Shandisa ruzivo rweNEJM Boka uye masevhisi kugadzirira kuve chiremba, kuunganidza ruzivo, kutungamira sangano rehutano uye kusimudzira basa rako.
Muna Ndira 2020, iyo US Food and Drug Administration (FDA) yakatanga kufunga nezvemhinduro yeUS kuCovid-19.Musi waKukadzi 4, mushure mekuzivisa nezvehutano hweveruzhinji, takatanga kubvumidza kuongororwa hutachiona hunoshanda.Munjodzi yakadai, iyo FDA inogona kupa mvumo yekushandiswa kwekukurumidzira (EUA) yezvigadzirwa zvekurapa zvichienderana nekuongorora kwehumbowo hwesainzi.Kutora zviyero zvakaderera zveEUA, pane kumirira kubvumidzwa kuzere kuti uwane humbowo hwakakura, kunogona kukurumidza kukurumidza kuwana bvunzo dzakakwana.Mushure mekutaura nyaya dzeasymptomatic, zviri pachena kuti isu tinofanirwa kutora mamwe mazano ekunzwisisa kupararira kwechokwadi kweSARS-CoV-2 munyika yose.Munguva yekubuda kwehutachiona hwekare, serological (kureva, masoja ekudzivirira chirwere) haina kuitwa kana kushandiswa kushoma.Nekudaro, mune iyi kesi, iyo FDA inoziva kuti kuve nechokwadi chekuwana nekukurumidza uye kwakaringana kuyedza serological muUnited States kunogona kusimudzira kutsvagisa kwesainzi uye kunzwisisa kweCovid-19, nokudaro zvichibatsira kupindura nyika.
Kuongororwa kweserological kunogona kuona kuchinjika kwemuviri kupindura kune hutachiona hwekare.Naizvozvo, kuyedzwa kweserological chete hakugone kuona kuti munhu parizvino akatapukirwa neSARS-CoV-2.Uye zvakare, kunyangwe ruzivo rwemamwe mavhairasi rwakaratidza kuti kuvapo kweSARS-CoV-2 masoja ekudzivirira chirwere anogona kupa imwe dziviriro kubva mukutapukirwazve, hatizive kana paine masoja ekudzivirira chirwere?Kana imwe nhanho yemasoja ekudzivirira chirwere?Zvinoreva kuti munhu ane immune yekutapukirwa zvakare, uye kana zvirizvo, kusadzivirirwa uku kuchagara kwenguva yakareba sei?
Kuitira kugonesa kuwanikwa kwekutanga kuongororwa serological nemarabhoritari nevatarisi vehutano, FDA yakapa nhungamiro munaKurume 16. Mitemo inobvumira vanogadzira kusimudzira bvunzo dzavo pasina EUA.Chero bedzi bvunzo ichipfuura ongororo, ivo vanozoziviswa.FDA, uye mushumo webvunzo une ruzivo rwakakosha nezvezvirambidzo, kusanganisira chirevo chekuti bvunzo haina kuongororwa neFDA uye mhedzisiro haigone kushandiswa kuongorora kana kubvisa hutachiona.1
Panguva iyoyo, kuongorora serological kwaisawanzo shandiswa mukutarisira varwere.Isu tinoshandisa mamwe matanho ekudzivirira nekumisa kushandiswa kwayo kumarabhoritari akatenderwa neMedicare neMedicaid Services Centers kuita bvunzo dzakaoma-dzika maererano neClinical Laboratory Improvement Amendment (CLIA).Marabhoritari akadaro ane vashandi vanonyatsofunga nezvekuita kwebvunzo uye vanosarudza bvunzo yakanakisa yechinangwa chakapihwa.Mahofisi emugadziri ane chinangwa chekushandisa bvunzo dzeserological kumba kana panzvimbo yekuchengeta (semuenzaniso vanachiremba) (kunze kwekunge vadzivirirwa nechitupa cheCLIA chemurabhoritari) vanofanirwa kuramba vachiendesa fomu reEUA uye vatenderwe neFDA kuti vaongororwe.Isu tinoronga kuongorora mutemo uyu mushure mekunge bvunzo dzinoverengeka dzeserological dzabvumidzwa.Nekudaro, mukutarisa, takaona kuti marongero akataurwa mugwaro redu raKurume 16 aive asina kunaka.
Pakupera kwaKurume, makumi matatu nevanomwe vagadziri vekutengesa vaive vazivisa iyo FDA nezvekuunza kwavo bvunzo dzeserological mumusika weUS.Iyo FDA yakagamuchira chikumbiro cheEUA chekuongororwa serological uye yakatanga kubvumidza bvunzo yekutanga muna Kubvumbi.Nekudaro, mukutanga kwaKubvumbi, vakuru vakuru vehurumende vakatanga kutaura zvingangoitika zvebvunzo idzi pakuvhurwazve kwehupfumi uye vakapa inishuwarenzi yekushandisa isingatsigirwe nesainzi uye isingaite zvipimo zvakatarwa neFDA.Nekuda kweizvozvo, musika wakazara nemaserological bvunzo, mamwe acho ane mhedzisiro, uye mazhinji anotengeswa nenzira dzinopokana neFDA.Pakazopera Kubvumbi, 164 vagadziri vekutengesa vaive vazivisa iyo FDA kuti vaive vaita serological test.Iyi nhevedzano yezviitiko zvakasiyana neruzivo rwedu mune zvekutengesa diagnostic bvunzo.Muchiitiko ichi, miedzo mishoma inopiwa pasi pechiziviso;vagadziri vanowanzosimudzira bvunzo dzavo pachinzvimbo chekunyora zvigadzirwa zvakagadzirwa nevamwe, kazhinji vasiri vekuUS vagadziri, semamwe bvunzo dzeserological;manyepo ekunyepa uye data Kune mashoma kwazvo zviitiko zvekukanganisa.
Musi waKubvumbi 17, FDA yakapa tsamba kune vanopa mabasa ekurapa ichitsanangura kuti vamwe vanogadzira vakashandisa zvisizvo runyoro rwekuzivisa bvunzo dzekuongorora nhema kuti bvunzo dzavo dzakabvumidzwa kana kubvumidzwa nesangano.2 Kunyangwe paine vanopfuura mazana maviri vanogadzira serological test reagent, FDA yakazvidira kuendesa EUA kana kuronga kuendesa EUA, saka FDA yakachinja mutemo wayo musi wa4 Chivabvu kuti isu tiongorore hwaro hwesainzi hwekuyedzwa kwese kwekutengeserana kwakagoverwa uye kuongorora kushanda kwayo. Bonde.3 Kubva muna Kukadzi 1, 2021, FDA yakadzima chibvumirano.Rondedzero yebvunzo mazana maviri nemakumi maviri neshanu dzakanyorwa kubva pawebhusaiti yedu, tsamba gumi neshanu dzekunyevera dzakapihwa, uye yambiro dzekutyora mutemo dzakapihwa kumakambani makumi masere nemasere.
Panguva imwecheteyo, kubva munaKurume, FDA yanga ichibatirana neNational Institutes of Health (NIH), iyo Centers for Disease Control and Prevention, uye Agency for Advanced Research and Development muBiomedicine kubatsira National Cancer Institute (NCI) simbisa kugona kuongorora serology.Kubatsira kuzivisa sarudzo dzeFDA pabvunzo dzega (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data - kits-part-validation).Chikwata chekuongorora chakaunganidzwa neNCI chine makumi matatu akaomeswa nechando SARS-CoV-2 antibody-positive serum samples uye makumi masere echando antibody-negative serum uye anticoagulated citrate glucose solution formula A plasma samples.Saizi uye kuumbwa kwepaneru kwakasarudzwa kuti igone kugonesa murabhoritari-yakavakirwa ongororo uye kupa fungidziro inonzwisisika uye nguva dzekuvimba dzekuita bvunzo pasi pekuwanikwa kwemuenzaniso kushoma.Iri basa rinoratidza kekutanga hurumende yemubatanidzwa yakaita kuzviongorora kuzivisa iyo FDA yemvumo.Mushure mezvo, National Institutes of Health (NIH) yakashandisa hukama hwayo nenzvimbo yezvidzidzo kuita ongororo yekutanga yekuvimbisa nzvimbo-yekutarisira nzvimbo uye kumba Covid-19 bvunzo dzekuongorora pasi pechirongwa chayo cheRADx (Rapid Diagnostic Acceleration).4
Isu takambotsanangura ruzivo rwedu muCovid-19 diagnostic tests.5 Chokwadi chakakodzera uye vatori vechikamu-uye zviito zveFDA?Mamiriro ekuongorora serological akasiyanawo, uye zvidzidzo zvatakadzidza zvakasiyanawo.
Chekutanga, ruzivo rwedu mukuyedzwa kweserological runosimbisa kukosha kwemvumo yakazvimirira yezvigadzirwa zvekurapa pane inonzwika sainzi hwaro, uye haitenderi zvigadzirwa zvekuyedza zvisina mvumo kupinda mumusika.Kuziva zvatave kuziva, kunyangwe pasina zvirambidzo zvatakamisa pakutanga, hatingabvumire kuyedzwa kweserological pasina FDA ongororo uye mvumo.Kunyangwe zvimwe zvinhu zvingakonzeresa mafashama ezvigadzirwa zvisina mvumo mumusika, yedu Kurume 16 mutemo unobvumira izvi kuti zviitike.
Chechipiri, sechikamu chechirongwa chekubuda, hurumende yemubatanidzwa inofanirwa kuronga gadziriro yezvirongwa zvekutsvagisa veruzhinji kuti zvigadzirise nyaya dzezvirwere zvine chekuita nekutapurirana kwechirwere uye kusadzivirirwa mukutanga kwedenda.Kuedza kwakabatana kuchabatsira kuona kuti tsvakiridzo inodiwa inoitwa nenguva, kuderedza kudzokororwa kwetsvagiridzo, uye kushandisa zvizere zviwanikwa zvemubatanidzwa.
Chetatu, isu tinofanirwa kumisa kugona kuongorora kuita kwebvunzo mukati mehurumende yemubatanidzwa kana kumiririra hurumende yemubatanidzwa isati yatanga, kuitira kuti ongororo dzakazvimirira dziitwe nekukurumidza panguva yekubuda.Kudyidzana kwedu neNCI kwatiratidza kukosha kwemaitiro aya.Yakasanganiswa nemvumo yeFDA, zano iri rinogona kubvumira kuongororwa nekukurumidza uye kwakazvimiririra kwekururama kwema molecular diagnostics, antigen uye serological bvunzo, uye kuderedza kudiwa kwevanovandudza kutsvaga varwere vevarwere kana mamwe masampuli ekiriniki kuti asimbise bvunzo dzavo, nekudaro kukurumidza Kushandiswa kwechokwadi. kuedza kunovandudzwa.Hurumende yemubatanidzwa inofanirwawo kufunga nezvekushandisa nzira iyi kune matekinoroji anoshandiswa kunze kwedenda.Semuenzaniso, NIH's RADx chirongwa chinogona kuenderera uye kuwedzera kupfuura Covid-19.Mukufamba kwenguva, isu tinoda nzira yakajairika yekuona bvunzo dhizaini uye kuita.
Chechina, nharaunda yesainzi neyekurapa inofanirwa kunzwisisa chinangwa uye kushandiswa kwekiriniki kwekuongorora serological, uye mashandisiro emhedzisiro yebvunzo nenzira kwayo kuzivisa kutarisirwa kwevarwere zvakazara.Nekuvandudzwa kweruzivo rwesainzi, dzidzo inoenderera mberi yakakosha mune chero mhinduro yehutano hweveruzhinji, kunyanya tichifunga kuti nzira dzekuongorora serological dzinoshandiswa zvisizvo pakuongororwa, uye vanhu vane huwandu hwehutachiona hwakaderera vanogona kushandisa imwe nzira yekuyedza.Pachave nemhedzisiro yenhema uye inoonekwa kusadzivirirwa kuhutachiona.Nzira dzedu dzekuyedza dzinoda kugara dzichivandudzwa uye kutungamirwa nesainzi yakavimbika.
Chekupedzisira, mapato ese ane chekuita nehutano hweveruzhinji mhinduro anofanirwa kuwana ruzivo rwuri nani nekukurumidza.Sezvinongoita nyanzvi dzekurapa dziri kukurumidza kuyedza kunzwisisa kuti Covid-19 inobata sei varwere uye nekurapa zvakanyanya varwere, iyo FDA inofanirwa kujairana neruzivo rushoma uye rwunobuda, kunyanya mumatanho ekutanga ekuputika.Kugadzwa kwezvakanzwika uye zvakarongeka nzira dzenyika nedzepasirese dzekuunganidza humbowo uye kuunganidza, kugovana uye kuparadzira ruzivo kwakakosha pakupedza denda riripo uye kupindura kune ramangwana rehutano hweveruzhinji.
Tichitarisa kumberi, sezvo denda richikura, iyo FDA icharamba ichitora matanho ekuona kuti kwakaringana uye kwakavimbika bvunzo dzeantibody dzinopihwa panguva yakakodzera kuti isangane nehutano hweveruzhinji.
1. Food and Drug Administration.Iyo mutemo wekuongororwa bvunzo dze2019 coronavirus chirwere muhutano hweveruzhinji emergency.Kurume 16, 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/download).
2. Food and Drug Administration.Tsamba kune varapi vehutano nezve ruzivo rwakakosha nezve kushandiswa kweserology (antibodies) kuona COVID-19.Kubvumbi 17, 2020 (yakagadziridzwa muna Chikumi 19, 2020) (https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests- covid-19 -tsamba kumutarisiri wehutano).
3. Shah A naShurenJ.Dzidza zvakawanda nezve FDA yakagadziridzwa antibody yekuongorora mutemo: Isa pamberi pekuwana uye huchokwadi.Silver Spring, MD, Food and Drug Administration (FDA), Chivabvu 4, 2020 (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy -antibody-tests-prioritizing- kuwana-uye -kururama).
4. National Institutes of Health.Rapid Diagnostic Acceleration (RADx) (https://www.nih.gov/research-training/medical-research-initiatives/radx).
5. Shuren J, Stenzel T. Covid-19 molecular diagnostic test akadzidza chidzidzo.The English Journal of Medicine 2020;383(17): e97-e97.
Nguva yekutumira: Mar-10-2021