Gwajin asibiti na farko a Amurka ya tabbatar da cewa gwajin sauri na mintuna 15 na Clungene® SARS-CoV-2 virus IgG/IgM ya gano daidaitattun ƙwayoyin rigakafin 100% na marasa lafiya na COVID-tabbatacce bayan kwanaki 13.

Gwajin asibiti na farko a Amurka ya tabbatar da cewa gwajin sauri na mintuna 15 na Clungene® SARS-CoV-2 virus IgG/IgM ya gano daidaitattun ƙwayoyin rigakafin 100% na marasa lafiya na COVID-tabbatacce bayan kwanaki 13.
Taron Plymouth, Pennsylvania, Yuni 15, 2021/PRNewswire/- Gwajin asibiti na Amurka don saurin gwajin COVID-19 wanda Hukumar Binciken Cibiyoyi ta amince da shi ya gano cewa takamaiman majinyata marasa lafiya na Covid-19 da RT-PCR ta tabbatar ya kasance 100% (95) % tazarar amincewa, 88.4% -100.0%);wannan yana nufin 100% yarjejeniya tsakanin mummunan RT-PCR da mummunan sakamakon gwajin serological Clungene.A cikin marasa lafiya waɗanda suka gwada ingancin kwayar cutar bayan kwanaki 13, yarjejeniya tsakanin Clungene® SARS-CoV-2 cutar IgG/IgM gwajin sauri na mintuna 15 da gwajin sarkar polymerase (PCR) ya fi 90%.Sakamakon ya nuna cewa waɗannan gwaje-gwajen na iya zama ingantaccen kayan aiki don gano kasancewar ƙwayoyin rigakafi a cikin mutanen da suka kamu da cutar.Sharp Healthcare na San Diego, California ne ya gudanar da gwajin, kuma ya haɗa da marasa lafiya a wuraren jinya da marasa lafiya.An gudanar da gwajin kafin a samu allurar rigakafin cutar.Ana buga ainihin sakamakon binciken da aka yi bita a cikin mujallar LymphoSign (https://lymphosign.com/journal/lpsn).
"Wadannan sakamakon suna da ban sha'awa mai ban sha'awa saboda suna nuna cewa CLUNGENE® SARS-COV-2 kwayar cutar (COVID-19) IgG / IgM kayan gwajin sauri yana da matukar tasiri wajen gano mutane masu amsawar rigakafi, yana nuna cewa kwanan nan ko na baya Cutar ta kasance. daidai da tsarin da Hukumar Abinci da Magunguna ta Amurka da ake sa ran za ta yi na amfani da manufofin ba da izini na gaggawa a halin yanzu,” in ji Dokta Fadi Haddad, kwararre kan cututtuka daga Ƙungiyar Al'ummar Sharp Medical Community wanda ya taimaka wajen gudanar da wannan bincike."Wannan yana da matukar mahimmanci a lokacin da ba a yiwa miliyoyin mutane allurar rigakafi ba kuma yiwuwar kamuwa da cuta har yanzu lamari ne na gaske."
"Muna matukar alfahari da sakamakon gwajin," in ji Proven CEO Scott Wise."Wannan gwajin ya tabbatar da fa'idar gwaje-gwaje kamar Clungene® SARS-CoV-2 virus IgG/IgM gwajin sauri na mintuna 15 don taimakawa kwararrun masana kiwon lafiya.Sauƙin sa da sauƙin amfani da shi ya sa ya zama kayan aikin tantancewa mai amfani.”
Kwayar cutar Clungeneâ SARS-CoV-2 (COVID-19) IgG/IgM kayan gwajin sauri na iya samar da sakamako cikin mintuna 15.Wannan gwajin baya buƙatar kayan aikin dakin gwaje-gwaje masu rikitarwa don aiwatar da karatun.
Game da PROVEN PHARMA An kafa shi a cikin 2012, Proven Pharma mai bada sabis ne a cikin masana'antar kiwon lafiya da kimiyyar rayuwa.Kamfanin yana ba da mafita mai yawa, gami da rarraba ƙwararru, siyan kwatancen gwaji na asibiti, ƙungiyar tallace-tallace ta sadaukar da kai, tallafin tallace-tallace, canjin dijital da shawarwarin fasaha.Suna da kwarewa fiye da shekaru ashirin na wadata a fannoni da yawa na fannin kiwon lafiya kuma suna ba su mafita.
A cikin masana'antar da ke cike da rashin tabbas, Proven Pharma yana ba abokan cinikinta kwarin gwiwa.Kamfanin yana ba da kan lokaci kowane lokaci ta amfani da ingantaccen ayyuka da matakai don tabbatar da aminci da yarda a kowane mataki.Proven Pharma ya himmatu don ci gaba da haɓaka ƙwarewar abokin ciniki ta yadda waɗannan abokan cinikin za su iya inganta rayuwar marasa lafiya.Nasarar da kamfanin ya samu ya samo asali ne daga gaskiya, mutunci da amincin kungiyarsa.
Game da Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. babban fasaha ne, jagorar kera kayan halitta da samfuran bincike na in vitro.Kamfanin yana da suna don samar da ayyuka daban-daban da sassaucin ra'ayi ga ƙwararrun masu rarrabawa da abokan hulɗa a kasuwar duniya.
An kafa kamfanin Hangzhou Kelon Biotechnology Co., Ltd a shekara ta 2004. Yana da ingantaccen tsarin ISO 13485: 2016 ƙwararrun R&D da masana'antu a Hangzhou na kasar Sin, daidai da GMP na kasar Sin, wanda ya mamaye fadin murabba'in murabba'in mita 19,000.Samfuran sa sun sami takaddun CE, takaddun FSC da amincewar FDA 510 (k) (lambar rajista na FDA: 3009414546).
CLUNGENE® SARS-COV-2 kwayar cutar (COVID-19) IgG/IgM kayan gwajin sauri na iya samuwa bisa ga jagororin FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- Yin amfani da gaggawar izini-na'urar likitanci/in vitro diagnostic-euas-serology-da-sauran-amsa-jigilar-amsa-gwajin-sars-cov-2
Ban da abun ciki da aka kayyade a cikin Umarnin Amfani (IFU), duk wani amfani ko sanarwa an haramta shi sosai.Da fatan za a ziyarci www.proven.com ko kira 1-855-678-7768 don ƙarin bayani.


Lokacin aikawa: Juni-18-2021