SARS-CoV-2 Virus Antigen - Teko ea lapeng

Tlhaloso e Khutšoanyane:

Setsi sena sa Detection ke sa ho lemoha boleng ba in vitro antigen ea SARS-CoV-2 ka lisampole tsa swab ea nko.Teko ena e reretsoe ho itlhahloba ka mokhoa o sa reroang lapeng ka lisampole tse iketlileng tsa pele tsa nasal (nares) ho tsoa ho batho ba lilemo tse 15 kapa ho feta ba belaelloang ka COVID-19 kapa batho ba baholo ba bokelletse lisampole tsa nko ho batho ba ka tlase ho lilemo tse 15. ba belaelloang ka COVID-19.

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HWTS-RT062IA/B/C-SARS-CoV-2 Virus Antigen Detection Kit (mokhoa oa khauta oa colloidal) -Nasal

Setifikeiti

CE1434

Epidemiology

Coronavirus Disease 2019(COVID-19), ke pneumonia e bakoang ke ts'oaetso ea coronavirus e ncha e bitsoang Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2).SARS-CoV-2 ke "coronavirus" e ncha ka mofuta oa β, likaroloana tse apesitsoeng ka bophara kapa oval, ka bophara ho tloha ho 60 nm ho isa ho 140 nm.Motho ka kakaretso o kotsing ea SARS-CoV-2.Mehloli ea mantlha ea ts'oaetso ke bakuli ba netefalitsoeng ba COVID-19 le bajari ba asymptomatic ba SARSCoV-2.

Thuto ea bongaka

Ts'ebetso ea Antigen Detection Kit e ile ea hlahlojoa ho bakuli ba 554 ba li-nasal swabs tse bokelletsoeng ho babelaelloa ba nang le matšoao a COVID-19 nakong ea matsatsi a 7 kamora ho qala ha matšoao ha ho bapisoa le tlhahlobo ea RT-PCR.Ts'ebetso ea SARS-CoV-2 Ag Test Kit e tjena:

SARS-CoV-2 Virus Antigen (setsi sa lipatlisiso)	Sesebelisoa sa RT-PCR		Kakaretso
SARS-CoV-2 Virus Antigen (setsi sa lipatlisiso)	E ntle	E mpe	Kakaretso
E ntle	97	0	97
E mpe	7	450	457
Kakaretso	104	450	554

Kutloisiso	93.27%	95.0% CI	86.62% - 97.25%
Tse khethehileng	100.00%	95.0% CI	99.18% - 100.00%
Kakaretso	98.74%	95.0% CI	97.41% - 99.49%

Tekheniki Parameters

Mocheso oa polokelo	4℃-30℃
Mofuta oa mohlala	Mehlala ea ho phunya nko
Shelf bophelo	Likhoeli tse 24
Lisebelisoa tse thusang	Ha e hlokehe
Lisebelisoa tse Eketsehileng	Ha e hlokehe
Nako ea ho lemoha	15-20 mets
Tse khethehileng	Ha ho na cross-reactivity le likokoana-hloko tse kang Coronavirus ea motho (HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), ntaramane ea selemo A (H1N1, H3N2, H5N1, H7N9) , Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 le 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55 ).

Phallo ea Mosebetsi

1. Mohlala
●Ka bonolo kenya ntlha eohle e bonolo ea swab (hangata e le 1/2 ho isa ho 3/4 ea inch) ka har'a nko e le 'ngoe, U sebelisa khatello e mahareng, itlotsa ka har'a mabota ohle a ka hare a nko ea hau.Etsa bonyane li-circles tse 5 tse kholo.'Me nko e' ngoe le e 'ngoe e tlameha ho hlajoa ka metsotsoana e ka bang 15. U sebelisa sesepa se tšoanang, pheta se tšoanang ka nko ea hau e 'ngoe.

●Ho qhibiliha ha mohlala.Kenya sesepa ka ho feletseng ka har'a tharollo ea ho ntša mohlala;Senya thupa ea swab sebakeng sa ho robeha, u siee ntlha e bonolo ka har'a tube.Screw holim'a cap, fetola makhetlo a 10 'me u behe tube sebakeng se tsitsitseng.