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【Intshayelelo】
Iintsholongwane ezintsha ze-coronavirus zezohlobo lwe-β. I-COVID-19 sisifo esosulelayo esibangelwa kukuphefumla ngokukhawuleza. Abantu ngokubanzi basengozini. Okwangoku, abaguli abosulelwe yintsholongwane entsha ye-coronavirus ngabona mthombo wosulelo; abantu abosulelweyo abangenazo iimpawu banokuba ngumthombo wosulelo. Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufunxa liqala kwiintsuku ezi-1 ukuya kwezi-14, uninzi lwazo iintsuku ezi-3 ukuya kwezi-7. Iimpawu eziphambili ziquka umkhuhlane, ukudinwa kunye nokukhwehlela okomileyo. Ukuxinana kwempumlo, impumlo egobhozayo, umphimbo obuhlungu, i-myalgia kunye norhudo zifumaneka kwiimeko ezimbalwa. Ukufunyanwa kwangethuba kwabantu abosulelweyo kubalulekile ekuthinteleni ukusasazeka kwesi sifo.
【Ukusetyenziswa okucwangcisiweyo】
Uvavanyo lweNovel Coronavirus (SARS-CoV-2) Antigen Rapid Test (Colloidal Gold) yikiti yokufumanisa i-antigen ye-coronavirus entsha evezwa kwi-human Oropharyngeal swabs, kwi-Anterior Nasal swabs, okanye kwi-Nasopharyngeal swabs. Le khithi yovavanyo yenzelwe ukusetyenziswa kuphela ziingcali zezempilo kunye nelebhu ukufumanisa kwangethuba izigulane ezineempawu zeklinikhi zosulelo lwe-SARS-COV-2.
Ikhithi yovavanyo ingasetyenziswa nakweyiphi na indawo ehlangabezana neemfuno zemiyalelo kunye nemigaqo yendawo. Olu vavanyo lubonelela kuphela ngeziphumo zovavanyo lokuqala. Iziphumo ezingalunganga azinakukhupha usulelo lwe-SARS-COV-2, kwaye kufuneka zidityaniswe nokuhlolwa kweklinikhi, imbali kunye nolwazi lwe-epidemiological. Iziphumo zolu vavanyo akufuneki zibe sisiseko sodwa sokuxilongwa; uvavanyo lokuqinisekisa luyafuneka.
【Umgaqo wovavanyo】
Le khithi yovavanyo isebenzisa iteknoloji ye-colloidal gold immunochromatography. Xa isisombululo sokukhupha isampuli sihamba phambili ecaleni komcu wovavanyo ukusuka kumngxuma wesampuli ukuya kwi-absorbent pad phantsi kwesenzo se-capillary, Ukuba isisombululo sokukhupha isampuli sine-antigen entsha ye-coronaviruses, i-antigen iya kubopha kwi-colloidal gold-ilebheli ye-anti-novel coronavirus monoclonal antibody, ukuze yenze i-immune complex. Emva koko i-immune complex iya kubanjwa yenye i-anti-novel coronavirus monoclonal antibody, eqiniswe kwi-nitrocellulose membrane. Umgca onemibala uya kuvela kummandla womgca wovavanyo "T", obonisa i-antigen entsha ye-coronavirus; Ukuba umgca wovavanyo "T" awubonisi mbala, kuya kufunyanwa isiphumo esibi.
Ikhasethi yovavanyo ikwanayo nomgca wokulawula umgangatho "C", oza kuvela nokuba kukho umgca we-T obonakalayo.
【Izinto eziphambili】
1) Iswabhu yokuvavanya iintsholongwane elahlwayo elahlwayo
2) Ityhubhu yokutsala eneNozzle Cap kunye ne-extraction buffer
3) Ikhasethi yovavanyo
4) Imiyalelo Yokusetyenziswa
5) Ingxowa yenkunkuma enobungozi kwizinto eziphilayo
【Ukugcinwa kunye nozinzo】
1. Gcina kwi-4~30℃ kude nelanga elithe ngqo, kwaye isebenza iinyanga ezingama-24 ukusukela kuMhla wokuveliswa.
2. Gcina yomile, kwaye ungasebenzisi izixhobo ezikhenkcezisiweyo neziphelelwe lixesha.
3. Ikhasethi yovavanyo mayisetyenziswe kwisithuba sesiqingatha seyure emva kokuba ivuliwe ingxowa yefoyile yeAluminiyam.
【Isilumkiso kunye noBulumko】
1. Le khithi yenzelwe ukufunyanwa kwe-in vitro kuphela. Nceda usebenzise le khithi ngexesha elifanelekileyo.
2. Olu vavanyo lujoliswe ekuncedeni ekuxilongweni kosulelo lwe-COVID-19 olukhoyo ngoku. Nceda udibane nengcali yezempilo ukuze uxoxe ngeziphumo zakho kwaye ukuba kukho naluphi na uvavanyo olongezelelweyo olufunekayo.
3. Nceda ugcine ikhithi njengoko i-IFU ibonisa, kwaye uphephe iimeko zokuqandisa ixesha elide.
4. Funda kwaye ulandele imiyalelo ngononophelo ngaphambi kokusebenzisa ikhithi, kungenjalo iziphumo ezingachanekanga zinokufunyanwa.
5. Musa ukutshintsha izinto ezisetyenzisiweyo ukusuka kwenye ikhithi ukuya kwenye.
6. Lumkela ukufuma, ungayivuli ingxowa yeplatinum ye-aluminiyam ngaphambi kokuba ilungele ukuvavanywa. Musa ukuyisebenzisa ingxowa yefoyile ye-aluminiyam xa ifunyenwe ivuliwe.
7. Zonke izinto ezikule khithi mazifakwe kwibhegi yenkunkuma enobungozi kwiBioo kwaye zilahlwe ngokweemfuno zasekuhlaleni.
8.Kuphephe ukulahla, ukutshiza.
9. Gcina izixhobo zovavanyo kunye nezixhobo kude nabantwana kunye nezilwanyana zasekhaya ngaphambi nasemva kokusetyenziswa.
10. Qinisekisa ukuba kukho ukukhanya okwaneleyo xa uvavanya
11. Musa ukusela okanye ukulahla i-antigen extraction buffer eluswini lwakho.
12. Abantwana abangaphantsi kweminyaka eli-18 kufuneka bavavanywe okanye bakhokelwe ngumntu omdala.
13. Igazi eligqithisileyo okanye i-mucus kwisampuli ye-swab inokuphazamisa ukusebenza kakuhle kwaye inokubangela iziphumo ezingalunganga.
【Ukuqokelelwa kunye nokulungiswa kweesampuli】
Ingqokelela yeesampuli:
I-Anterior impumlo swab
1. Faka yonke incam yengqokelela yeswab enikiweyo ngaphakathi kwempumlo.
2.Thatha isampuli eqinileyo eludongeni lwempumlo ngokujikelezisa iswab ngendlela ejikelezayo eludongeni lwempumlo ubuncinane izihlandlo ezi-4.
3.Thatha malunga nemizuzwana eli-15 ukuqokelela isampuli. Qiniseka ukuba uqokelela naluphi na ulwelo oluphuma empumlweni olunokuba lukhona kwiswab.
4. Phinda kwenye imphumlo usebenzisa iswab efanayo.
5. Susa kancinci iswab.
Ukulungiselela isisombululo semizekelo:
1. Khupha i-Sealing membrane kwityhubhu ye-Extraction.
2.Faka incam yelaphu leswab kwi-extraction buffer ekwibhotile yetyhubhu.
3. Xuba uze ucinezele intloko yeswabhu eludongeni lwetyhubhu yokukhupha ukuze ukhulule i-antigen, ujikeleze iswabhu umzuzu omnye.
4. Susa iswabhu ngelixa ucinezela ityhubhu yokukhupha kuyo.
(Qiniseka ukuba ulwelo oluninzi olukwincam yelaphu leswab lususiwe kangangoko kunokwenzeka).
5. Cinezela iNozzle Cap enikiweyo ngokuqinileyo kwityhubhu yokukhupha ukuze kuthintelwe ukuvuza okunokwenzeka.
6. Lahla iiswabhu kwingxowa yenkunkuma enobungozi kwizinto eziphilayo.
Impumlo evuthuzayo
Hlamba izandla
Fumana i-swab
Qokelela isampuli
Faka, Cinezela kwaye ujikelezise iswab
Yaphula iswab uze ufake isiciko endaweni yaso
Khulula isiciko esibonakalayo
Isisombululo sesampuli singahlala sizinzile iiyure ezi-8 kwi-2 ~ 8℃, iiyure ezi-3 kubushushu begumbi (15 ~ 30℃). Kuphephe ukukhenkceza nokunyibilikisa okuphindaphindiweyo izihlandlo ezingaphezu kwesine.
【Inkqubo yovavanyo】
Musa ukuvula isikhwama ude ulungele ukwenza uvavanyo, kwaye uvavanyo lucetyiswa ukuba lwenziwe kubushushu begumbi (15 ~ 30℃), kwaye uphephe indawo enomswakama kakhulu.
1. Susa ikhasethi yovavanyo kwingxowa yefoyile uze uyibeke kwindawo ecocekileyo neyomileyo ethe tye.
2. Jikelezisa ityhubhu yokukhupha, faka amathontsi amathathu kumngxunya wesampuli ezantsi kwekhasethi yovavanyo, uze uqalise isibali-xesha.
3. Linda uze ufunde iziphumo kwimizuzu eli-15 ukuya kwengama-25. Iziphumo ngaphambi kwemizuzu eli-15 nasemva kwemizuzu engama-25 azisebenzi.
Yongeza isisombululo sesampuli
Funda iziphumo kwimizuzu eli-15 ukuya kwengama-25
【Ukutolikwa kwesiphumo sovavanyo】
Isiphumo esibi: Ukuba umgca wolawulo lomgangatho uvela, kodwa umgca wovavanyo u-T awunambala, isiphumo sibi, nto leyo ebonisa ukuba akukho antigen yeNovel Coronavirus efunyenweyo.
Iziphumo ezilungileyo: Ukuba zombini umgca wolawulo lomgangatho C kunye nomgca wovavanyo T ziyavela, iziphumo ziya kuba ntle, nto leyo ebonisa ukuba i-antigen yeNovel Coronavirus ifunyenwe.
Isiphumo esingasebenziyo: Ukuba akukho mgca wokulawula umgangatho C, nokuba umgca wovavanyo T uvela okanye awuveli, oko kubonisa ukuba uvavanyo alusebenzi kwaye uvavanyo luza kuphinda luphindwe.
【Imida】
1. Le reagent isetyenziselwa ukufumanisa kuphela umgangatho kwaye ayinakubonisa inqanaba le-antigen entsha ye-coronavirus kwisampuli.
2. Ngenxa yokunqongophala kwendlela yokufumanisa isifo, iziphumo ezingezizo azinakuthintela ukuba umntu angosuleleka. Iziphumo ezilungileyo azifanele zithathwe njengoxilongo oluqinisekisiweyo. Kufuneka kwenziwe isigqibo kunye neempawu zonyango kunye nezinye iindlela zokuxilongwa.
3.Kwinqanaba lokuqala losulelo, iziphumo zovavanyo zinokuba zimbi kuba inqanaba eliphantsi le-SARS-CoV-2 antigen kwisampuli.
4. Ukuchaneka kovavanyo kuxhomekeke kwinkqubo yokuqokelelwa kwesampuli kunye nokulungiselela. Ukuqokelelwa okungafanelekanga, ukugcinwa kokuthutha okanye ukukhenkcezwa nokunyibilikiswa kuya kuchaphazela iziphumo zovavanyo.
5. Umthamo we-buffer ongezelelweyo xa i-swab isusiwe ungaphezulu kakhulu, ukusebenza kwe-elution okungekho semgangathweni, i-virus titer ephantsi kwisampuli, zonke ezi zinto zinokukhokelela kwiziphumo ezingezizo ezilungileyo.
6. Ilungile xa ususa iiswabs ezine-antigen extraction buffer ehambelanayo. Ukusebenzisa ezinye izinyibilikisi kunokubangela iziphumo ezingalunganga.
7. Iimpendulo ezinqamlezileyo mhlawumbi zikhona ngenxa yokuba iprotheyini ye-N kwi-SARS inokuhambelana okuphezulu ne-SARS-CoV-2, ingakumbi kwi-titer ephezulu.
Ixesha lokuthumela: Jan-13-2023
Useto lwabucala