COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

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ZVIRI KUSHANDISA

Iyo COVID-19 Antigen Rapid Test Cassette (Colloidal Goridhe) ndeye lateral kuyerera immunoassay yakanangana neiyo yemhando yekuona SARS-CoV-2 nucleocapsid antigens mumhino swab kubva kune vanhu vanofungidzirwa kuti vane COVID-19 nemupi wavo wehutano.

Mhedzisiro ndeyekuzivikanwa kweSARS-CoV-2 nucleocapsid antigen.Antigen inowanzoonekwa mumhino swab panguva yakaoma yehutachiona.Mhedzisiro yakanaka inoratidza kuvepo kwehutachiona hwehutachiona, asi kuwirirana kwekiriniki nenhoroondo yemurwere uye rumwe ruzivo rwekuongorora rwakakosha kuti uone mamiriro ehutachiona.Zvibereko zvakanaka hazviregi hutachiona hwehutachiona kana kubatana pamwe nemamwe mavhairasi.Mumiririri akaonekwa anogona kunge asiri iwo chaiwo chikonzero chechirwere.

Mhedzisiro yakaipa haibvise hutachiona hweSARS-CoV-2 uye haifanirwe kushandiswa seyo chete hwaro hwekurapa kana sarudzo dzekutonga kwemurwere, kusanganisira sarudzo dzekudzora hutachiona.Mhedzisiro isina kunaka inofanirwa kutariswa mumamiriro ekufumurwa kwemurwere nguva pfupi yadarika, nhoroondo uye kuvapo kwezviratidzo zvekiriniki nezviratidzo zvinoenderana neCCIDID-19, uye yakasimbiswa nemolecular assay, kana zvichidikanwa pakutarisira murwere.Kiti iyi ndeyekushandisa pamba nevanhu vasina basa munzvimbo isiri murabhoritari (semusha wemunhu kana dzimwe nzvimbo dzisiri dzechinyakare dzakaita semahofisi, zviitiko zvemitambo, zvikoro nezvimwewo).Mhedzisiro yebvunzo dzekiti iyi ndeyekuongororwa kwekiriniki chete.Zvinokurudzirwa kuita ongororo yakazara yemamiriro acho zvichienderana nevarwere kuratidzwa kwekiriniki uye mamwe ma laboratory bvunzo.

SUMMARY

Iyo novel coronaviruses (SARS-CoV-2) ndeyeiyo β genus.COVID-19 chirwere chekufema chinotapukira.Vanhu vanowanzo batwa nedambudziko iri.Parizvino, varwere vakatapukirwa neinoveli coronavirus ndiyo honzeri yehutachiona;asymptomatic vanhu vane hutachiona vanogona zvakare kuve nehutachiona sosi.Zvichienderana neazvino epidemiological kuferefeta, iyo incubation nguva ndeye 1 kusvika 14 mazuva, kazhinji 3 kusvika 7 mazuva.Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma.Nasal congestion, runny mhino, kurwadziwa kwehuro, myalgia uye manyoka zvinowanikwa mune zvishoma.

PRINCIPLE

Iyo COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ndeye lateral inoyerera immunoassay yakavakirwa pamusimboti wembiri-antibody sandwich maitiro.SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugat- ine ruvara microparticles inoshandiswa se detector uye yakapfapfaidza pane conjugation pad.Munguva yekuyedzwa, SARS-CoV-2 antigen mumuenzaniso inopindirana neSARS-CoV-2 antibody yakasanganiswa neruvara microparticles ichiita antigen-antibody yakanyorwa yakaoma.Iyi yakaoma inotama pa membrane kuburikidza necapillary chiito kusvika pamutsetse wekuyedza, kwainozotorwa neiyo pre-yakavharwa SARS-CoV-2 nucleocapsid protein monoclonal antibody.Mutsara wekuyedza weruvara (T) waizoonekwa muhwindo remhedzisiro kana maSARS-CoV-2 maantigen aripo mumuenzaniso.Kusavapo kweT line kunoratidza mhedzisiro yakaipa.Mutsetse wekudzora (C) unoshandiswa pakuita kudzora, uye unofanirwa kugara uchionekwa kana maitiro ebvunzo akaitwa nemazvo.

YAMBIRO UYE CHENJERERO

•Ku Self test in vitro diagnostic shandisa chete.Kaseti iyi yetset ndeyekushandisa kamwe chete uye haigoni kushandiswazve kana kushandiswa nevanhu vakawanda.

• Usashandise chigadzirwa ichi sechikonzero chega chekuongorora kana kusabvisa hutachiona hweSARS-CoV-2 kana kuzivisa mamiriro ehutachiona hweCOVID-19.

•Ndokumbira uverenge ruzivo rwese rwuri pakapepa rino usati waita bvunzo.

• Usashandise chigadzirwa ichi mushure mekupera kwemazuva.

•Kaseti yebvunzo inofanira kuramba iri muhomwe yakavharwa kusvika yashandiswa.

• Mienzaniso yese inofanirwa kutorwa seine njodzi uye inobatwa nenzira imwechete seanotapurira utachiona.

•Kuongororwa kwevana nevechidiki kunofanira kushandiswa nemunhu mukuru.

•Kaseti yebvunzo yakashandiswa inofanirwa kuraswa zvinoenderana nemubatanidzwa, yenyika uye nemirairo yemuno.

•Musashandise bvunzo kuvana vari pasi pemakore maviri okuberekwa.

•Vana vadiki vanofanira kugezwa nerubatsiro rwechipiri.

•Geza maoko zvakakwana usati waabata uye wapedza.

COMPOSITION

Zvinhu Zvakagoverwa

•Edzai Makaseti: kaseti imwe neimwe ine desiccant muhomwe yega foil

•Prepackaged Extraction Reagents:

•Sterilized Swabs: shandisa sterile swab yekuunganidza sampuli

•Package Insert

Zvinhu Zvinodiwa Asi Zvisina Kupiwa

•Timer

KUCHENGA UYE KUgadzikana

•Chengeta sezvakaputirwa muhomwe yakavharwa patembiricha (4-30℃ kana 40-86℉).Iyo kit yakagadzikana mukati menguva yekupera yakadhindwa pane iyo yakanyorwa.

• Kana wangovhura homwe, bvunzo dzinofanirwa kushandiswa mukati meawa imwe chete.Kugara kwenguva refu kunzvimbo inopisa uye ine mwando kunokonzera kukanganisa kwechigadzirwa.

•USAIZE.

SPECIMEN

Mienzaniso yakawanikwa kare panguva yechiratidzo ichange iine hutachiona hwepamusoro-soro;zvienzaniso zvinowanikwa mushure memazuva mashanu ezviratidzo zvinowanzoita mhedzisiro yakaipa kana zvichienzaniswa neRT-PCR assay.Kusakwana kwemuenzaniso muunganidzwa, kusabatwa zvakanaka kwemuenzaniso uye/kana kutakura kunogona kupa mhedzisiro yenhema;saka, kudzidziswa mukuunganidzwa kwemuenzaniso kunokurudzirwa zvakanyanya nekuda kwekukosha kwemhando yemuenzaniso kuti uwane mhinduro dzebvunzo dzakakwana.Rudzi rwemuenzaniso runogamuchirika rweyedzo ndeye yakananga nasal swab sampuli inowanikwa nembiri mbiri nares nzira yekuunganidza.Gadzirira chubhu yekubvisa zvinoenderana neMaitiro eKuedza uye shandisa iyo sterile swab yakapihwa mukiti yekuunganidza sampuli.

Nasal Swab Muenzaniso Collection

1.Bvisa swab kubva pasuru.

2.Tarisa musoro wemurwere kumashure anenge 70°.

3.1-2Paunenge uchitenderedza swab zvinyoro nyoro, isa swab ingangoita 2.5 cm (1 inch) mumhino kusvika kuramba kwasangana pamaturbinates.

4. Tenderedza swab kakawanda kumadziro emhino uye dzokorora mune imwe mhino uchishandisa swab imwechete.

Muenzaniso Kutakura uye Kuchengeta

Usadzorera swab kune yekutanga swab packaging.Zvichangobva kuunganidzwa zvienzaniso zvinofanirwa kugadziriswa nekukurumidza sezvinobvira, asi pasina nguva inopfuura awa imwe mushure mekuunganidzwa kwemuenzaniso.

TEST PROCEDURE

Cherechedza:Bvumira makaseti ebvunzo, reagents uye zvienzaniso kuti zvienzane netembiricha yekamuri (15-30 ℃ kana 59-86 ℉) isati yaedzwa.

1.Isai chubhu yekubvisa munzvimbo yekushanda.

2.Bvisa aluminium foil seal kubva kumusoro kwechubhu yekubvisa ine chubhu yekubvisa ine buffer yekubvisa.

3.Sampling inoreva chikamu 'Specimen Collection'.

4.Ipinza nasal swab specimen muchubhu yekudhonza iyo ine extraction reagent.Rongedza swab kanokwana kashanu uchidzvanya musoro kuzasi nedivi rechubhu yekubvisa.Siya swab yemhino muchubhu yekubvisa kweminiti imwe.

5.Bvisa nasal swab uchikwenya mativi echubhu kuti ubvise mvura kubva mugomba.Mhinduro yakabviswa ichashandiswa semuenzaniso webvunzo.6.Kuvhara chubhu yekubvisa ne dropper tip zvakasimba.

7.Bvisa kaseti yebvunzo kubva muhomwe yakavharwa.

8.Dzora specimen extraction tube, kubata chubhu yakatwasuka, tumira madonhwe matatu (anenge 100 μL) zvishoma nezvishoma kumuenzaniso wakanaka (S) wekaseti yekuedza, wozotanga timer.

9.Mirira kuti mitsetse ine mavara ionekwe.Dudzira mhinduro dzebvunzo pamaminitsi gumi nemashanu.Usaverenge mhinduro mushure memaminitsi makumi maviri.

[PERFORMANCE CHARACTERISTICS]

Clinical Performance

Kufungidzira prerformance yekiriniki pakati peCCIDID-19 Antigen Rapid Test Cassette nePCR comparotor, 628 nasal swab yakaunganidzwa kubva kuvarwere vaifungidzirwa kuti vane COVID-19. Summary data yeCCIDID-19 Antigen Rapid Test Cassette (Nasal Swab) sepazasi .

COVID-19 antigen		RT-PCR		Total
COVID-19 antigen		Positive	Negative	Total
HEO®	Positive	172	0	172
HEO®	Negative	3	453	456
Total		175	453	628

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

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Specificity)

Muganho Wekuonekwa (Analytical Sensitivity)

Chidzidzo ichi chakashandisa hutachiona hweSARS-CoV-2 hwakagadzirwa (Isolate USA-WA1/2020 NR- 52287), iyo inopisa isingashande uye yakanyudzwa mumhino swab specimen.Muganho weKuonekwa (LoD) ndeye 1.0 × 10²TCID₅₀/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity yakaongororwa nekuyedza 32 commensal uye pathogenic microorganisms inogona kunge iripo mumhino.

Hapana kuyambuka-reactivity kwakaonekwa nerecombinant MERS-CoV NP protein payakaedzwa pamusangano we50 pg / mL.

Hapana kuyambuka-reactivity kwakaonekwa nemavhairasi anotevera paakaedzwa pakusangana kwe1.0 × 106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata), Influenza B ( Victoria), Adenovirus (rudzi 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Parainfluenza virus (mhando 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Hapana kuyambuka-reactivity kwakaonekwa neanotevera mabhakitiriya paakaedzwa pakusangana kwe1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (boka A), Streptococcus pneumoniae, Candida pneumoniae, Candida Staphylococcus aureus.

Kupindira

Zvinotevera zvinogona kukanganisa zvinhu zvakaongororwa neCCIDID-19 Antigen Rapid Test Cassette (Nasal Swab) pane zvakarongwa pazasi uye zvakaonekwa zvisingakanganisi kuita kwebvunzo.

Kuisa Mushonga

Mucin 2%

Benzocaine 5 mg/mL Saline nasal spray 15%

Oxymetazoline 15%

Tobramycin 5 μg/mL Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg/mL

Fluticasone propionate 5%

Triamcinolone 10 mg/mL

Ropa rose 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

High-dose Hook Effect

Iyo COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) yakaedzwa kusvika 1.0×10⁵TCID50/mL ye inactivated SARS-CoV-2 uye hapana yakakwira-dose hook maitiro akaonekwa.

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