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Ukwamkelwa kwe-Aehealth BfArM

Uvavanyo lwe-Aehealth ka-2019- nCov antigen lufumene imvume ekhethekileyo kwiZiko laseJamani leZiyobisi kunye neZixhobo zoNyango (BfArM) ngokwe-§11 umhlathi woku-1 woMthetho weZixhobo zoNyango waseJamani (MPG) wovavanyo lwe-antigen ukuze kufunyanwe i-coronavirus.

Ukubambelela kwifilosofi “yonyango olungcono kuluntu”, i-Aehealth ibisoloko isebenzela ukwanelisa imfuno yehlabathi yovavanyo olukhawulezileyo kuthintelo kunye nolawulo lwendyikityha yehlabathi jikelele.I-Aehealth 2019- nCoV Antigen Test (igolide ye-colloidal) eyenziwa ngesampulu ye-swab kwi-nasal cavity ihambisa iziphumo kwimizuzu ye-15, inciphisa kakhulu ixesha lokufumanisa, xa kuthelekiswa nendlela ye-PCR.Uvavanyo lunokunika abasebenzisi ukuguquguquka okuphezulu kunye neziphumo ezilungileyo kakhulu.

Umphathiswa wezempilo waseJamani uJens Spahn uthe ukuvunywa kovavanyo lwe-antigen ye-COVID-19 kuvumela abantu abaninzi ukuba bavavanywe.Ukuchongwa kwangethuba kwabantu abane-asymptomatic kunokwaphula ikhonkco losulelo ngokufanelekileyo, ukunqanda ukusasazeka kosulelo.

UVavanyo oluKhawulezayo lwe-COVID-19 ye-Antigen yi-colloidal yegolide ye-immunochromatography eyenzelwe ukufunyaniswa okusemgangathweni kwee-antigens ze-nucleocapsid ezivela kwi-COVID-19 kwi-swabs yeempumlo zabantu, ukuswantsulana komqala okanye izinkcwe kubantu abarhanelwa ukuba bane-COVID-19 ngumboneleli wabo wezempilo.

Inoveli coronaviruses yeyodidi lwe-β.I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla.

Iziphumo zezochongo lwe-COVID-19 nucleocapsid antigen.I-antigen ibonakala ngokubanzi kwiisampuli eziphezulu zokuphefumla okanye iisampulu ezisezantsi zokuphefumla ngexesha lesigaba esinzima sosulelo.

Iziphumo ezilungileyo zibonisa ubukho be-antigens yentsholongwane, kodwa ukulungelelaniswa kweklinikhi kunye nembali yesigulane kunye nolunye ulwazi lokuxilonga luyimfuneko ukufumanisa imeko yokusuleleka.

Iziphumo ezilungileyo aziluthinteli usulelo lwebhaktiriya okanye ukosuleleka ngokubambisana nezinye iintsholongwane.I-antigen efunyenweyo ayinakuba ngunobangela oqinisekileyo wesifo.

Iziphumo ezibi aziyikhupheli ngaphandle i-COVID-19 kwaye akufuneki isetyenziswe njengesiseko kuphela sonyango okanye izigqibo zolawulo lwesigulane, kubandakanywa nezigqibo zolawulo losulelo.

Iziphumo ezibi kufuneka ziqwalaselwe kumxholo wokuvezwa kwesigulana kutshanje, imbali kunye nobukho beempawu zonyango kunye neempawu ezihambelana ne-COVID-19 kwaye zingqinwe ngovavanyo lwe-moecular, ukuba kuyimfuneko kulawulo lwesigulana.

Njengenkampani ephethe izatifikethi zovavanyo lwe-antigen ka-2019-nCoV, i-Aehealth izibophelele ekwenzeni igalelo kumlo wehlabathi wokulwa nobhubhane.Iimvavanyo ezininzi ze-Aehealth ze-COVID-19 zifumene ukuvunywa kwamanqaku e-CE kwaye zaqinisekiswa lilizwe lomrhwebi ngokwemigangatho nemimiselo yasekhaya.I-Aehealth ngoku ibonelela ngesisombululo esidityanisiweyo se-“PCR+ Antigen+Neutralization Antibody” esihlangabezana neemeko ezahlukahlukeneyo zokufunyaniswa kosulelo lwe-COVID-19.


Ixesha lokuposa: Dec-12-2021
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