COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

Nkọwa dị mkpirikpi:

Nkọwa ngwaahịa

Mkpado ngwaahịa

Ezubere iji

The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) bụ a mpụta eruba immunoassay ezubere maka qualitative nchọpụta SARS-CoV-2 nucleocap-sid antigens na imi swab site n'aka ndị na-enyo enyo na COVID-19 site n'aka onye na-ahụ maka ahụike ha.

Nsonaazụ bụ maka njirimara SARS-CoV-2 nucleocapsid antigen.A na-achọpụtakarị Antigen n'imi imi n'oge oke ọrịa.Nsonaazụ dị mma na-egosi ọnụnọ nke nje antigens, mana njikọ ụlọ ọgwụ na akụkọ ihe mere eme nke onye ọrịa na ozi nyocha ndị ọzọ dị mkpa iji chọpụta ọnọdụ ọrịa.Nsonaazụ dị mma anaghị ewepụ ọrịa nje ma ọ bụ njikọ nje na nje ndị ọzọ.Onye nnọchi anya achọpụtara nwere ike ọ gaghị abụ ihe kpatara ọrịa.

Nsonaazụ na-adịghị mma anaghị ewepụ ọrịa SARS-CoV-2 yana ekwesighi iji ya naanị maka ọgwụgwọ ma ọ bụ mkpebi njikwa onye ọrịa, gụnyere mkpebi njikwa ọrịa.Ekwesịrị ịtụle nsonaazụ na-adịghị mma n'ihe gbasara mkpughe nke onye ọrịa n'oge na-adịbeghị anya, akụkọ ihe mere eme na ọnụnọ nke akara na mgbaàmà ụlọ ọgwụ kwekọrọ na COVID-19, wee jiri nyocha mkpụrụ ndụ gosipụta ya, ọ bụrụ na ọ dị mkpa maka njikwa onye ọrịa.Ngwa a bụ maka iji ụlọ nke ndị nkịtị nọ n'ụlọ na-abụghị ụlọ nyocha (dị ka ebe obibi mmadụ ma ọ bụ ụfọdụ saịtị na-abụghị omenala dị ka ụlọ ọrụ, mmemme egwuregwu, ụlọ akwụkwọ wdg).Nsonaazụ ule nke ngwa a bụ naanị maka ntụle aka ụlọọgwụ.A na-atụ aro ka ịme nyocha zuru oke nke ọnọdụ ahụ dabere na ngosipụta ụlọ ọgwụ ndị ọrịa na nyocha ụlọ nyocha ndị ọzọ.

Nchịkọta

Akwụkwọ akụkọ coronaviruses (SARS-CoV-2) bụ nke β genus.COVID-19 bụ nnukwu ọrịa na-efe efe nke iku ume.Ndị mmadụ na-enwekarị nsogbu.Ugbu a, ndị ọrịa bu ọrịa coronavirus ọhụrụ bụ isi ihe na-ebute ọrịa;ndị butere ọrịa asymptomatic nwekwara ike ịbụ isi iyi na-efe efe.Dabere na nyocha ọrịa ọrịa ugbu a, oge nnabata bụ ụbọchị 1 ruo 14, ọkachasị ụbọchị 3 ruo 7.Ihe ngosi ndị bụ isi gụnyere ahụ ọkụ, ike ọgwụgwụ na ụkwara akọrọ.A na-ahụ mkpọchi imi, imi na-agba agba, akpịrị akpịrị, myalgia na afọ ọsịsa n'ọnọdụ ole na ole.

Ụkpụrụ

COVID-19 Antigen Rapid Test Cassette (Nasal Swab) bụ immunoassay na-erugharị n'akụkụ dabere n'ụkpụrụ nke usoro Sanwichi mgbochi mmadụ abụọ.SARS-CoV-2 nucleocapsid protein monoclonal antibody jikọtara ya na microparticles agba ka a na-eji ihe nchọpụta ma fesa na pad conjugation.N'oge ule ahụ, SARS-CoV-2 antigen na ụdị ahụ na-emekọrịta ihe na mgbochi SARS-CoV-2 jikọtara ya na microparticles agba na-eme ka a na-akpọ antigen-antibody dị mgbagwoju anya.Ihe mgbagwoju anya a na-akwaga na akpụkpọ ahụ site na capillary edinam ruo n'ahịrị ule, ebe ọ ga-ejide ya site na SARS-CoV-2 nucleocapsid protein monoclonal antibody.A ga-ahụ ahịrị ule nwere agba (T) na windo nsonaazụ ma ọ bụrụ na antigens SARS-CoV-2 dị na ụdị.Enweghị ahịrị T na-egosi nsonaazụ na-adịghị mma.A na-eji akara njikwa (C) maka njikwa usoro, ma kwesịrị ịpụta mgbe niile ma ọ bụrụ na a na-eme usoro nyocha nke ọma.

Ịdọ aka ná ntị na ịkpachara anya

• Maka nyocha onwe onye in vitro diagnostic ojiji naanị. Nke a kaseti tset bụ maka ojiji otu oge na ọtụtụ mmadụ enweghị ike ijikwa ya ọzọ ma ọ bụ jiri ya mee ihe.

• Ejila ngwaahịa a dị ka naanị ihe ndabere iji chọpụta ma ọ bụ wepu ọrịa SARS-CoV-2 ma ọ bụ iji gwa ọkwa ọrịa COVID-19.

• Biko gụọ ozi niile dị na mpempe akwụkwọ a tupu ịme ule ahụ.

• Ejila ngwaahịa a mgbe ụbọchị ngafe gachara.

• Cassette ule kwesịrị ịdị n'ime obere akpa ahụ emechiri emechi ruo mgbe ejiri ya.

• Ekwesịrị ịtụle ụdịdị niile dị ka ihe dị ize ndụ ma mee ya n'otu ụzọ ahụ dịka ndị na-efe efe na-efe efe.

•Ekwesịrị iji ule maka ụmụaka na ndị ntorobịa na okenye.

• Ekwesịrị ịtụfu kaseti ule eji eme ihe dịka iwu gọọmentị etiti, steeti na mpaghara siri dị.

• Ejila ule ahụ na ụmụaka na-erubeghị afọ 2.

• Ụmụntakịrị kwesịrị ịsacha ya site n'enyemaka nke okenye nke abụọ.

•Sachaa aka nke ọma tupu na mgbe ejirichara ya.

MGBE

Ihe Enyere

•Nnwale Cassettes: Cassette ọ bụla nwere desiccant na obere akpa foil nke ọ bụla

• Reagents ewepụtara nke akwadoro:

• Sterilized Swabs: swab na-adịghị mma nke otu eji maka nchịkọta ihe atụ

• Fanye ngwugwu

Ihe achọrọ mana enyeghị ya

• Ngụ oge

Nchekwa na Nkwụsi ike

• Chekwaa dị ka ngwugwu na akpa akara na okpomọkụ (4-30 ℃ ma ọ bụ 40-86 ℉).Ngwa ahụ kwụsiri ike n'ime ụbọchị njedebe nke ebipụtara na labeling.

• Ozugbo emepere obere akpa ahụ, a ga-eji ule ahụ n'ime otu awa.Ikpughe ogologo oge na gburugburu ebe dị ọkụ na iru mmiri ga-ebute mmebi ngwaahịa.

•AKWỤKWỌ KWESỊRỊ.

Ụdị

Nlereanya enwetara n'isi n'oge mmalite mgbaàmà ga-enwe titer viral kachasị elu;ihe nlere anya enwetara mgbe ụbọchị ise nke mgbaàmà gachara na-ebute nsonaazụ na-adịghị mma ma e jiri ya tụnyere nyocha RT-PCR.Nchịkọta ihe atụ ezughị oke, njikwa ụdị na/ma ọ bụ mbugharị na-ezighi ezi nwere ike iwepụta nsonaazụ ụgha;ya mere, ọzụzụ n'ịchịkọta ihe atụ na-atụ aro nke ukwuu n'ihi mkpa ọ dị mma iji nweta nsonaazụ ule ziri ezi.Ụdị ụdị a na-anabata maka ule bụ ihe nlere anya imi imi enwetara site na usoro nchịkọta nke abụọ.Kwadebe tube mmịpụta dịka Usoro Nnwale siri dị ma jiri swab na-adịghị mma nke enyere na ngwa maka nchịkọta ihe atụ.

Mkpokọta ụdị swab imi

1.Wepu swab na ngwugwu.

2.Tilt ọrịa isi azụ banyere 70°.

3.1-2 Ka ị na-eji nwayọọ na-atụgharị swab ahụ, tinye swab ihe dịka 2.5 cm (1 inch) n'ime imi imi ruo mgbe a ga-ezute nguzogide na turbinates.

4.Gbagharịa swab ọtụtụ ugboro megide mgbidi imi ma na-emegharị imi ọzọ na-eji otu swab ahụ.

Ụgbọ njem na nchekwa ihe atụ

Ejighachila swab na nkwakọ ngwaahịa swab mbụ.Ekwesịrị ịhazi ụdị ụdị achịkọtara ọhụrụ ozugbo enwere ike, mana ọ gafechara otu awa ka anakọtara ihe atụ.

Usoro ule

Mara:Kwe ka cassettes, reagents na ihe nlere anya ka ọ dabara na ọnụ ụlọ (15-30℃ ma ọ bụ 59-86℉) tupu anwale.

1. Tinye tube mmịpụta na ebe a na-arụ ọrụ.

2.Kpechapụ ihe mkpuchi aluminom si n'elu nke tube nke na-emepụta ihe nke nwere ihe ntanetị nke nwere ihe nkwụnye ihe.

3.Sampling na-ezo aka na ngalaba 'Nchịkọta ihe atụ'.

4.Tinye ụdị swab imi n'ime tube mmịpụta nke nwere reagent mmịpụta.Tụgharịa swab ma ọ dịkarịa ala ugboro 5 ka ị na-agbanye isi na ala na akụkụ nke tube mmịpụta.Hapụ imi imi n'ime tube mmịpụta maka otu nkeji.

5.Wepụ imi imi mgbe ị na-atụgharị akụkụ nke tube iji wepụ mmiri mmiri na swab.A ga-eji ihe ngwọta ewepụtara dị ka nlele nlele.6.Na-ekpuchi tube mmịpụta na ntụ ntụ nke ọma.

7.Wepu cassette ule na obere akpa akara.

8.Reverse tube mmịpụta ihe atụ, na-ejide tube kwụ ọtọ, nyefee 3 tụlee (ihe dị ka 100 μL) nwayọọ nwayọọ na ihe atụ nke ọma (S) nke cassette ule, wee malite ngụ oge.

9.Chere ka ahịrị agba pụta.Tụgharịa asụsụ nsonaazụ ule na nkeji iri na ise.Agụla nsonaazụ mgbe nkeji iri abụọ gachara.

[Ụkpụrụ omume]

Arụmọrụ ụlọ ọgwụ

Iji mee atụmatụ ịdị adị nke ụlọ ọgwụ n'etiti COVID-19 Antigen Rapid Test Cassette na PCR comparotor, anakọtara swab imi 628 n'aka ndị ọrịa a na-enyo enyo na ha nwere COVID-19. Nchịkọta data nke COVID-19 Antigen Rapid Test Cassette (Nasal Swab) dị n'okpuru. .

COVID-19 antigen		RT-PCR		Mkpokọta
COVID-19 antigen		Nke dị mma	Ihe ọjọọ	Mkpokọta
HEO®	Nke dị mma	172	0	172
HEO®	Ihe ọjọọ	3	453	456
Mkpokọta		175	453	628

PPA = 98.28% (172/175), (95% CI: 95.08% ~ 99.64%) NPA = 100% (453/453), (95% CI: 99.34% ~ 100%)

PPA - Nkwekọrịta Pasent ziri ezi (Mmetụta) NPA - Nkwekọrịta Pasent Na-adịghị mma (Nkọwa)

Oke nke nchọpụta (Mmetụta nyocha)

Ọmụmụ ihe ahụ jiri nje SARS-CoV-2 mebere ya (Isolate USA-WA1/2020 NR-52287), nke a na-eme ka okpomọkụ anaghị arụ ọrụ ma gbasaa n'ime ụdị swab imi.Oke nchọpụta (LoD) bụ 1.0 × 10²TCID₅₀/ml.

Cross Reactivity (Nkọwa nyocha)

A tụlere mmeghachi omume gafere site na ịnwale 32 commensal na microorganisms pathogenic nke nwere ike ịdị na oghere imi.

Ọ dịghị cross-reactivity hụrụ na recombinant MERS-CoV NP protein mgbe a nwalere na ntinye nke 50 pg/mL.

Ọ dịghị cross-reactivity hụrụ na nje ndị na-esonụ mgbe a nwalere na ntinye nke 1.0 × 106 PFU / ml: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata), Influenza B ( Victoria), Adenovirus (ụdị 1, 2, 3, 5, 7, 55), metapneumovirus mmadụ,

Ọrịa Parainfluenza (ụdị 1, 2, 3, 4), nje syncytial iku ume, Enterovirus, Rhinovirus, coronavirus mmadụ 229E, coronavirus mmadụ OC43, coronavirus mmadụ NL63, coronavirus mmadụ HKU1.

Ọ dịghị cross-reactivity hụrụ na ndị na-esonụ nje bacteria mgbe a nwalere na ịta nke 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamy-dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (otu A), Streptococcus. Staphylococcus aureus.

Ntinye aka

Ejiri COVID-19 Antigen Rapid Test Cassette (Nasal Swab) nyochaa ihe nnyonye anya ndị a na mkpokọta ndị edepụtara n'okpuru wee hụ na ọ naghị emetụta arụmọrụ nnwale.

Ntinye uche nke ihe

Nri 2%

Benzocaine 5 mg/mL Saline ịgba imi 15%

Oxymetazoline 15%

Tobramycin 5 μg/mL Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg / ml

Fluticasone propionate 5%

Triamcinolone 10 mg / ml

Ọbara zuru oke 4%

menthol 10 mg / ml

Phenylephrine 15%

Mupirocin 10 mg / ml

Zanamivir 5 mg / ml

Ribavirin 5 mg / ml

Dexamethasone 5 mg / ml

Histamine 10 mg/mL dihydrochloride

Mmetụta nko dị elu

A nwalere kaseti nyocha ngwa ngwa nke COVID-19 Antigen (Colloidal Gold) ruo 1.0×10⁵TCID50/mL nke SARS-CoV-2 anaghị arụ ọrụ yana enweghị mmetụta nko dị elu ahụghị.

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