Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - Nasopharyngeal, oropharyngeal
Tsanangudzo Yakadzama
Chinangwa Kushandiswa
Iyo LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Goridhe) in vitro immunoassay. Iyo assay ndeye yakananga uye yemhando yekuona antigen yeSARS-CoV-2 kubva nasopharyngeal secretions uye oropharyngeal secretions specimens. Iyo kit ndeye in vitro diagnostic kushandiswa.
Nezve COVID-19
COVID-19 chirwere chekufema chinotapukira. Vanhu vanowanzo batwa nechirwere ichi. Parizvino, varwere vakatapukirwa neiyo novel coronavirus ndiyo honzeri yehutachiona; asymptomatic vanhu vane hutachiona vanogona zvakare kuve nehutachiona sosi. Zvichienderana neazvino epidemiological kuferefeta, iyo incubation nguva ndeye 1 kusvika 14 mazuva, kazhinji 3 kusvika 7 mazuva. Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma. Nasal congestion, runny mhino, kurwadziwa kwehuro, myalgia uye manyoka zvinowanikwa mune zvishoma.
Zviri mukati
Package tsanangudzo: 25 T / kit
1) SARS-CoV-2 antigen test Cassette
2) Kubvisa chubhu ine sampuli yekubvisa mhinduro uye zano
3) Cotton swab
4) IFU: 1 chidimbu/kiti
5) tubu stand: 1 chidimbu / kiti
Kuwedzera kunodiwa zvinhu: wachi/ timer/ stopwatch
Ongorora: Usasanganise kana kuchinjanisa mabheti akasiyana emakiti.
Zvinotsanangurwa
| Test Item | Muenzaniso Type | Storage Condition |
| SARS-CoV-2 antigen | Nasopharyngeal swab/oropharyngeal swab | 2-30℃ |
| Methodology | Nguva Yekuedza | Sherufu Hupenyu |
| Colloidal Gold | 15mins | 24 mwedzi |
Operation
Kuunganidza uye Kuchengeta
1.Bata zvienzaniso zvose sekunge vanokwanisa kutumira hutachiona hwehutachiona.
2.Usati watora sampuli, iva nechokwadi chokuti chubhu yemuenzaniso yakavharwa uye buffer yekubvisa haina kubuda kunze. Wobvarura firimu rayo rekuvhara uye uve wakamirira.
3.Kuunganidzwa kweSpecimens:
- Oropharyngeal specimen: Nemusoro wemurwere wakasimudzwa zvishoma, uye muromo wakashama, toni dzemurwere dzinobuda pachena. Nekucheneswa kwakachena, toni dzemurwere dzinokwizwa zvinyoro nyoro kumashure nekudzoka kanenge ka3, uye ipapo madziro epashure epharyngeal emurwere anokwizwa kumashure nekudzoka kanenge katatu.
- Nasopharyngeal specimen: Rega musoro wemurwere usununguke. Shandura swab kumadziro emhino zvishoma nezvishoma kupinda mumhino, kumukanwa wemhino, wozotenderedza uchipukuta wobvisa zvishoma nezvishoma.
Mabatirwo eSpecimen: Isai musoro weswab mubhafa yekubvisa mushure mekuunganidzwa kwemuenzaniso, sanganisa zvakanaka, svina swab 10-15 nguva nekudzvanya madziro echubhu kurwisa swab, uye rega imire kwemaminetsi maviri kuchengetedza masampuli akawanda se zvinokwanisika mumuenzaniso wekubvisa buffer. Rasa mubato we swab.
4.Swab mienzaniso inofanira kuongororwa nokukurumidza sezvinobvira mushure mekuunganidza. Shandisa zvichangobva kuunganidzwa zvemhando yepamusoro bvunzo kuita.
5.Kana isina kuongororwa nekukasika, zvienzaniso zve swab zvinogona kuchengetwa pa 2-8 ° C kwemaawa makumi maviri nemana mushure mekuunganidzwa. Kana chengetedzo yenguva refu -
6.Usashandisa zvienzaniso zviri pachena zvakasvibiswa neropa, sezvo zvingakanganisa kuyerera kwemuenzaniso nekududzirwa kwemigumisiro yekuedza.
Test Procedure
1.Kugadzirira
1.1 Mienzaniso inofanirwa kuongororwa uye ma reagents anodiwa achabviswa kubva pakuchengetedza mamiriro uye kuenzana nekamuri tembiricha;
1.2 Kiti ichabviswa mubhegi rekurongedzerwa uye kuiswa pasi pabhenji rakaoma.
2.Kuedza
2.1 Isa kit yebvunzo yakachinjika patafura.
2.2 Wedzera muenzaniso
Isa yakachena inodonhedza tipi pachubhu yemuenzaniso uye shandura chubhu yemuenzaniso kuitira kuti ienderane negomba remuenzaniso (S) uye wowedzera madonhwe matatu (angangoita 100ul) emuenzaniso. Seta timer kwemaminitsi gumi nemashanu.
2.3 Kuverenga mhedzisiro
Izvo zvakanaka zvienzaniso zvinogona kuonekwa pamaminitsi gumi nemashanu mushure mekuwedzera kwemuenzaniso.
Dudziro yeZvabuda
POSITIVE:Mitsetse miviri ine mavara inoonekwa pa membrane. Imwe mutsara weruvara unoonekwa munharaunda yekudzora (C) uye imwe mutsara inoonekwa munzvimbo yekuyedza (T).
NEGATIVE:Mutsara mumwe chete wemavara unoonekwa munharaunda yekutonga (C). Hapana mutsara weruvara unoonekwa munzvimbo yekuyedza (T).
INVALIDMutsara wekutonga hauoneki. Mhedzisiro yebvunzo iyo isingaratidzi mutsara wekutonga mushure menguva yakatarwa yekuverenga inofanira kuraswa. Muenzaniso wekuunganidza unofanirwa kuongororwa uye kudzokororwa nemuedzo mutsva. Rega kushandisa test kit nekukasira uye bata mutengesi wako wepano kana dambudziko rikaramba.
KUCHENJERA
1. Kusimba kweruvara munzvimbo yekuyedzwa (T) kunogona kusiyana zvichienderana nekuwanda kwemapuroteni ehutachiona ari mumhino yemucus sample. Naizvozvo, chero ruvara munzvimbo yekuyedza inofanira kutorwa seyakanaka. Izvo zvinofanirwa kucherechedzwa kuti iyi ingori bvunzo yemhando uye haigone kuona kuwanda kwehutachiona hwemapuroteni mumhino mucus sample.
2. Kusakwana kwekuenzanisa vhoriyamu, nzira isina kufanira kana miedzo yakapera ndiyo zvikonzero zvinonyanya kuita kuti mutsara wekutonga urege kuoneka.
Clinical Performance
Sensitivity: 95.07% Zvakananga: 99.74% Kururama: 98.12%
Zvirongwa zvekuvanzika