Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test (Colloidal Gold) Instruction for Use

【Introduction】
Cov kab mob tshiab coronaviruses yog nyob rau β genus. COVID-19 yog tus kab mob ua pa hnyav heev. Tib neeg feem ntau raug mob. Tam sim no, cov neeg mob kis los ntawm tus kabmob tshiab no yog qhov tseem ceeb ntawm kev kis tus kabmob; Cov neeg mob asymptomatic kuj tuaj yeem yog qhov kis tau. Raws li kev tshawb nrhiav kev kis kabmob tam sim no, lub sijhawm incubation yog 1 txog 14 hnub, feem ntau yog 3 txog 7 hnub. Cov tsos mob tseem ceeb muaj xws li kub taub hau, qaug zog thiab hnoos qhuav. Qhov ntswg congestion, los ntswg qhov ntswg, mob caj pas, myalgia thiab raws plab yog pom nyob rau hauv ob peb kis. Kev tshawb pom ntxov ntawm cov neeg muaj mob yog qhov tseem ceeb rau kev txwv tsis pub kis tus kab mob no.
【Thov siv】
Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test (Colloidal Gold) yog ib qho khoom siv hauv vitro qualitative detection kit for the antigen of novel coronavirus present in human Oropharyngeal swabs, Anterior Nasal swabs, or Nasopharyngeal swabs. Cov khoom siv kuaj no yog tsim los siv los ntawm kev saib xyuas kev noj qab haus huv thiab cov kws kuaj mob nkaus xwb rau kev kuaj mob ntxov ntawm cov neeg mob uas muaj cov tsos mob ntawm tus kab mob SARS-COV-2.
Cov khoom siv xeem tuaj yeem siv rau hauv ib puag ncig uas ua tau raws li cov lus qhia thiab cov kev cai hauv zos. Qhov kev xeem no tsuas yog muab cov qhabnias xeem ua ntej xwb. Cov txiaj ntsig tsis zoo tsis tuaj yeem tshem tawm tus kab mob SARS-COV-2, thiab lawv yuav tsum tau ua ke nrog kev soj ntsuam, keeb kwm thiab cov ntaub ntawv sib kis. Cov txiaj ntsig ntawm qhov kev sim no yuav tsum tsis yog lub hauv paus rau kev kuaj mob; yuav tsum tau kuaj xyuas.
【Tsim txoj cai】
Cov khoom siv kuaj no siv cov tshuab colloidal kub immunochromatography. Thaum cov tshuaj tshem tawm cov hnoos qeev txav mus rau pem hauv ntej ntawm txoj kab kuaj kab mob los ntawm qhov hnoos qeev mus rau lub qhov nqus nqus pa hauv qab capillary kev txiav txim, Yog tias cov tshuaj tshem tawm cov hnoos qeev muaj cov tshuaj tiv thaiv tshiab coronaviruses antigen, cov antigen yuav khi rau lub colloidal kub-labeled nrog anti-novel coronavirus monoclonal antibody. , los tsim ib qho kev tiv thaiv kab mob. Tom qab ntawd lub cev tiv thaiv kab mob yuav raug ntes los ntawm lwm cov tshuaj tiv thaiv kab mob coronavirus monoclonal antibody, uas yog tsau hauv nitrocellulose membrane. Cov kab muaj yeeb yuj yuav tshwm sim hauv kab ntsuas "T" cheeb tsam, qhia tias muaj tus kabmob coronavirus tshiab antigen zoo; Yog tias kab "T" tsis qhia xim, yuav tau txais cov txiaj ntsig tsis zoo.
Cov kab ntawv xeem kuj tseem muaj cov kab tswj kev ua tau zoo "C", uas yuav tshwm sim tsis hais seb puas muaj kab T pom.
【Main Cheebtsam】
1) Sterilized disposable virus sampling swab
2) Extraction raj nrog Nozzle Cap thiab extraction tsis
3) Test cassette
4) Cov lus qhia rau kev siv
5) Biohazardous pov tseg hnab
【Storage thiab stability】
1.Khoom ntawm 4 ~ 30 ℃ tawm ntawm tshav ntuj ncaj qha, thiab nws siv tau rau 24 lub hlis txij hnub tsim khoom.
2.Ua kom qhuav, thiab tsis txhob siv cov khoom khov thiab tas sij hawm.
3.Test cassette yuav tsum tau siv nyob rau hauv ib nrab 1 teev ib zaug qhib lub Aluminium ntawv nyiaj hnab.
【Kev ceeb toom thiab ceev faj】
1.Cov khoom siv no yog rau kev kuaj pom hauv vitro nkaus xwb. Thov siv cov khoom siv hauv lub sijhawm siv tau.
2.Qhov Kev Ntsuas no yog npaj los pab kuaj xyuas tus kab mob COVID-19 tam sim no. Thov nrog ib tus kws kho mob tham los tham txog koj cov txiaj ntsig thiab yog tias xav tau kev kuaj ntxiv.
3.Thov khaws cov khoom siv raws li IFU qhia, thiab zam kom tsis txhob khov rau lub sijhawm ntev.
4.Nyeem thiab ua raws li cov lus qhia ua tib zoo ua ntej siv cov khoom siv, lossis muaj qhov tshwm sim tsis raug.
5.Tsis txhob hloov cov khoom siv los ntawm ib qho khoom mus rau lwm qhov.
6.Kev tiv thaiv kev ya raws, tsis txhob qhib lub hnab aluminium platinum ua ntej nws npaj rau kev sim. Tsis txhob siv lub hnab aluminium foil thaum pom qhib.
7.Tag nrho cov khoom ntawm cov khoom siv no yuav tsum muab tso rau hauv Biohazardous pov tseg hnab thiab muab pov tseg raws li lub zos xav tau.
8. Tsis txhob muab pov tseg, txaws.
9. Khaws cov khoom siv kuaj thiab cov ntaub ntawv tawm ntawm qhov ncav cuag ntawm cov menyuam yaus thiab cov tsiaj ua ntej thiab tom qab siv.
10.Ua kom muaj lub teeb txaus thaum kuaj
11.Tsis txhob haus dej lossis pov tseg cov tshuaj tua kab mob antigen rau koj cov tawv nqaij.
12. Cov menyuam yaus hnub nyoog qis dua 18 xyoo yuav tsum tau kuaj lossis coj los ntawm tus neeg laus.
13. Cov ntshav ntau dhau los yog cov hnoos qeev ntawm qhov hnoos qeev tuaj yeem cuam tshuam kev ua haujlwm thiab yuav ua rau muaj qhov tsis zoo.
【Specimen Collection thiab npaj】
Cov khoom siv:
Anterior Nasal swb
1.Ntxig tag nrho cov lus sau ntawm lub swab muab rau hauv lub qhov ntswg.
2.Ntawm cov phab ntsa ntawm qhov ntswg los ntawm kev tig lub swab nyob rau hauv ib ncig ntawm lub qhov ntswg phab ntsa yam tsawg kawg yog 4 zaug.
3.Ua li ntawm 15 vib nas this los sau cov qauv. Nco ntsoov sau tej qhov ntswg qhov ntswg uas tej zaum yuav muaj nyob rau ntawm lub swab.
4. Rov ua dua nyob rau hauv lwm lub qhov ntswg siv tib lub swab.
5. Maj mam tshem lub swab.
Specimen solution npaj:
1.Peel qhib lub sealing membrane nyob rau hauv lub Extraction raj.
2.Insert cov ntaub npuag ntawm lub swab mus rau hauv lub extraction tsis nyob rau hauv lub raj mis ntawm lub raj.
3.Stir thiab Nias lub taub hau swab tiv thaiv phab ntsa extraction raj kom tso cov antigen, tig lub swab rau 1 feeb.
4. Tshem tawm lub swab thaum pinch lub extraction raj tiv thaiv nws.
(Nco ntsoov tias cov kua ntau npaum li cas hauv cov ntaub npuag ntawm lub swab raug tshem tawm raws li qhov ua tau).
5.Nias lub Nozzle Cap muab nruj nreem rau hauv lub raj rho tawm kom tsis txhob muaj qhov xau.
6. Pov tseg cov swabs rau biohazard pov tseg hnab.