Nnwale ụlọ ọgwụ izizi na United States gosipụtara na nnwale ngwa ngwa nkeji iri na ise nke Clungene® SARS-CoV-2 virus IgG/IgM chọpụtara n'ụzọ ziri ezi ọgwụ mgbochi nke 100% nke ndị ọrịa nwere COVID mgbe ụbọchị iri na atọ gachara.
Ọgbakọ Plymouth, Pennsylvania, June 15, 2021/PRNewswire/-Nnwale ụlọ ọgwụ US maka nnwale COVID-19 ngwa ngwa nke Board Review Institutional kwadoro na nkọwapụta nke ndị ọrịa Covid-19 na-adịghị mma nke RT-PCR kwadoro bụ 100% (95). % oge ntụkwasị obi, 88.4% -100.0%);Nke a pụtara nkwekọrịta 100% n'etiti RT-PCR na-adịghị mma yana nsonaazụ ule serological Clungene na-adịghị mma.N'ime ndị ọrịa nwalere ihe dị mma maka nje a mgbe ụbọchị iri na atọ gachara, nkwekọrịta dị n'etiti nje Clungene® SARS-CoV-2 IgG/IgM nkeji iri na ise na nnwale polymerase chain (PCR) karịrị 90%.Nsonaazụ na-egosi na nyocha ndị a nwere ike ịbụ ngwá ọrụ dị irè iji chọpụta ọnụnọ nke ọgwụ nje na ndị bu nje a.Ọ bụ Sharp Healthcare nke San Diego, California duziri ikpe a, ma tinyekwa ndị ọrịa n'ụlọ ọrụ inpatient na outpatient.E mere nnwale ahụ tupu ọgwụ mgbochi a na-enweta ebe niile.A na-ebipụta nsonaazụ nyocha izizi nke ndị ọgbọ na magazin LymphoSign (https://lymphosign.com/journal/lpsn).
"Nsonaazụ ndị a na-agba ume nke ukwuu n'ihi na ha gosipụtara na CLUNGENE® SARS-COV-2 virus (COVID-19) ngwa ngwa ule IgG/IgM dị irè nke ukwuu n'ịchọpụta ndị mmadụ nwere nzaghachi mgbochi na-agbanwe agbanwe, na-egosi na ọrịa na-adịbeghị anya ma ọ bụ nke gara aga bụ. n'ikwekọ na amụma ikike iji ihe mberede eme ihe mberede nke US ugbu a, "Dr. Fadi Haddad, ọkachamara n'ọrịa na-efe efe sitere na Sharp Medical Community Group onye nyere aka mee nyocha a kwuru."Nke a dị ezigbo mkpa n'oge a gbabeghị ọtụtụ nde mmadụ ọgwụ mgbochi yana ohere nke ibute ọrịa ka bụ okwu dị adị."
"Anyị nwere nnọọ mpako maka nsonaazụ nke ikpe a," ka Proven CEO Scott Wise kwuru.“Nnwale a gosipụtara uru nke ule dị ka nje Clungene® SARS-CoV-2 IgG/IgM nkeji iri na ise iji nyere ndị ọkachamara ahụike aka.Ịdị mfe ya na ịdị mfe iji mee ihe na-eme ka ọ bụrụ ngwá ọrụ nyocha bara uru. "
Ngwa ngwa ule Clungene SARS-CoV-2 (COVID-19) IgG/IgM nwere ike mepụta nsonaazụ n'ime nkeji iri na ise.Nnwale a anaghị achọ ngwa ụlọ nyocha gbagwojuru anya iji hazie ọgụgụ ya.
Banyere PROVEN PHARMA Tọrọ ntọala na 2012, Proven Pharma bụ onye na-eweta ọrụ na ahụike na ụlọ ọrụ sayensị ndụ.Ụlọ ọrụ ahụ na-enye ụzọ dịgasị iche iche nke ngwọta, gụnyere nkesa ọkachamara, ịzụ ahịa comparator ikpe ụlọ ọgwụ, ndị na-ere ahịa n'ime ụlọ raara onwe ya nye, nkwado ahịa, mgbanwe dijitalụ na ndụmọdụ teknụzụ.Ha nwere ihe karịrị afọ iri abụọ nke ahụmahụ bara ụba n'ọtụtụ mpaghara ahụike ahụike ma nye ha ngwọta.
N'ime ụlọ ọrụ jupụtara na ejighị n'aka, Proven Pharma na-enye ndị ahịa ya obi ike.Ụlọ ọrụ ahụ na-ewepụta oge ọ bụla na-eji usoro na usoro kachasị mma ama ama iji hụ na nchekwa na nnabata na usoro ọ bụla.Proven Pharma na-agba mbọ na-aga n'ihu na-emeziwanye ahụmịhe ndị ahịa ka ndị ahịa a nwee ike imeziwanye ndụ ndị ọrịa.Ihe ịga nke ọma nke ụlọ ọrụ ahụ sitere n'eziokwu, iguzosi ike n'ezi ihe na ntụkwasị obi nke otu ya.
Banyere Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. bụ teknụzụ dị elu, na-eduga ndị na-emepụta ihe ndị dị ndụ na ngwaahịa nchọpụta in vitro.Ụlọ ọrụ ahụ nwere aha ọma maka ịnye ọrụ dịgasị iche iche na mgbanwe dị elu nye ndị na-ekesa ọkachamara na ndị mmekọ na ahịa ụwa.
Hangzhou Kelon Biotechnology Co., Ltd. e hiwere na 2004. Ọ nwere ihe kasị elu ISO 13485: 2016 gbaara R&D na ụlọ ọrụ mmepụta ihe na Hangzhou, China, n'ahịrị na China GMP, ekpuchi ebe nke 19,000 square mita.Ngwaahịa ya enwetala asambodo CE, asambodo FSC na nkwado US FDA 510(k) (nọmba ndebanye aha FDA: 3009414546).
CLUNGENE® SARS-COV-2 nje (COVID-19) IgG/IgM ngwa ule ngwa ngwa nwere ike nweta dị ka FDA EUA ntuziaka: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid- 19- ikike iji ihe mberede-ngwaọrụ ahụike/in vitro diagnostic-euas-serology-na-other-adaptive-immune-response- tests-sars-cov-2
Ewezuga ọdịnaya akọwapụtara na ntuziaka maka ojiji (IFU), amachibidoro ojiji ma ọ bụ nkwupụta ọ bụla.Biko gaa na www.proven.com ma ọ bụ kpọọ 1-855-678-7768 maka ozi ndị ọzọ.
Oge nzipu: Jun-18-2021