SARS-CoV-2 Antigen Rapid Test Cassette

ZOYENERA KUGWIRITSA NTCHITO

TheSARS-CoV-2 Antigen Rapid Test Cassettendi chromatographic immunoassay yofulumira kuti izindikire bwino za antigen ya SARS-CoV-2 mu swabs za Oropharyngeal zamunthu. mofulumira kusiyana matenda aCOVID 19matenda.

Tsatanetsatane wa Phukusi

25 mayeso / paketi, 50 mayeso / paketi, 100 mayeso / paketi

MAU OYAMBA

Ma coronaviruses atsopano ndi a mtundu wa β.COVID 19Pakali pano, odwala omwe ali ndi kachilombo ka coronavirus ndiye gwero lalikulu la matenda; anthu omwe ali ndi kachilombo koyambitsa matenda amathanso kukhala gwero lopatsirana. kwa masiku 14, makamaka 3 mpaka 7 masiku.The mawonetseredwe aakulu monga malungo, kutopa ndi youma chifuwa.Kutsekeka kwa mphuno, mphuno, zilonda zapakhosi, myalgia ndi kutsekula m'mimba zimapezeka nthawi zingapo.

REAGENTS

Kaseti yoyeserera ili ndi tinthu tating'onoting'ono ta anti-SARS-CoV-2 Nucleocapsid ndi anti-SARS-CoV-2 Nucleocapsid mapuloteni okutidwa pa nembanemba.

KUSAMALITSA

Chonde werengani zonse zomwe zili mu phukusili musanachite mayeso.

1.Kwa akatswiri mu vitro diagnostic ntchito kokha.Osagwiritsa ntchito pambuyo pa tsiku lotha ntchito.

2.Mayeso amayenera kukhala muthumba losindikizidwa mpaka atakonzeka kugwiritsidwa ntchito.

3.Zitsanzo zonse ziyenera kuganiziridwa kuti zingakhale zoopsa ndikusamalidwa mofanana ndi wothandizira matenda.

4.Mayeso ogwiritsidwa ntchito ayenera kutayidwa malinga ndi malamulo a m'deralo.

5.Pewani kugwiritsa ntchito zitsanzo zamagazi.

6.Valani magolovesi mukupereka zitsanzo, pewani kukhudza nembanemba ya reagent ndi chitsanzo bwino.

KUSINTHA NDI KUKHALA

Nthawi yovomerezeka ndi miyezi 18 ngati mankhwalawa asungidwa m'malo a

2-30 ℃.Mayesowa ndi okhazikika kupyola tsiku lotha ntchito losindikizidwa pathumba losindikizidwa.Mayeso amayenera kukhala muthumba losindikizidwa mpaka atagwiritsidwa ntchito..OSATI KUZIMISA.Osagwiritsa ntchito kupitirira tsiku lotha ntchito.

KUSONGA ZINTHU NDI KUKONZEKERA

1. Kutulutsa kwapakhosi: Lowetsani chofufumitsa chopanda pakhosi kuchokera mkamwa, chokhazikika pakhoma la mmero ndi malo ofiira a mkamwa, pukutani matani a pharyngeal ndi khoma lakumbuyo kwa pharyngeal

mphamvu, pewani kukhudza lilime ndi kuchotsa swab.

2.Chotsani chitsanzocho nthawi yomweyo ndi njira yothetsera chitsanzo yomwe imaperekedwa muzitsulo pambuyo posonkhanitsa chitsanzo.Ngati sichingasinthidwe nthawi yomweyo, chitsanzocho chiyenera kusungidwa mu chubu chapulasitiki chouma, chosawilitsidwa komanso chosindikizidwa kwambiri.Zitha kusungidwa pa 2-8 ℃ kwa maola 8, ndipo zitha kusungidwa kwa nthawi yayitali pa -70 ℃.

3. Zitsanzo zomwe zaipitsidwa kwambiri ndi zotsalira zapakamwa sizingagwiritsidwe ntchito poyesa mankhwalawa.Zitsanzo zomwe zasonkhanitsidwa kuchokera ku swabs zomwe zili zowoneka bwino kwambiri kapena zophatikizika sizovomerezeka kuyesa mankhwalawa.Ngati ma swabs ali oipitsidwa ndi magazi ambiri, savomerezedwa kuti ayesedwe.Sitikulimbikitsidwa kugwiritsa ntchito zitsanzo zomwe zimakonzedwa ndi njira yotulutsira zitsanzo zomwe sizinaperekedwe mu chida ichi poyesa mankhwalawa.

ZAMBIRI ZA KIT

Zipangizo zimapereka

Zofunika koma osapereka

Zofotokozera25

mayeso/paketi50

mayeso/paketi100

mayeso / paketiSample m'zigawo Reagent25 mayesero / paketi50 mayeso / paketi100 mayeso / paketi Zitsanzo m'zigawo

chubu≥25 tests/pack≥50 tests/pack≥100 test/packInstructionPezani ku

phukusi Onani ku

phukusi Onani ku

phukusi

MALANGIZO OGWIRITSA NTCHITO

Lolani kuyesa, chitsanzo, chotchinga chotsitsa kuti chifanane ndi kutentha kwachipinda (15-30 ℃) musanayesedwe.

1. Chotsani makaseti oyesera m'thumba losindikizidwa ndikugwiritsa ntchito mkati mwa mphindi 15.Zotsatira zabwino zingapezeke ngati kuyesako kuchitidwa mwamsanga mutangotsegula thumba la zojambulazo.

2.Ikani chubu cha Extraction mu malo ogwirira ntchito. Gwirani botolo la reagent yochotsa mozondoka molunjika. Finyani botolo ndikulola kuti yankho lonse (Approx,250μL) ligwere mu chubu chotulutsa momasuka popanda kukhudza m'mphepete mwa chubu kupita ku Extraction. Chubu.

3.Ikani chitsanzo cha swab mu Extraction Tube.Tembenuzani swab kwa masekondi pafupifupi 10 pamene mukukanikiza mutu mkati mwa chubu kuti mutulutse antigen mu swab.

4.Chotsani swab pamene mukufinya mutu wa swab mkati mwa Extraction Tube pamene mukuchotsa kuti mutulutse madzi ambiri momwe mungathere kupanga swab.Tayani swab mogwirizana ndi ndondomeko yanu ya kutaya zinyalala za biohazard.

5.Gwiritsani nsonga ya dropper pamwamba pa chubu chochotsa.Ikani kaseti yoyesera pamalo oyera komanso apamwamba.

6.Onjezani madontho a 2 a yankho (pafupifupi, 65μL) ku chitsanzo bwino ndikuyambitsa nthawi.Werengani zotsatira zowonetsera mkati mwa mphindi 20-30, ndipo zotsatira zomwe zimawerengedwa pambuyo pa mphindi 30 ndizosavomerezeka.

KUMASULIRIDWA KWA ZOTSATIRA

Mzere umodzi wachikuda umapezeka muchigawo cha mzere wowongolera (C).Palibe mzere womwe umapezeka mdera loyeserera (T). Zotsatira zoyipa zikuwonetsa kuti antigen ya SARS-CoV-2 palibe pachitsanzocho, kapena ilipo pansi pamlingo wozindikirika wa mayesowo.

ZABWINOZOTSATIRA:

Mizere iwiri ikuwonekera.mzere wachikuda umodzi uyenera kukhala m'chigawo chowongolera (C) ndipo mzere wina wowoneka wamitundu uyenera kukhala m'chigawo choyesera (T). Zotsatira zabwino zikuwonetsa kuti SARS-CoV-2 idapezeka pachitsanzocho.

ZOTSATIRA ZAKE:

Mzere wowongolera walephera kuwonekera.Kusakwanira kwachitsanzo kwachitsanzo kapena njira zolakwika ndi zifukwa zomwe zimalepheretsa mzere wowongolera.Unikaninso ndondomekoyi ndikubwereza mayesowo ndi mayeso atsopano.Vuto likapitilira, siyani kugwiritsa ntchito zida zoyeserera nthawi yomweyo ndipo funsani wofalitsa wapafupipafupi.

ZINDIKIRANI:

Kuchuluka kwa mtundu wamtundu wa test line (T) kumasiyana malinga ndi kuchuluka kwa SARS-CoV-2 Antigen komwe kuli pachitsanzocho.Chifukwa chake, mtundu uliwonse wamtundu wamtundu woyeserera (T) uyenera kuwonedwa ngati wabwino.

KUKHALA KWAKHALIDWE

• Kuwongolera kwadongosolo kumaphatikizidwa muyeso.Mzere wachikuda womwe ukuwonekera m'chigawo chowongolera (C) umatengedwa ngati njira yowongolera mkati. Imatsimikizira kupukuta kokwanira kwa membrane.
• Miyezo yowongolera siyikuperekedwa ndi zida izi;komabe, tikulimbikitsidwa kuti ziwongolero zabwino ndi zoyipa ziyesedwe ngati njira yabwino ya labotale kutsimikizira njira yoyezera ndikuwonetsetsa momwe mayeso akuyendera.

ZOPHUNZITSAZA MAYESERO

1. TheSARS-CoV-2 Antigen Rapid Test CassetteMayesowa ayenera kugwiritsidwa ntchito pozindikira SARS-CoV-2 Antigen mu Oropharyngeal Swab. Palibe kuchuluka kapena kuchuluka kwa kuchuluka kwa SARS-CoV-2 ndende sikungadziwike ndi mtundu uwu. mayeso.
2. Kulondola kwa mayeso kumadalira mtundu wa swab sample.Zoyipa zabodza zitha kupanga kusungirako kolakwika kwachitsanzo.
3. Makaseti a SARS-CoV-2 Antigen Rapid Test Cassette amangowonetsa kupezeka kwa SARS-CoV-2 pachitsanzo kuchokera ku mitundu yonse ya SARS-CoV-2 coronavirus yotheka komanso yosatheka.
4. Mofanana ndi mayesero onse ozindikira matenda, zotsatira zonse ziyenera kutanthauziridwa pamodzi ndi zidziwitso zina zachipatala zomwe dokotala angapeze.
5. Zotsatira zoyipa zomwe zapezedwa kuchokera ku zidazi ziyenera kutsimikiziridwa ndi PCR. Zotsatira zoyipa zitha kupezeka ngati kuchuluka kwa SARS-CoV-2 komwe kuli mu swab sikuli kokwanira kapena kuli pansi pamlingo wozindikirika wa mayeso.
6. Magazi ochulukirapo kapena ntchofu pachitsanzo cha swab amatha kusokoneza magwiridwe antchito ndipo atha kutulutsa zotsatira zabodza.
7. Zotsatira zabwino za SARS-CoV-2 sizimaletsa kufalikira komwe kumachitika ndi anther pathogen.Chifukwa chake kuthekera kwa matenda a bakiteriya osakhazikika kuyenera kuganiziridwa.
8. Zotsatira zoyipa sizimaletsa matenda a SARS-CoV-2, makamaka kwa omwe adakumana ndi kachilomboka.Kuyezetsa kotsatira ndi kufufuza kwa maselo kuyenera kuganiziridwa kuti kuthetse matenda mwa anthuwa.
9. Zotsatira zabwino zitha kukhala chifukwa chopezeka ndi matenda a coronavirus omwe si a SARS-CoV-2, monga coronavirus HKU1, NL63, OC43, kapena 229E.
10. Zotsatira zochokera pakuyezetsa ma antigen siziyenera kugwiritsidwa ntchito ngati njira yokhayo yodziwira kapena kupatula matenda a SARS-CoV-2 kapena kudziwitsa matenda.
11. M'zigawo reagent amatha kupha kachilomboka , koma sangathe inactivate 100% ya virus.The njira inactivating HIV angatchulidwe: ndi njira akulimbikitsidwa ndi WHO/CDC, kapena izo zikhoza kuchitidwa molingana ndi malamulo m'deralo.

ZINTHU ZOCHITIKA

KumvererandiMwatsatanetsatane

Makaseti a SARS-CoV-2 Antigen Rapid Test Cassette adawunikidwa ndi zitsanzo zopezedwa kuchokera kwa odwala.PCR imagwiritsidwa ntchito ngati njira yolozera ya SARS-CoV-2 Antigen Rapid Test Cassette.Zitsanzo zidawonedwa ngati zabwino ngati PCR iwonetsa zotsatira zabwino.

Kutengeka Kwachibale :95.0%(95%CI*:83.1%-99.4%)

Zachibale:99.2%(95%CI*:97.6% -99.8%)

*Nthawi za Chidaliro

Kuzindikira malire

Pamene kachilombo kameneka kakuposa 400TCID₅₀/ml, chiwopsezo chodziwika bwino ndi chachikulu kuposa 95%.Pamene kachilombo kameneka kamakhala kosakwana 200TCID₅₀/ ml, kuchuluka kwazomwe zimadziwika ndi zosakwana 95%, ndiye kuti malire ochepera a mankhwalawa ndi 400TCID.₅₀/ml.

Kulondola

Magulu atatu otsatizana a reagents adayesedwa molondola.Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zoyipa zomwezo nthawi 10 motsatizana, ndipo zotsatira zake zonse zinali zoipa.Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zabwino zomwezo ka 10 motsatizana, ndipo zotsatira zake zonse zinali zabwino.

HOOK zotsatira

Pamene kachilombo kamene kali mu chitsanzo kuti ayezedwe kufika pa 4.0 * 10⁵TCID₅₀/ml, zotsatira zake sizikuwonetsa zotsatira za HOOK.

Cross-Reactivity

Cross-reactivity of the Kit idawunikidwa.Zotsatira zake sizinawonetse kuyanjananso ndi chitsanzo chotsatirachi.

Ikusokoneza Zinthu

Zotsatira zoyezetsa sizisokonezedwa ndi zinthu zomwe zili m'magulu otsatirawa:

IBIBLIOGRAPHY

1.Weiss SR,Leibowitz JZ.Coronavirus pathogenesis.Adv Virus Res 2011; 81:85-164
2.Cui J,Li F,Shi ZL.Origin and evolution of pathogenic coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S,Wong G,Shi W,et al.Epidemiology,kuphatikizananso kwa majini,ndi matenda a coronavirus.TrendsMicrobiol 2016; 24:490-502.