Vivera Pharmaceuticals, Inc. na onye na-ekesa ule diagnostic Areum Bio LLC taa kwuputara nguzobe nke mmekorita ọwa iji gbasaa Access Bio, Inc.'s CareStart™ COVID-19 ule antigen ngwa ngwa yana ikike ojiji mberede FDA (EUA) nkesa ngwaahịa) .Areum Bio abụrụla onye na-ekesa CareStart™ COVID-19 nnwale antigen ngwa ngwa sitere n'aka onye nrụpụta New Jersey Access Bio, ọ ga-achọkwa ime ka ọrụ ọkọnọ ya sie ike site na nnukwu netwọkụ nke ndị na-ahụ maka ahụike na ndị otu Vivera.
Dị ka mahadum, azụmahịa, ụgbọ elu, na ebe ọha na eze na-eji ule oge niile dị ka akụkụ nke nlọghachi ụlọ akwụkwọ, ọrụ, njem na nkwekọrịta otu, nnweta nnwale COVID-19 a pụrụ ịdabere na ya ka bụ isi ihe dị mkpa.Ịrụ ọrụ nke EUA-authorized Point-of-Care (POC) CareStart™ ngwa ngwa antigen, yana ike nkesa Vivera buru ibu, ga-eme ka ọ dị mfe ịnweta ngwọta nyocha ngwa ngwa.
United States enwetala nnukwu ihe ịrịba ama n'imeri ọnụ ọgụgụ kasị elu nke ọrịa a, mana n'ihi na ọnụego ịgba ọgwụ mgbochi ọrịa dị n'okpuru ọkwa dị mma yana iyi egwu nke ụdị ọhụrụ na-aga n'ihu na-apụta n'ụwa niile, ọ ka dị mkpa na obodo ahụ ga-aga n'ihu na-agbaso usoro nyocha COVID-19 belata mgbasa .Mmekọrịta nkesa n'etiti Vivera, Areum Bio na Access Bio ga-eme ka nnwale dị ngwa ngwa ngwa ngwa enwere ike.Dị ka onye nkesa ikike nke CareStart™ ngwa ngwa antigen, Vivera na-ezube ịgbasa mkpuchi ya iji hụ na ndị na-ahụ maka ahụike na ndị ọrịa nwere ohere nyocha ngwa ngwa iji nyere aka hụ na nchekwa nke obodo anyị.
Paul Edalat, Onye isi oche na onye isi oche nke Vivera Pharmaceuticals kwuru, "Mmekọrịta nkwado a na-egosi njikọ aka ọhụrụ maka Vivera."“Asọpụrụ ụlọ ọrụ ahụ ka ya na Areum Bio na Access Bio rụkọọ ọrụ iji nye nnwale COVID-19 nke EUA nyere ngwa ngwa na ntụkwasị obi maka ụlọ ọrụ ahụike na ndị ọrịa na mba niile.Site n'ịgbasa ule nnwale, Vivera ga-ahụ na ndị mmekọ anyị na ndị ọrịa, ọkachasị obodo ndị nwere nsogbu na-adabere na anyị nwere ike nweta nsonaazụ a na-atụghị anya ya. "
"Nke a bụ ohere magburu onwe ya maka Areum Bio iji soro ụlọ ọrụ ọgwụ ama ama Vivera na-ekesa CareStart™ COVID-19 ngwa ngwa antigen na mba," Dr. Jong Kim, Areum Bio's president kwuru."Site na mmekorita a, na-eji mmasị na nka anyị na-enwekarị, anyị ga-enwe ike ịnye ndị obodo dị iche iche ngwa ule ngwa ngwa na nke a pụrụ ịdabere na ya n'ụzọ dị irè karị.Anyị kwenyere na ọbụna ngwá ọrụ ahụike kachasị ọhụrụ, Ha abaghị uru ọ gwụla ma ekesara ndị ọrịa na-achọ ha.Na Areum Bio, anyị kwenyesiri ike na anyị ga-aga nke ọma naanị mgbe ngwaọrụ ọhụrụ anyị ruru ndị ọrịa na ndị na-eweta ya wee mezuo ebumnuche ha.Ya mere, anyị na-arụsi ọrụ ike mgbe niile., Iji nyefee ndị ahịa ngwaahịa anyị ngwa ngwa ma dị irè. "
Site na mmekorita nkesa atụmatụ ha, Vivera, Areum Bio na Access Bio nwere olile anya ịkwado mba ahụ na nloghachi dị mma na enweghị nkebi site n'ịbawanye nnweta nnwale ngwa ngwa na mba niile.
CareStart ™ COVID-19 Antigen Test bụ n'akụkụ eruba immunochromatographic ule eji nke ọma chọpụta nucleocapsid protein antigen sitere na SARS-CoV-2 na nasopharyngeal ma ọ bụ imi swab ụdị anakọtara ozugbo site n'aka ndị a na-enyo enyo ndị nwere COVID-19 na-enyo enyo na COVID-19. Onye na-ahụ maka ahụike na-anwale ule abụọ n'ime ụbọchị ise mbụ nke mmalite nke mgbaàmà, ma ọ bụ site n'aka ndị na-enweghị ihe mgbaàmà ma ọ bụ ihe ndị ọzọ na-efe efe, ọ dịkarịa ala awa 24 n'etiti ule na ọ dịghị ihe karịrị awa 48.
Nnwale nwere oke na ụlọ nyocha ndị enwetara ikike n'okpuru Ndezigharị Nkwalite Ahụhụ Clinical (CLIA) nke 1988, 42 USC §263a, ụlọ nyocha ndị a na-emezu ihe achọrọ maka ịme ule mgbagwoju anya, nke dị elu ma ọ bụ nke apụrụ.Enyere ikike iji ule a na-elekọta nlekọta (POC), ya bụ, gburugburu ebe nlekọta ndị ọrịa na-arụ ọrụ n'okpuru asambodo Nwepu CLIA, asambodo nnabata, ma ọ bụ asambodo asambodo.
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Areum Bio, LLC bụ onye nkesa ngwaọrụ ahụike ntụkwasị obi ma guzobe mmekọrịta ntụkwasị obi na Access Bio, Inc. Areum Bio bụ enyemaka nke Ivy Pharma Inc. nke hiwere isi na New Jersey.Ụlọ ọrụ ahụ na-akwado ọtụtụ ndị mmekọ azụmahịa ma guzobe ọwa nkesa n'ụwa nile.Na mgbakwunye na akụkọ nkesa afọ 15 ya na United States, o nwere Iji nyere aka, Areum Bio gbagoro iji nyere aka kesaa ngwa ngwa nyocha coronavirus ntụkwasị obi site na netwọkụ ya buru ibu.Ụlọ ọrụ ahụ na-agba mbọ na-aga n'ihu na-akwalite ahụike ọha na eze na ọdịmma mmadụ site na ịnye ngwa nyocha nyocha ziri ezi na nke a pụrụ ịdabere na ya n'oge.
Access Bio, Inc. bụ onye nrụpụta ama ama ama ama ama dị na New Jersey, ka na-elekwasị anya na nyocha, mmepe na mmepụta nke nchọpụta ọrịa na-efe efe.Access Bio na-agba mbọ igbochi na nyocha mmalite nke ọrịa na-efe efe site na nyocha, mmepe na imepụta ule nyocha ngwa ngwa in vitro, biosensors na ngwaahịa nchoputa nke mkpụrụ ndụ.Dabere na mkpa kachasị ukwuu na ikike ime ihe ọma, ụlọ ọrụ ahụ na-akwado ndị mmekọ gburugburu ụwa, gụnyere Bill na Melinda Gates Foundation, Òtù Ahụ Ike Ụwa, na United Nations Children Fund.
Oge nzipu: Jul-01-2021