SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) yekuzviongorora

SARS-CoV-2 Antigen Rapid Test (Colloidal Goridhe) yekuzviedza iwe pachako inoitirwa kuongororwa kwemhando yeSARS-CoV-2 Antigen (Nucleocapsid protein) mumasamples emunhu mu vitro.

Izvo zvinoshandiswa kune zvinotevera zviitiko:

1. kuongororwa kwehuwandu hwevanhu, sechipatara, airport, chiteshi, nharaunda, nezvimwe.

2. kutariswa kwenguva pfupi kunoramba kuripo.

* Anterior nasal swab specimen, isingasviki

* Yakanyanya nyore kushandisa

* Yakanaka, hapana chiridzwa chinodiwa

* Nekukurumidza, mhedzisiro mukati me15 ~ 20 maminetsi

* Mari-inoshanda

Iyo SARS-CoV-2 hutachiona chidimbu inoumbwa nezvikamu zvishanu: RNA gene cheni uye mana mapuroteni. Iro rekunze rechikamu iSpike Protein (S), uye Viral Envelope iri pazasi peSpike inoumbwa neEmvuropu Protein (E) uye Membrane Protein (M). Iyo yakakosha iri mukati mehamvuropu ndeye helical yakapetwa chimiro chinoumbwa neRNA gene cheni uye Nucleocapsid mapuroteni (N). Uchishandisa musimboti wekusunga chaiko kweantigen uye antibody, kuvapo kweSARS-CoV-2 antigen (Nucleocapsid protein) inogona kuwonekwa neanorwisa matutu.

Zvakanakira pamusoro paElisa uye PCR

Kuita kweSARS-CoV-2 Antigen Rapid Test (Colloidal Goridhe) yakavambwa iine mazana masere nemakumi mashanu nematatu emhando dzakaunganidzwa kubva kuvarwere vane zviratidzo vaifungidzirwa kuti vane COVID-19. Anterior nasal swab specimens akaunganidzwa uye akaedzwa maererano nezvinodiwa zveMirairo Yekushandisa. Kuchengetwa, kutakurwa uye kucherechedzwa kwemasampuli mushure mekuunganidzwa kwakasangana nezvinodiwa zveMirairo Yekushandisa. Panguva imwecheteyo, SARS-CoV-2 yakaonekwa ne emergency nucleic acid yekuona reagent.

Clinical performance pfupiso yeWIZ'S SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

PPA: 95.91% (C.I. 93.25% ~ 97.55%)

NPA: 100.00% (C.I. 99.26% ~ 100.00%)

OPA: 98.37% (C.I. 97.28% ~ 99.03%)

Isu, mugadziri, pano, tinozivisa kuti chigadzirwa (s) sezvakatsanangurwa pamusoro zvinosangana nezvinodiwa zveEuropean Directive 98/79/EC pa in vitro Diagnostic Medical Devices. Ese anotsigira magwaro ehunyanzvi anoratidza kutevedzera anochengetwa nemugadziri uye anogona kuitwa kuti awanikwe neMumiriri Akabvumidzwa muEurope.

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