[OKUHLOSIWEYO UKUSETYENZISWA]

I-COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette yindlela yokuhlola esecaleni ejoliswe ekubhaqweni okusemgangathweni kwe-SARSCoV-2, umkhuhlane A kunye ne-antigens ye-viral nucleoprotein yomkhuhlane B kwi-nasopharyngeal swab evela kubantu ekurhanelwa ukuba banosulelo lwentsholongwane yokuphefumla. -19 ngumboneleli wabo wezempilo.Iimpawu zosulelo lwentsholongwane yokuphefumla ngenxa ye-SARS-CoV-2 kunye nomkhuhlane zinokufana.I-COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette yenzelwe ukuchongwa kunye nokwahlulwa kwe-SARS-CoV-2, umkhuhlane A kunye nomkhuhlane B wentsholongwane ye-nucleoprotein antigens.Ii-Antigens zibonwa ngokubanzi kwiisampuli ze-nasopharyngeal ngexesha lesigaba esinzima sosulelo.Iziphumo ezilungileyo zibonisa ubukho be-antigens yentsholongwane, kodwa uQhagamshelwano lweklinikhi kunye nembali yesigulane kunye nolunye ulwazi lokuxilonga luyimfuneko ukumisela imeko yosulelo.Iziphumo ezincomekayo azilukhuhli usulelo lwebhaktiriya okanye ukosuleleka kunye nezinye iintsholongwane.Iziphumo ezibi aziyikhuphi i-SARS-CoV-2, umkhuhlane A okanye usulelo lomkhuhlane kwaye akufuneki isetyenziswe njengesona siseko sonyango okanye izigqibo zolawulo lwesigulana, kubandakanya nezigqibo zolawulo losulelo.Iziphumo ezibi kufuneka zidibaniswe nokuqwalaselwa kweklinikhi, imbali yesigulane kunye nolwazi lwe-epidemiological, kunye nokuqinisekiswa ngovavanyo lwe-molecular, ukuba kuyimfuneko yokulawula isigulane.I-COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette yenzelwe ukuba isetyenziswe ngabasebenzi abaqeqeshiweyo baselebhu yezonyango abayalelwe ngokukodwa kwaye baqeqeshelwe iinkqubo zokuxilonga kwi-vitro.

[USHWANKATHELO]

Iintsholongwane ezinoveli ze-corona (i-SARS-CoV-2) zezodidi lwe-β.I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla.Ngokuqhelekileyo abantu basengozini.Ngoku, izigulana ezosulelwe yinoveli yentsholongwane ye-Corona ngoyena mthombo wosulelo;abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo.Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela li-1 ukuya kwiintsuku ezili-14, uninzi lweentsuku ezi-3 ukuya kwezi-7.Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhohlela okomileyo.Ukuxinana kweempumlo, impumlo, umqala obuhlungu, urhudo olubi lufumaneka kwiimeko ezimbalwa.Umkhuhlane (umkhuhlane) sisifo esosulelayo sokuphefumla esibangelwa ziiVirus zomkhuhlane.Inokubangela ukugula okuphakathi ukuya kwisifo esibi.Iziphumo ezimandundu zosulelo lomkhuhlane zinokubangela ukuba ulaliswe esibhedlele okanye usweleke.Abanye abantu, njengabantu abadala, abantwana abancinci, kunye nabantu abaneemeko ezithile zempilo, basengozini enkulu yeengxaki ezinzulu zomkhuhlane.Zimbini iindidi eziphambili zentsholongwane yomkhuhlane (umkhuhlane): Iindidi A kunye no-B. Umkhuhlane A kunye neentsholongwane ezithi zisasazeke rhoqo ebantwini (iintsholongwane zomkhuhlane woluntu) zingunobangela wobhubhane womkhuhlane wamaxesha athile ngonyaka.

[UMGAQO]

UVavanyo oluKhawulezayo lwe-COVID-19 lwe-antigen luvavanyo lwe-immunoassay olusekwe kumgaqo-nkqubo wesangweji ye-antibody ephindwe kabini.I-SARS-CoV-2nucleocapsid protein monoclonal antibody edityaniswe nombala wemicroparticlesis esetyenziswa njenge detector kwaye itshizwe kwiconjugation pad.Ngexesha lovavanyo, i-antigen ye-SARS-CoV-2 kumzekelo inxibelelana ne-SARS-CoV-2antibody edityaniswe namasuntswana amancinci anombala enza i-antigen-antibody ebhalwe ngobunzima.Olu bunzima lufudukela kwi-membrane ngesenzo se-capillary kude kube kumgca wovavanyo, apho luya kuthinjwa yi-SARSCoV-2 nucleocapsid protein monoclonal antibody.Umgca wovavanyo olunemibala (T)

[UHLELO]

Izixhobo ezibonelelwe ngeCassette yoVavanyo: ikhasethi yovavanyo iquka i-COVID-19 Antigen Test Strip kunye ne-Influenza A+B Test Strip, ezimiliselwe ngaphakathi kwisixhobo seplastiki.

· I-Reagent yokukhupha: I-Ampoule equlethe i-0.4 mL ye-reagent yokukhupha

· I-Swab enezintsholongwane

· Umbhobho wokutsalwa

· Ingcebiso yokulahla

· Isitishi sokuSebenza

· Faka ipakethe

Ubungakanani beemvavanyo zaprintwa kwiileyibhile.Izinto ezifunekayo kodwa azibonelelwanga

Isibali-xesha

[UGCINA KUNYE NOZInzo]

· Gcina njengoko zipakishwe kwisingxobo esitywiniweyo kwiqondo lobushushu (4-30℃ okanye 40-86℉).Ikhithi izinzile ngaphakathi komhla wokuphelelwa oshicilelwe kwilebhile.

· Wakuba uvule isingxobo, uvavanyo kufuneka lusetyenziswe kwiyure enye.Ukuba sesichengeni ixesha elide kwindawo eshushu nefumileyo kuya kubangela ukuwohloka kwemveliso.I-LOT kunye nomhla wokuphelelwa kwawo zashicilelwa kwilebhile.

[UMBONO]

Iisampulu ezifunyenwe kwangoko ngexesha lokuqala kweempawu ziya kuqulatha ezona titer zentsholongwane egazini;imizekelo efunyenwe emva kweentsuku ezintlanu zeempawu kusenokwenzeka ukuba ivelise iziphumo ezingalunganga xa ithelekiswa novavanyo lwe-RT-PCR.Ukungaqokelelwa kwesampulu enganelanga, ukuphathwa ngendlela engafanelekanga kwesampulu kunye/okanye uthutho lusenokuvelisa iziphumo ezingalunganga;ke ngoko, uqeqesho kwingqokelela yesampulu lucetyiswa kakhulu ngenxa yokubaluleka komgangatho womzekelo wokuvelisa iziphumo zovavanyo ezichanekileyo.