I-China SARS-CoV-2 Antigen Rapid Test(amakhala) abakhiqizi nabaphakeli |I-Liming Bio

I-SARS-CoV-2 Antigen Rapid Test (amakhala)

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

Incazelo emfushane:

REF	500200	Ukucaciswa	1 Izivivinyo/Ibhokisi ;5 Izivivinyo/ibhokisi; 20 Izivivinyo/ibhokisi
Umgomo wokutholwa	Ukuhlolwa kwe-Immunochromatographic	Izibonelo	I-Anterior nasal swab
Ukusetshenziswa Okuhlosiwe	I-StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette isebenzisa ubuchwepheshe be-immunochromatography ukuze ithole i-SARS- CoV-2 nucleocapsid antigen esibonelweni se-swab yamakhala yomuntu yangaphambili.Lokhu testis ukusetshenziswa kanye kuphela futhi ihloselwe ukuzihlola wena.Kunconywa ukuthi usebenzise lesi sivivinyo phakathi nezinsuku ezi-5 zokuqala kwezimpawu.Isekelwa ukuhlolwa kokusebenza komtholampilo.

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Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Umkhiqizo une-ejenti ekhethekile eNew Zealand.Uma ungathanda ukuthenga, imininingwane yokuxhumana imi kanje:
UMick Dienhoff
Umphathi ovamile
Inombolo yocingo: 0755564763
Inombolo yeselula: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz

UKUSETSHENZISWA OKUHLOSIWE
I-StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette isebenzisa ubuchwepheshe be-immunochromatography ukuze ithole i-SARS- CoV-2 nucleocapsid antigen esibonelweni se-swab yamakhala yomuntu yangaphambili.Lokhu testis ukusetshenziswa kanye kuphela futhi ihloselwe ukuzihlola wena.Kunconywa ukuthi usebenzise lesi sivivinyo phakathi nezinsuku ezi-5 zokuqala kwezimpawu.Isekelwa ukuhlolwa kokusebenza komtholampilo.

ISINGENISO
Ama-coronavirus anoveli ayingxenye yohlobo lwe-totiie p.I-COVID-19 yisifo esithathelwanayo sokuphefumula esiyingozi.Ngokuvamile abantu bayathinteka.Njengamanje, iziguli ezingenwe yinoveli cxjronavinis ziwumthombo oyinhloko wokutheleleka;abantu abane-asymptomatic abangenwe yileli gciwane bangaba umthombo othathelwanayo.Ngokusekelwe ophenyweni lwamanje lwe-epidemiological 1, isikhathi sokufukamela siyizinsuku ezi-1 kuye kweziyi-14, kakhulukazi izinsuku ezi-3 kuye kweziyi-7.Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile.Ukucinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.

ISIMISO
I-StrongStep® SARS-CoV-2 Antigen Test isebenzisa ukuhlolwa kwe-immunochromatographic.Amasosha omzimba e-Latex conjugated (Latex-Ab) ahambelana ne-SARS-CoV-2 awomile-ayinyakazi ekupheleni komugqa we-nitrocellulose membrane.Amasosha omzimba akwa-SARS-CoV-2 ayibhondi ku-Test Zone (T) kanti i-Biotin-BSA iyibhondi ku-Control Zone (C).Lapho isampula yengezwa, ifuduka ngokusakazwa kwe-capillary ibuyisela amanzi emanzini i-latex conjugate.Uma ekhona kusampula, ama-antigen e-SARS-CoV-2 azobopha nama-anti-conjugated akha izinhlayiya.Lezi zinhlayiya zizoqhubeka zifuduka eduze komugqa kuze kube yi-Test Zone (T) lapho zithathwe khona amasosha omzimba akwa-SARS-CoV-2 akhiqiza ulayini obomvu obonakalayo.Uma engekho ama-antigen e-SARS-CoV-2 kusampula, awukho umugqa obomvu owenziwe ku-Test Zone (T).I-streptavidin conjugate izoqhubeka nokuthutha iyodwa ize ithathwe ku-Control Zone(C) yi-Biotin-BSA ehlanganisa umugqa oluhlaza okwesibhakabhaka, okubonisa ukufaneleka kokuhlolwa.

IZINTO ZEKHITHI

1 ukuhlolwa / ibhokisi; 5 ukuhlolwa / ibhokisi:

Isikhwama se-foil esivaliwe esipakishwe amadivayisi wokuhlola	Idivayisi ngayinye iqukethe umugqa onama-conjugates anemibala nama-reagents asebenzayo asakazwe ngaphambilini ezindaweni ezihambisanayo.
Izitsha ze-Dilution Buffer	0.1 M I-Phosphate buffered saline (PBS) kanye ne-0.02% sodium azide.
Amashubhu Okukhipha	Ukusetshenziswa kokulungiswa kwezibonelo.
Amaphakethe we-swab	Okokuqoqwa kwesifanekiso.
Indawo yokusebenza	Indawo yokugcina ama-buffer vials namashubhu.
Faka iphakheji	Ukuze uthole imiyalelo yokusebenza.

Izivivinyo ezingama-20/ibhokisi

20 Imishini yokuhlola epakishwe ngayinye	Idivayisi ngayinye iqukethe umucu onama-conjugate anemibala nama-reagents asebenzayo asakazwe ngaphambilini kuma-reqions ahambisanayo.
2 Isizinda sebhafa izitsha	0.1 M I-Phosphate buffered saline (P8S) kanye ne-0.02% sodium azide.
20 Ukukhipha amashubhu	Ukusetshenziswa kokulungiswa kwezibonelo.
1 Indawo yokusebenza	Indawo yokugcina ama-buffer vials namashubhu.
1 Faka iphakheji	Ukuze uthole imiyalelo yokusebenza.

IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE

Isikhathi	Ukusebenzisa isikhathi.
Noma yiziphi izinto ezidingekayo zokuzivikela

IZINYATHELO ZOKUZIVIKELA

-Le kit isetshenziselwa ukuxilonga i-IN VITRO kuphela.

Funda imiyalelo ngokucophelela ngaphambi kokwenza ukuhlolwa.
Lo mkhiqizo awunazo izinto ezisetshenziswa umuntu.

-Ungasebenzisi okuqukethwe kwekhithi ngemuva kosuku lokuphelelwa yisikhathi.

Gqoka amagilavu phakathi nayo yonke inqubo.

ISITOREJI NOKUZInza

Izikhwama ezivaliwe kukhithi yokuhlola zingagcinwa phakathi kuka-2-30 C isikhathi eside sempilo yeshalofu njengoba kukhonjisiwe esikhwameni.

UKUQOQWA KANYE NESIGCINISO

Isampula ye-swab yamakhala yangaphambili ingaqoqwa noma ngumuntu ngamunye osebenzisa i-self-swab.

Izingane ezingaphansi kweminyaka engu-18 ubudala, kufanele zenziwe ngokugadwa yi-aduK.Abantu abadala abaneminyaka engu-18 nangaphezulu bangenza i-swab yamakhala yangaphambili bebodwa.Sicela ulandele imihlahlandlela yakho yasendaweni yokuqoqwa kwesifanekiso sezingane.

, Faka i-swab eyodwa ekhaleni elilodwa lesiguli.Ithiphu ye-swab kufanele ifakwe kuze kufike ku-2.5 cm (intshi engu-1) ukusuka ekugcineni kwekhala.Roll swab izikhathi ezi-5 eduze kwe-mucosa ngaphakathi kwekhala ukuze uqinisekise ukuthi kokubili amafinyila namaseli kuqoqwe.

• Sebenzisa i-swab efanayo, phinda le nqubo kwenye ikhala ukuze uqinisekise ukuthi isampula elanele liqoqwa kuyo yomibili imigodi yamakhala.

Kunconywa ukuba izibonelo zibekusetshenziwengokushesha ngangokunokwenzeka ngemva kokuqoqwa.Izibonelo zingagcinwa esitsheni sehora le-uptol ekushiseni kukamama (15°C kuya ku-30"C), noma kufikela emahoreni angama-24 uma rsfrigeratod (2°C kuya ku-8^eC) ngaphambi kokucubungula.

INQUBO

Letha izinto zokuhlola, izifanekiso, ibhafa kanye/noma izilawuli ekamelweni lokushisa (15-30°C) ngaphambi kokusetshenziswa.

♦I-Plac® ishubhu le-specimen Extraction eqoqiwe endaweni eqokiwe yendawo yokusebenza.

♦Cindezela yonke i-Dilution Buffer kushubhu yerediyo ephumayo.

♦Faka i-specimen swab ku-tube.Hlanganisa ngamandla isixazululo ngokuzungezisa i-swab ngamandla ohlangothini lweshubhu okungenani izikhathi eziyi-15 (ngenkathi ucwile emanzini).Imiphumela emihle kakhulu itholakala uma isifanekiso sixutshwe ngamandla esixazululweni.

♦Vumela i-swab ukuthi icwile ku-Extraction Buffer umzuzu owodwa ngaphambi kwesinyathelo esilandelayo.

♦Khama ukhiphe uketshezi oluningi ngangokunokwenzeka ku-swab ngokucindezela uhlangothi lweshubhu yokukhipha eguquguqukayo njengoba i-swab isuswa.Okungenani isisombululo sebhafa sesampula esingu-1/2oftie kumele sihlale kushubhu ukuze kwenzeke ukufuduka kwe-capillary okwanele.Beka i-cap ku-tube ekhishiwe.

♦Lahla i-swab esitsheni esifanelekile sikadoti we-biohazardous.

♦Ama-specimens akhishiwe angagcina ekamelweni lokushisa imizuzu engu-30 ngaphandle kokuphazamisa umphumela wokuhlolwa.

♦Khipha le divayisi yokuhlola esikhwameni sayo esivaliwe, bese usibeka endaweni esezingeni eliphansi, eleveli.Lebula idivayisi ngesihlonzi sesiguli noma sokulawula.Ukuze uthole umphumela omuhle kakhulu, ukuhlolwa kufanele kwenziwe kungakapheli imizuzu engama-30.

♦Engeza amathonsi angu-3 (cishe u-100 pL) wesampula ekhishiwe ku-Extraction Tube kuya kusampula eyindilinga emthonjeni wokuhlola kudivayisi.

Gwema ukubamba amabhamuza omoya Emthonjeni wesampula (S), futhi ungawisi noma yisiphi isisombululo Efasiteleni lokubuka.Njengoba ukuhlola kuqala ukusebenza, uzobona umbala unyakaza kulwelwesi.

♦Insumpa ukuze kuvele amabhendi anombala.Umphumela kufanele ufundwe ngokubonwa kumaminithi angu-15.Ungahumushi umphumela ngemuva kwemizuzu engama-30.

•Faka ishubhu lokuhlola eliqukethe i-swab kanye nomshini wokuhlola osetshenzisiwe Esikhwameni esinamathiselwe se-biohazard bese usivala, bese usilahla esitsheni esifanelekile sikadoti we-biohazard.Bese ulahla Izinto ezisele

•Gezaizandla zakho noma uphinde ufake isicoci sesandla.

Lahla Amashubhu Okukhipha asetshenzisiwe kanye Namadivayisi Okuhlola esitsheni esifanelekile sikadoti we-biohazardous.

UKUTOLIZWA KWEMIPHUMELA

IMIKHAWULO YOKUHLOLA

1- Ikhithi ihloselwe ukusetshenziselwa ukutholwa kwekhwalithi yama-antigen e-SARS-CoV-2 avela eNasal.
2.Lokhu kuhlolwa kuthola kokubili i-SARS-CoV-2 esebenzayo (bukhoma) kanye nengasebenzi.Ukusebenza kokuhlolwa kuncike enanini legciwane (i-antigen) kusampula futhi kungenzeka noma lingahlobani nemiphumela ye-viral culture eyenziwe kusampula efanayo.
3.Umphumela webele ongemuhle ungase ube khona uma izinga le-antigen kusampula lingaphansi komkhawulo wokutholwa wokuhlolwa noma uma isampula liqoqwe noma lahanjiswa ngendlela engafanele.
4.Ukwehluleka ukulandela Inqubo Yokuhlola kungase kuthinte kabi ukusebenza kokuhlolwa kanye/noma kwenze umphumela wokuhlolwa ungasebenzi.
5. Imiphumela yokuhlolwa kufanele ihlotshaniswe nomlando womtholampilo, idatha ye-epidemiological, kanye nolunye ulwazi olutholakala kudokotela ohlola isiguli.
6.Imiphumela yokuhlolwa eqondile ayikukhiphi ukutheleleka ngokuhlanganyela namanye amagciwane.
7. Imiphumela yokuhlolwa engemihle ayihloselwe ukulawula kwezinye izifo ezingewona ama-SARS ngegciwane noma amagciwane.
8.Imiphumela engemihle evela ezigulini ezinezimpawu eziqalayo ngaphezu kwezinsuku eziyisikhombisa, kufanele ithathwe njengokucabangelayo futhi iqinisekiswe ngokuhlolwa kwamangqamuzana okugunyazwe yi-FDA yendawo, uma kunesidingo, ekuphathweni komtholampilo, okuhlanganisa nokulawula ukutheleleka.
9.Izincomo zokuzinza kwesifanekiso zisekelwe phezu kwedatha yokuzinza evela ekuhlolweni komkhuhlane futhi ukusebenza kungase kuhluke nge-SARS-CoV-2.Abasebenzisi kufanele bahlole izifanekiso ngokushesha ngangokunokwenzeka ngemva kokuqoqwa kwesifanekiso.
10.Ukuzwela kokuhlolwa kwe-RT-PCR ekuxilongweni kwe-COVID-19 kungama-50% -80% kuphela ngenxa yesampula empofu yekhwalithi noma indawo yesikhathi sokugula esigabeni esitholiwe, njll.I-SARS-CoV-2 Antigen Rapid Test Device ngokombono ukuthi iyazwela. ephansi ngenxa yendlela yokusebenza kwayo.
11.Ukuze uthole igciwane elanele, kuphakanyiswa ukuthi kusetshenziswe ama-swab amabili noma ngaphezulu ukuze kuqoqwe amasayithi ahlukene esampula futhi kukhishwe yonke isampula ye-swab kushubhu efanayo.
12.Amanani abikezelayo amahle kanye namabi ancike kakhulu kumazinga okuvama.
13. Imiphumela yokuhlolwa eqondile cishe imele imiphumela engelona iqiniso ngezikhathi zomsebenzi omncane we-I no-SARS-CoV-2 lapho ukutholakala kwezifo kuphansi. Imiphumela yokuhlolwa engemihle engelona iqiniso ingenzeka kakhulu lapho ukusabalala kwezifo ezibangelwa i-SARS-CoV-2 phezulu.
14.Amasosha omzimba e-Monoclonal angase ehluleke ukuthola, noma ukuthola ngokuzwela okuncane, amagciwane omkhuhlane we-SARS-CoV-2 athole izinguquko ezincane ze-amino acid endaweni ehlosiwe ye-epitope.
15.Ukusebenza kwalokhu kuhlolwa akuzange kuhlolwe ukuthi kusetshenziswe ezigulini ezingenazo izimpawu nezimpawu zokutheleleka kokuphefumula kanye nokusebenza kungase kwehluke kubantu abangenazimpawu.
16.Inani le-antigen Kusampula lingase lehle njengoba ubude bokugula Bukhula.Izibonelo eziqoqwe ngemva kosuku lwesi-5 lokugula maningi amathuba okuba zibe negethivu uma kuqhathaniswa nokuhlolwa kwe-RT-PCR.
17.Ukuzwela kokuhlolwa ngemva kwezinsuku ezinhlanu zokuqala kwezimpawu kuboniswe ukuthi kuncipha uma kuqhathaniswa nokuhlolwa kwe-RT-PCR.
18.Kuphakanyiswa ukuthi kusetshenziswe i-StrongStep® SARS-CoV-2 IgM/IgG antibody quick test (caW 502090) ukuze kutholwe i-antibody ukuze kwandiswe ukuzwela kokuxilongwa kwe-COVID-19.
19.Akunconyiwe ukusebenzisa isifanekiso se-Virus Transportation medla(VTM) Kulesi sivivinyo, Uma amakhasimende Ephikelela ukusebenzisa lolu hlobo lwesampula, amakhasimende kufanele aziqinisekise.
20.I-StrongStep® SARS-CoV-2 Antigen Rapid Test yaqinisekiswa ngama-swabs anikezwe kukhithi.Ukusetshenziswa kwamanye ama-swabs kungase kuphumele emiphumeleni engamanga.
21. Ukuhlola njalo kuyadingeka ukuze kwandiswe ukuzwela kokuxilongwa kwe-COVID-19.
22.Akukho ukwehla kokuzwela uma kuqhathaniswa nohlobo lwasendle oludlwenguliwe kokuhlukile okulandelayo - VOC1 Kent, UK, B.1.1.7 kanye ne-VOC2 South Africa, B.1.351.

23 Gcina endaweni lapho izingane zingafinyeleleki khona.
24. Imiphumela emihle ibonisa ukuthi kutholwe ama-antigen egciwane kusampula ethathiwe, sicela Uzihlukanise futhi Wazise udokotela wakho womndeni ngokushesha.

I-Nanjing Liming Bio-Products Co., Ltd.
No. 12 Huayuan Road, Nanjing, Jiangsu, 210042 PR China.
Ucingo: +86(25) 85288506
Ifeksi: (0086)25 85476387
I-imeyili:sales@limingbio.com
Iwebhusayithi: www.limingbio.com
Technical support: poct_tech@limingbio.com

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