I-COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

Ukulinganiselwa

1.Le reagent isetyenziselwa kuphela ukuxilongwa kwe-in vitro.

2.Esi sixhobo sisetyenziswa kuphela ukubona iimpumlo zomntu/i-oropharyngeal swabs specimen.Iziphumo zeminye iisampulu zinokuba zingalunganga.

3.Le reagenti isetyenziselwa kuphela ukuchongwa komgangatho kwaye ayikwazi ukubona inqanaba lenoveli ye-corona virus antigen kumzekelo.

I-4.Le reagent kuphela isixhobo sokuxilongwa kweklinikhi.Ukuba umphumo ulungile, kucetyiswa ukuba kusetyenziswe ezinye iindlela zokuvavanya ngakumbi ngexesha kwaye ukuxilongwa ngugqirha kuya kuphumelela.

5.Ukuba isiphumo sovavanyo sibi kwaye iimpawu zeklinikhi ziyaqhubeka.Kuyacetyiswa ukuba kuphindwe ukusampula okanye ukusebenzisa ezinye iindlela zovavanyo kuvavanyo.Isiphumo esibi asinakukuthintela ukuba sesichengeni okanye usulelo lwentsholongwane ye-SARS-CoV-2 nangaliphi na ixesha.

6. Iziphumo zovavanyo zeekhithi zovavanyo zezereferensi yoonompilo kuphela, kwaye akufunekanga zisetyenziswe njengesiseko kuphela soxilongo lwasekliniki.Ulawulo lwezonyango lwezigulane kufuneka luqwalaselwe ngokubanzi ngokudibanisa neempawu / iimpawu zabo, imbali yonyango, ezinye iimvavanyo zebhubhoratri kunye neempendulo zonyango, njl.

I-7.Ngenxa yokukhawulelana kwendlela yokufumanisa i-reagent, umda wokufumanisa le reagent ngokuqhelekileyo iphantsi kune-nucleic acid reagents.Ke ngoko, abasebenzi bovavanyo kufuneka bahlawule ngakumbi kwiziphumo ezibi kwaye kufuneka badibanise ezinye iziphumo zovavanyo ukwenza isigwebo esibanzi.Kuyacetyiswa ukuba kusetyenziswe uvavanyo lwe-nucleic acid okanye ukuhlukaniswa kwentsholongwane kunye neendlela zokuchongwa kwenkcubeko ukuphonononga iziphumo ezibi ezinokuthandabuza.

8.Iziphumo zovavanyo oluqinisekileyo alubandakanyi ukosuleleka kunye nezinye iintsholongwane.

9. Iziphumo ezingezizo ezingezizo zinokuthi zenzeke xa inqanaba le-antigen le-SARS-CoV-2 kwisampulu lisezantsi kunomda wokubona wekhithi okanye ukuqokelelwa komzekelo kunye nokuhamba kungafanelekanga.Ke ngoko, nokuba iziphumo zovavanyo azinayo, ukuba nokwenzeka kosulelo lwe-SARS-CoV-2 akunakukhutshelwa ngaphandle.

10.Amaxabiso aqikelelwayo alungileyo nangalunganga axhomekeke kakhulu kumazinga okuxhaphaka.Iziphumo zovavanyo oluqinisekileyo zinokubonisa iziphumo ezingezizo zobuxoki ngexesha lomsebenzi omncinci/ungekho we-SARS-CoV-2 xa ukuxhaphaka kwesifo kusezantsi.Iziphumo zovavanyo ezingezizo ezingezizo zinokwenzeka ngakumbi xa ukuxhaphaka kwezifo ezibangelwa yi-SARS-CoV-2 kuphezulu.

11. Uhlalutyo lweziphumo ezingalunganga ezinokwenzeka:
(1) Ukuqokelelwa komzekelo okungenangqiqo, ukuthuthwa kunye nokucubungula, i-virus ephantsi ye-virus kwisampulu, akukho sampuli esitsha okanye ukukhenkceza kunye nokunyibilika kwebhayisikile yesampuli kunokukhokelela kwiziphumo ezingezizo zobuxoki.
(2) Ukuguqulwa kofuzo lwentsholongwane kungakhokelela ekutshintsheni kwimimiselo ye-antigenic, ekhokelela kwiziphumo ezibi.
(3) Uphando lwe-SARS-CoV-2 alukhange lucokiseke ngokupheleleyo;intsholongwane isenokuguquka kwaye ibangele iyantlukwano kwelona xesha lilungileyo lokuthatha isampulu (incopho ye-virus titer) kunye nendawo yesampulu.Ngoko ke, kwisigulane esifanayo, sinokuqokelela iisampulu kwiindawo ezininzi okanye silandele amaxesha amaninzi sinciphisa amathuba okuba neziphumo ezibi zobuxoki.

I-12.Izilwa-buhlungu ze-Monoclonal zinokusilela ukubhaqa, okanye ukufumanisa ngovakalelo oluncinci, iintsholongwane ze-SARS-CoV-2 eziye zafumana utshintsho oluncinci lwe-amino acid kummandla we-epitope ekujoliswe kuwo.