthi izindlela zokuhlola i-serological zisetshenziswa kabi ekuxilongeni, futhi abantu abanamazinga aphansi okutheleleka bangasebenzisa indlela eyodwa yokuhlola.Kuzoba nemiphumela emihle engamanga kanye nokungavikeleki okubonakala ekuthelelekeni.Izindlela zethu zokuhlola zidinga ukubuyekezwa njalo futhi ziqondiswe isayensi ethembekile.
Okokugcina, zonke izinhlangothi ezithintekayo ekuphenduleni izimo eziphuthumayo zezempilo yomphakathi zidinga ukuthola ulwazi olungcono ngokushesha.Njengoba nje ochwepheshe bezokwelapha bezama ngokushesha ukuqonda ukuthi i-Covid-19 izithinta kanjani iziguli nokuthi ziphathwa kanjani kangcono iziguli, i-FDA kumele izivumelanise nolwazi olulinganiselwe noluvelayo, ikakhulukazi ezigabeni zokuqala zokuqubuka kodlame.Ukusungulwa kwezindlela ezizwakalayo nezididiyelwe zikazwelonke nezamazwe ngamazwe zokuqoqa ubufakazi nokuqoqa, ukwabelana nokusabalalisa ulwazi kubalulekile ekuqedeni ubhubhane olukhona kanye nokusabela ezimeni eziphuthumayo zezempilo zomphakathi ezizayo.
Uma sibheka phambili, njengoba ubhubhane lukhula, i-FDA izoqhubeka nokuthatha izinyathelo zokuqinisekisa ukuthi ukuhlolwa okunembile nokuthembekile kwe-antibody kunikezwa ngesikhathi esifanele ukuze kuhlangatshezwane nezidingo zezempilo zomphakathi.
1. Ukuphathwa Kwezokudla Nezidakamizwa.Inqubomgomo yokuhlolwa kokuxilonga yesifo se-coronavirus yango-2019 ezimeni eziphuthumayo zezempilo zomphakathi.Mashi 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Ukuphathwa Kwezokudla Nezidakamizwa.Incwadi eya kubahlinzeki bezempilo mayelana nolwazi olubalulekile mayelana nokusetshenziswa kwe-serology (amasosha omzimba) ukuthola i-COVID-19.Ephreli 17, 2020 (kubuyekezwe ngoJuni 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 -incwadi eya kumhlinzeki wezempilo).
3. UShah A noShurenJ.Funda kabanzi mayelana nenqubomgomo ebuyekeziwe ye-FDA yokuhlola amasosha omzimba: Beka kuqala ukufinyelela nokunemba.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- ukufinyelela-nokunemba).
4. Izikhungo Zezempilo Zikazwelonke.I-Rapid Diagnostic Acceleration (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. U-Shuren J, uStenzel T. Covid-19 ukuhlolwa kokuxilonga kwamangqamuzana afunde isifundo.I-English Journal of Medicine 2020;383(17): e97-e97.
Isikhathi sokuthumela: Mar-10-2021