PRODUCT NAME

I-COVID -19 Antigen Rapid Test Cassette (Colloidal Gold)

UKUPAKA

1 ucezu/isikhwama

1 ucezu/ibhokisi  noma 28izingcezu/ibhokisi

Usayizi webhokisi ngocezu olu-1 ebhokisini ngalinye: 180*65*15mm

Ibhokisi usayizi for 28pieces ibhokisi ngalinye: 190 * 125 * 75mm

OKUHLOSIWE SEBENZISA

Lo mkhiqizo ulungele ukutholwa kwekhwalithi ye-coronavirus yenoveli, noma i-COVID-19, e-Saliva.Kuyasiza ekuxilongeni ukutheleleka nge-coronavirus yenoveli.

ISIFINYEZO

I-novel coronaviruses (i-SARS-CoV-2) iyingxenye yohlobo lwe-β.I-COVID-19 yisifo esithathelwanayo sokuphefumula esiyingozi.Ngokuvamile abantu bangenwa kalula yizifo.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 kuye kweziyi-14, ikakhulukazi izinsuku ezi-3 kuya kweziyi-7.Izimpawu eziyinhloko zihlanganisa imfiva, ukukhathala, nokukhwehlela okomile.Ukuminyana emakhaleni, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia, nesifo sohudo nakho kuyatholakala kwezinye izimo.

ISIMISO

I-COVID -19 Antigen Rapid Test Cassette iyisivivinyo solwelwesi lwe-immunochromatographic esebenzisa amasosha omzimba azwela kakhulu e-monoclonal ukuthola iphrotheni ye-nucleocapsid evela kwa-SARS-CoV-2 kumasampula amathe.Umugqa wokuhlola wakhiwe izingxenye ezilandelayo: okuyiphedi yesampula, iphedi ye-reagent, i-membrane yokusabela, nephedi yokumunca.Iphedi ye-reagent iqukethe i-colloidal-gold conjugated ne-monoclonal antibodies ngokumelene ne-nucleocapsid protein ye-SARS-CoV-2;i-membrane yokusabela iqukethe amasosha omzimba wesibili we-nucleocapsid protein ye-SARS-CoV-2.Umucu wonke ufakwe ngaphakathi kwensimbi yepulasitiki.Lapho isampula yengezwa emthonjeni wesampula, ama-conjugate omisiwe kuphedi ye-reagent ayahlakazwa futhi athuthe kanye nesampula.Uma i-antigen yakwa-SARS-CoV-2 yethula kusampula, inkimbinkimbi eyakhiwe phakathi kwe-anti-SARS-2 conjugate kanye negciwane izobanjwa ama-anti-SARS-2 monoclonal antibodies ambozwe esifundeni somugqa wokuhlola (T).Ukungabikho komugqa T kuphakamisa umphumela ongemuhle.Ukuze usebenze njengokulawula kwenqubo ulayini obomvu uzohlala uvela endaweni yolayini wokulawula (C) okubonisa ukuthi ivolumu efanele yesampula yengeziwe futhi i-membrane wicking yenzekile.

COMPOSITION

1. Ithuluzi lokuhlola elilahlwayo

2. Isikhwama sokuqoqa amathe sepulasitiki esilahlwayo

Enye idivayisi edingekayo ngokunganikezwanga:

Isikhathi

PRECUTION

Sicela ufunde yonke imininingwane ekule phakheji ngaphambi kokwenza ukuhlolwa.

1. Nge-ukusetshenziswa kwe-vitro diagnostic kuphela.Ungasebenzisi ngemuva kosuku lokuphelelwa yisikhathi

2. Ukuhlola kufanele kuhlale esikhwameni esivaliwe noma ku-canister evaliwe kuze kube yilapho isilungele ukusetshenziswa.

3. Zonke izifanekiso kufanele zibhekwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti ethelelanayo.

4. Ukuhlolwa okusetshenzisiwe kufanele kulahlwe ngokwemithetho yendawo

ISITOREJI KANYE UKUZINDLA

1. Gcina njengoba kupakishwe esikhwameni esivalwe nge-hermetically ezingeni lokushisa (4-30 ℃ noma40-86℉) futhi ugweme ukukhanya kwelanga okuqondile.Ikhithi izinzile phakathi nedethi yokuphelelwa yisikhathi ephrintwe kulebula.

2. Uma isikhwama esivaliwe sivuliwe, ukuhlolwa kufanele kusetshenziswe phakathi nehora elilodwa.

Ukuchayeka isikhathi eside ezindaweni ezishisayo nezinomswakama kuzodala ukuwohloka komkhiqizo.

3. Inombolo yenkatho kanye nosuku lokuphelelwa yisikhathi kuphrintiwe esikhwameni ngasinye esivaliwe.

TEST INQUBO

Vumela idivayisi yokuhlola nezifanekiso ukuthi zilingane nezinga lokushisa legumbi (15-30℃ noma 59-86℉) ngaphambi kokuhlolwa.

1.Qoqa okungenani u-2 ml wamathe amasha esikhwameni sepulasitiki esilahlwayo.

2.Vula isikhwama se-aluminium foil bese ukhipha ikhasethi lokuhlola.

3.Khumula ikepisi yekhasethi.

4.Gxilisa iphedi elimunca esikhwameni samathe bese ulinda imizuzu emi-2.

5.Susa ikhadi lokuhlola enkomishini yamathe, bese ubuyisela ikepisi bese ubeka phansi ikhasethi lokuhlola endaweni eyisicaba.

6.Humusha umphumela wokuhlolwa emizuzwini eyi-15, ungafundi umphumela wokuhlolwa ngemuva kwemizuzu engama-20.

Qaphela:

1.Don't uyifake emlonyeni.

2.Don't ukusebenzisa amathe negazi.

3.Uma uketshezi lunganyakazi, faka u-1 ml wamanzi okuphuza enkomishini yepulasitiki namathe, hlanganisa amanzi namathe ngokulinganayo. , bese ubuyisela iphedi elimuncayo esikhwameni ukuze limunce amathe engeziwe.

UKUTOlika OF IMIPHUMELA (NGAPHAKATHI 15 MINUTES)

Okuhle(+):Yomibili imigqa engu-T no-C ivela phakathi kwemizuzu engu-15.Okubi(-):Umugqa u-C uvela ngenkathi ungekho umugqa we-T ovele ngemva kwemizuzu eyi-15.

Okungavumelekile:Uma ulayini C ungaveli, lokhu kubonisa ukuthi umphumela wokuhlola awuvumelekile, futhi kufanele uphinde uhlole isifanekiso ngenye idivayisi yokuhlola.

IMIKHAWULO

I-1.COVID -19 Antigen Rapid Test Cassette iwukuhlola kwekhwalithi okwandulelayo, ngakho-ke, inani lomthamo noma izinga lokunyuka kwe-COVID -19 okunganqunywa yilokhu kuhlolwa.

2.Umphumela wokuhlola ongemuhle ungenzeka uma ukugxiliswa kwe-antigen kusampula kungaphansi komkhawulo wokuthola wokuhlola.Umkhawulo wokutholwa kokuhlolwa unqunywe nge-recombinant SARS-CoV-2 nucleoprotein futhi ingu-10 pg/ml.

3. Ukusebenza kwekhasethi lokuhlola i-antigen lakwa-SARS-CoV-2 kuhlolwe kuphela ngezindlela ezichazwe kulesi siqephu sephakheji.Izinguquko kulezi zinqubo zingashintsha ukusebenza kokuhlolwa.

4.Imiphumela engemihle engemihle ingenzeka uma isampula ingatholwanga ngokwanele, ithuthwa noma isingathwa.

5.Imiphumela engamanga ingase yenzeke uma amasampula ehlolwa ngaphezu kwehora ngemva kokuthatha amasampula.Amasampula kufanele ahlolwe ngokushesha ngangokunokwenzeka ngemva kokuthatha amasampula.

6.Imiphumela yokuhlolwa eqondile ayizange ikhiphe ukuthelelana kanye namanye amagciwane.

7. Imiphumela yokuhlolwa engemihle ayihloselwe ukuveza okunye ukutheleleka ngegciwane noma amagciwane kwa-SARS-CoV-2.

8.Imiphumela engemihle evela ezigulini ezinezimpawu zokuqala ngemva kwezinsuku ezingaphezu kweziyisikhombisa kufanele ziphathwe njengokucatshangelwa futhi ziqinisekiswe ngokunye ukuhlola kwamangqamuzana.

9. Uma ukuhlukaniswa kwezinhlobo ezithile ze-SARS-CoV-2 kuyadingeka, ukuhlolwa okwengeziwe kuyadingeka ngokubonisana neziphathimandla zezempilo zomphakathi noma zendawo.

10.Izingane zingase zikhiphe amagciwane isikhathi eside kunabantu abadala, okungase kuholele ekuzweleni okuhlukile phakathi kwabantu abadala nezingane kanye nokuqhathaniseka okunzima.

11.Lokhu kuhlolwa kunikeza ukuxilongwa okucatshangelwayo kwe-COVID -19.Ukuxilongwa okuqinisekisiwe kwe-COVID-19 kufanele kwenziwe ngudokotela kuphela ngemuva kokuthi konke okutholwe emitholampilo naselabhorethri sekuhlolisisiwe.

AMANOTHI

1. I-COVID -19 Antigen Rapid Test Cassette isebenza kuphela kumasampula amathe.

Igazi, i-serum, i-plasma, umchamo, namanye amasampula angabangela imiphumela engavamile.Uma noma iyiphi isampula yokuhlola itholakele, sicela ubone abaphathi bezempilo endaweni yangakini ukuze uthole ukuxilongwa okwengeziwe komtholampilo kanye nokubikwa kwemiphumela.2. Qiniseka ukuthi iiphedi yokumuncaimanziswe ngokugcwele.

3.Imiphumela emihle ingahlulelwa ngokushesha uma u-C line bese kuvela umugqa T, futhi imiphumela engemihle idinga ukuchitha imizuzu eyi-15 egcwele.

4.Idivayisi yokuhlola iwumkhiqizo olahlwayo futhi izoqukatha izingozi ze-bio ngemva kokusetshenziswa.

Sicela ulahle kahle amathuluzi okuhlola, izibonelo, nazo zonke izinto zokuqoqa ngemva kokusetshenziswa.

5.Kufanele isetshenziswe ngaphambi kosuku lokuphelelwa yisikhathi ekulebulani komkhiqizo.

6.Uma ingxenye yolwelwesi lokuhlola oluqukethe ama-reagents iphumile ekuhlolweni

ifasitela, noma ngaphezu kuka-2 mm wephepha lokuhlunga noma i-latex pad ivezwa ku-

iwindi lokuhlola, ungalisebenzisi ngoba imiphumela yokuhlolwa izobe ingavumelekile.Sebenzisa entsha

ikhithi yokuhlola esikhundleni salokho.