SARS-CoV-2 Nje Virus Antigen – Nnwale ụlọ

Nkọwa dị mkpirikpi:

Ngwa nchọpụta a bụ maka nchọpụta qualitative in vitro nke SARS-CoV-2 antigen na nlele imi imi.Ezubere ule a maka ụlọ na-abụghị ọgwụ iji nyocha onwe ya site n'aka ndị dị afọ 15 ma ọ bụ karịa ndị a na-enyo enyo na ha nwere COVID-19 ma ọ bụ ndị okenye anakọtara sample swab imi n'aka ndị na-erubeghị afọ 15. ndị a na-enyo enyo na ha nwere COVID-19.

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Nkọwa ngwaahịa

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Aha ngwaahịa

HWTS-RT062IA/B/C-SARS-CoV-2 Nje Virus nchọpụta Antigen (usoro ọla edo colloidal) -Isi imi

Asambodo

CE 1434

Epidemiology

Ọrịa Coronavirus 2019 (COVID-19), bụ oyi baa n'ihi ọrịa nwere coronavirus akwụkwọ akụkọ aha ya bụ Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2).SARS-CoV-2 bụ coronavirus akwụkwọ akụkọ dị na β genus, ihe mkpuchi kpuchiri gburugburu ma ọ bụ oval, nke nwere dayameta site na 60 nm ruo 140 nm.Mmadụ na-enwekarị ike ibute SARS-CoV-2.Isi mmalite nke ọrịa bụ ndị ọrịa COVID-19 enwetara na onye na-ebu asymptomatic nke SARSCoV-2.

Ọmụmụ ụlọ ọgwụ

A tụlere arụmọrụ nke ngwa nchọpụta Antigen n'ime ndị ọrịa 554 nke imi imi anakọtara site na ndị a na-enyo enyo na COVID-19 n'ime ụbọchị 7 ka akara mmalite malitere ma e jiri ya tụnyere nyocha RT-PCR.Arụ ọrụ nke ngwa ule SARS-CoV-2 Ag bụ nke a:

SARS-CoV-2 Nje Virus Antigen (reagent nyocha)	RT-PCR reagent		Mkpokọta
SARS-CoV-2 Nje Virus Antigen (reagent nyocha)	Nke dị mma	Ihe ọjọọ	Mkpokọta
Nke dị mma	97	0	97
Ihe ọjọọ	7	450	457
Mkpokọta	104	450	554

Mmetụta	93.27%	95.0% CI	86.62% - 97.25%
Nkọwapụta	100.00%	95.0% CI	99.18% - 100.00%
Mkpokọta	98.74%	95.0% CI	97.41% - 99.49%

Nka nka

Ọnọdụ nchekwa	4 ℃-30 ℃
Ụdị ihe atụ	Ihe nlele imi imi
Ndụ nchekwa	Ọnwa iri abụọ na anọ
Ngwa inyeaka	Ọ dịghị mkpa
Ngwa ahịa ndị ọzọ	Ọ dịghị mkpa
Oge nchọpụta	15-20 nkeji
Nkọwapụta	Ọ dịghị cross-reactivity na pathogens dị ka mmadụ Coronavirus (HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), seasonal influenza A (H1N1, H3N2, H5N1, H7N9) , Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 na 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55). ).

Usoro ọrụ

1. Nlereanya
●Jiri nwayọọ tinye ọnụ ọnụ dị nro nke swab (na-abụkarị 1/2 ruo 3/4 nke anụ ọhịa) n'otu oghere imi, Na-eji nrụgide na-adịchaghị mkpa, kpoo swab ahụ n'ime mgbidi niile nke imi gị.Mee opekata mpe nnukwu okirikiri 5.A ghaghị ịsacha imi imi ọ bụla maka ihe dịka 15 sekọnd. N'iji otu swab, megharịa otu ihe ahụ na imi gị ọzọ.

●Nlereanya mgbaze.Tinye swab ahụ kpamkpam n'ime ngwọta mmịpụta sample;Gbajie osisi swab na ebe a na-agbaji, na-ahapụ njedebe dị nro na tube.Kpọchie na okpu, tụgharịa ugboro 10 ma tinye tube n'ebe kwụsiri ike.