Ua hōʻoia ka hoʻokolohua lapaʻau mua ma United States i ka hoʻāʻo wikiwiki 15 mau minuke o Clungene® SARS-CoV-2 virus IgG/IgM i ʻike pololei i nā antibodies o 100% o nā maʻi maʻi COVID ma hope o 13 mau lā.
Plymouth, Pennsylvania Conference, Iune 15, 2021/PRNewswire/-He hoʻokolohua lapaʻau US no ka hoʻāʻo wikiwiki COVID-19 i ʻae ʻia e ka Institutional Review Board i ʻike i ka kikoʻī o nā mea maʻi Covid-19-negative i hōʻoia ʻia e RT-PCR he 100% (95 % ka manawa hilinaʻi, 88.4% -100.0%);ʻO kēia ka 100% ʻaelike ma waena o ka RT-PCR maikaʻi ʻole a me nā hopena hoʻāʻo serological Clungene® maikaʻi ʻole.I nā poʻe maʻi i hoʻāʻo maikaʻi i ka maʻi ma hope o 13 mau lā, ʻo ka ʻaelike ma waena o ka Clungene® SARS-CoV-2 virus IgG/IgM 15-minuke wikiwiki a me ka hoʻāʻo ʻana o ka polymerase chain reaction (PCR) ma mua o 90%.Hōʻike nā hopena i kēia mau hoʻokolohua he mea hana pono e ʻike ai i ka hiki ʻana o nā antibodies i nā poʻe i loaʻa i ka maʻi.Ua alakaʻi ʻia ka hoʻokolokolo e Sharp Healthcare o San Diego, Kaleponi, a ua hoʻokomo ʻia nā mea maʻi i loko o nā hale maʻi maʻi a me waho.Ua mālama ʻia ka hoʻokolokolo ma mua o ka loaʻa ʻana o ke kano.Ua paʻi ʻia nā hualoaʻa noiʻi loiloi mua ma LymphoSign (https://lymphosign.com/journal/lpsn).
"He mea hōʻeuʻeu kēia mau hopena no ka mea e hōʻike ana lākou i ka CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM kit hoʻāʻo wikiwiki i ka hoʻomaopopo ʻana i nā poʻe me nā pane kūlohelohe adaptive. e like me ka mea i manaʻo ʻia e ka US Food and Drug Administration i kēia manawa i ke kulekele ʻae ʻana i ka hoʻohana ʻana i ka pilikia, "wahi a Kauka Fadi Haddad, he loea maʻi maʻi mai ka Sharp Medical Community Group nāna i kōkua i kēia noiʻi."He mea koʻikoʻi kēia i ka manawa ʻaʻole i hoʻopaʻa ʻia ka miliona o ka poʻe a ʻo ka hiki ʻana o ka maʻi ke pilikia maoli."
"Haʻaheo loa mākou i nā hopena o ka hoʻokolokolo," i ʻōlelo ai ʻo Proven CEO Scott Wise."Ke hōʻoia nei kēia hōʻike i ka pono o nā hoʻokolohua e like me ka Clungene® SARS-CoV-2 virus IgG/IgM 15 mau minuke wikiwiki i ke kōkua ʻana i nā limahana mālama olakino.ʻO kona maʻalahi a me ka maʻalahi o ka hoʻohana ʻana e lilo ia i mea hana hōʻoia pono. "
ʻO ka Clungeneâ SARS-CoV-2 virus (COVID-19) IgG/IgM kit hoʻāʻo wikiwiki hiki ke hana i nā hopena i loko o 15 mau minuke.ʻAʻole pono kēia hoʻāʻo i nā mea hana paʻakikī no ka hoʻoponopono ʻana i nā heluhelu.
E pili ana i PROVEN PHARMA I hoʻokumu ʻia ma 2012, ʻo Proven Pharma kahi mea lawelawe i ka ʻoihana mālama olakino a me ka ʻepekema ola.Hāʻawi ka hui i kahi ākea o nā hopena, me ka hāʻawi ʻana i ka ʻoihana, ke kūʻai ʻana i ka mea hoʻohālikelike hoʻokolohua lapaʻau, ka hui kūʻai kūloko i hoʻolaʻa ʻia, ke kākoʻo kūʻai aku, ka hoʻololi kikohoʻe a me ke kūkākūkā ʻenehana.Loaʻa iā lākou ma mua o ʻelua mau makahiki o ka ʻike waiwai ma nā wahi he nui o ke kahua mālama olakino a hāʻawi iā lākou i nā hopena.
Ma kahi ʻoihana piha i ka maopopo ʻole, hāʻawi ʻo Proven Pharma i kāna mea kūʻai aku me ka hilinaʻi.Hāʻawi ka hui i ka manawa i kēlā me kēia manawa me ka hoʻohana ʻana i nā hana maikaʻi loa a me nā kaʻina hana e hōʻoia i ka palekana a me ka hoʻokō ʻana i kēlā me kēia pae.Hoʻoikaika ʻo Proven Pharma i ka hoʻomaikaʻi mau ʻana i ka ʻike mea kūʻai aku i hiki i kēia mau mea kūʻai ke hoʻomaikaʻi i ke ola o nā maʻi.Loaʻa ka holomua o ka hui ma muli o ka ʻoiaʻiʻo, kūpaʻa a me ka hilinaʻi o kāna hui.
No Hangzhou Kelon Biotechnology ʻO Hangzhou Kelon Biotechnology Co., Ltd. he ʻenehana kiʻekiʻe, mea hana alakaʻi o nā mea olaola a me nā huahana diagnostic in vitro.He kūlana kaulana ka ʻoihana no ka hoʻolako ʻana i nā lawelawe like ʻole a me ka maʻalahi i nā mea hoʻolaha ʻoihana a me nā hoa hana ma ka mākeke honua.
Ua hoʻokumu ʻia ʻo Hangzhou Kelon Biotechnology Co., Ltd. ma 2004. Loaʻa iā ia ka ISO 13485: 2016 i hōʻoia ʻia i ka R&D a me nā mea hana hana ma Hangzhou, Kina, e like me ka GMP o Kina, e uhi ana i kahi ʻāpana o 19,000 square meters.Ua loaʻa i kāna mau huahana nā palapala CE, nā palapala FSC a me ka ʻae ʻana o US FDA 510 (k) (helu inoa inoa FDA: 3009414546).
ʻO CLUGENE® SARS-COV-2 virus (COVID-19) IgG/IgM kit hoʻāʻo wikiwiki hiki ke loaʻa e like me nā alakaʻi FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Hoʻohana pilikia i ka ʻae ʻana-mea hana lapaʻau/in vitro diagnostic-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
Koe na mea i hoakaka ia ma ka Instructions for Use (IFU), ua papa loa ia kekahi hoohana a olelo paha.E ʻoluʻolu e kipa www.proven.com a i ʻole kelepona 1-855-678-7768 no ka ʻike hou aku.
Ka manawa hoʻouna: Iune-18-2021