SARS-CoV-2 Antigen Rapid Test Cassette

ZVIRI KUSHANDISA

TheSARS-CoV-2 Antigen Rapid Test Cassetteis a quick chromatographic immunoassay for the qualitative kuonekwa kweSARS-CoV-2 antigen muvanhu Oropharyngeal swabs.Kuzivikanwa kunobva pane monoclonal antibodies chaiwo eNucleocapsid (N) Protein yeSARS-CoV-2.Inoitirwa kubatsira mu kukurumidza kusiyanisa kuongororwa kweCOVID 19utachiona.

Package Zvinotsanangurwa

25 bvunzo / paki, makumi mashanu bvunzo / paki, zana bvunzo / paki

NHUNGAMIDZO

Iyo novel coronaviruses ndeye β genus.COVID 19Chirwere chinotapukira chinotapukira. Vanhu vanowanzo batwa nechirwere ichi. Parizvino, varwere vane hutachiona hwekoronavirus ndivo vanonyanya kutapurira utachiona; vanhu vane utachiona husina hutachiona hunogonawo kutapuriranwa. Zvichienderana neongororo yazvino yechirwere ichi, nguva yekudzivirira i1 kusvika kumazuva gumi nemana, kazhinji 3 kusvika ku7 mazuva. Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma. Nasal congestion, runny mhuno, maronda ehuro, myalgia uye manyoka zvinowanikwa mune dzimwe nguva.

REAGENTS

Iyo bvunzo kaseti ine anti-SARS-CoV-2 Nucleocapsid protein particles uye anti-SARS-CoV-2 Nucleocapsid protein yakavharwa pa membrane.

ZVEKUNGWARIRIRA

Ndokumbira uverenge ruzivo rwese mune ino pasuru isa usati waita bvunzo.

1.Kushandisa in vitro diagnostic kushandiswa chete. Usashandise mushure mekupera kwezuva.

2.Muedzo unofanira kuramba uri muhomwe yakavharwa kusvika wagadzirira kushandisa.

3.Zvose zvienzaniso zvinofanira kuonekwa sezvingave zvine ngozi uye zvinobatwa nenzira imwechete semumiririri wehutachiona.

4.Muedzo wakashandiswa unofanirwa kuraswa maererano nemitemo yemunharaunda.

5.Dzivisa kushandisa sampuli dzine ropa.

6.Kupfeka magirovhosi wen uchipa samples, dzivisa kubata reagent membrane uye sampuli zvakanaka.

KUCHENGA UYE KUgadzikana

Nguva yechokwadi ndeye 18 mwedzi kana chigadzirwa ichi chakachengetwa munzvimbo ye

2-30 ℃.Muedzo wakatsiga kuburikidza nezuva rekupera nguva rakadhindwa pahomwe yakavharwa.Muedzo unofanira kuramba uri muhomwe yakavharwa kusvikira washandiswa..USAIZE.Usashandise kupfuura zuva rekupera.

SPECIMN KUCHENGA UYE KUGADZIRIRA

1.Throat secretion collection: Isai sterile swab muhuro zvachose kubva mumuromo, pakati pehuro madziro nenzvimbo yakatsvuka yemukaramo tonsils, pukuta bilateral pharyngeal tonsils uye posterior pharyngeal madziro zvine mwero.

simba, dzivisa kubata rurimi uye kubvisa swab.

2.Gadzirisa sampuli nekukasira nesample extraction solution inopiwa mukiti mushure mekunge sampu yaunganidzwa. Kana isingakwanise kugadziriswa nekukasira, sampuli inofanira kuchengetwa muvhu rakaoma, sterilized uye rakavharwa zvakasimba epurasitiki chubhu. Inogona kuchengetwa pa2-8 ℃ kwemaawa masere, uye inogona kuchengetwa kwenguva yakareba pa -70 ℃.

3. Mienzaniso yakasvibiswa zvakanyanya nemasara ezvokudya zvemuromo haigoni kushandiswa pakuongorora chigadzirwa ichi. Samples dzakaunganidzwa kubva kune swabs dzakanyanya viscous kana agglomerated hazvikurudzirwe kuongororwa chigadzirwa ichi. Kana iyo swabs yakasvibiswa nehuwandu hweropa, haina kukurudzirwa kuongororwa. Izvo hazvikurudzirwe kushandisa masampula akagadziriswa nesample yekubvisa mhinduro isina kupihwa mune ino kit yekuyedza chigadzirwa ichi.

KIT COMPONENTS

Zvinhu zvinopa

Zvinhu zvinodiwa asi kwete kupa

Zvinotsanangurwa25

bvunzo/pack50

bvunzo/pack100

bvunzo / paki Sample Extraction Reagent25 bvunzo / pack50 bvunzo / pack100 bvunzo / packKutora Sample

chubhu≥25 bvunzo/ pakiti≥50 bvunzo/ pakiti≥100 bvunzo/packInstructionRevera kune

packageRevera kune

packageRevera kune

package

MAZANO EKUSHANDISA

Bvumira bvunzo, sampuli, yekubvisa buffer kuti ienzane nekamuri tembiricha (15-30 ℃) isati yaedzwa.

1.Bvisa kaseti yekuedza kubva muhomwe yefoil yakavharwa uye shandisa mukati memaminitsi gumi nemashanu. Mhedzisiro yakanakisa ichawanikwa kana assay ikaitwa pakarepo mushure mekuvhura foil pouch.

2.Isai Extraction Tube panzvimbo yebasa.Bata bhodhoro reagent reagent wakatarisa pasi vertically. Sveta bhodhoro uye rega mhinduro yose (Approx,250μL) idonhe muchubhu yekubvisa zvakasununguka pasina kubata kumucheto kwechubhu kuKubvisa. Tube.

3.Isa mufananidzo we swab muExtraction Tube.Dzungudza swab kweinenge 10 seconds uchidzvanya musoro nechemukati mechubhu kuburitsa antigen muswab.

4.Bvisa swab paunenge uchisvina musoro nemukati meExtraction Tube uchiibvisa kuti ibudise mvura yakawanda sezvinobvira gadzira swab.Rasa swab maererano neprotocol yako yekurasa tsvina yebiohazard.

5.Fit the dropper tip pamusoro pechubhu yekubvisa.Isa test cassette panzvimbo yakachena uye yepamusoro.

6.Wedzera madonhwe maviri emushonga (approx,65μL) kumuenzaniso zvakanaka uye wobva watanga timer.Verenga mhinduro yakaratidzwa mukati memaminitsi makumi maviri-makumi matatu, uye zvigumisiro zvakaverengwa mushure memaminitsi makumi matatu hazvibvumirwi.

DUDZIRIRO YEMIZVO

Mutsara mumwe wemavara unoonekwa munharaunda yekutonga (C). Hapana mutsara unoonekwa mudunhu rekuyedza (T). Mhedzisiro isina kunaka inoratidza kuti SARS-CoV-2 antigen haisipo mumuenzaniso, kana iripo pazasi pezinga rinoonekwa rebvunzo.

POSITIVERESULT

Mitsetse miviri inooneka.mutsetse une ruvara unofanira kunge uri munharaunda yekudzora (C) uye mumwe mutsara unoonekera une ruvara unofanira kunge uri munharaunda yebvunzo (T).Mugumisiro wakanaka unoratidza kuti SARS-CoV-2 yaonekwa mumuenzaniso.

ZVINHU ZVISIVIRI

Mutsara wekudzora watadza kuoneka.Kusakwana kuenzanisa vhoriyamu kana nzira dzisiridzo dzemaitiro ndizvo zvingangove zvikonzero zvekutadza kutonga kwetambo. Ongorora maitiro uye dzokorora bvunzo nebvunzo nyowani. Kana dambudziko rikaramba riripo, regedza kushandisa test kit nekukasira uye ubate mushambadzi wenzvimbo yako.

CHERECHEDZA:

Kusimba kweruvara munharaunda yebvunzo mutsara (T) kuchasiyana zvichienderana nekusangana kweSARS-CoV-2 Antigen iripo mumuenzaniso. Naizvozvo, chero mumvuri weruvara munharaunda yebvunzo (T) inofanirwa kutorwa seyakanaka.

HUNHU KUDZORA

• A procedural control inosanganisirwa muyedzo. Mutsara weruvara unoonekwa munharaunda yekutonga (C) unoonekwa seyemukati maitiro ekutonga.Inosimbisa yakakwana membrane wicking.
• Kudzora zviyero hazvina kupihwa nekiti iyi; zvisinei, zvinokurudzirwa kuti zvidzore zvakanaka uye zvisina kunaka zviongororwe sechiito chakanaka chemurabhoritari kusimbisa maitirwo ebvunzo uye kuona mashandiro ebvunzo.

ZVIKATAURWAYEMUYEdzo

1. Iyo SARS-CoV-2 Antigen Rapid Test Cassette ndeyehunyanzvi in ​​vitro diagnostic kushandiswa chete.Muedzo unofanirwa kushandiswa kuona SARS-CoV-2 Antigen muOropharyngeal Swab.Kusina kukosha kwehuwandu kana mwero wekuwedzera muSARS- CoV-2 kusungwa kunogona kutsanangurwa neiyi bvunzo yemhando.
2. Iko kurongeka kwebvunzo kunoenderana nemhando yeiyo swab sample.Nhema dzisina kunaka dzinogona kuguma kuumba isina kufanira sampuli yekuunganidza kuchengetedza.
3. Iyo SARS-CoV-2 Antigen Rapid Test Cassette inongoratidza kuvepo kweSARS-CoV-2 mumuenzaniso kubva kune zvese zvinoshanda uye zvisingaite SARS-CoV-2 coronavirus strains.
4. Sezvinei zvese zvekuongororwa bvunzo, zvese zvawanikwa zvinofanirwa kududzirwa pamwe chete nerumwe ruzivo rwekiriniki rwunowanikwa kuna chiremba.
5. Mhedzisiro isina kunaka yakawanikwa kubva kukiti iyi inofanirwa kusimbiswa nePCR. Mhedzisiro isina kunaka inogona kuwanikwa kana kusungirirwa kweSARS-CoV-2 iripo muswab isina kukwana kana iri pazasi pedanho rinoonekwa rebvunzo.
6. Ropa rakawandisa kana nyuchi pamuenzaniso we swab inogona kukanganisa kushanda uye inogona kupa mhedzisiro yenhema.
7. Mhedzisiro yakanaka yeSARS-CoV-2 haivharidzire hutachiona hwekubatana neanther pathogen. Nokudaro mukana wehutachiona hwehutachiona husina hutachiona hunofanirwa kufungwa.
8. Mhedzisiro yakaipa haitore hutachiona hweSARS-CoV-2, kunyanya kune avo vanga vachisangana nehutachiona. Kuongororwa kwekutevera nekuongorora kwema molecular kunofanirwa kutariswa sekutonga kunze kwehutachiona muvanhu ava.
9. Mhedzisiro yakanaka inogona kunge iri nekuda kwekuvapo kwehutachiona neasiri-SARS-CoV-2 coronavirus strains, senge coronavirus HKU1, NL63, OC43, kana 229E.
10. Mhedzisiro kubva mukuongororwa kweantigen haifanirwe kushandiswa seyo chete hwaro hwekuongorora kana kusabvisa hutachiona hweSARS-CoV-2 kana kuzivisa mamiriro ehutachiona.
11. Extraction reagent ine simba rekuuraya hutachiona, asi haigoni kumisa 100% yehutachiona.Nzira yekudzivirira hutachiona inogona kutaurwa kune: ndeipi nzira inokurudzirwa neWHO / CDC, kana kuti inogona kushandiswa maererano nemitemo yemunharaunda.

PERFORMANCE CHARACTERISTICS

SensitivityuyeZvakananga

Iyo SARS-CoV-2 Antigen Rapid Test Cassette yakaongororwa nemuenzaniso wakawanikwa kubva kuvarwere.PCR inoshandiswa senzira yereferensi yeSARS-CoV-2 Antigen Rapid Test Cassette.Mienzaniso yakaonekwa seyakanaka kana PCR yakaratidza mhedzisiro yakanaka.

Relative Sensitivity :95.0%(95%CI*:83.1% -99.4%)

Zvinoenderana Nehukama:99.2%(95%CI*:97.6% -99.8%)

*Kuvimbika Nguva

Detection Limit

Kana hutachiona hwemukati hwakakura kupfuura 400TCID₅₀/ml, iyo yakanaka yekuona mwero yakakura kupfuura 95%. Kana hutachiona huri pasi pe200TCID₅₀/ml, mwero wekutarisa wakanaka uri pasi pe95%, saka iyo shoma yekuona muganho wechigadzirwa ichi ndeye 400TCID.₅₀/ml.

Precision

Mabheji matatu akateedzana emareagents akaedzwa kuti anyatso. Mabheji akasiyana emareagents akashandiswa kuyedza samu imwechete yakaipa 10 nguva dzakateedzana, uye mhedzisiro yese yaive yakaipa. Mabheji akasiyana emareagents akashandiswa kuyedza yakafanana yakanaka sampuli 10 nguva dzakateedzana, uye mhedzisiro yese yaive yakanaka.

HOOK maitiro

Kana hutachiona huri mumuenzaniso wekuongororwa hunosvika 4.0 * 10⁵TCID₅₀/ml, mhedzisiro yebvunzo haisati yaratidza HOOK maitiro.

Muchinjikwa-Reactivity

Cross-reactivity yeKit yakaongororwa. Mhedzisiro yacho yakaratidza hapana kuchinjika reactivity nemuenzaniso unotevera.

Ikukanganisa Zvinhu

Mhedzisiro yebvunzo haikanganiswe nechinhu ichi pane inotevera kuunganidzwa:

IBIBLIOGRAPHY

1.Weiss SR,Leibowitz JZ.Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164
2.Cui J,Li F,Shi ZL.Mavambo uye kushanduka kwepathogenic coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, uye pathogenesis yemakona. TrendsMicrobiol 2016;24:490-502.