Nge-28 ka-Okthobha, 2020, i-SARS-CoV-2 Antigen Rapid Test Kit yaseNanjing Liming Bio-products Co., Ltd. yamkelwe yi-US FDA (EUA).Ukulandela ikiti yokubona i-antigen ye-SARS-CoV-2 ifumene isatifikethi saseGuatemala kunye nesatifikethi se-FDA sase-Indonesia, ezi zezinye iindaba ezilungileyo.

Umzobo 1 US FDA EUA ileta yokwamkelwa

Umfanekiso wesi-2 isatifikethi sobhaliso sase-Indonesia se-SARS-CoV-2 Antigen Rapid Test Kit

Umzobo 3 isiqinisekiso saseGuatemala se-SARS-CoV-2 Antigen Rapid Test Kit

Xa kuthelekiswa ne-PCR nucleic acid yokubona itekhnoloji, indlela yokugonywa kwe-immunoloji kulula ukuyisebenzisa ngokubanzi ngenxa yeenzuzo zayo ezikhawulezayo, eziluncedo nezinexabiso eliphantsi.Ukufunyaniswa kwe-antibody, ixesha lefestile lokubhaqwa kwe-antigen lingaphambili, elifaneleke ngakumbi kuvavanyo lobungakanani bokuqala, kwaye i-Nucleic acid kunye nokufunyanwa kwe-antibody nako kubaluleke kakhulu kuxilongo oluncedisayo lwekliniki.

Ukuthelekisa iingenelo zendlela yokufumanisa i-nucleic acid kunye netekhnoloji yokufumanisa i-antigen:

	Ukufunyanwa kwe-nucleic acid ye-RT-PCR	I-Immunological Methodology ye-Antigen yokubona iTekhnoloji
Uvakalelo	Uvakalelo lungaphezulu kwama-95%.Ngokwethiyori, ngenxa yokuba ukubonwa kwe-nucleic acid kunokukhulisa iitemplates zentsholongwane, uvakalelo lwayo luphezulu kunolo lweendlela zokufumanisa i-immunological.	I-Sensitivity ranges ukusuka kwi-60% ukuya kwi-90%, iindlela ze-immunological zifuna iimfuno zesampulu ezisezantsi, kwaye iiprotheni ze-antigen zizinzile, ngoko ke uvakalelo lwekiti yokufumanisa i-antigen luzinzile.
Ukuchaza ngokuthe ngqo	ngaphezulu kwe-95%	Ngapha kwe 80%
Ukufumanisa ixesha elide	Iziphumo zovavanyo zinokufunyanwa ngaphezu kweeyure ze-2, kwaye ngenxa yezixhobo kunye nezinye izizathu, uhlolo olukhawulezayo kwisiza alunakwenziwa.	Isampuli idinga kuphela imizuzu eyi-10-15 ukuvelisa iziphumo, ezinokuhlolwa ngokukhawuleza kwisayithi.
Nokuba kusetyenziswe izixhobo	Ifuna izixhobo ezibiza kakhulu njengezixhobo zePCR.	Akukho sixhobo sifunekayo.
Nokuba umsebenzi omnye	Hayi, zonke ziisampuli zebhetshi.	Ngaba.
Ubunzima bobugcisa bokusebenza	Inzima kwaye ifuna iingcali.	Elula kwaye kulula ukuyisebenzisa.
Iimeko zothutho kunye nokugcinwa	Ezothutho kunye nevenkile kwi-minus 20℃.	Ubushushu begumbi.
ixabiso Reagent	Iyabiza.	Ngexabiso eliphantsi.

SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Antigen Rapid Test Kit