FDA yo gupima antibody ya Covid-19

Koresha amakuru na serivisi bya NEJM Itsinda kugirango witegure kuba umuganga, gukusanya ubumenyi, kuyobora umuryango wita ku buzima no guteza imbere umwuga wawe.
Muri Mutarama 2020, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyatangiye gusuzuma igisubizo cy’Amerika kuri Covid-19.Ku ya 4 Gashyantare, nyuma yo gutangaza ko ubuzima bw’abaturage bwihutirwa, twatangiye gutanga uburenganzira bwo gupima indwara zanduye.Mu bihe byihutirwa, FDA irashobora gutanga uruhushya rwo gukoresha byihutirwa (EUA) kubicuruzwa byubuvuzi bishingiye ku gusuzuma ibimenyetso bya siyansi.Kwemeza amahame yo hasi ya EUA, aho gutegereza ibyemezo byuzuye kugirango ubone ibimenyetso byagutse, birashobora kwihutisha umuvuduko wo kubona ibizamini nyabyo.Nyuma yo gutanga raporo zidafite ibimenyetso, biragaragara ko tugomba gufata izindi ngamba kugirango twumve ikwirakwizwa ryukuri rya SARS-CoV-2 mu gihugu hose.Mugihe cya virusi yabanjirije icyorezo, ibizamini bya serologiya (ni ukuvuga antibody) ntabwo byakozwe cyangwa bifite imikoreshereze mike.Ariko, muriki gihe, FDA yemera ko kwemeza byihuse kandi bihagije kwipimisha serologiya muri Amerika bishobora guteza imbere ubushakashatsi bwa siyansi no gusobanukirwa Covid-19, bityo bigafasha gusubiza igihugu.
Igeragezwa rya serologiya rirashobora kumenya uburyo umubiri urwanya indwara zanduye.Kubwibyo, kwipimisha serologiya byonyine ntibishobora kumenya niba umuntu yanduye SARS-CoV-2.Byongeye kandi, nubwo uburambe bwizindi virusi bwerekanye ko kuba antibodiyite za SARS-CoV-2 zishobora kurinda umutekano muke, ntituzi niba hari antibodi?Cyangwa urwego runaka rwa antibodies?Bisobanura ko umuntu afite ubudahangarwa bwo kongera kwandura, kandi niba aribyo, ubwo budahangarwa buzamara igihe kingana iki?
Mu rwego rwo koroshya uburyo bwo kwipimisha hakiri kare na laboratoire hamwe n’abatanga ubuvuzi, FDA yatanze amabwiriza ku ya 16 Werurwe. Amabwiriza yemerera abashinzwe iterambere kuzamura ibizamini byabo nta EUA.Igihe cyose ikizamini cyatsinze igenzura, bazamenyeshwa.FDA, na raporo y'ibizamini ikubiyemo amakuru y'ingenzi yerekeye ibibujijwe, harimo amagambo avuga ko ikizamini kitigeze gisuzumwa na FDA kandi ibisubizo ntibishobora gukoreshwa mu gusuzuma cyangwa kwirinda indwara.1
Muri kiriya gihe, gupima serologiya ntabwo byakoreshwaga mu kwita ku barwayi.Dushyira mu bikorwa izindi ngamba zo gukingira tugabanya imikoreshereze ya laboratoire yemewe na Medicare na Medicaid Services Centre kugira ngo dukore ibizamini bigoye cyane dukurikije ivugururwa rya Clinical Laboratory Impinduka (CLIA).Laboratwari nkizo zifite abakozi batekereza cyane cyane imikorere yikizamini bagahitamo ikizamini cyiza kubwintego runaka.Ibiro byabatezimbere bifuza gukoresha ibizamini bya serologi murugo cyangwa aho bita (urugero: abaganga) (keretse niba barinzwe nicyemezo cya laboratoire ya CLIA) bagomba gukomeza gutanga ibyifuzo bya EUA kandi babiherewe uburenganzira na FDA kubipimisha.Turateganya gusubiramo iyi politiki nyuma y'ibizamini byinshi bya serologiya byemewe.Ariko, urebye neza, twabonye ko politiki yavuzwe mumabwiriza yacu yo ku ya 16 Werurwe yari afite amakosa.
Mu mpera za Werurwe, inganda 37 z’ubucuruzi zari zamenyesheje FDA ko zinjije ibizamini bya serologiya ku isoko ry’Amerika.FDA yakiriye icyifuzo cya EUA cyo gupima serologiya kandi itangira gutanga ikizamini cya mbere muri Mata.Icyakora, mu ntangiriro za Mata, abayobozi ba leta batangiye kuvuga ingaruka zishobora guterwa n’ibi bizamini ku kongera ubukungu ndetse banatanga ubwishingizi bwo gukoresha budashyigikiwe na siyansi kandi butujuje imbibi zashyizweho na FDA.Kubera iyo mpamvu, isoko ryuzuyemo ibizamini bya serologiya, bimwe muribyo bifite ibisubizo bibi, kandi byinshi bigurishwa muburyo buvuguruza politiki ya FDA.Mu mpera za Mata, abakora ubucuruzi 164 bari bamenyesheje FDA ko bakoze ibizamini bya serologiya.Uru ruhererekane rwibyabaye bitandukanye nubunararibonye bwacu mubizamini byo kwisuzumisha.Muri uru rubanza, ibizamini bike bitangwa mubimenyeshejwe;ababikora mubisanzwe bazamura ibizamini byabo aho gutondekanya ibicuruzwa byakozwe nabandi, mubisanzwe abatari abanyamerika, nkibizamini bimwe na bimwe bya serologiya;Ibinyoma nibisobanuro Hariho ibibazo bike cyane byo kunyereza.
Ku ya 17 Mata, FDA yahaye ibaruwa abatanga serivisi z'ubuvuzi isobanura ko bamwe mu bashinzwe iterambere bakoresheje nabi urutonde rw’imenyekanisha ry'ibizamini bya serologiya kugira ngo babeshye ko ibizamini byabo byemejwe cyangwa byemewe n'ikigo.2 Nubwo hari abaterankunga barenga 200 ba serologi basubiramo reagent, FDA yatanze ubushake bwa EUA cyangwa irateganya gutanga EUA, FDA rero yahinduye politiki yayo ku ya 4 Gicurasi kugirango dusuzume ishingiro ryubumenyi ryibizamini byose byakwirakwijwe mubucuruzi no gusuzuma imikorere yabyo Imibonano mpuzabitsina.3 Guhera ku ya 1 Gashyantare 2021, FDA yahagaritse amasezerano.Urutonde rwibizamini 225 rwashyizwe ku rubuga rwacu, hatanzwe amabaruwa 15 yo kuburira, naho imenyekanisha ry’ibicuruzwa bitumizwa mu mahanga ryahawe ibigo 88.
Muri icyo gihe, kuva muri Werurwe, FDA yagiye ikorana n’ikigo cy’igihugu cyita ku buzima (NIH), Ikigo gishinzwe kurwanya no gukumira indwara, n’ikigo gishinzwe ubushakashatsi n’iterambere ry’iterambere muri Biomedicine kugira ngo gifashe Ikigo cy’igihugu gishinzwe kanseri (NCI) shiraho ubushobozi bwo gusuzuma serologiya.Gufasha kumenyesha ibyemezo byubuyobozi bwa FDA kubizamini bya buri muntu (https://www.fda.gov/amakuru-yamakuru/amakuru-yatangajwe/coronavirus-covid-19-amakuru agezweho-fda ibikoresho-igice-kwemeza).Itsinda rishinzwe gusuzuma ryateranijwe na NCI rigizwe na 30 za SARS-CoV-2 zahagaritswe na antibody-nziza ya serumu hamwe na serumu 80 ya antibody-mbi ya serumu hamwe na citrate glucose ikemura ya formula ya plasma.Ingano n'ibigize itsinda byatoranijwe kugirango bishoboke gusuzumwa na laboratoire no gutanga igereranya ryumvikana hamwe nigihe cyizere cyo gukora ikizamini munsi yicyitegererezo kiboneka.Uyu murimo ni ubwa mbere guverinoma ihuriweho na leta yisuzumishije kugirango imenyeshe FDA uburenganzira.Nyuma yaho, Ikigo cy’igihugu cyita ku buzima (NIH) cyakoresheje umubano wacyo n’ikigo cy’amasomo kugira ngo gikore isuzuma ryibanze ry’ingingo zita ku barwayi hamwe n’ibizamini byo kwisuzumisha mu rugo Covid-19 muri gahunda ya RADx (Rapid Diagnostic Acceleration).4
Twabanje kwerekana uburambe bwacu mubizamini byo gusuzuma Covid-19.5 Ibintu bifatika n'abitabiriye-n'ibikorwa bya FDA?Ibizamini bya serologiya nabyo biratandukanye, kandi amasomo twize nayo aratandukanye.
Ubwa mbere, uburambe bwacu mugupima serologiya bushimangira akamaro ko gutanga uburenganzira bwigenga bwibicuruzwa byubuvuzi ku buryo bwa siyansi yumvikana, kandi ntibyemera ko ibicuruzwa byipimisha bitemewe byinjira ku isoko.Kumenya ibyo tuzi ubu, nubwo nta mbogamizi twashyizeho mbere, ntitwakwemera kwipimisha serologiya tutabanje kubisuzuma no kubiherwa uburenganzira.Nubwo izindi mpamvu zishobora gutera umwuzure wibicuruzwa bitemewe ku isoko, politiki yacu yo ku ya 16 Werurwe iremera ko bibaho.
Icya kabiri, muri gahunda y’icyorezo, guverinoma ihuriweho na leta igomba guhuza itegurwa rya gahunda z’ubushakashatsi bwa Leta n’abikorera kugira ngo bakemure ibibazo by’ibyorezo bijyanye no kwandura indwara n’ubudahangarwa mu ntangiriro y’icyorezo.Imbaraga zishyize hamwe zizafasha kwemeza ko ubushakashatsi bukenewe bukorwa mugihe gikwiye, kugabanya kwigana ubushakashatsi, no gukoresha neza umutungo wa leta.
Icya gatatu, dukwiye gushyiraho ubushobozi bwo gusuzuma imikorere yikizamini muri guverinoma ihuriweho na leta cyangwa mu izina rya guverinoma ihuriweho na leta mbere y’iki cyorezo, kugira ngo isuzuma ryigenga rishobore gukorwa vuba mu gihe cy’icyorezo.Ubufatanye bwacu na NCI bwatweretse agaciro k'ubu buryo.Hamwe n’uruhushya rwa FDA, iyi ngamba irashobora kwemerera isuzuma ryihuse kandi ryigenga ryerekana ukuri kwa kwisuzumisha kwa molekile, ibizamini bya antigen na serologiya, kandi bikagabanya ibikenewe kubateza imbere gushakisha ingero z’abarwayi cyangwa izindi ngero z’amavuriro kugira ngo bemeze ibizamini byabo, bityo byihutishe imikoreshereze yukuri ikizamini cyanonosowe.Guverinoma ihuriweho na none igomba gutekereza gukoresha ubu buryo mu ikoranabuhanga rikoreshwa hanze y’icyorezo.Kurugero, gahunda ya RADx ya NIH irashobora gukomeza no kwaguka kurenga Covid-19.Mugihe kirekire, dukeneye uburyo rusange bwo kugenzura igishushanyo mbonera n'imikorere.
Icya kane, umuryango wubumenyi nubuvuzi ugomba gusobanukirwa intego nogukoresha kwa muganga kwipimisha serologiya, nuburyo bwo gukoresha ibisubizo byikizamini kugirango umenyeshe ubuvuzi muri rusange.Hamwe niterambere ryubumenyi bwa siyanse, uburezi buhoraho nibyingenzi mubisubizo byubuzima bwihutirwa rusange, cyane cyane urebye ko uburyo bwo gupima serologiya bukoreshwa nabi mugupima, kandi abantu bafite ubwandu buke barashobora gukoresha uburyo bumwe bwo gupima.Hazabaho ibisubizo byiza byibinyoma no kubona ubudahangarwa bwo kwandura.Uburyo bwacu bwo kwipimisha bugomba guhora buvugururwa kandi bukayoborwa na siyanse yizewe.
Hanyuma, impande zose zigira uruhare mubibazo byubuzima bwihutirwa zikeneye kubona amakuru meza byihuse.Nkuko inzobere mu buvuzi zigerageza vuba kumva uburyo Covid-19 igira ingaruka ku barwayi n’uburyo bwo kuvura neza abarwayi, FDA igomba guhuza n’amakuru make kandi agenda ahinduka, cyane cyane mu ntangiriro y’icyorezo.Gushiraho uburyo bunoze kandi buhuriweho n’igihugu ndetse n’amahanga yo gukusanya ibimenyetso no gukusanya, gusangira no gukwirakwiza amakuru ni ngombwa mu guca icyorezo cy’iki gihe no guhangana n’ibiza byihutirwa by’ubuzima rusange.
Urebye imbere, uko icyorezo kigenda gitera imbere, FDA izakomeza gufata ingamba kugirango ibizamini bya antibody byukuri kandi byizewe bitangwe mugihe gikwiye kugirango ubuzima rusange bukenewe.
1. Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge.Politiki yo gupima indwara ya coronavirus ya 2019 mugihe cyihutirwa cyubuzima rusange.Ku ya 16 Werurwe 2020 (https://web.archive.org/web/20200410023229/https://www.fda.gov/media/135659/kuramo).
2. Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge.Ibaruwa yandikiwe abashinzwe ubuzima kubyerekeye amakuru yingenzi yerekeye ikoreshwa rya serologiya (antibodies) kugirango bamenye COVID-19.Ku ya 17 Mata 2020 (byavuguruwe ku ya 19 Kamena 2020) ( -kwandika kubashinzwe ubuzima).
3. Shah A na ShurenJ.Wige byinshi kuri politiki yo gupima antibody ya FDA ivuguruye: Shyira imbere uburyo bwuzuye.Isoko rya silver, MD, Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge (FDA), ku ya 4 Gicurasi 2020 (https://www.fda.gov/amakuru-amakuru kwinjira-na -ibisobanuro).
4. Ikigo cyigihugu cyubuzima.Kwihutisha Gusuzuma Byihuse (RADx) (https://www.nih.gov/ubushakashatsi-yitoza/ubuvuzi-ubushakashatsi-ibikorwa/radx).
5. Shuren J, Stenzel T. Covid-19 ikizamini cyo gusuzuma indwara ya molekile yize isomo.Ikinyamakuru cyo mu Bwongereza cy’Ubuvuzi 2020;383 (17): e97-e97.