Ngomhla zingama-28 kuMfumfu 2020, i-SARS-CoV-2 Antigen Rapid Test Kit ye-Nanjing Liming Bio-products Co., Ltd. yamukelwe yi-US FDA (EUA).Ukulandela ikhithi yokuthola i-antigen yakwa-SARS-CoV-2 ithole isitifiketi sase-Guatemala nesitifiketi se-FDA ye-Indonesia, lezi ezinye izindaba ezinhle kakhulu.

Umfanekiso 1 incwadi yokwamukela ye-US FDA EUA

Umfanekiso 2 isitifiketi sokubhalisa sase-Indonesia se-SARS-CoV-2 Antigen Rapid Test Kit

Umfanekiso 3 Isitifiketi saseGuatemala se-SARS-CoV-2 Antigen Rapid Test Kit

Uma kuqhathaniswa nobuchwepheshe bokutholwa kwe-PCR nucleic acid, indlela ye-immunology ilula ukusetshenziswa kabanzi ngenxa yezinzuzo zayo ezisheshayo, ezilula nezingabizi kakhulu.Ukuze kutholwe amasosha omzimba, isikhathi sefasitela sokutholwa kwe-antigen singaphambidlana, esifaneleka kakhudlwana ukuhlolwa kwangaphambi kwesikhathi kwesilinganiso esikhulu, futhi ukutholwa kwe-Nucleic acid kanye ne-antibody nakho kubaluleke kakhulu ekuxilongweni okuwusizo komtholampilo.

Ukuqhathaniswa kobuhle bendlela yokuthola i-nucleic acid kanye nobuchwepheshe bokutholwa kwe-antigen:

	Ukutholwa kwe-nucleic acid ye-RT-PCR	I-Immunological Methodology ye-Antigen Detection Technology
Ukuzwela	Ukuzwela kungaphezu kwama-95%.Ngokombono, ngenxa yokuthi ukutholwa kwe-nucleic acid kungakhulisa izifanekiso zegciwane, ukuzwela kwalo kuphakeme kunokwezindlela zokutholwa kwe-immunological.	Ukuzwela kusuka ku-60% kuya ku-90%, izindlela zokuzivikela komzimba zidinga izidingo zesampula eziphansi, futhi amaprotheni e-antigen azinzile uma kuqhathaniswa, ngakho ukuzwela kwekhithi yokuthola i-antigen kuzinzile.
Ukucaciswa	ngaphezu kwama-95%	Ngaphezu kuka-80%
Ukutholwa okudla isikhathi	Imiphumela yokuhlolwa ingatholwa ngaphezu kwamahora ama-2, futhi ngenxa yemishini nezinye izizathu, ukuhlolwa okusheshayo esizeni akukwazi ukwenziwa.	Isampula idinga kuphela imizuzu eyi-10-15 ukukhiqiza imiphumela, engahlolwa ngokushesha esizeni.
Ukuthi usebenzise okokusebenza	Idinga amathuluzi abizayo njengamathuluzi e-PCR.	Azikho izinto zokusebenza ezidingekayo.
Ukuthi ukuhlinzwa okukodwa	Cha, wonke angamasampula eqoqo.	Angakwazi.
Ubunzima bokusebenza kwezobuchwepheshe	Iyinkimbinkimbi futhi idinga ochwepheshe.	Simple futhi kulula ukusebenza.
Izimo zokuhamba nezokugcina	Ezokuthutha kanye nesitolo ku-minus 20℃.	Izinga lokushisa legumbi.
Intengo ye-reagent	Kuyabiza.	Kushibhile.

Ukuhlolwa Okusheshayo kwe-SARS-CoV-2 Antigen

Ikhithi Yokuhlola Esheshayo yakwa-SARS-CoV-2 Antigen Rapid