I-FDA ivume uvavanyo lwayo lokuqala lwe-antibody, olungasebenzisi iisampulu zegazi ukujonga ubungqina bosulelo lwe-COVID-19, kodwa endaweni yoko ixhomekeke kwi-swabs yomlomo elula, engenantlungu.
Ukuxilongwa ngokukhawuleza kwe-lateral flow eyenziwa yi-Diabetomics ifumene isigunyaziso esiphuthumayo kwi-arhente, evumela ukuba isetyenziswe kumanqaku okunyamekela abantu abadala kunye nabantwana.Uvavanyo lwe-CovAb lwenzelwe ukubonelela ngeziphumo kwimizuzu eli-15 kwaye alufuni naziphi na izixhobo ezongezelelweyo okanye izixhobo.
Ngokutsho kwenkampani, xa impendulo ye-antibody yomzimba ifikelela kwinqanaba eliphezulu emva kweentsuku ezili-15 ubuncinane emva kokuqala kweempawu, izinga lobuxoki lovavanyo lingaphantsi kwe-3%, kwaye izinga lobuxoki lisondele kwi-1% .
Le reagent yokuxilonga inokubona izilwa-buhlungu ze-IgA, IgG kunye ne-IgM, kwaye sele ifumene uphawu lwe-CE ngaphambili eYurophu.EUnited States, uvavanyo luthengiswa yinkampani encedisayo yeCOVYDx.
Emva kokusebenza ukuphuhlisa uvavanyo olusekwe kumathe ukuqikelela amanqanaba eswekile yegazi evekini yohlobo lwesi-2 lweswekile yabaguli, iDiabetomics yajikela iinzame zayo kubhubhani we-COVID-19.Ikwasebenza kuvavanyo olusekelwe kwigazi lokufumanisa kwangaphambili uhlobo lwe-1 yeswekile kubantwana nakubantu abadala;kananjalo ayikavunywa yi-FDA.
Inkampani ngaphambili yaqalisa uvavanyo lwe-point-of-care ukufumanisa i-pre-eclampsia kwi-trimester yokuqala yokukhulelwa.Le ngxaki inokuba yingozi inxulumene noxinzelelo lwegazi oluphezulu kunye nomonakalo wamalungu, kodwa akunakubakho ezinye iimpawu.
Kutshanje, iimvavanyo ze-antibody sele ziqalisile ukucacisa ngokucacileyo kwiinyanga ezimbalwa zokuqala zobhubhani we-COVID-19, ukunika ubungqina bokuba i-coronavirus ifikelele kunxweme lwase-United States kwakudala ngaphambi kokuba ithathwe njengengxakeko yesizwe, kwaye inezigidi ukuya kumashumi eenkulungwane. izigidi.Iimeko ezinokuthi zibekho zimpawu azikafunyaniswa.
Uphando olwenziwe ngamaZiko ezeMpilo eSizwe luxhomekeke kwiisampuli zegazi ezigciniweyo nezomisiweyo eziqokelelwe kumashumi amawaka abathathi-nxaxheba.
Uphononongo olusebenzisa iisampulu ezaqokelelwa okokuqala kwi-NIH "Sonke" inkqubo yophando lwabemi kwiinyanga ezimbalwa zokuqala zika-2020 zafumanisa ukuba ii-antibodies ze-COVID zazikhomba kusulelo olusebenzayo kulo lonke elase-United States kwasekuqaleni kukaDisemba ka-2019 (ukuba akunjalo ngaphambili).Ezi ziphumo zisekelwe kwingxelo yoMnqamlezo oBomvu yaseMelika, efumene izilwa-buhlungu ekunikeleni ngegazi ngelo xesha.
Olunye uphononongo oluqeshe ngaphezu kwe-240,000 yabathathi-nxaxheba bafumanisa ukuba inani lamatyala asemthethweni njengehlobo elidlulileyo linokuthi lehle malunga nezigidi ezingama-20.Abaphandi baqikelela ukuba ngokusekwe kwinani labantu abavavanyiweyo ukuba banazo ii-antibodies, kulo lonke usulelo oluqinisekisiweyo lwe-COVID, phantse abantu aba-5 abafunyaniswanga.
Ixesha lokuposa: Jul-14-2021