Teko ea pele ea bongaka United States e netefalitse hore tlhahlobo e potlakileng ea metsotso e 15 ea vaerase ea Clungene® SARS-CoV-2 IgG/IgM e bonts'itse ka nepo li-antibodies tsa 100% ea bakuli ba nang le COVID kamora matsatsi a 13.
Plymouth, Seboka sa Pennsylvania, Phuptjane 15, 2021/PRNewswire/-Teko ea bongaka ea US bakeng sa tlhahlobo e potlakileng ea COVID-19 e amohetsoeng ke Boto ea Tlhahlobo ea Setsi e fumane hore ho nepahala ha bakuli ba Covid-19-ntle ho netefalitsoeng ke RT-PCR e ne e le 100% (95). % nako ea tšepo, 88.4% -100.0%);sena se bolela tumellano ea 100% pakeng tsa RT-PCR e mpe le liphetho tse mpe tsa Clungene® tsa tlhahlobo ea serological.Ho bakuli ba ileng ba etsa tlhahlobo ea kokoana-hloko ka mor'a matsatsi a 13, tumellano pakeng tsa tlhahlobo e potlakileng ea Clungene® SARS-CoV-2 IgG/IgM metsotso e 15 le tlhahlobo ea polymerase chain reaction (PCR) e ne e feta 90%.Liphetho li bonts'a hore liteko tsena e ka ba sesebelisoa se sebetsang sa ho bona boteng ba li-antibodies ho batho ba tšoaelitsoeng ke vaerase.Nyeoe e entsoe ke Sharp Healthcare ea San Diego, California, 'me e kenyelelitse bakuli litsing tsa bakuli le bakuli ba kantle ho naha.Teko e ile ea etsoa pele ente e fumaneha hohle.Liphetho tsa mantlha tse hlahlobiloeng ke lithaka li phatlalalitsoe makasineng ea LymphoSign (https://lymphosign.com/journal/lpsn).
"Liphetho tsena li khothatsa haholo hobane li bonts'a hore tlhahlobo e potlakileng ea kokoana-hloko ea CLUNGENE® SARS-COV-2 (COVID-19) IgG/IgM e sebetsa haholo ho tsebahatseng batho ba nang le karabelo ea 'mele ea ho itšireletsa mafung, e bonts'a hore ts'oaetso ea morao-rao kapa e fetileng tumellanong le leano la hajoale la tumello ea ts'ebeliso ea ts'ebeliso ea tšohanyetso ea Tsamaiso ea Lijo le Lithethefatsi ea US, "ho boletse Dr. Fadi Haddad, setsebi sa mafu a tšoaetsanoang ho tsoa ho Sharp Medical Community Group ea thusitseng ho etsa lipatlisiso tsena."Sena se bohlokoa haholo nakong eo ka eona batho ba limilione ba sa entoeng 'me monyetla oa ho tšoaetsoa e ntse e le taba ea sebele."
"Re motlotlo haholo ka sephetho sa nyeoe," ho boletse CEO ea Proven Scott Wise.“Teko ena e tiisa molemo oa liteko tse kang tlhahlobo e potlakileng ea Clungene® SARS-CoV-2 IgG/IgM ea metsotso e 15 ho thusa litsebi tsa bophelo bo botle.Ho ba bonolo ha eona le ho sebelisoa habonolo ho etsa hore e be sesebelisoa se molemo sa ho hlahloba. ”
Sesebelisoa sa tlhahlobo se potlakileng sa Clungeneâ SARS-CoV-2 (COVID-19) IgG/IgM se ka hlahisa liphetho nakong ea metsotso e 15.Teko ena ha e hloke lisebelisoa tsa laboratori tse rarahaneng ho sebetsa lipalo.
Mabapi le PROVEN PHARMA E Thehiloe ka 2012, Proven Pharma ke mofani oa litšebeletso lefapheng la bophelo bo botle le saense ea bophelo.Khampani e fana ka litharollo tse ngata tse fapaneng, tse kenyelletsang ho ajoa ha litsebi, ho reka lisebelisoa tsa liteko tsa tleliniki, sehlopha se inehetseng sa thekiso ea ka hare, tšehetso ea papatso, phetoho ea dijithale le boeletsi ba theknoloji.Ba na le lilemo tse fetang mashome a mabeli tsa boiphihlelo bo ruileng libakeng tse ngata tsa lefapha la tlhokomelo ea bophelo bo botle mme ba ba fa tharollo.
Indastering e tletseng ho hloka botsitso, Proven Pharma e fa bareki ba eona kholiseho.Khamphani e fana ka nako le nako e sebelisang mekhoa le lits'ebetso tse tsebahalang ho netefatsa polokeho le ho latela mohato o mong le o mong.Proven Pharma e ikemiselitse ho tsoela pele ho ntlafatsa boiphihlelo ba bareki e le hore bareki bana ba ka ntlafatsa maphelo a bakuli.Katleho ea k'hamphani e bakoa ke botšepehi, botšepehi le botšepehi ba sehlopha sa eona.
Mabapi le Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. ke moetsi oa theknoloji e phahameng, ea etelletseng pele oa lisebelisoa tsa baeloji le lihlahisoa tsa tlhahlobo ea in vitro.Khamphani e na le botumo ba ho fana ka lits'ebeletso tse fapaneng le maemo a holimo ho barekisi ba litsebi le balekane 'marakeng oa lefatše.
Hangzhou Kelon Biotechnology Co., Ltd. e thehiloe ka 2004. E na le R&D e netefalitsoeng ea 2016 e tsoetseng pele ka ho fetesisa le lits'ebeletso tsa tlhahiso Hangzhou, China, tumellanong le GMP ea China, e nkang sebaka sa lisekoere-mithara tse 19,000.Lihlahisoa tsa eona li fumane litifikeiti tsa CE, litifikeiti tsa FSC le tumello ea US FDA 510(k) (nomoro ea ngoliso ea FDA: 3009414546).
CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM kit ea tlhahlobo e potlakileng e ka fumanoa ho latela tataiso ea FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Tšebeliso ea ts'ebeliso ea ts'ohanyetso-sesebelisoa sa bongaka/in vitro diagnostic-euas-serology-le-tse ling-adaptive-immune-response-test-sars-cov-2
Ntle le litaba tse boletsoeng ho Litaelo tsa Tšebeliso (IFU), tšebeliso efe kapa efe kapa polelo e thibetsoe ka thata.Ka kopo etela www.proven.com kapa letsetsa 1-855-678-7768 bakeng sa lintlha tse ling.
Nako ea poso: Jun-18-2021