Ua hoʻolaha ʻo Vivera Pharmaceuticals, Inc. a me ka mea hoʻolaha hoʻāʻo diagnostic ʻo Areum Bio LLC i kēia lā i ka hoʻokumu ʻana i kahi hui kaila e hoʻonui i ka hoʻāʻo antigen wikiwiki o Access Bio, Inc.'s CareStart™ COVID-19 a me ka FDA emergency use authorization (EUA) product line Distribution) .ʻO Areum Bio ka mea hoʻolaha nui o CareStart ™ COVID-19 wikiwiki antigen hōʻike mai New Jersey mea hana Access Bio, a e ʻimi e hoʻoikaika i kāna hana kaulahao ma o ka pūnaewele nui o Vivera o nā mea mālama olakino a me nā hui.
Ke hoʻohana nei nā kulanui, nā ʻoihana, nā mokulele, a me nā wahi ākea i ka hoʻāʻo maʻamau ma ke ʻano he ʻāpana o kā lākou back-to-school, hana, huakaʻi, a me nā ʻaelike pāʻina, ʻo ka loaʻa ʻana o ka hoʻāʻo COVID-19 hilinaʻi i mea nui e pono ai.ʻO ka maikaʻi o ka EUA-authorized Point-of-Care (POC) CareStart™ hoʻāʻo antigen wikiwiki, i hui pū ʻia me nā mana hoʻohele ākea o Vivera, e hōʻoia i ka maʻalahi o ka loaʻa ʻana o nā hopena hoʻokolohua diagnostic wikiwiki.
Ua hoʻokō ʻo ʻAmelika i nā mea nui i ka lanakila ʻana i ka piko o ka maʻi maʻi, akā no ka mea ʻoi aku ka nui o ka maʻi maʻi ma lalo o nā pae kūpono a ke hoʻomau nei ka hoʻoweliweli o nā ʻano hou i ka honua holoʻokoʻa, he mea nui ia e hoʻomau ka ʻāina i ka hahai ʻana i nā protocol hoʻāʻo COVID-19 e hoemi i ka laha .ʻO ka hui pū ʻana ma waena o Vivera, Areum Bio a me Access Bio e maʻalahi i ka hoʻāʻo wikiwiki i ka hiki.Ma ke ʻano he mea hoʻolaha ʻae ʻia o CareStart™ wikiwiki antigen hoʻāʻo, manaʻo ʻo Vivera e hoʻonui i kāna uhi e hōʻoia i ka loaʻa ʻana o nā mea mālama olakino a me nā mea maʻi i ka hoʻāʻo wikiwiki e kōkua i ka palekana o ko mākou kaiāulu.
"Ke hōʻailona nei kēia hui pū ʻana i kahi hui kuikahi hou no Vivera," wahi a Paul Edalat, Luna Hoʻokele a me Luna Nui o Vivera Pharmaceuticals."Hoʻohanohano ʻia ka hui e hana pū me Areum Bio a me Access Bio e hāʻawi i ka hoʻāʻo wikiwiki a me ka hilinaʻi ʻo EUA-ʻae ʻia ʻo COVID-19 no kā mākou hui mālama olakino a me nā maʻi ma ka ʻāina.Ma ka hoʻonui ʻana i ke ʻano o ka hoʻāʻo ʻana, e hōʻoia ʻo Vivera i kā mākou mau hoa a me nā mea maʻi, ʻoi aku ka maikaʻi o nā kaiāulu i hilinaʻi nui ʻia iā mākou e hiki ke loaʻa i nā hopena i hiki ke ana.
"He manawa kūpono loa kēia no Areum Bio e hui pū me ka hui lāʻau lapaʻau kaulana ʻo Vivera e hāʻawi i ka CareStart™ COVID-19 wikiwiki antigen test ma ka ʻāina," wahi a Kauka Jong Kim, ka pelekikena o Areum Bio."Ma o kēia hui ʻana, me ka hoʻohana ʻana i kā mākou makemake a me kā mākou ʻike, hiki iā mākou ke hāʻawi i nā pahu hoʻāʻo wikiwiki a hilinaʻi hoʻi i nā kaiāulu a puni ka ʻāina i ka manawa kūpono a me ka maikaʻi.Ke manaʻoʻiʻo nei mākou ʻo nā mea lapaʻau hou loa, ʻaʻole waiwai lākou ke ʻole e hāʻawi ʻia i nā maʻi e pono ai.Ma Areum Bio, manaʻoʻiʻo mākou e kūleʻa wale ana mākou i ka wā e hiki ai kā mākou mau mea hana hou i nā maʻi a me nā mea hoʻolako a hoʻokō i kā lākou mau pahuhopu.No laila, hoʻoikaika mau mākou., E hāʻawi i kā mākou huahana i nā mea kūʻai aku ma ke ʻano wikiwiki a maikaʻi.
Ma o kā lākou hui hoʻolaha hoʻolālā, manaʻolana ʻo Vivera, Areum Bio, a me Access Bio e kākoʻo i ka hoʻihoʻi ʻana o ka ʻāina i ka maʻamau ma o ka hoʻonui ʻana i ka loaʻa ʻana o ka hoʻāʻo wikiwiki kiʻekiʻe ma ka ʻāina.
ʻO CareStart ™ COVID-19 Antigen Test kahi hoʻāʻo immunochromatographic kahe lateral i hoʻohana ʻia e ʻike pono i ka antigen protein nucleocapsid mai SARS-CoV-2 i nā specimens nasopharyngeal a i ʻole nasal swab i hōʻiliʻili pololei ʻia mai nā mea kānalua. Lawe ka mea mālama ola i ʻelua mau hoʻāʻo i loko o nā lā ʻelima mua o ka hoʻomaka ʻana o nā hōʻailona, a i ʻole mai nā poʻe me ka ʻole o nā hōʻailona a i ʻole nā kumu maʻi maʻi ʻē aʻe, ma kahi o 24 mau hola ma waena o nā hoʻokolohua A ʻaʻole ʻoi aku ma mua o 48 mau hola.
Ua kaupalena ʻia ka hoʻāʻo ʻana i nā laboratories i hōʻoia ʻia ma lalo o ka Clinical Laboratory Improvement Amendment (CLIA) o 1988, 42 USC §263a, a ua hoʻokō kēia mau laboratories i nā koi no ka hoʻokō ʻana i nā hoʻokolohua paʻakikī, kiʻekiʻe, a i ʻole.Ua ʻae ʻia ka hoʻāʻo e hoʻohana i ka point-of-care (POC), ʻo ia hoʻi, nā wahi mālama mālama maʻi i hana ʻia ma lalo o nā palapala hoʻokuʻu CLIA, nā palapala hoʻokō, a i ʻole nā palapala hōʻoia.
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ʻO Areum Bio, LLC kahi mea hoʻolaha lāʻau lapaʻau hilinaʻi a ua hoʻokumu i kahi hui hilinaʻi me Access Bio, Inc. ʻO Areum Bio kahi lālā o Ivy Pharma Inc.Ua hui pū ka hui me nā hoa ʻoihana he nui a ua hoʻokumu i nā ala hoʻolaha ma ka honua holoʻokoʻa.Ma kahi o kāna moʻolelo hoʻolaha 15 mau makahiki ma ʻAmelika Hui Pū ʻIa, ua kōkua ʻo Areum Bio e kōkua wikiwiki i ka hāʻawi ʻana i nā pahu hoʻāʻo coronavirus hilinaʻi ma o kāna pūnaewele ākea.Ua kūpaʻa ka ʻoihana i ka hoʻolaha mau ʻana i ke olakino lehulehu a me ke ola kanaka ma o ka hāʻawi ʻana i nā pahu hoʻāʻo diagnostic pololei a hilinaʻi i ka manawa kūpono.
He mea hana diagnostic kaulana ʻo Access Bio, Inc. ma New Jersey, e nānā mau ana i ka noiʻi, hoʻomohala a me ka hana ʻana i nā diagnostics maʻi maʻi.Ua kūpaʻa ʻo Access Bio i ka pale ʻana a me ka ʻike mua ʻana i nā maʻi maʻi ma o ka noiʻi ʻana, hoʻomohala a me ka hana ʻana i nā hoʻokolohua diagnostic wikiwiki in vitro, biosensors a me nā huahana diagnostic molecular.Ma muli o nā pono nui a me ka hiki ke hana i ka maikaʻi, hui pū ka hui me nā hoa a puni ka honua, me ka Bill and Melinda Gates Foundation, ka World Health Organization, a me ka United Nations Children's Fund.
Ka manawa hoʻouna: Jul-01-2021