I-antigen ekujoliswe kuyo: Iprotheni ye-Nucleocapsid, engachatshazelwa kukuguqulwa kwentsholongwane
Imathiriyeli ekrwada egqwesileyo: I-antibody eyenzelwe abantu, ukucaciswa okuphezulu
I-nanoparticles yegolide evela kwisiJamani, i-Merck (i-Top 1), i-sensitivity ephezulu
Eyona Khithi yoVavanyo lwe-COVID-19 ye-Antigen AMPRP78
I-SARS-CoV-2 Antigen Test Kit AMPRP78 yindlela ekhawulezayo yokuhlola i-immunoassay yokubona ngokusemgangathweni ii-antigens ezithile ukuya kwi-AMPRP78 kwindlela yokuphefumla yomntu, incede ekuhloleni okanye ekuchongeni usulelo oluqatha okanye lwakwangoko lwenoveli coronavirus.
Ukukhetha okugqwesileyo kwezixhobo
I-1.I-antigen ejoliswe kuyo: Iprotheni ye-Nucleocapsid, engachaphazelekiyo yintsholongwane.
2.Egqwesileyo imathiriyeli ekrwada: I-antibody eyenzelwe abantu, ingcaciso ephezulu.
I-3.I-nanoparticles yegolide evela kwisiJamani, i-Merck (i-Top 1), i-sensitivity ephezulu.
I-4.NC i-membrane evela eJamani, iSartorius (i-Top 1), umgangatho ophezulu.
I-5.Sterile swab eqinisekisiwe nguMzimba owaziwayo.
I-Lepu COVID-19 antigen test kit AMPRP78 iyathengiswa Ukusebenza okulula kunye nokusetyenziswa
1.Iikhithi zokucaciswa okuninzi: 1, 5, 10, 25 T/Kit zinokubonelelwa.
I-2.I-diluent epakishwe ngaphambili inokuxutywa ngokuthe ngqo kunye neesampuli ze-swab kwaye zisetyenziswe, ezingafuneki ukuba zihlulwe kwakhona.Isebenziseka ngakumbi, inokusetyenziswa kunye nepakethe yereagent enobungakanani obuncinci ukwenza mfutshane inkqubo kunye nokunciphisa ungcoliseko olwenziwa ngumntu.
Ikhithi yovavanyo ye-antigen ye-Lepu ye-COVID-19 AMPRP78 iyathengiswa Ukusebenza okukhuphisanayo kwezonyango
Imvumelwano yepesenti ye-1.Positive (uvakalelo): 95.03% (95% CI: 90.77% ~ 97.70%)
I-2.Imvumelwano yepesenti engalunganga (inkcukacha): 99.02% (95% CI: 96.52-99.88%)
I-3.Isivumelwano sepesenti ngokubanzi (ukuchaneka): 97.15% (95% CI: 94.96% ~ 98.57%)
Ilizwe lobhaliso: eJamani, eFransi, eItali, ePeru, eSerbia kunye nokunye.