【Intshayelelo】
Inoveli coronaviruses yeyodidi lwe-β. I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla. Ngokuqhelekileyo abantu basengozini. Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo; abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo. Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7. Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo. Ukuxinana kweempumlo, iimpumlo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa. Ukufunyaniswa kwangoko kwabantu abosulelekileyo kubalulekile ukunqanda ukusasazeka kwesi sifo.
【Usetyenziso olucetywayo】
Inoveli yeCoronavirus (i-SARS-CoV-2) yoVavanyo oluKhawulezayo lwe-Antigen (iGolide ye-Colloidal) yikiti yokufumanisa esemgangathweni ye-in-vitro ye-antigen yenoveli ye-coronavirus eboniswe kwi-Oropharyngeal swabs yabantu, i-Anterior Nasal swabs, okanye i-Nasopharyngeal swabs. Le khithi yovavanyo yenzelwe ukusetyenziswa kuphela ngokhathalelo lwempilo kunye neengcali zelabhoratri ukuxilongwa kwangoko kwezigulana ezineempawu zeklinikhi zosulelo lwe-SARS-COV-2.
Ikhithi yovavanyo ingasetyenziswa kuyo nayiphi na imeko ehlangabezana neemfuno zemiyalelo kunye nemimiselo yendawo. Olu vavanyo lubonelela kuphela ngeziphumo zovavanyo lokuqala. Iziphumo ezibi azinakukhuphela ngaphandle usulelo lwe-SARS-COV-2, kwaye kufuneka zidityaniswe nokujongwa kwezonyango, imbali kunye nolwazi lwe-epidemiological. Isiphumo solu vavanyo akufanele sibe sisiseko sodwa sokuxilongwa; uvavanyo lokuqinisekisa luyafuneka.
【Umgaqo wovavanyo】
Le khithi yovavanyo ithatha itekhnoloji ye-colloidal yegolide ye-immunochromatography. Xa isisombululo sokutsalwa komzekelo sihambela phambili ecaleni komcu wovavanyo ukusuka kumngxunya wesampulu ukuya kwiphedi yokufunxa phantsi kwenyathelo le-capillary, ukuba isisombululo sokutsalwa komzekelo sinenoveli ye-antigen ye-coronavirus, i-antigen iya kuzibophelela kwi-colloidal yegolide ebhalwe nge-anti-noveli coronavirus monoclonal antibody. , ukwenza i-immune complex. Emva koko i-immune complex iya kubanjwa yenye i-anti-novel coronavirus monoclonal antibody, efakwe kwi-nitrocellulose membrane. Umgca onemibala uya kubonakala kumgca wovavanyo "T" kummandla, ebonisa inoveli coronavirus antigen positive; Ukuba umgca wovavanyo "T" awubonisi umbala, umphumo ongalunganga uya kufumaneka.
I-cassette yokuvavanya iqulethe umgca wokulawula umgangatho "C", oya kubonakala kungakhathaliseki ukuba kukho umgca we-T obonakalayo.
【Amalungu aphambili】
1) Iintsholongwane ezilahlwayo zesampulu yesampulu yentsholongwane
2) ityhubhu yokukhupha ngeNozzle Cap kunye ne-extraction buffer
3) Uvavanyo lwekhasethi
4) Umyalelo wokusetyenziswa
5) Ingxowa yenkunkuma ye-Biohazardous
【Ugcino kunye nokuzinza】
1.Gcina kwi-4 ~ 30℃ ngaphandle kwelanga elithe ngqo, kwaye isebenza kwiinyanga ezingama-24 ukusuka kuMhla weMveliso.
2.Gcina womile, kwaye ungasebenzisi izixhobo ezikhenkcezisiweyo neziphelelwe lixesha.
3.Ikhasethi yovavanyo kufuneka isetyenziswe kwisiqingatha seyure xa kuvulwe isingxobo sefoyile yeAluminiyam.
【Isilumkiso kunye noLumkelo】
1.Le khithi yeyokubhaqwa kwe-in vitro kuphela. Nceda usebenzise ikhithi kwixesha elisemthethweni.
2. Uvavanyo lujonge ukunceda ekufunyanisweni kosulelo lwangoku lwe-COVID-19. Nceda udibane nochwepheshe wezempilo ukuze uxoxe ngeziphumo zakho kwaye ukuba kukho naluphi na uvavanyo olongezelelweyo olufunekayo.
3.Nceda ugcine ikiti njengoko i-IFU ibonisa, kwaye uphephe iimeko zokukhenkceza ixesha elide.
4.Funda kwaye ulandele imiyalelo ngocoselelo phambi kokuba usebenzise ikiti, okanye isiphumo esingachanekanga sinokuqulathwa.
5.Musa ukutshintsha amacandelo ukusuka kwenye ikhithi ukuya kwenye.
6.Khusela ukufuma, musa ukuvula isikhwama seplatinam ye-aluminium ngaphambi kokuba ilungele ukuvavanywa. Musa ukusebenzisa ingxowa yefoyile ye-aluminiyam xa ifunyenwe ivuliwe.
7. Onke amacandelo ale khithi kufuneka afakwe kwingxowa yenkunkuma ye-Biohazardous kwaye ilahlwe ngokwemfuno yendawo.
8.Kuphephe ukulahla, ukutshiza.
9. Gcina ikhithi yovavanyo kunye nemathiriyeli kwindawo ekungafikeleli kuyo abantwana kunye nezilwanyana zasekhaya phambi nasemva kokusetyenziswa.
10.Qinisekisa ukuba kukho ukukhanya okwaneleyo xa uvavanywa
11.Musa ukusela okanye ukulahla i-antigen extraction buffer esikhumbeni sakho.
12.Abantwana abangaphantsi kweminyaka eyi-18 kufuneka bavavanywe okanye bakhokelwe ngumntu omdala.
13.Igazi eligqithisileyo okanye i-mucus kwi-specimen ye-swab inokuphazamisa ukusebenza kwaye inokuvelisa umphumo ongeyonyani.
【Ukuqokelelwa komzekelo kunye nolungiselelo】
Ingqokelela yomfanekiso:
Iswab yempumlo yangaphambili
1.Faka yonke incam yengqokelela yeswab enikezelweyo ngaphakathi kwempumlo.
2.Ngokuqinisekileyo isampula eludongeni lwempumlo ngokujikeleza i-swab kwindlela ejikelezayo malunga nodonga lwama-4 ubuncinane.
3.Thatha malunga nemizuzwana eyi-15 ukuqokelela umzekelo. Qinisekisa ukuba uqokelela naziphi na iimpumlo zokukhupha amanzi anokuthi abekhona kwiswabhu.
4.Phinda kwenye impumlo usebenzisa iswab efanayo.
5.Susa ngokukhawuleza i-swab.
Ukulungiswa kwesisombululo somfanekiso:
1.I-Peel vula i-membrane yokutywina kwi-tube yokukhupha.
2.Faka incam yelaphu yeswab kwi-extraction buffer kwibhotile yombhobho.
3.Vula kwaye Cinezela intloko ye-swab ngokubhekiselele kwindonga ye-tube yokukhupha ukukhulula i-antigen, ujikeleze i-swab ye-1 ngomzuzu.
4.Susa i-swab ngelixa ucofa ityhubhu yokukhupha kuyo.
(Qinisekisa ukuba ulwelo oluninzi kwincam yelaphu le swab luyasuswa kangangoko kunokwenzeka).
5.Cofa i-Nozzle Cap enikezelwe ngokuqinileyo kwityhubhu yokukhupha ukuthintela nakuphi na ukuvuza okunokwenzeka.
6.Lahla i-swabs kwingxowa yenkunkuma ye-biohazard.
Vuthela impumlo
Hlamba izandla
Fumana iswab
Qokelela isampulu
Faka, Cinezela kwaye Jikelezisa iswab
Hlukanisa i-swab kwaye ubuyisele i-cap
Khulula ikepusi ekhanyayo
Isisombululo somfanekiso sinokuzinza kwiiyure ezi-8 kwi-2 ~ 8 ℃, iiyure ezi-3 kwiqondo lobushushu begumbi(15 ~ 30℃). Kuphephe ukuba ngaphezu kwamaxesha amane okuphinda umkhenkce nokunyibilika.
【Inkqubo yovavanyo】
Sukuvula isingxobo ude ube ukulungele ukwenza uvavanyo, kwaye uvavanyo luyacetyiswa ukuba luqhutywe kwiqondo lobushushu legumbi (15 ~ 30 ℃), kwaye uthintele imeko efumileyo kakhulu.
1.Susa ikhasethi yovavanyo kwisingxobo sefoil kwaye uyibeke kwindawo ecocekileyo ethe tye eyomileyo.
2.Ujonge phantsi ityhubhu yokutsalwa, faka amathontsi amathathu kumngxuma womzekelo osezantsi kwekhasethi yovavanyo, kwaye uqalise isibali-xesha.
3.Linda kwaye ufunde iziphumo kwi-15 ~ 25 imizuzu. Iziphumo phambi kwemizuzu eyi-15 nasemva kwemizuzu engama-25 azivumelekanga.
Yongeza isisombululo somzekelo
Funda umphumo kwi-15 ~ 25 min
【Ukutolikwa kweziphumo zovavanyo】
Isiphumo esibi: Ukuba umgca wolawulo lomgangatho C ubonakala, kodwa umgca wovavanyo T awunambala, isiphumo sibi, esibonisa ukuba akukho antigen yeNoveli yeCoronavirus ifunyenwe.
Iziphumo ezincomekayo: Ukuba zombini umgca wolawulo lomgangatho C kunye nomgca wovavanyo T uyavela, isiphumo sivuma, esibonisa ukuba i-antigen yeNoveli yeCoronavirus ichongiwe.
Isiphumo esingavumelekanga: Ukuba akukho mgca wokulawula umgangatho we-C, nokuba umgca wokuvavanya u-T ubonakala okanye awubonakali, kubonisa ukuba uvavanyo aluvumelekanga kwaye uvavanyo luya kuphinda luphindwe.
【Imida】
1.Le reagent isetyenziselwa kuphela ukufumanisa umgangatho kwaye ayikwazi ukubonisa inqanaba le-novel coronavirus antigen kumzekelo.
I-2.Ngenxa yokunciphisa indlela yokufumanisa, umphumo ongalunganga awunakungabandakanyi ukusuleleka kwintsholongwane. Isiphumo esihle akufanele sithathwe njengoxilongo oluqinisekisiweyo. Isigwebo kufuneka senziwe kunye neempawu zeklinikhi kunye neendlela zokuxilonga ezongezelelweyo.
3. Kwinqanaba lokuqala losulelo, iziphumo zovavanyo zinokuba zibi kuba inqanaba elisezantsi le-SARS-CoV-2 antigen kwisampulu.
4.Ukuchaneka kovavanyo kuxhomekeke ekuqokeleleni isampuli kunye nenkqubo yokulungiselela. Ukuqokelela okungafanelekanga, ukugcinwa kwezothutho okanye ukukhenkceza kunye nokunyibilika kuya kuchaphazela iziphumo zovavanyo.
5.Umthamo wesithinteli esongeziweyo xa eluted swab kakhulu, non- emgangathweni elution operation, intsholongwane titer ephantsi kwisampulu, ezi zonke zinokukhokelela iziphumo ezimbi zobuxoki.
6.Yeyona nto ilungileyo xa eluting swabs nge-antigen extraction buffer ehambelanayo. Ukusebenzisa ezinye izinyibilikisi kunokukhokelela kwiziphumo ezingalunganga.
7.Iimpendulo ezinqamlezileyo mhlawumbi zikhona ngenxa yeprotheyini ye-N kwi-SARS ine-homology ephezulu kunye ne-SARS-CoV-2, ngakumbi kwi-titer ephezulu.
Ixesha lokuposa: Jan-13-2023