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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 wekutonga (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.

DUDZIRIRO YEMIZVO

Positive

C T

Mitsetse miviri inooneka.Mutsara mumwe weruvara unoonekwa wekusimba kwemutsetse webvunzo.

Negative

Mutsara mumwe weruvara unoonekwa padunhu rekutonga (C), uye hapana mutsara unoonekwa munzvimbo yekuyedza (T).

Hazvina basa

C T

Kudzora line anokundikana to oneka. Kusakwana specimen vhoriyamu kana zvisirizvo maitiro emaitiro ndizvo zvinonyanya zvikonzero zvekutadza kwekudzora mutsara.Ongorora maitiro uye dzokorora bvunzo uchishandisa kaseti nyowani yekuyedza.Kana dambudziko rikaramba riripo, rega kushandisa mijenya nekukasira uye bata muparidzi wenzvimbo yako.

HUNHU KUDZORERA

A procedural control inosanganisirwa muyedzo.Mutsara weruvara unoonekwa munharaunda yekutonga (C) unoonekwa seyemukati maitiro ekudzora.Iyo inosimbisa yakakwana yemuenzaniso vhoriyamu, yakakwana membrane wicking uye inogadzirisa maitiro maitiro.

Kudzora zviyero hazvina kupihwa nekiti iyi.Nekudaro, zvinokurudzirwa kuti zvidzore zvakanaka uye zvisina kunaka zviongororwe seyakanaka marabhoritari tsika yekusimbisa maitiro ebvunzo uye kuona kwakaringana kuita kwebvunzo.

ZVIKATAURWA

•Chigadzirwa chacho chinogumira kuti chipe hunhu hwekuona.Kusimba kwemutsara wekuedza hakurevi kuenderana nekusangana kweantigen yezvienzaniso.

•Zvabuda zvisina kunaka hazvidziviriri utachiona hweSARS-CoV-2 uye kana zviratidzo zviripo unofanira kutsvaga kumwe kuongororwa nekukasika Via PCR Method.

• Chiremba anofanira kududzira migumisiro pamwe chete nenhoroondo yemurwere, zvakawanikwa mumuviri, uye mamwe maitiro ekuongorora.

• Mhedzisiro yakaipa yakawanikwa kubva muKit iyi inofanirwa kusimbiswa nePCR.Mhedzisiro yakaipa inogona kuitika kana huwandu hweSARS-CoV-2 antigens huripo mumuenzaniso huri pazasi penzvimbo yekuona yeassay, kana hutachiona hwakaita diki maamino acid mutation (s) munharaunda yepitope inocherechedzwa nemonoclonal antibodies. inoshandiswa mukuedza.

•Ropa rakawandisa kana machuru pamuenzaniso we swab anogona kukanganisa kushanda uye anogona kupa mhedzisiro yenhema.

PERFORMANCE CHARACTERISTICS

Clinical Performance

COVID-19 antigen		RT-PCR		Totale
COVID-19 antigen		Positive	Negative	Totale
HEO®	Positive	212	0	212
HEO®	Negative	3	569	572
Total		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Specific) 95% *Kuvimbana Kwenguva

Mazuva kubva chiratidzo	RT-PCR	HEO TECHNOLOGY	Chibvumirano(%)
0-3	95	92	96.84%
4-7	120	120	100%

CT Kukosha	RT-PCR	HEO TECHNOLOGY	Chibvumirano(%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
＜37	9	7	77.78%

Muganho Wekuonekwa (Analytical Sensitivity)

Chidzidzo ichi chakashandisa hutachiona hweSARS-CoV-2 hwakagadzirwa, husina kupisa husingashandiswe uye hwakapinzwa mumhuno swab specimen.Muganhu weKuonekwa (LoD) ndeye 1.0 ×102 TCID50/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 (H7N9), 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, Albicans Staphylococcus aureus.

Kupindira

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

Substance	Concentration	Substance	Concentration
Mucin	2%	Ropa rose	4%
Benzocaine	5 mg/mL	Menthol	10 mg/mL
Saline nasal spray	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/mL
Tobramycin	5 μg/mL	Zanamivir	5 mg/mL
Oseltamivir phosphate	10 mg/mL	Ribavirin	5 mg/mL
Arbidol	5 mg/mL	Dexamethasone	5 mg/mL
Fluticasone propionate	5%	Histamine dihydrochloride	10 mg/mL
Triamcinolone	10 mg/mL	Histamine dihydrochloride	10 mg/mL

High-dose Hook Effect

Iyo COVID-19 Antigen Rapid Test Cassette (Colloidal Goridhe) yakaedzwa kusvika pa1.0 × 10 5 TCID50 /mL yeiyo inactivated SARS-CoV-2 uye hapana yakakwira-dose hook maitiro akaonekwa.

Mubvunzo Unowanzo bvunzwa

1.Ko iyo SARS-CoV-2 Antigen Rapid Test inoshanda sei?Muedzo ndewekuonekwa kwemhando yeSARS-CoV-2 maantigen mune ega-akaunganidza swab samples.Mhedzisiro yakanaka inoratidza SARS-CoV-2 maantigens aripo mumuenzaniso.

Kuedza kunofanira kushandiswa riini?

SARS-CoV-2 antigen inogona kuwonekwa mune acute kufema turakiti kutapukira, zvinokurudzirwa kumhanyisa bvunzo kana zviratidzo zvinosanganisira kamwe kamwe kutanga kweimwe yeinotevera: kukosora, fivha, kupfupika kwekufema, kuneta, kuderera kwechido, myalgia.

Mugumisiro wacho ungave usina kururama here?

Migumisiro yacho yakarurama kusvika pakuremekedzwa kwemirayiridzo.Zvakadaro, mhedzisiro inogona kunge isiriyo kana vhoriyamu yesampling isina kukwana kana SARS-CoV-2 Antigen Rapid Test ikanyorova isati yaita bvunzo, kana huwandu hwemadonhwe ekubvisa buffer ari pasi pe3 kana kupfuura 4. Kunze kwezvo, nekuda kwemitemo yeimmunological inobatanidzwa, kune mikana yemigumisiro yenhema muzviitiko zvisingawanzoitiki.Kubvunzurudza nachiremba nguva dzose kunokurudzirwa kuongororwa kwakadaro kunobva pamitemo yeimmunological.

Nzira yekududzira sei muedzo kana ruvara uye kusimba kwemitsara zvakasiyana?Ruvara uye kusimba kwemitsara hakuna kukosha pakududzira mhedzisiro.Mitsetse yacho inofanira kuva yakafanana uye inooneka zvakajeka.Muedzo unofanirwa kutariswa sewakanaka chero kusimba kwemavara emutsetse webvunzo.5.Chii chandinofanira kuita kana chigumisiro chisina kunaka?

Mhedzisiro isina kunaka inoreva kuti hauna hutachiona kana kuti huwandu hwehutachiona hwakaderera

kuti ndizivikanwe nebvunzo.Nekudaro, zvinogoneka kuti bvunzo iyi ipe mhedzisiro isiriyo (yenhema negative) mune vamwe vanhu vane COVID-19.Izvi zvinoreva kuti unogona kunge uchine COVID-19 kunyangwe bvunzo yacho isina kunaka.

Kana ukaona zviratidzo zvakadai sekutemwa nemusoro, migraines, fivha, kurasikirwa nekunzwa kunhuwa uye kuravira, taura nechipatara chiri pedyo uchishandisa mitemo yehurumende yako.Pamusoro pezvo, unogona kudzokorora bvunzo nekiti nyowani yekuyedza.Kana paine fungidziro, dzokorora bvunzo mushure memazuva 1-2, sezvo coronavirus isinganyatso kuoneka muzvikamu zvese zvehutachiona.Kureba uye mitemo yehutsanana inofanira kuramba ichicherechedzwa.Kunyangwe paine mhedzisiro yakaipa yebvunzo, chinhambwe uye mitemo yehutsanana inofanirwa kucherechedzwa, kutama/kufamba, kuenda kuzviitiko uye nezvimwe zvinofanirwa kutevedzera zvirevo/zvinodiwa zveCCIDID.6.Chii chandinofanira kuita kana chigumisiro chiri chakanaka?

Mhedzisiro yakanaka inoreva kuvapo kweSARS-CoV-2 antigens.Mhedzisiro yakanaka zvinoreva kuti unogona kunge uine COVID-19.Ibva wangozviparadzanisa nevamwe zvinoenderana negwara renzvimbo uye nekukasira taura nachiremba wako / chiremba kana dhipatimendi rehutano remunharaunda maererano nemirayiridzo yevakuru venzvimbo yako.Mhedzisiro yako yebvunzo inotariswa nePCR yekusimbisa bvunzo uye iwe unozotsanangurwa matanho anotevera.