China SARS-CoV-2 Antigen Rapid Test(mhino) vagadziri uye vatengesi |Liming Bio

SARS-CoV-2 Antigen Rapid Test (nasal)

Tsanangudzo Pfupi

REF	500200	Tsanangudzo	1 Miedzo/Bhokisi;5 Miedzo/bhokisi; 20 Miedzo/bhokisi
Kuona musimboti	Immunochromatographic assay	Sayenzi	Anterior nasal swab
Chinangwa Kushandiswa	StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette inoshandisa immunochromatography tekinoroji kuona iyo SARS- CoV-2 nucleocapsid antigen mumunhu anterior nasal swab specimen.Iyi testis inoshandiswa kamwe chete uye yakagadzirirwa kuzviongorora wega.Zvinokurudzirwa kushandisa bvunzo iyi mukati memazuva mashanu kubva pakatanga chiratidzo.Inotsigirwa nekliniki yekuongorora maitiro.

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Chigadzirwa chine yakasarudzika mumiriri muNew Zealand.Kana iwe uchida kutenga, iyo yekuonana nayo ndeiyi inotevera:
Mick Dienhoff
General Manager
Nhamba dzenhare: 0755564763
Nharembozha: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz

ZVIRI KUSHANDISA
StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette inoshandisa immunochromatography tekinoroji kuona iyo SARS- CoV-2 nucleocapsid antigen mumunhu anterior nasal swab specimen.Iyi testis inoshandiswa kamwe chete uye yakagadzirirwa kuzviongorora wega.Zvinokurudzirwa kushandisa bvunzo iyi mukati memazuva mashanu kubva pakatanga chiratidzo.Inotsigirwa nekliniki yekuongorora maitiro.

NHUNGAMIDZO
Iyo novel coronaviruses ndeye totiie p genus.COVID-19 chirwere chekufema chinotapukira.Vanhu vanowanzo batwa nechirwere ichi.Parizvino, varwere vakatapukirwa nenovel cxjronavinis ndivo vanonyanya kutapurira utachiona;asymptomatic vanhu vane hutachiona vanogona zvakare kuve hutachiona hwehutachiona.Kubva pane 1hezvino epidemiological tsvakurudzo, nguva ye incubation izuva 1 kusvika ku14, kunyanya mazuva matatu kusvika ku7.Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma.Nasal congestion, runny mhuno, kurwadziwa kwehuro, myalgia uye manyoka zvinowanikwa mune zvishoma.

PRINCIPLE
Iyo StrongStep® SARS-CoV-2 Antigen Test inoshandisa immunochromatographic bvunzo.Latex conjugated antibodies (Latex-Ab) inoenderana neSARS-CoV-2 yakaoma-inomira pakupera kwenitrocellulose membrane strip.SARS-CoV-2 masoja ekudzivirira chirwere anosungwa paTest Zone (T) uye Biotin-BSA iri bond kuControl Zone (C).Kana sampu yawedzerwa, inotama necapillary diffusion ichidzoreredza iyo latex conjugate.Kana iripo mumuenzaniso, SARS-CoV-2 maantigens anosunga neakabatana masoja ekudzivirira chirwere achigadzira zvimedu.Zvimedu izvi zvicharamba zvichifamba zvichitevedza tambo kusvika Test Zone (T) kwadzinotorwa neSARS-CoV-2 masoja ekudzivirira chirwere achigadzira mutsara mutsvuku unooneka.Kana pasina SARS-CoV-2 maantigen mumuenzaniso, hapana mutsara mutsvuku unoumbwa muTest Zone (T).Iyo streptavidin conjugate icharamba ichitama yega kusvikira yabatwa muDhipatimendi Rokudzora (C) neBiotin-BSA inounganidza mumutsara webhuruu, iyo inoratidza chokwadi chekuedza.

KIT COMPONENTS

1 bvunzo / bhokisi; 5 miedzo / bhokisi:

Yakavharwa foil homwe yakazara bvunzo zvishandiso	Chishandiso chega chega chine tambo ine mavara conjugates uye reactive reagents pre-yakapararira kumatunhu anoenderana.
Dilution Buffer vials	0.1 M Phosphate buffered saline (PBS) uye 0.02% sodium azide.
Extraction Tubes	Kushandisa mienzaniso yekugadzirira.
Packs of swab	Zvekuunganidza sampuli.
Workstation	Nzvimbo yekubata buffer vials nemachubhu.
Pakeji isa	Kurairirwa kushanda.

20 miedzo / bhokisi

20 ega akarongedzerwa bvunzo zvishandiso	Chishandiso chega chega chine tambo ine mavara conjugates uye reactive reagents pre-yakapararira pane inoenderana reqions.
2 Extraction Buffer vials	0.1 M Phosphate buffered saline (P8S) uye0.02% sodium azide.
20 Machubhu ekubvisa	Kushandisa mienzaniso yekugadzirira.
1 Workstation	Nzvimbo yekubata buffer vials nemachubhu.
1 Package isa	Kurairirwa kushanda.

ZVINHU ZVINODIWA ASI ZVISINA KUPIWA

Timer	Yekushandisa nguva.
Chero chipi zvacho chinodiwa chekuzvidzivirira nacho

ZVEKUNGWARIRIRA

-Iyi kit ndeye IN VITRO yekuongorora kushandiswa chete.

Verenga mirairo zvakanaka usati waita bvunzo.
Ichi chigadzirwa hachina chero zvinhu zvemunhu.

-Usashandise kit zviri mukati mushure mekupera kwezuva.

Pfeka magirovhosi panguva yese yekuita.

KUCHENGA UYE KUgadzikana

Iwo mahomwe akavharirwa mutest kit anogona kuchengetwa pakati pe2-30 C kwenguva yese yehupenyu hwesherufu sezvakaratidzwa pahomwe.

SPECIMN KUCHENGA UYE KUCHENGETA

Anterior nasal swab sample inogona kuunganidzwa kana neIndividual perfofmlng a self-swab.

Vana vari pasi pemakore gumi nemasere, vanofanirwa kuitwa nekutariswa kwavo neaduK.Vakuru vane makore 18 zvichikwira vanogona kuita anterior nasal swab vari voga.Ndokumbira uteedzere nhungamiro yemunharaunda yako yekutorwa kwemuenzaniso nevana.

, Isai swab imwe mumhino imwe yemurwere.The swab tip inofanira kuiswa kusvika 2.5 cm (1 inch) kubva kumucheto kwemhino.Rongedza swab kashanu uchitenderedza mucosa mukati memhino kuti uve nechokwadi chekuti zvese nemaseru zvakaunganidzwa.

• Shandisa swab imwe chete, dzokorora nzira iyi kune imwe mhino kuti uone kuti muenzaniso wakakwana watorwa kubva mumaburi ose emhino.

Zvinokurudzirwa kuti zvienzanise zviveprocessednekukurumidza sezvinobvira mushure mekuunganidza.Mienzaniso inogona kuchengetwa mumudziyo uptol awa pa tembiricha yaamai (15°C kusvika 30″), kana kusvika maawa makumi maviri nemana kana rsfrigeratod (2°C kusvika 8°C).^eC) isati yagadziriswa.

PROCEDURE

Huya nemidziyo yekuyedza, zvienzaniso, buffer uye/kana zvidzoreso kune tembiricha yemumba (15-30°C) usati washandisa.

♦Plac® iyo yakaunganidzwa specimen Extraction chubhu munzvimbo yakatarwa yenzvimbo yekushandira.

♦Svina ese Dilution Buffer muext radion chubhu.

♦Isa specimen swab muchubhu.Sanganisa zvine simba mhinduro nekutenderedza swab zvine simba padivi pechubhu kwenguva dzinenge gumi neshanu (ichiri pasi pemvura).Mhedzisiro yakanakisa inowanikwa kana sampuli yakasanganiswa zvine simba mumhinduro.

♦Bvumira swab kunyura muKubvisa Buffer kweminiti imwe isati yasvika Danho rinotevera.

♦Svina mvura yakawanda sezvinobvira kubva muswabhi nekudzvanya padivi pechubhu inochinjika yekubvisa sezvo swab inobviswa.Inenge 1/2ofttie sampuli yebuffer mhinduro inofanira kuramba iri muchubhu kuitira kuti capillary mig yakakwana iite.Isa chivharo pachubhu yakabviswa.

♦Rasa swab mune yakakodzera biohazardous tsvina mugaba.

♦Mienzaniso yakabviswa inogona kuchengetedza mukamuri tembiricha kwemaminetsi makumi matatu pasina kukanganisa mhedzisiro yebvunzo.

♦Bvisa ths test mudziyo kubva muhomwe yayo yakavharwa, woiisa pane dean, pamwero wepamwero.Nyora mudziyo nemurwere kana chitupa chekudzora.Kuti uwane mhedzisiro yakanaka, kuyedza kunofanirwa kuitwa mukati memaminitsi makumi matatu.

♦Wedzera madonhwe matatu (angangoita zana pL) emuenzaniso wakatorwa kubva muExtraction Tube kune yakatenderedza sampu pamudziyo wekuyedza.

Dzivisa kuteya mabhuru emhepo Mumuenzaniso mutsime (S), uye usadonhedze chero mhinduro Mukutarisa hwindo.Sezvo bvunzo inotanga kushanda, iwe uchaona ruvara ruchifamba nepakati pe membrane.

♦Wart kuti mabhendi ane mavara aoneke.Chigumisiro chinofanira kuverengwa nekuona pa 15 minutas.Usadudzire mhinduro mushure memaminitsi makumi matatu.

•Isa chubhu yekuyedza ine swab uye mudziyo wekuyedza washandiswa Mubhegi rakanamirwa rebiohazard woinama, wobva wairasa mumudziyo unokodzera marara ebiohazard.Worasa Zvinhu zvasara

•Gezamaoko ako kana kuzorazve sanitizer yeruoko.

Rasa akashandiswa Extraction Tubes uye Test Devices mune yakakodzera biohazardous tsvina mugaba.

DUDZIRIRO YEMIZVO

ZVIKAMUDZISWA PAMUEDZO

1- Iyo kit inoitirwa kushandiswa kuona yemhando yeSARS-CoV-2 antigens kubva kuNasal.
2.Muedzo uyu unoona zvese zvinogoneka (kurarama) uye zvisingaite SARS-CoV-2.Kuitwa kwebvunzo kunoenderana nehuwandu hwehutachiona (antigen) mumuenzaniso uye inogona kana kusagona kuenderana nehutachiona hwetsika nemhedzisiro yakaitwa pamuenzaniso mumwe chete.
3.A negative teat result inogona kuitika kana chiyero che antigen mumuenzaniso chiri pasi peyero yekuona yekuongorora kana kana sampuli yakaunganidzwa kana kutakurwa zvisina kunaka.
4.Kutadza kutevedzera Test Procedure kunogona kukanganisa kuita kwebvunzo uye/kana kuita kuti bvunzo dzipere.
5.Kuongororwa kwemigumisiro inofanira kuwirirana nenhoroondo yekiriniki, epidemiological data, uye imwe data inowanikwa kune chiremba anoongorora murwere.
6.Positive test results haiti kubvisa co-infections nemamwe zvirwere.
7.Negative test results haisi chinangwa chekutonga mune dzimwe dzisiri dzeSARS hutachiona hwehutachiona kana hutachiona.
8.Negative migumisiro kubva kuvarwere vane zviratidzo zvinotanga kupfuura mazuva manomwe, inofanira kubatwa sekufungidzira uye yakasimbiswa neFDA yemunharaunda inobvumirwa molecular assay, kana zvichidiwa, yehutano hwehutano, kusanganisira kutonga kwehutachiona.
9.Specimen kugadzikana kurudziro yakavakirwa pakugadzikana kwedata kubva mukuyedzwa furuwenza uye kuita kungave © kwakasiyana neSARS-CoV-2.Vashandisi vanofanirwa kuyedza zvidhori nekukurumidza sezvinobvira mushure mekuunganidzwa kwemuenzaniso.
10.Kunzwa kweRT-PCR assay mukuongororwa kweCCIDID-19 ingori 50% -80% nekuda kwehurombo hwemhando yemhando kana chirwere chenguva padanho rakadzoreswa, etc.SARS-CoV-2 Antigen Rapid Test Device's sensitivity inofungidzirwa. yakaderera nekuda kwemaitiro ayo.
11.Kuti uwane hutachiwana hwakakwana, zvinokurudzirwa kushandisa mabhii maviri kana kupfuura kuti uunganidze nzvimbo dzakasiyana-siyana dzemuenzaniso uye kubvisa zvose zvakasarudzwa swab muchubhu imwechete.
12.Positive and negative predictive values zvinonyanya kutsamira pahuwandu hwehuwandu.
13.Positive bvunzo mhinduro dzinowanzo kumiririra nhema mhedzisiro panguva yediki ini ndisina SARS-CoV-2 chiitiko kana huwandu hwechirwere hushoma. Mamiriro ekunyepa asina kunaka anowanzoitika kana kupararira kwechirwere chinokonzerwa neSARS-CoV-2 kuchiitika. high.
14.Masoja ekudzivirira emuviri anogona kutadza kuona, kana kuona nekunzwa kushoma, SARS-CoV-2 utachiona hwefuruwenza hwakaita shanduko diki dzeamino acid munharaunda yepitope yakanangwa.
15.Kuitwa kwemuedzo uyu hakuna kuongororwa kuti ishandiswe kune varwere vasina zviratidzo uye zviratidzo zvehutachiona hwekufema uye kuenzanisa kunogona kusiyana muvanhu vasina zviratidzo.
16.Kuwanda kweantigen Mumuenzaniso kunogona kuderera sezvo nguva yeKurwara Kunowedzera.Mienzaniso inounganidzwa mushure mezuva rechishanu rechirwere inowanzove isina kunaka kana ichienzaniswa neRT-PCR assay.
17.Sensitivity yekuedzwa mushure memazuva mashanu ekutanga ekutanga kwezviratidzo zvakaratidzwa kuderera kana zvichienzaniswa neRT-PCR assay.
18. Zvinokurudzirwa kushandisa StrongStep® SARS-CoV-2 IgM/IgG antibody nekukurumidza bvunzo (caW 502090) kuona masoja ekudzivirira chirwere kuti awedzere kunzwa kwekuongororwa kweCCIDID-19.
19.Hazvikurudzirwe kushandisa Virus Transportation medla(VTM) specimen Mubvunzo uyu, Kana vatengi Vakaramba kushandisa iyi sampuli mhando, vatengi vanofanirwa kuzvisimbisa ivo pachavo.
20.Iyo StrongStep® SARS-CoV-2 Antigen Rapid Test yakasimbiswa nemaswabhu akapihwa mukiti.Kushandiswa kwedzimwe swabs kunogona kuguma Mune mhedzisiro yenhema.
21.Kugara uchiyedzwa kunodiwa kuti uwedzere kunzwisiswa kwekuongororwa kweCCIDID-19.
22.Hapana kudonha kwekunzwa kana zvichienzaniswa nemhando yesango ine rasp kune anotevera akasiyana - VOC1 Kent, UK, B.1.1.7 uye VOC2 South Africa, B.1.351.

23 Chengeta kure nevana.
24. Mhedzisiro yakanaka inoratidza kuti maantigen ehutachiona akaonekwa mumuenzaniso wakatorwa, ndapota Self-quarantine uye Zivisa chiremba wemhuri yako nekukurumidza.

Iyo kambani Nanjing Liming Bio-Products Co., Ltd.
Nhamba 12 Huayuan Road, Nanjing, Jiangsu, 210042 PR China.
Tel: +86(25) 85288506
Fax: (0086)25 85476387
E-mail:sales@limingbio.com
Webhusaiti: www.limingbio.com
Technical support: poct_tech@limingbio.com

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