Dhawaan, Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) reagent ogaanshaha antigen "StrongStep® SARS-CoV-2 Antigen Rapid Test" wuxuu helay xaqiijinta waxqabadka Paul-Ehrlich-Institut (PEI *) gudaha Jarmalka, badeecadan ayaa ahayd shahaado ay siisay Wakaaladda Federaalka Jarmalka ee Dawooyinka iyo Maamulka Qalabka Caafimaadka (BfArM).LimingBio waxay noqotay mid ka mid ah soosaarayaasha yar ee Shiinaha ee helay shahaadada labadaba ee BfArM+PEI ee Jarmalka.Tijaabada degdega ah ee antigen-ka ee Liming Bio ayaa ka gudubtay shahaadada awooda leh ee Wasaaradda Caafimaadka ee wadamo badan, taas oo si buuxda u caddaynaysa waxqabadka wanaagsan ee xirmada.
Tijaabada degdega ah ee Liming Bio ee antigen ayaa si guul leh uga gudubtay xaqiijinta waxqabadka PEI ee Jarmalka
PS PEI: Paul Ehrlich Institute (Jarmal: Paul-Ehrlich-Institut), oo sidoo kale loo yaqaan Machadka Federaalka Jarmalka ee Tallaalka iyo Biomedicine, waa hay'ad cilmi-baaris iyo hay'ad sharciyeed caafimaad oo ka tirsan Xiriirka Jarmalka, oo hadda hoos yimaada Wasaaradda Caafimaadka ee Federaalka (BMG) ), waxa uu leeyahay hawl qabad madax banaan ee baadhista badeecada noolaha, ogolaanshaha tijaabada caafimaad, ogolaanshaha alaabta iyo suuqgayn, iyo soo saarista dufcaddii.Isla markaana, waxa ay sidoo kale qabataa diyaarinta, dib-u-eegista xeerarka khuseeya, iyobixinstalo cilmiyeedka ururada kala duwan, gaar ahaan qaar ka mid ah dalalka Midowga Yurub, Midowga Yurub iyo guddiyada caalamiga ah.Asidoo kale, waabixinsla-talin xirfadle ah oo ku socota dawladda Jarmalka, wakaaladaha maxalliga ah iyo baarlamaanka, iyo bixintasmacluumaadka khuseeya bukaanka iyo macaamiisha.
Tijaabada degdega ah ee Liming Bio's antigen ayaa si guul leh uga gudubtay shahaadada Jarmalka ee BfArM
StrongStep® SARS-CoV-2 Tijaabada Degdegga ah ee Antigen ee uu sameeyay Nanjing Liming Bio ayaa si guul leh u heshay shahaadada Midowga Yurub ee CE, xaqiijinta hubinta diiwaangelinta Machadka Qaranka ee Shiinaha ee Xakamaynta Cunnada iyo Dawooyinka (NIFDC), waxay gashay liiska lagu taliyey ee Rockefeller Foundation, iyo Guatemala shahaadada , Shahaadada Wasaaradda Caafimaadka Talyaaniga, Shahaadada Jarmalka, Shahaadada Ecuador, shahaado Brazil (ANVISA), shahaado Chile, shahaadada Argentina, shahaadada Dominica, shahaado Guatemala, Shahaadada HSA Singapore, Malaysia (MDA) shahaado, shahaadada Philippines FDA, shahaadada Indonesia, Thailand shahaado.Waxay ku guulaysatay ammaan qiimaynta madaxa bannaan ee Waaxda Caafimaadka iyo Adeegyada Aadanaha ee Ingiriiska (DHSC) iyo (shahaadada AAA ee Ingiriiska).
Malaysia MDA Novel Coronavirus Antigen Shahaadada Is-tijaabinta
Tilmaamaha iyo faa'iidooyinka
01 Muunad ku habboon: ururinta muunada aan fiicneyn, candhuufta ama sanka sanka.
02 Ogaanshaha degdega ah: Habka ogaanshaha oo dhan wuxuu qaataa 15 daqiiqo oo keliya, natiijadana waxaa si toos ah isha ugu haya.
03 Qalliin fudud: Waxaa lagu shaqayn karaa iyada oo aan wax qalab ah oo caawimo ah iyo khibrad la'aan.
04 Waxqabad heer sare ah: gaar ahaan waa 99.26%, xasaasinimadu waa 96.2%, iyo saxnaanta guud waa 95%.
05 Baahida u habaynta: Waqtigan xaadirka ah, shirkadu waxay leedahay nooc caafimaad oo xirfad leh, is-tijaabinta guriga (candhuufta + nasopharyngeal swab) nooca iyo nooca is-imtixaanka Mini, iwm.
Qalabkan Nidaamka ee SARS-CoV-2 Antigen Rapid Test (nooca qalinka) wuxuu ku qalabaysan yahay aalad ilaalinta badbaadada noolaha, kaas oo si wax ku ool ah uga xannibi kara fayraska ku jira xalka muunada inuu hawada u beddelo, wasakheeyo deegaanka, si wax ku ool ahna u ilaaliyo hawlwadeenka inta lagu jiro ogaanshaha SARS-CoV-2 antigen-ka tijaabada degdega ah.
Xaaladda hadda jirta ee cudurka faafa ee adduunka ayaa weli ah mid daran.Markii uu soo shaac baxay iyo faafitaanka noocyada kala duwan ee fayraska cusub ee Coronavirus, xaaladda cudurka faafa ee waddamo iyo gobollo badan ayaa soo laba kacleeyay, waxaana dadaallada ka hortagga iyo xakameynta ay wajahayaan caqabado waaweyn.Tijaabada degdega ah ee SARS-CoV-2 Antigen waa mid dhakhso badan, sax ah, fududahay in lagu shaqeeyo, oo u baahan qalab iyo shaqaale hooseeya.Aad bay ugu habboon tahay baadhista degdegga ah ee kiisaska looga shakisan yahay caabuqa fayraska taajka cusub ee baaxadda weyn, waxayna si gaar ah waxtar ugu leedahay ogaanshaha degdegga ah ee dillaaca xoogga leh.Waxa loo isticmaali karaa sidii safka koowaad ee difaaca ee xakamaynta faafidda, lagu dabaqo ogaanshaha caabuqyada hore, si loo caawiyo ka-hortagga iyo xakamaynta faafidda, iyo xakamaynta fiditaanka fayraska.
Nanjing Liming Bio-products Co., Ltd. waxaa la aasaasay sannadkii 2001. Waa shirkad ogaanshaha noolaha oo ku takhasusay cilmi-baarista iyo horumarinta, wax soo saarka iyo iibinta microbial kiliinikada in vitro reagents ogaanshaha.Waxay leedahay 20 sano oo tayo wanaagsan leh waxayna ururisay nidaam tayo dhammaystiran, waxayna heshay shahaadada IS013485.Maamulka wax soo saarku wuxuu u shaqeeyaa si adag si waafaqsan nidaamka maaraynta tayada caalamiga ah, isagoo hubinaya in alaabooyinka tayada sare leh ay u adeegaan macaamiisha adduunka oo dhan.Waxay si tartiib tartiib ah u horumartay oo noqotay shirkad caalami ah oo caan ah oo weyn iyo mid dhexdhexaad ah oo caalami ah oo ku takhasustay R&D, wax soo saarka, iibinta iyo adeegga in vitro reagents ogaanshaha degdega ah.
Waqtiga boostada: Oct-28-2021
