COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Kuganhurirwa
1.Iyi reagent inoshandiswa chete kune in vitro diagnosis.
2.Iri reagent rinoshandiswa chete kuona munhu nasal swabs/oropharyngeal swabs specimen.Mibairo yezvimwe zvienzaniso inogona kunge isiriyo.
3.Iyi reagent inongoshandiswa pakuongorora kwehutano uye haigoni kuona huwandu hweinoveli corona virus antigen mumuenzaniso.
4.Iyi reagent inongova kliniki yekubatsira kuongororwa.Kana chigumisiro chiri chakanaka, zvinokurudzirwa kushandisa dzimwe nzira dzekuwedzera kuongororwa munguva uye kuongororwa kwechiremba kuchakunda.
5.Kana chigumisiro chekuedza chisina kunaka uye zviratidzo zvechipatara zvinopfuurira.Zvinokurudzirwa kudzokorora sampling kana kushandisa dzimwe nzira dzekuyedza dzekuyedza.Mhedzisiro yakaipa haigone kudzivirira mukana wekuratidzwa kana kutapukirwa nehutachiona hweSARS-CoV-2 chero nguva.
6. Migumisiro yebvunzo dzetest kits ndeyekutarisa kwevakiriniki chete, uye haifanirwe kushandiswa seyo chete hwaro hwekuongororwa kwekiriniki.Makiriniki manejimendi evarwere anofanirwa kutariswa zvakazara mukubatana nezviratidzo / zviratidzo zvavo, nhoroondo yekurapa, kumwe kuongororwa kwema laboratory uye mhinduro dzekurapa, nezvimwe.
7.Nekuda kwekuganhurirwa kweiyo yekuona reagent methodology, muganho wekuonekwa kweiyi reagent kazhinji yakaderera pane iyo nucleic acid reagents.Naizvozvo, vashandi vebvunzo vanofanirwa kutarisisa zvakanyanya kune zvakaipa zvabuda uye vanofanirwa kusanganisa mimwe mibairo yebvunzo kuita mutongo wakakwana.Zvinokurudzirwa kushandisa nucleic acid kuyedza kana hutachiona hwekuzviparadzanisa nevamwe uye nzira dzekuziva tsika kuti uongorore zvakaipa mhedzisiro ine kupokana.
8.Positive test results haisanganisi co-infection nemamwe zvirwere.
9.Nhema dzisina kunaka mhedzisiro dzinogona kuitika kana iyo SARS-CoV-2 antigen level mumuenzaniso yakaderera pane yekuona muganho wekiti kana sampuli yekuunganidza uye yekufambisa zvisina kukodzera.Naizvozvo, kunyangwe kana mhinduro dzisina kunaka, mukana wehutachiona hweSARS-CoV-2 haugone kubviswa.
10.Positive and negative predictive values zvinonyanya kutsamira pahuwandu hwehuwandu.Mhedzisiro yakanaka yebvunzo inowanzo miririra mhedzisiro yenhema panguva yezvidiki/zvisina SARS-CoV-2 chiitiko kana kuwanda kwechirwere kwakadzikira.Enhema mhedzisiro yekuyedzwa kwakashata inowanzoitika kana kuwanda kwechirwere chinokonzerwa neSARS-CoV-2 kwakakwira.
11. Ongororo yemukana wenhema mhedzisiro yakaipa:
(1) Kusanzwisisika kuunganidzwa kwemuenzaniso, kutakura uye kugadzirisa, yakaderera hutachiona titer mumuenzaniso, hapana sampuli nyowani kana kutonhora uye kunyungudutsa bhasikoro remuenzaniso kunogona kutungamirira kune nhema mhedzisiro.
(2) Kuchinja kwehutachiona hwemajini kunogona kutungamirira kukuchinja kune antigenic determinants, izvo zvinotungamirira kumigumisiro yakaipa.
(3) Tsvagiridzo paSARS-CoV-2 haina kunyatso nyatso;hutachiona hunogona kushanduka uye hukonzeresa mutsauko wenguva yesampling yakanaka (virus titer peak) uye nzvimbo yesampling.Naizvozvo, kumurwere mumwechete, tinogona kuunganidza sampuli kubva kunzvimbo dzakawanda kana kutevera kakawanda kudzikisa mukana wemhedzisiro yakaipa.
12.Monoclonal antibodies inogona kutadza kuona, kana kuona nekunzwa kushoma, mavhairasi eSARS-CoV-2 ayo aita shanduko diki dzeamino acid munzvimbo inotarirwa epitope.
