China SARS-CoV-2 Antigen Rapid Test(iimpumlo) abavelisi kunye nababoneleli |Liming Bio

Uvavanyo oluKhawulezayo lwe-SARS-CoV-2 Antigen (empumlweni)

SARS-CoV-2 Antigen Rapid Test（nasal） Featured Image

Inkcazelo emfutshane:

I-REF	500200	Inkcazo	1 Uvavanyo / Ibhokisi ; Iimvavanyo ezi-5 / ibhokisi ; Iimvavanyo ezingama-20 / ibhokisi
Umgaqo wokufumanisa	Uvavanyo lwe-Immunochromatographic	Imizekelo	I-swab yempumlo yangaphambili
Usetyenziso olucetywayo	I-StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette isebenzisa itekhnoloji ye-immunochromatography ukukhangela i-SARS- CoV-2 nucleocapsid antigen kumzekelo weswab yempumlo yangaphambili yomntu.Olu vavanyo lusetyenziswa kuphela kwaye lujolise ekuzivavanyeni.Kucetyiswa ukuba kusetyenziswe olu vavanyo phakathi kweentsuku ezi-5 zokuqala kweempawu.Ixhaswa luvavanyo lwentsebenzo yeklinikhi.

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Iinkcukacha zeMveliso

Iithegi zeMveliso

Imveliso ine-arhente ekhethekileyo eNew Zealand.Ukuba unomdla ekuthengeni, iinkcukacha zoqhagamshelwano zimi ngolu hlobo lulandelayo:
Mick Dienhoff
Umlawuli jikelele
Inombolo yomnxeba: 0755564763
Inombolo yeselula: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz

UKUSETYENZISWA OKUHLOSIWEYO
I-StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette isebenzisa itekhnoloji ye-immunochromatography ukukhangela i-SARS- CoV-2 nucleocapsid antigen kumzekelo weswab yempumlo yangaphambili yomntu.Olu vavanyo lusetyenziswa kuphela kwaye lujolise ekuzivavanyeni.Kucetyiswa ukuba kusetyenziswe olu vavanyo phakathi kweentsuku ezi-5 zokuqala kweempawu.Ixhaswa luvavanyo lwentsebenzo yeklinikhi.

INTSHAYELELO
Inoveli coronaviruses yeyohlobo lwe totiie p.I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla.Ngokuqhelekileyo abantu basengozini.Okwangoku, izigulane ezosulelwe yinoveli cxjronavinis ngowona mthombo wosulelo;abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo.Ngokusekwe kuphando lwe-epidemiological yangoku, ixesha lokufukamela liyi-1 ukuya kwiintsuku eziyi-14, uninzi lweentsuku ezi-3 ukuya kwezi-7.Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo.Ukuxinana kweempumlo, impumlo evuzayo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.

UMGAQO
Uvavanyo lwe-StrongStep® SARS-CoV-2 Antigen lusebenzisa uvavanyo lwe-immunochromatographic.I-Latex conjugated antibodies (Latex-Ab) ehambelana ne-SARS-CoV-2 yomile-immobilized ekupheleni kwe-nitrocellulose membrane strip.Izilwa-buhlungu ze-SARS-CoV-2 zibond kuMmandla woVavanyo (T) kwaye i-Biotin-BSA ibhondi kuMmandla woLawulo (C).Xa isampuli yongezwa, ifuduka nge-capillary diffusion ibuyisela amanzi kwi-latex conjugate.Ukuba ikhona kwisampulu, ii-antigens ze-SARS-CoV-2 ziya kuzibophelela ngee-antibodies ezidityanisiweyo zenza amasuntswana.La masuntswana aya kuqhubeka efuduka ecaleni komtya kude kube kuMmandla woVavanyo (T) apho athinjwa khona zii-antibodies ze-SARS-CoV-2 ezivelisa umgca obomvu obonakalayo.Ukuba akukho zi-antigens ze-SARS-CoV-2 kwisampulu, akukho mgca ubomvu wenziwayo kuMmandla woVavanyo (T).I-conjugate ye-streptavidin iya kuqhubeka ifuduka yodwa ide ibanjwe kwi-Control Zone (C) yi-Biotin-BSA edibeneyo kumgca ohlaza okwesibhakabhaka, obonisa ukunyaniseka kovavanyo.

AMANQAKU EKIT

1 uvavanyo / ibhokisi; 5 uvavanyo / ibhokisi:

Ifoyile etywiniweyo epakishwe izixhobo zovavanyo	Isixhobo ngasinye siqulethe i-strip ene-conjugates enemibala kunye nee-reagents ezisebenzayo ezisasazwe kwangaphambili kwiindawo ezihambelanayo.
Dilution Buffer izitya	I-0.1 M I-Phosphate buffered saline (PBS) kunye ne-0.02% ye-sodium azide.
Imibhobho yokukhupha	Ukulungiselela imizekelo yokusetyenziswa.
Iipakethi zeswab	Ukuqokelela isampuli.
Indawo yokusebenzela	Indawo yokugcina i-buffer vials kunye netyhubhu.
Faka iphakheji	Ngomyalelo wokusebenza.

Iimvavanyo ezingama-20/ibhokisi

20 Izixhobo zovavanyo ezipakishwe ngumntu ngamnye	Isixhobo ngasinye sinomgca onemibala edibanisayo kunye ne-reagents esebenzayo esasazwe kwangaphambili kwiireqions ezihambelanayo.
Iingqayi ezi-2 zokutsalwa kwesithinteli	I-0.1 M I-Phosphate buffered saline (P8S) kunye ne-0.02% ye-sodium azide.
20 Iityhubhu zokukhupha	Ukulungiselela imizekelo yokusetyenziswa.
1 Indawo yokusebenzela	Indawo yokugcina i-buffer vials kunye netyhubhu.
1 Ukufakwa kwephakheji	Ngomyalelo wokusebenza.

IZINTO EZIFUNEKAYO KODWA AKUNIKEZWE

Isibali-xesha	Ukusetyenziswa kwexesha.
Nasiphi na isixhobo esiyimfuneko sokuzikhusela

UKULUMKELA

-Le khithi ye-IN VITRO yokusetyenziswa kokuxilongwa kuphela.

Funda imiyalelo ngononophelo phambi kokuba wenze uvavanyo.
Le mveliso ayinayo nayiphi na imathiriyeli yabantu.

-Musa ukusebenzisa imixholo yekhithi emva komhla wokuphelelwa.

Nxiba iiglavu ngexesha lenkqubo yonke.

UKUGCINWA NOZINZI

Izingxobo ezitywiniweyo ezikwikhithi yovavanyo zinokugcinwa phakathi kwe-2-30 C kangangexesha lokuhlala kweshelufu njengoko kubonisiwe kwisingxobo.

UKUQOKELELWA KOMSEBENZI NOKUGCINWA

Isampulu yangaphambili yeempumlo swab ingaqokelelwa okanye nguMntu ngamnye perfofmlng a self-swab.

Abantwana abangaphantsi kweminyaka eli-18 ubudala, kufuneka benziwe luhlolo lwe-aduK.Abantu abadala abaneminyaka eyi-18 nangaphezulu banokwenza i-swab yempumlo yangaphambili bebodwa.Nceda ulandele izikhokelo zakho zasekhaya zokuqokelelwa kwesampulu ngabantwana.

, Faka iswayi enye kwimpumlo enye yesigulana.Incam yeswab kufuneka ifakwe ukuya kuthi ga kwi-2.5 cm (1 intshi) ukusuka kumda wempumlo.Roll swab ngamaxesha ama-5 ecaleni kwe-mucosa ngaphakathi kwempumlo ukuqinisekisa ukuba zombini i-mucus kunye neeseli ziqokelelwa.

• Sebenzisa iswab efanayo, phinda le nkqubo kwitha enye impumlo ukuqinisekisa ukuba isampulu eyaneleyo iqokelelwa kuyo yomibini imingxuma yeempumlo.

Kucetyiswa ukuba imizekelo ibekhokusetyenzwangokukhawuleza emva kokuqokelela.Iisampulu zingabanjwa kwisikhongozeli seyure kwiqondo lobushushu likamama (15°C ukuya kuma-30″), okanye ukuya kuthi ga kwiiyure ezingama-24 xa rsfrigeratod (2°C ukuya ku-8).^eC) phambi kokucubungula.

INKQUBO

Zisa izixhobo zovavanyo, imizekelo, isithinteli kunye/okanye nolawulo kwiqondo lobushushu legumbi (15-30°C) phambi kokusetyenziswa.

♦I-Plac® ityhubhu yesampula eqokelelweyo kwindawo echongiweyo yendawo yokusebenza.

♦Cofa yonke i-Dilution Buffer kwityhubhu yerediyo ephumayo.

♦Faka i-specimen swab kwi-tube.Hlanganisa ngamandla isisombululo ngokujikeleza i-swab ngamandla kwicala lombhobho ubuncinane ngamaxesha angama-15 (ngelixa lifakwe emanzini).Iziphumo ezilungileyo zifumaneka xa i-specimen ixutywe ngamandla kwisisombululo.

♦Vumela i-swab ukuba ifakwe kwi-Extraction Buffer umzuzu omnye ngaphambi kweNyathelo elilandelayo.

♦Khupha ulwelo oluninzi kangangoko kunokwenzeka kwiswab ngokucinezela icala letyhubhu yokutsalwa ebhetyebhetye njengoko iswab isuswa.Ubuncinci i-1/2oftie yesisombululo sesithinteli sesampulu kufuneka ihlale kwityhubhu ukuze kubekho imfuduko eyaneleyo ye-capillary.Beka ikepusi kwityhubhu ekhutshiweyo.

♦Lahla i-swab kwisikhongozeli esifanelekileyo senkunkuma ye-biohazardous.

♦Iisampuli ezikhutshiweyo zingagcina kwiqondo lokushisa kwemizuzu engama-30 ngaphandle kokuchaphazela umphumo wovavanyo.

♦Susa esi sixhobo sovavanyo kwisingxobo saso esitywiniweyo, kwaye usibeke kumphezulu wedean, umgangatho.Faka ileyibhile kwisixhobo ngesazisi sesigulane okanye solawulo.Ukufumana iziphumo ezilungileyo, uvavanyo kufuneka lwenziwe kwimizuzu engama-30.

♦Yongeza i-3 yehla (malunga ne-100 pL) yesampuli ekhutshwe kwi-Extraction Tube ukuya kwisampuli ejikelezayo kakuhle kwisixhobo sokuvavanya.

Kuphephe ukubambisa amaqamza omoya Kwisampulu kakuhle (S), kwaye musa ukuwisa nasiphi na isisombululo Kwifestile yokujonga.Njengoko uvavanyo luqala ukusebenza, uya kubona umbala uhamba kwi-membrane.

♦Intsusa ye (s) ezinemibala ukubonakala.Isiphumo kufuneka sifundwe ngokubonwayo kwimizuzu eyi-15.Musa ukutolika umphumo emva kwemizuzu engama-30.

•Faka ityhubhu yovavanyo equlethe iswabhu kunye nesixhobo sovavanyo esisetyenzisiweyo Kwingxowa encamatheleyo yebiohazard uze uyitywine, uze uyilahle kwisingxobo senkunkuma esifanelekileyo.Emva koko ulahle izinto eziseleyo

•Hlambaizandla zakho okanye uphinde usebenzise isicoci sesandla.

Lahla iityhubhu zokutsalwa ezisetyenzisiweyo kunye neZixhobo zoVavanyo kwisikhongozeli esifanelekileyo senkunkuma enobungozi.

UKUTOLIKWA KWEZIPHUMO

IMIDA YOVAVANYO

I-1- Ikhithi yenzelwe ukusetyenziselwa ukufumanisa umgangatho we-SARS-CoV-2 antigens kwi-Nasal.
2.Olu vavanyo lufumanisa zombini i-SARS-CoV-2 esebenzayo kunye nengasebenziyo.Ukusebenza kovavanyo kuxhomekeke kubungakanani bentsholongwane (i-antigen) kwisampulu kwaye inokuthi okanye inganxibelelani neziphumo zenkcubeko yentsholongwane efakwe kwisampulu efanayo.
I-3.Isiphumo esibi se-teat sinokuthi senzeke ukuba izinga le-antigen kwisampuli lingaphantsi komda wokubona uvavanyo okanye ukuba isampuli iqokelelwe okanye ihanjiswe ngokungafanelekanga.
4.Ukungaphumeleli ukulandela iNkqubo yoVavanyo kunokuchaphazela kakubi ukusebenza kovavanyo kunye/okanye kungabi nakusebenza iziphumo zovavanyo.
I-5.Iziphumo zovavanyo kufuneka zihambelane nembali yeklinikhi, idatha ye-epidemiological, kunye nenye idatha ekhoyo kugqirha ovavanya isigulane.
6.Iziphumo zovavanyo oluqinisekileyo aziyikhuphi insulelo kunye nezinye iintsholongwane.
7. Iziphumo zovavanyo olubi azenzelwanga ukulawula ezinye izifo ezingezizo ii-SARS zentsholongwane okanye iintsholongwane.
I-8.Iziphumo ezibi ezivela kwizigulane ezinempawu eziqala ngaphaya kweentsuku ezisixhenxe, kufuneka ziphathwe njengento ecingelwayo kwaye ziqinisekiswe nge-FDA yendawo egunyazisiweyo yovavanyo lwe-molecular, ukuba kuyimfuneko, kulawulo lweklinikhi, kubandakanywa nokulawulwa kosulelo.
9.Izindululo zozinzo lomboniso zisekelwe phezu kozinzo lwedatha evela kuvavanyo lomkhuhlane kunye nokusebenza kungab © kwahluka nge-SARS-CoV-2.Abasebenzisi kufuneka bavavanye iisampulu ngokukhawuleza emva kokuqokelelwa kwesampuli.
10.Uvakalelo lovavanyo lwe-RT-PCR ekufunyanisweni kwe-COVID-19 ngama-50% ukuya kuma-80% kuphela ngenxa yomgangatho ophantsi wesampulu okanye ixesha lesifo kwinqanaba elifunyenweyo, njl. isezantsi ngenxa yendlela yokusebenza kwayo.
I-11.Ukuze ufumane i-virus eyaneleyo, kucetyiswa ukuba kusetyenziswe ii-swabs ezimbini okanye ngaphezulu ukuqokelela iindawo ezahlukeneyo zesampuli kunye nokukhupha yonke i-swab yesampuli kwi-tube efanayo.
I-12.Amaxabiso aqikelelwayo alungileyo nangalunganga axhomekeke kakhulu kumazinga okuxhaphaka.
13. Iziphumo zovavanyo oluqinisekileyo zilindeleke ukuba zibonise iziphumo zobuxoki ngexesha lomsebenzi omncinci we-I no-SARS-CoV-2 xa ukuxhaphaka kwesifo kusezantsi. Iziphumo zovavanyo olungeyonyani zinokwenzeka xa ukuxhaphaka kwesifo esibangelwa yi-SARS-CoV-2 phezulu.
14.Izilwa-buhlungu ze-Monoclonal zinokusilela ukubhaqa, okanye ukufumanisa ngovakalelo oluncinci, iintsholongwane zomkhuhlane we-SARS-CoV-2 eziye zafumana utshintsho oluncinci lwe-amino acid kwindawo ekujoliswe kuyo ye-epitope.
I-15.Ukwenziwa kolu vavanyo akuzange kuhlolwe ukuba kusetyenziswe izigulane ngaphandle kweempawu kunye neempawu zosulelo lokuphefumula kunye nokusebenza kunokwahluka kubantu abangabonakaliyo.
16.Inani le-antigen Kwisampulu inokuncipha njengoko ixesha lokugula linyuka.Iisampulu eziqokelelwe emva komhla we-5 wokugula kunokwenzeka ukuba zingabikho xa kuthelekiswa novavanyo lwe-RT-PCR.
I-17.I-sensitivity yovavanyo emva kweentsuku ezintlanu zokuqala zokuqala kweempawu zibonakaliswe ukunciphisa xa kuthelekiswa novavanyo lwe-RT-PCR.
18.Kucetyiswa ukuba kusetyenziswe i-StrongStep® SARS-CoV-2 IgM/IgG yovavanyo olukhawulezayo lwe-antibody (caW 502090) ukufumanisa isithinteli-gazi ukunyusa ubuntununtunu bokuxilongwa kwe-COVID-19.
19.Akukhuthazwa ukusebenzisa i-Virus Transportation medla (VTM) isampuli Kolu vavanyo, Ukuba abathengi bayanyanzelisa ukusebenzisa olu hlobo lwesampuli, abathengi kufuneka baziqinisekise ngokwabo.
20.IStrongStep® SARS-CoV-2 Antigen Rapid Test yaqinisekiswa ngeeswabs ezibonelelwe kwikhithi.Ukusetyenziswa kwezinye iiswabs kunokubangela iziphumo ezibubuxoki.
21. Uvavanyo lwarhoqo luyimfuneko ukunyusa ubuntununtunu bokuxilongwa kwe-COVID-19.
22. Akukho kwehla kubuntununtunu xa kuthelekiswa nohlobo lwasendle oludlwengulweyo kwezi ntlobo zilandelayo - VOC1 Kent, UK, B.1.1.7 kunye neVOC2 South Africa, B.1.351.

23 Gcina kwindawo ekude nabantwana.
24. Iziphumo ezilungileyo zibonisa ukuba ii-antigens zentsholongwane ziye zafunyanwa kwisampuli ethathiweyo, nceda u-Self-quarantine kwaye Yazisa ugqirha wakho wosapho ngokukhawuleza.

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Umnxeba: +86(25) 85288506
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I-imeyile:sales@limingbio.com
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