Izindaba - Ukuhlolwa Okusheshayo Kwe-Coronavirus (SARS-CoV-2) Okusheshayo Kwe-Antigen (Colloidal Gold) Umyalelo Wokusetshenziswa

【Isingeniso】
Ama-coronavirus amasha angowohlobo lwe-β. I-COVID-19 iyisifo esithathelwanayo esibangelwa ukuphefumula okubukhali. Abantu ngokuvamile bayathinteka kalula. Njengamanje, iziguli ezitheleleke yi-coronavirus entsha ziwumthombo oyinhloko wokutheleleka; abantu abanegciwane abangenazo izimpawu bangaba umthombo othelelanayo. Ngokusekelwe ocwaningweni lwamanje lwe-epidemiological, isikhathi sokufukamela siyizinsuku ezi-1 kuya kweziyi-14, ikakhulukazi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zifaka phakathi umkhuhlane, ukukhathala kanye nokukhwehlela okomile. Ukuminyana kwamakhala, ikhala eligelezayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa. Ukutholwa kusenesikhathi kwabantu abanegciwane kubalulekile ekuvimbeleni ukusabalala kwalesi sifo.
【Ukusetshenziswa okuhlosiwe】
Ukuhlolwa Okusheshayo Kwe-Coronavirus (SARS-CoV-2) Antigen Rapid (Colloidal Gold) kuyikhithi yokuthola i-in-vitro qualitative ye-antigen ye-coronavirus entsha evezwa kuma-swabs e-Oropharyngeal womuntu, ama-swabs e-Anterior Nasal, noma ama-swabs e-Nasopharyngeal. Le khithi yokuhlola ihloselwe ukusetshenziswa kuphela ochwepheshe bezempilo kanye nabelabhorethri ukuze kutholakale ngokushesha iziguli ezinezimpawu zomtholampilo zokutheleleka kwe-SARS-COV-2.
Ikhithi yokuhlola ingasetshenziswa kunoma iyiphi indawo ehlangabezana nezidingo zemiyalelo kanye nemithethonqubo yendawo. Lokhu kuhlolwa kunikeza imiphumela yokuhlola yokuqala kuphela. Imiphumela emibi ayikwazi ukukhipha ukutheleleka kwe-SARS-COV-2, futhi kumele ihlanganiswe nokubonwa kwezokwelapha, umlando kanye nolwazi lwe-epidemiological. Umphumela walokhu kuhlolwa akufanele ube yiwona kuphela oyisisekelo sokuxilongwa; ukuhlolwa okuqinisekisayo kuyadingeka.
【Isimiso sokuhlola】
Le khithi yokuhlola isebenzisa ubuchwepheshe be-colloidal gold immunochromatography. Lapho ikhambi lokukhipha isampula liqhubekela phambili eceleni komcu wokuhlola lisuka emgodini wesampula liye ephepheni lokumunca ngaphansi kwesenzo se-capillary, Uma ikhambi lokukhipha isampula liqukethe i-antigen entsha ye-coronavirus, i-antigen izobopha ku-colloidal gold-elebed nge-anti-novel coronavirus monoclonal antibody, ukuze yakhe i-immune complex. Ngemuva kwalokho i-immune complex izobanjwa enye i-anti-novel coronavirus monoclonal antibody, eqiniswe kulwelwesi lwe-nitrocellulose. Umugqa onemibala uzovela esifundeni somugqa wokuhlola "T", okubonisa ukuthi i-antigen entsha ye-coronavirus ilungile; Uma umugqa wokuhlola "T" ungabonisi umbala, kuzotholakala umphumela ongemuhle.
Ikhasethi yokuhlola iqukethe nomugqa wokulawula ikhwalithi "C", ozovela kungakhathaliseki ukuthi ukhona yini umugqa we-T obonakalayo.
【Izingxenye eziyinhloko】
1) I-swab yokuthatha amasampula egciwane elahlwayo ehlanziwe ngamagciwane
2) Ishubhu lokukhipha elinesivalo se-Nozzle kanye ne-buffer yokukhipha
3) Ikhasethi yokuhlola
4) Imiyalelo Yokusetshenziswa
5) Isikhwama sikadoti esiyingozi ezintweni eziphilayo
【Isitoreji kanye nokuqina】
1. Gcina ku-4~30℃ kude nelanga eliqondile, futhi isebenza izinyanga ezingama-24 kusukela ngosuku lokukhiqiza.
2. Gcina komile, futhi ungasebenzisi amadivayisi aqandisiwe naphelelwe yisikhathi.
3. Ikhasethi yokuhlola kufanele isetshenziswe zingakapheli isigamu sehora uma ivula isikhwama se-aluminium foil.
【Isexwayiso Nokuqapha】
1. Le khithi iwukuthola i-in vitro kuphela. Sicela usebenzise ikhithi phakathi nesikhathi sokusebenza kwayo.
2. Ukuhlolwa kuhloselwe ukusiza ekuxilongweni kokutheleleka kwe-COVID-19 kwamanje. Sicela uxhumane nochwepheshe wezempilo ukuze uxoxe ngemiphumela yakho nokuthi uma kudingeka ukuhlolwa okwengeziwe.
3. Sicela ugcine ikhithi njengoba i-IFU ibonisa, futhi ugweme izimo zokuqandisa isikhathi eside.
4. Funda futhi ulandele imiyalelo ngokucophelela ngaphambi kokusebenzisa ikhithi, kungenjalo umphumela onganembile ungase utholakale.
5. Ungashintshi izingxenye kusuka kwelinye ikhithi uye kwelinye.
6. Vikela umswakama, ungavuli isikhwama seplatinum se-aluminium ngaphambi kokuba silungele ukuhlolwa. Ungasebenzisi isikhwama se-aluminium foil uma sitholakala sivuliwe.
7. Zonke izingxenye zale khithi kufanele zifakwe esikhwameni sikadoti esiyingozi futhi zilahlwe ngokwezidingo zendawo.
8. Gwema ukulahla, ukuchelela.
9. Gcina ikhithi yokuhlola nezinto zokwakha kude nezingane nezilwane ezifuywayo ngaphambi nangemva kokusebenzisa.
10. Qiniseka ukuthi kukhona ukukhanya okwanele lapho uhlola
11. Ungaphuzi noma ulahle i-antigen extraction buffer esikhumbeni sakho.
12. Izingane ezingaphansi kweminyaka engu-18 kufanele zihlolwe noma ziqondiswe ngumuntu omdala.
13. Igazi eliningi noma i-mucus kusampula ye-swab kungaphazamisa ukusebenza kahle futhi kungabangela umphumela ongalungile.
【Ukuqoqwa kanye nokulungiswa kwezinhlobo zezibonelo】
Iqoqo lezibonelo:
I-Anterior Anterior swab
1. Faka lonke iphuzu leqoqo le-swab elinikezwe ngaphakathi kwekhala.
2. Sampula ngokuqinile udonga lwekhala ngokujikelezisa i-swab ngendlela eyindilinga odongeni lwekhala okungenani izikhathi ezine.
3. Thatha cishe imizuzwana eyi-15 ukuqoqa isampula. Qiniseka ukuthi uqoqa noma yikuphi ukuphuma kwamanzi ekhaleni okungenzeka ukuthi kukhona ku-swab.
4. Phinda kwenye ikhala usebenzisa i-swab efanayo.
5. Susa kancane kancane i-swab.
Ukulungiswa kwesisombululo sesampula:
1. Vula i-Sealing membrane epayipini lokukhipha.
2. Faka isihloko sendwangu ye-swab ku-extraction buffer ebhodleleni le-tube.
3. Hlanganisa bese ucindezela ikhanda le-swab odongeni lwe-extraction tube ukuze ukhulule i-antigen, ujikeleze i-swab umzuzu owodwa.
4. Susa i-swab ngenkathi ucindezela ithubhu lokukhipha kuyo.
(Qiniseka ukuthi uketshezi oluningi olusesihlokweni sendwangu ye-swab lususiwe ngangokunokwenzeka).
5. Cindezela i-Nozzle Cap enikeziwe ngokuqinile epayipini lokukhipha ukuze ugweme noma yikuphi ukuvuza okungenzeka.
6. Lahla ama-swabs esikhwameni semfucuza esiyingozi.

Impumulo evuthayo

Geza izandla

Thola i-swab

Qoqa isampula

Faka, Cindezela bese Ujika i-swab

Phula i-swab bese ubuyisela isivalo

Khulula isikulufu esibonakalayo

Isixazululo sesampula singahlala sizinzile amahora angu-8 ku-2 ~ 8℃, amahora ama-3 ekushiseni kwegumbi (15 ~ 30℃). Gwema ukuqandisa nokuncibilikisa okuphindaphindwayo izikhathi ezingaphezu kwezine.
【Inqubo yokuhlola】
Ungavuli isikhwama uze ulungele ukwenza isivivinyo, futhi isivivinyo sinconywa ukuthi senziwe ekushiseni kwegumbi (15 ~ 30℃), futhi ugweme indawo enomswakama omkhulu.
1. Susa ikhasethi yokuhlola esikhwameni se-foil bese uyibeka endaweni ehlanzekile neyomile evundlile.
2. Phezu kwepayipi lokukhipha, faka amaconsi amathathu emgodini wesampula phansi kwekhasethi yokuhlola, bese uqala i-timer.
3. Linda bese ufunda imiphumela ngemizuzu eyi-15-25. Imiphumela ngaphambi kwemizuzu eyi-15 nangemva kwemizuzu engama-25 ayisebenzi.

Engeza isixazululo sesampula

Funda umphumela kumaminithi angu-15 ~ 25

【Ukuhunyushwa komphumela wokuhlolwa】
Umphumela ongemuhle: Uma kuvela umugqa wokulawula ikhwalithi C, kodwa umugqa wokuhlola u-T ungenambala, umphumela uba muhle, okubonisa ukuthi akukho antigen ye-Novel Coronavirus etholakele.
Imiphumela emihle: Uma kuvela kokubili umugqa wokulawula ikhwalithi C kanye nomugqa wokuhlola T, umphumela uba muhle, okubonisa ukuthi i-antigen ye-Novel Coronavirus itholakele.
Umphumela ongavumelekile: Uma kungekho umugqa wokulawula ikhwalithi C, kungakhathaliseki ukuthi umugqa wokuhlola T uvela noma cha, kusho ukuthi ukuhlolwa akuvumelekile futhi ukuhlolwa kufanele kuphindwe.

【Ukulinganiselwa】
1. Le reagent isetshenziselwa ukuthola kuphela ikhwalithi futhi ayikwazi ukukhombisa izinga le-antigen entsha ye-coronavirus kusampula.
2.Ngenxa yokulinganiselwa kwendlela yokuthola, umphumela ongemuhle awukwazi ukuvimbela amathuba okutheleleka. Umphumela omuhle akufanele uthathwe njengokuxilongwa okuqinisekisiwe. Ukwahlulela kufanele kwenziwe kanye nezimpawu zomtholampilo kanye nezindlela ezengeziwe zokuxilonga.
3.Esigabeni sokuqala sokutheleleka, umphumela wokuhlolwa ungaba mubi ngenxa yezinga eliphansi le-antigen ye-SARS-CoV-2 kusampula.
4. Ukunemba kokuhlolwa kuncike enqubweni yokuqoqwa kwesampula kanye nokulungiselela. Ukuqoqwa okungafanele, ukugcinwa kokuthuthwa noma ukuqandisa nokuncibilikiswa kuzothinta imiphumela yokuhlolwa.
5. Umthamo we-buffer owengeziwe uma u-swab uphumile ukhulu kakhulu, ukusebenza kwe-elution okungajwayelekile, i-virus titer ephansi kusampula, konke lokhu kungaholela emiphumeleni emibi engamanga.
6. Kungcono kakhulu uma ususa ama-swabs ane-antigen extraction buffer ehambisanayo. Ukusebenzisa ezinye izinciphisi kungabangela imiphumela engalungile.
7. Ukusabela okuphambene kungenzeka kube khona ngenxa yokuthi iphrotheni ye-N ku-SARS inobudlelwano obuphezulu ne-SARS-CoV-2, ikakhulukazi uma i-titer iphezulu.

Isikhathi sokuthunyelwe: Jan-13-2023