I-China SARS-Cov-2 Antigen Rapid Test (Nasal) Abakhiqizi nabathengisi

I-SARS-Cov-2 Antigen Rapid Test (Nasal)

Incazelo emfushane:

Inkonti encane	500200	Ukucacisa	1 izivivinyo / ibhokisi; izivivinyo / ibhokisi eli-5; izivivinyo / ibhokisi eli-20
Isimiso sokutholwa	Immunochrochrographic assay	Izindola	I-Anterior Nasal Swab
Ukusetshenziswa okuhlosiwe	I-ConfSTep® SARS-Cov-2 Antigen Suptope Cessette isebenzisa ubuchwepheshe be-Immunochromatography ukuthola i-SARS- I-Antigen ye-NUCLEOCACAppID e-Anterior Nasal Swab specimen yabantu. Le testis ukusetshenziswa okukodwa kuphela futhi ihloselwe ukuzihlola. Kunconywa ukusebenzisa lolu vivinyo kungakapheli izinsuku ezi-5 zokuqala uphawu. Isekelwa ukuhlolwa kokusebenza komtholampilo.

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Imininingwane Yomkhiqizo

Amathegi Omkhiqizo

Umkhiqizo une-ejenti ekhethekile eNew Zealand. Uma unesifiso sokuthenga, imininingwane yokuxhumana imi ngale ndlela elandelayo:
UMick Dienhoff
Umphathi ovamile
Inombolo yocingo: 0755564763
Inombolo Yeselula: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz

Ukusetshenziswa okuhlosiwe
I-ConfSTep® SARS-Cov-2 Antigen Suptope Cessette isebenzisa ubuchwepheshe be-Immunochromatography ukuthola i-SARS- I-Antigen ye-NUCLEOCACAppID e-Anterior Nasal Swab specimen yabantu. Le testis ukusetshenziswa okukodwa kuphela futhi ihloselwe ukuzihlola. Kunconywa ukusebenzisa lolu vivinyo kungakapheli izinsuku ezi-5 zokuqala uphawu. Isekelwa ukuhlolwa kokusebenza komtholampilo.

Ukuqalisa
Ama-coronaviruses angamanoveli angokwakhe uGenus. I-COVIIL-19 yisifo esibuhlungu sokuphefumula. Abantu ngokuvamile bathambekele. Njengamanje, iziguli ezingenwe yinoveli cxjronavinis zingumthombo omkhulu wokutheleleka; Abantu abatheleleke nge-asymptomatic bangaba nomthombo othathelwanayo. Kususelwa kuphenyo lwamanje lwe-1he lwamanje, isikhathi sokufakwa kokufakwa yizinsuku ezi-1 kuye kwezingu-14, iningi lezinsuku ezi-3 kuye kwezingu-7. Ukubonakaliswa okuyinhloko kufaka umkhuhlane, ukukhathala kanye nokukhwehlela owomile. Ukuxinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.

Isimiso
I-COSTSTESPEP® SARS-Cov-2 Antigen Test isebenzisa ukuhlolwa kwe-Immunochrogamaygraphic. Ama-antibodies ahlanganisiwe we-latex Ama-antibodies we-SARS-Cov-2 ahlanganiswe ne-test zone (T) ne-biotin-BSA i-bond endaweni yokulawula (c). Lapho kufakwa isampula, ifudukela ngokuphazamiseka kwe-capillary ukuvuselela kabusha i-latex conjugate. Uma ekhona ngesampula, ama-SARS-Cov-2 ama-antigen azobopha ngama-antibodies ahlanganisiwe akha izinhlayiya. Lezi zinhlayiya zizoqhubeka zihambisane nomucu kuze kube yilapho kuhlolwa khona (T) lapho zibanjwa khona yi-SARS-Cov-2 antibodies ekhiqiza umugqa obomvu obonakalayo. Uma kungekho-ama-antigens-ama-antigen-ama-2 ngesampula, awukho umugqa obomvu owakhiwa endaweni yokuhlola (T). I-streptavidin conjugate izoqhubeka nokufuduka yedwa ize ithathwe endaweni yokulawula (c) nge-biotin-BSA ihlanganisa umugqa ohlaza okwesibhakabhaka, okubonisa ukuba semthethweni kwalesi sivivinyo.

Izakhi zekhithi

1 Ukuhlolwa / ibhokisi; izivivinyo ezi-5 / Ibhokisi:

Amadivayisi we-Foil Pouch Pool ahlanganisiwe	Idivaysi ngayinye iqukethe umucu onezimbotshana ezinemibala kanye nokuphendula okusebenzayo kuqala ezifundeni ezihambisanayo.
Dilution buffer vers	0.1 m phosphate buffered saline (PBS) no-0.02% sodium Azide.
Amashubhu we-Extraction	Okwezinkulumo zokulungiselela ama-specimens.
Amaphakethe we-swab	Ngeqoqo le-specimen.
I-WorkStation	Beka ukubamba ama-buffer vials namashubhu.
Faka iphakheji	Ukufundiswa ukusebenza.

Izivivinyo / ibhokisi / ibhokisi

Amadivayisi wokuhlola agcwele angama-20 agcwele	Idivaysi ngayinye iqukethe umucu onezimbotshana ezinemibala nezimpendulo ezisebenzayo ngaphambi kokusatshalaliswa ezindaweni ezihambisanayo.
2 Ukukhishwa kwama-buffer vials	0.1 m phosphate buffered saline (p8s) no0.02% sodium azide.
Amashubhu wokukhipha ama-20	Okwezinkulumo zokulungiselela ama-specimens.
1 WorkStation	Beka ukubamba ama-buffer vials namashubhu.
1 Iphakheji Faka	Ukufundiswa ukusebenza.

Izinto ezidingekayo kodwa azinikeziwe

Umninisikhathi	Ngokusetshenziswa kwesikhathi.
Noma yimiphi imishini yokuvikela yomuntu siqu edingekayo

IZINYATHELO ZOKUZIVIKELA

-Lit kit ingeyokusetshenziswa kokuxilongwa kwe-vitro kuphela.

Funda imiyalo ngokucophelela ngaphambi kokwenza isivivinyo.
Lo mkhiqizo awunazo izinsiza zomthombo wabantu.

-Ungasebenzisi okuqukethwe kit ngemuva kosuku lokuphelelwa yisikhathi.

Gqoka amagilavu phakathi nenqubo yonke.

Ukugcinwa nokuqina

Izikhwama ezivalekile ekhitthini lokuhlola zingagcinwa phakathi kuka-2-30 c isikhathi sempilo yeshalofly njengoba kukhonjisiwe esikhwameni.

Ukuqoqwa kweqoqo nesitoreji

Isampula ye-swab ye-anterior yama-nasal ingaqoqwa noma yi-perfofmllng yomuntu ngamunye ozishintshayo.

Izingane ezingaphansi kweminyaka eyi-18, kufanele zenziwe ngokugadwa kwazo kwe-ADUK. Abantu abadala abaneminyaka engu-18 futhi ngaphezulu bangakwazi ukwenza i-swab yangaphandle ye-chab ngokwabo. Sicela ulandele imihlahlandlela yakho yasendaweni yokuqoqwa kwe-specimen yizingane.

, Faka i-swab eyodwa ibe emakhaleni elilodwa lesiguli. Ithiphu ye-Swab kufanele ifakwe ku-2,5 cm (1 inch) kusuka emaphethelweni ekhala. Roll i-Swab izikhathi ezi-5 eceleni kwe-mucosa ngaphakathi kwenkantolo yokuqinisekisa ukuthi zombili ama-mucus namaseli ayaqoqwa.

• Sebenzisa i-swab efanayo, phinda le nqubo ye-tha nezinye izinkamba ukuze uqinisekise ukuthi isampula eyanele liqoqwa kusuka kuwo wonke ama-nasal emithanjeni.

Kunconywa ukuthi ama-specimentens abe-setshenzisiwengokushesha okukhulu ngemuva kokuqoqwa. Izinhlobo ze-specimenters zingabanjwa esitsheni ihora le-uptol nge-mama lokushisa (15 ° C kuya ku-30 "c), noma amahora angama-24 lapho i-RSFrigeratod (2 ° C kuya ku-8^eC) ngaphambi kokucutshungulwa.

Indlela yokwenza izinto

Letha amadivaysi okuhlola, ama-specimentens, ama-buffer kanye / noma izilawuli zokushisa kwegumbi (15-30 ° C) BA.

‡I-Plac® the CORCECTE Specimen Extraction Extraction Tube endaweni ebekiwe ye-Workstation.

‡Cwilisa yonke i-dilution buffer ku-ext radion tube.

‡Beka i-specimen swab ku-tube. Hlanganisa isixazululo ngokuqinile ngokujikeleza i-swab ngamandla ngokumelene nohlangothi lwe-tube okungenani izikhathi eziyi-15 (ngenkathi kufakwa ngaphakathi). Imiphumela emihle itholakala lapho i-specimen ixubene ngamandla kwikhambi.

‡Vumela i-swab ukuthi icwile ku-buffer yokukhipha umzuzu owodwa ngaphambi kwesinyathelo esilandelayo.

‡Cwilisa uketshezi oluningi ngangokunokwenzeka kusuka ku-swab ngokucindezela uhlangothi lwe-tube ye-extraction eguquguqukayo njengoba kususwa i-swab. Okungenani kukhandi le-1 / 2OFTTIE SAMPLE AFFFFEL SOLL LOKUQHAWULA KU-TUBE KUFANELE UKUZE UQEQESHE UKUZE BALULEKILE. Faka i-cap ku-ihe ekhishwe.

‡Lahla i-swab esitsheni esisheshayo se-biohazarduous.

‡Ama-specimens akhishwe angagcina ekushiseni kwegumbi imizuzu engama-30 ngaphandle kokuthinta umphumela wokuhlolwa.

‡Susa idivaysi yokuhlola ye-THS kusuka esikhwameni sayo esivalekile, bese uyibeka endaweni ye-dean, indawo ephezulu. Faka ilebuli insiza ngesineke noma sokulawula ukukhonjwa. Ukuthola umphumela omuhle kakhulu, i-assay kufanele yenziwe kungakapheli imizuzu engama-30.

‡Faka amaconsi ama-3 (cishe ama-100 pl) wesampula ekhishwe kusuka ku-tube yokukhishwa kwisampula eliyindilinga kahle kudivayisi yokuhlola.

Gwema ukudonswa kwama-bubble air emithonjeni yesampula, futhi ungalahli noma yisiphi isixazululo ewindini lokubheka. Njengoba ukuhlolwa kuqala ukusebenza, uzobona umbala uhamba ngaphesheya kwe-membrane.

‡I-wart ye-band (s) enemibala yokuvela. Umphumela kufanele ufundwe ngokubonwayo ngamaminithi ayi-15. Ungahumushi umphumela ngemuva kwemizuzu engama-30.

•Beka ishubhu lokuhlola eliqukethe i-swab kanye nedivaysi yokuhlola esetshenzisiwe esikhwameni se-biohazard se-biohazard bese ulinamathisela, bese ulilahla esitsheni semfucumfucu efanelekile. Bese ulahle izinto ezisele

•Gezaizandla zakho noma uphinde ufake i-sanitizer yesandla.

Lahla amashubhu asetshenzisiwe asetshenzisiwe namadivayisi wokuhlola esitsheni esifanele semfucuza elungele i-biohazardious.

Ukuhunyushwa kwemiphumela

Ukulinganiselwa ku-Test

I-1
2.Lawo uvivinyo ubona bobabili abasebenzayo (bukhoma) futhi abangasebenzi-2-cov-2. Ukusebenza kokuhlola kuncike kwinani legciwane (antigen) kwisampula futhi kungenzeka noma kungahle kungahambelani nemiphumela yama-viral culture kufakwe kwisampula efanayo.
3. Umphumela we-teat ongemuhle kungenzeka uma izinga le-antigen kwisampula lingaphansi komkhawulo wokutholwa kwesivivinyo noma uma isampula liqoqwe noma lihanjiswa ngendlela efanele.
I-4.Failure Ukulandela Inqubo Yokuhlola kungathinta kabi ukusebenza kokuhlola kanye / noma kusebenze umphumela wokuhlola.
Imiphumela ye-5.Test kumele ixhumeke ngomlando wemitholampilo, idatha ye-epidemiological, kanye neminye imininingwane etholakala kumtholampilo ehlola isiguli.
Imiphumela yokuhlola engu-6.Positive ayibusi ngokutheleleka ngokubambisana namanye amagciwane.
Imiphumela engu-7.Negative Test ayihloselwe ukubusa kwezinye izifo ezingezona amagciwane noma izifo zamagciwane.
Ama-8.ngenetimative avela ezigulini ezinezimpawu zokuqala kusuka ngaphezu kwezinsuku eziyisikhombisa, kufanele aphathwe njengezigaba
Izincomo zokuqina ze-9 Abasebenzisi kufanele bahlole ama-specimentens ngokushesha ngangokunokwenzeka ngemuva kokuqoqwa kwe-specimen.
10.Ukuzwela kwe-RT-PCR ASSAY ekuhlolweni kwe-Covid-19 kungama-50% -80% ngenxa yekhwalithi yesampula empofu noma indawo yesikhathi sokuphumula esigabeni se-antiigen antiigen phansi ngenxa yendlela yalo.
11.I-ke ukuthola i-virus eyanele, kuphakanyiswa ukusebenzisa ama-swabs amabili noma ngaphezulu ukuqoqa amasayithi ahlukene wesampula futhi ukhiphe yonke i-swab esetshenzisiwe ngeshubhu elifanayo.
12.Positive kanye namanani aqagelayo abikezela ancike kakhulu kumanani akwabele.
Imiphumela yokuhlola engu-13 Phezulu.
Ama-antibodies angama-14.mondoclonal angahluleka ukuthola, noma ukuthola ngokuzwela okuncane, amagciwane akhuthazayo akhuthazayo aguqulwe aguqulwe izinguquko ezincane ze-amino acid esifundeni esinqunyiwe se-epitope.
15. Ukusebenza kwalolu vivinyo akuhloliswanga ukuze kusetshenziswe ezigulini ngaphandle kwezimpawu nezimpawu zokutheleleka okuphefumula kanye nobunzima kungahluka kumuntu ngamunye we-asymptomatic.
16.Inani le-antigen kwisampula lingancipha njengoba isikhathi sokugula siyanda. Izinhlobo eziqoqwe ngemuva kosuku lwe-5 lokugula kungenzeka ukuthi zibe zimbi kakhulu ngokuqhathaniswa ne-RT-PCR ASSAY.
I- 17.Shitivity of test ngemuva kwezinsuku ezinhlanu zokuqala zokuqala kwezimpawu kuboniswe ukwehla ukuthi kwehle ngokuqhathaniswa ne-RT-PCR ASSAY.
18.Kuhlongozwa ukusebenzisa i-CorfStep® SARS-Cov-2 I-IGM / IGG Antibody Rapid Test (CAW 502090) ukuthola i-antibody ukwandisa ukuzwela kwe-conc-19.
19.Kungakuncomi ukusebenzisa ama-virus ezokuThutha i-Medla (VTM) kulolu vivinyo, uma amakhasimende egcizelela ukusebenzisa lolu hlobo lwesampula, amakhasimende kufanele aqinisekise.
20.I-GrainStep® SARS-Cov-2 Antigen Rapid Test yaqinisekiswa ngama-swabs anikezwe ekhishini. Ukusetshenziswa kwamanye ama-swabs kungahle kube nomphumela wemiphumela yamanga.
Ukuhlolwa okungu-21. Kuyadingeka ukwandisa ukuzwela kokuxilongwa kwe-Covil-19.
22.Akukhohla ukuzwela uma kuqhathaniswa nohlobo lwasendle ngokuqhekeka kokuhluka okulandelayo - Voc1 Kent, UK, B.1.1.7 noVoc2 South Africa, B.1.351.

23 Hlala ungafinyeleleki ezinganeni.
24. Imiphumela emihle ikhombisa ukuthi ama-antigen angamagciwane atholwe kusampula ethathiwe, sicela uzenzele ukuzihlukanisa nokwazisa ngokushesha udokotela wakho womndeni.

I-Nanjing Liming Bio-Products Co, Ltd.
No. 12 Huayun Road, Nanjing, Jiangsu, 210042 PR China.
I-TEL: +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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