I-Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test (Colloidal Gold) Umyalelo Wokusetshenziswa

【Isingeniso】
Ama-coronavirus anoveli awohlobo lwe-β. I-COVID-19 yisifo esithathelwanayo sokuphefumula esinamandla. Ngokuvamile abantu bayathinteka. Njengamanje, iziguli ezingenwe yi-coronavirus yenoveli ziwumthombo oyinhloko wokutheleleka; abantu abane-asymptomatic abangenwe yileli gciwane bangaba umthombo othathelwanayo. Ngokusekelwe ophenyweni lwamanje lwe-epidemiological, isikhathi sokufukamela siyizinsuku ezi-1 kuya kweziyi-14, izikhathi eziningi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile. Ukucinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa. Ukutholwa kusenesikhathi kwabantu abanalesi sifo kubalulekile ukuze kunqandwe ukubhebhetheka kwalesi sifo.
【Ukusetshenziswa okuhlosiwe】
I-Novel Coronavirus (i-SARS-CoV-2) I-Antigen Rapid Test (i-Colloidal Gold) iyikhithi yokuthola i-in-vitro ye-antigen ye-coronavirus yenoveli evezwa kumaswabhu abantu be-Oropharyngeal, ama-Anterior Nasal swabs, noma ama-Nasopharyngeal swabs. Le khithi yokuhlola ihloselwe ukusetshenziswa kuphela ochwepheshe bezokunakekelwa kwempilo kanye naselabhorethri ekuxilongeni kusenesikhathi kweziguli ezinezimpawu zomtholampilo zokutheleleka kwe-SARS-COV-2.
Ikhithi yokuhlola ingasetshenziswa kunoma iyiphi indawo ehlangabezana nezidingo zemiyalelo nemithetho yendawo. Lokhu kuhlola kunikeza kuphela imiphumela yokuhlola yokuqala. Imiphumela engemihle ayikwazi ukukhipha ukutheleleka kwe-SARS-COV-2, futhi kufanele ihlanganiswe nokubhekwa komtholampilo, umlando kanye nolwazi lwe-epidemiological. Umphumela walokhu kuhlolwa akufanele kube ukuphela kwesisekelo sokuxilongwa; ukuhlolwa kokuqinisekisa kuyadingeka.
【Umgomo wokuhlola】
Le kit yokuhlola isebenzisa ubuchwepheshe be-colloidal gold immunochromatography. Lapho ikhambi lokukhipha isifanekiso liya phambili eduze komugqa wokuhlola lisuka embotsheni yesampula liya kuphedi elimunca ngaphansi kwesenzo se-capillary, Uma isixazululo sokukhipha isifanekiso sine-noveli coronaviruses antigen, i-antigen izobophezela ku-colloidal yegolide ebhalwe nge-anti-novel coronavirus monoclonal antibody. , ukwakha i-immune complex. Ngemuva kwalokho i-immune complex izothunjwa enye i-anti-novel coronavirus monoclonal antibody, efakwe kulwelwesi lwe-nitrocellulose. Kuzovela umugqa omibalabala endaweni yokuhlola "T", okhombisa inoveli coronavirus antigen positive; Uma umugqa wokuhlola “T” ungabonisi umbala, kuzotholwa umphumela onegethivu.
Ikhasethi lokuhlola liqukethe nomugqa wokulawula ikhwalithi “C”, ozovela kungakhathaliseki ukuthi kukhona umugqa we-T obonakalayo.
【Izingxenye eziyinhloko】
1) Inzalo ye-virus alahlwayo isampula swab
2) Ishubhu yokukhipha ene-Nozzle Cap kanye ne-bafa yokukhipha
3) Hlola ikhasethi
4) Umyalelo Wokusetshenziswa
5) Isikhwama sikadoti we-biohazardous
【Isitoreji nokuzinza】
1.Londoloza ku-4~30℃ ngaphandle kwelanga eliqondile, futhi isebenza izinyanga ezingu-24 kusukela ngedethi yokukhiqiza.
2.Gcina womile, futhi ungasebenzisi izisetshenziswa eziqandisiwe neziphelelwe yisikhathi.
3.Ikhasethi lokuhlola kufanele lisetshenziswe phakathi nengxenye yehora eli-1 ngemva kokuvula isikhwama se-Aluminium foil.
【Isexwayiso kanye nokuqapha】
1.Le khithi eyokutholwa kwe-in vitro kuphela. Sicela usebenzise ikhithi phakathi nesikhathi sokuqinisekisa.
2. Ukuhlolwa kuhloswe ukusiza ekuxilongeni ukutheleleka kwamanje kwe-COVID-19. Sicela uthintane nochwepheshe bezempilo ukuze nixoxe ngemiphumela yakho futhi uma kukhona ukuhlolwa okwengeziwe okudingekayo.
3.Sicela ugcine ikhithi njengoba i-IFU ibonisa, futhi ugweme izimo ezibanda isikhathi eside.
4.Funda futhi ulandele imiyalelo ngokucophelela ngaphambi kokusebenzisa ikhithi, noma kungenzeka kube nomphumela ongalungile.
5.Ungashintshi izingxenye zekhithi eyodwa uye kwenye.
6.Gcina umswakama, ungasivuli isikhwama seplatinamu ye-aluminium ngaphambi kokuthi silungele ukuhlolwa. Ungasisebenzisi isikhwama se-aluminium foil uma sitholakala sivuliwe.
7.Zonke izingxenye zale kit kufanele zifakwe esikhwameni sikadoti we-Biohazardous futhi zilahlwe ngokwesidingo sasendaweni.
8.Gwema ukulahla, ukuchaphaza.
9.Gcina ikhithi yokuhlola nezinto ezisetshenziswayo lapho izingane nezilwane ezifuywayo zingakwazi ukufinyelela kuzo ngaphambi nangemuva kokusetshenziswa.
10.Qinisekisa ukuthi kunokukhanya okwanele lapho uhlola
11.Ungaphuzi noma ulahle i-antigen extraction buffer esikhumbeni sakho.
12.Izingane ezingaphansi kweminyaka engu-18 kufanele zihlolwe noma ziqondiswe umuntu omdala.
13.Igazi eliningi noma amafinyila kusampula ye-swab kungase kuphazamise ukusebenza futhi kungase kuveze umphumela ongelona iqiniso.
【Ukuqoqwa nokulungiswa kwesifanekiso】
Iqoqo lesampula:
I-Anterior Nasal swab
1.Faka lonke ithiphu leqoqo le-swab enikezwe ngaphakathi kwekhala.
2.Qinisekisa isampula yodonga lwamakhala ngokuzungezisa i-swab endleleni eyindilinga odongeni lwamakhala okungenani izikhathi ezi-4.
3.Thatha cishe imizuzwana eyi-15 ukuqoqa isifanekiso. Qinisekisa ukuthi uqoqa noma yikuphi ukugeleza kwamanzi okungase kube khona ku-swab.
4.Phinda kwelinye ikhala usebenzisa i-swab efanayo.
5.Susa kancane i-swab.
Ukulungiswa kwesixazululo sesampula:
1.Peel vula i-Seal membrane kushubhu Lokukhipha.
2.Faka ithiphu lendwangu ye-swab ku-bafa yokukhipha ebhodleleni leshubhu.
3.Khuthaza futhi Cindezela ikhanda le-swab odongeni lweshubhu yokukhipha ukuze ukhulule i-antigen, uzungezisa i-swab iminithi elingu-1.
4.Susa i-swab ngenkathi ucindezela ishubhu yokukhipha kuyo.
(Qinisekisa ukuthi uketshezi oluningi endaweni yendwangu ye-swab luyasuswa ngangokunokwenzeka).
5.Cindezela i-Nozzle Cap enikezwe ngokuqinile eshubhuni yokukhipha ukuze ugweme noma yikuphi ukuvuza okungase kube khona.
6.Lahla ama-swabs esikhwameni sikadoti we-biohazard.

Vuthela-khala
Geza izandla

Vuthela ikhala

Geza izandla

Thola i-swab
Qoqa isampula

Thola i-swab

Qoqa isampula

Faka, Cindezela futhi Zungezisa i-swab
Hlukanisa i-swab bese Ubuyisela ikepisi

Faka, Cindezela futhi Zungezisa i-swab

Hlukanisa i-swab bese Ubuyisela ikepisi

Khumula ikepisi elibonisa ngale

Khumula ikepisi elibonisa ngale

Isixazululo se-specimen singahlala sizinzile amahora angu-8 ku-2 ~ 8℃, amahora angu-3 ekamelweni lokushisa (15 ~ 30℃). Gwema izikhathi ezingaphezu kwezine zokuqanda nokuncibilika okuphindaphindiwe.
【Inqubo yokuhlola】
Ungasivuli isikhwama kuze kube yilapho usulungele ukwenza isivivinyo, futhi ukuhlolwa kuphakanyiswa ukuthi kwenziwe kuzinga lokushisa legumbi (15 ~ 30℃), futhi ugweme indawo enomswakama owedlulele.
1.Khipha ikhasethi lokuhlola esikhwameni se-foil bese ulibeka endaweni ehlanzekile evundlile eyomile.
2.Ubheke phansi ishubhu yokukhipha, faka amaconsi amathathu embotsheni yesifanekiso engaphansi kwekhasethi lokuhlola, bese uqala isibali sikhathi.
3.Linda bese ufunda imiphumela ngemizuzu eyi-15 ~ 25. Imiphumela ngaphambi kwemizuzu eyi-15 nangemuva kwemizuzu engama-25 ayivumelekile.

Engeza isixazululo sesampula
Funda umphumela ku-15 ~ 25 min

Engeza isixazululo sesampula

Funda umphumela ku-15 ~ 25 min

【Ukuhunyushwa komphumela wokuhlolwa】
Umphumela omubi: Uma umugqa wokulawula ikhwalithi uvela, kodwa umugqa wokuhlola T ungenambala, umphumela uba mubi, okubonisa ukuthi ayikho i-antigen ye-Novel Coronavirus etholakele.
Imiphumela emihle: Uma kokubili umugqa wokulawula ikhwalithi C kanye nomugqa wokuhlola T kuvela, umphumela uba positive, okubonisa ukuthi i-Novel Coronavirus antigen itholakele.
Umphumela ongavumelekile: Uma ungekho umugqa wokulawula ikhwalithi C, noma ngabe umugqa wokuhlola T uyavela noma cha, kubonisa ukuthi ukuhlola akuvumelekile futhi ukuhlola kuzophindwa.

isithombe11

【Imikhawulo】
1.Lesi siphehli sisetshenziselwa ukutholwa kwekhwalithi kuphela futhi asikwazi ukukhombisa izinga le-antigen ye-coronavirus entsha kusifanekiso.
2.Ngenxa yomkhawulo wendlela yokuthola, umphumela ongemuhle awukwazi ukukhipha amathuba okutheleleka. Umphumela omuhle akufanele uthathwe njengokuxilongwa okuqinisekisiwe. Ukwahlulela kufanele kwenziwe kanye nezimpawu zomtholampilo kanye nezindlela zokuxilonga ezengeziwe.
3. Esigabeni sokuqala sokutheleleka, umphumela wokuhlolwa ungase ube awunayo ngenxa yokuthi izinga eliphansi le-antigen le-SARS-CoV-2 kusampula.
4.Ukunemba kokuhlolwa kuncike ekuqoqweni kwesifanekiso nenqubo yokulungiselela. Ukuqoqwa okungafanele, ukugcinwa kwezinto zokuhamba noma ukuqandisa nokuncibilika kuzothinta imiphumela yokuhlolwa.
5.Ivolumu ye-buffer eyengezwe lapho i-swab ikhishwa miningi kakhulu, ukusebenza kwe-lution okungajwayelekile, i-virus titer ephansi kusampula, konke lokhu kungase kuholele emiphumeleni engemihle engamanga.
6.Kuhle kakhulu lapho ususa ama-swabs ngesiviva sokukhipha i-antigen esifanisiwe. Ukusebenzisa ezinye izixuku kungase kubangele imiphumela engalungile.
7.Ukusabela okuphambanayo kungenzeka kube khona ngenxa ye-N protein ku-SARS ine-homology ephezulu ne-SARS-CoV-2, ikakhulukazi ku-high titer.


Isikhathi sokuthumela: Jan-13-2023
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