SARS-CoV-2 Antigen yihuta ya Cassette

UKORESHEJWE

UwitekaSARS-CoV-2 Antigen yihuta ya Cassetteni immunoassay yihuta ya chromatografique kugirango hamenyekane neza antigen ya SARS-CoV-2 muri swab ya Oropharyngeal ya muntu. Kumenyekanisha gushingiye kuri antibodiyite ya monoclonal yihariye ya Nucleocapsid (N) Poroteyine ya SARS-CoV-2.Bigamije gufasha muri isuzuma ryihuse ritandukanye ryaCOVID-19kwandura.

Ibisobanuro

Ibizamini 25 / ipaki, ibizamini 50 / ipaki, ibizamini 100 / paki

IRIBURIRO

Igitabo coronavirus ni icya gen.COVID-19ni indwara yandurira mu myanya y'ubuhumekero. Muri rusange abantu barashobora kwandura. Muri iki gihe, abarwayi banduye igitabo cyitwa coronavirus ni yo soko nyamukuru yandura; abantu banduye simptomatique na bo barashobora kuba isoko yandura. Dushingiye ku iperereza ryakozwe na epidemiologiya, igihe cyo gukuramo ni 1 kugeza ku minsi 14, ahanini iminsi 3 kugeza 7.Ibyigaragaza nyamukuru birimo umuriro, umunaniro hamwe no gukorora byumye.Umubyimba wizuru, izuru ritemba, kubabara mu muhogo, myalgia na diarrhea usanga mubihe bike.

REAGENTS

Cassette yipimishije irimo anti-SARS-CoV-2 Nucleocapsid proteine ​​na proteine ​​anti-SARS-CoV-2 Nucleocapsid proteine ​​zometse kuri membrane.

UMWITOZO

Nyamuneka soma amakuru yose muriyi paki shyiramo mbere yo gukora ikizamini.

1.Ku mwuga mukoresha vitro yo gusuzuma gusa.Ntukoreshe nyuma yitariki yo kurangiriraho.

2.Ikizamini kigomba kuguma mumufuka ufunze kugeza witeguye gukoresha.

3.Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe na agent wanduye.

4.Ikizamini cyakoreshejwe kigomba gutabwa ukurikije amabwiriza yaho.

5. Irinde gukoresha ingero zamaraso.

6.Wambare uturindantoki wen utanga ingero, irinde gukora kuri membrane ya reagent kandi ntangarugero neza.

Ububiko N'UBUHAMYA

Igihe cyemewe ni amezi 18 niba iki gicuruzwa kibitswe mubidukikije

2-30..NTABUNTU.Ntukoreshe kurenza itariki izarangiriraho.

GUKORANYA BIDASANZWE N'ITEGURWA

1.Icyegeranyo cyo gusohora ibyuya: Shyiramo sterile sterile mumuhogo rwose uhereye kumunwa, ushimangira kurukuta rwumuhogo hamwe nu gice gitukura cya toni ya palate, uhanagura toni ya faryngeal na rukuta rwinyuma rwa faryngeal hamwe

imbaraga, irinde gukora ku rurimi no gukuramo swab.

2.Kora icyitegererezo ako kanya hamwe nicyitegererezo cyo gukuramo cyatanzwe mugikoresho nyuma yicyitegererezo.Niba bidashobora gutunganywa ako kanya, icyitegererezo kigomba kubikwa mu cyuma cyumye, cyumye kandi gifunze neza.Irashobora kubikwa kuri 2-8 ℃ kumasaha 8, kandi irashobora kubikwa igihe kirekire kuri -70 ℃.

3. Ingero zandujwe cyane nibisigazwa byibiribwa byo munwa ntibishobora gukoreshwa mugupima ibicuruzwa.Ingero zegeranijwe zivuye muri swabs zisa neza cyangwa zegeranye ntabwo zisabwa kugerageza iki gicuruzwa.Niba ibishishwa byanduye n'amaraso menshi, ntibisabwa kwipimisha.Ntabwo byemewe gukoresha ingero zitunganywa hamwe nicyitegererezo cyo gukuramo ibisubizo bitatanzwe muriki gikoresho cyo kugerageza ibicuruzwa.

KIT KUBONA

Ibikoresho biratanga

Ibikoresho bisabwa ariko ntibitange

Ibisobanuro25

ibizamini / pack50

ibizamini / pack100

ibizamini / ipakiUrugero rwo gukuramo Reagent25 ibizamini / ibizamini bya pack50 / ibizamini bya pack100 / ipakiIcyitegererezo

tube≥25 ibizamini / pack≥50 ibizamini / pack≥100 ibizamini / packInyigisho Reba kuri

paketi Reba kuri

paketi Reba kuri

paki

AMABWIRIZA YO GUKORESHA

Emera ikizamini, ingero, gukuramo ibimera kugirango bingane n'ubushyuhe bw'icyumba (15-30 ℃) mbere yo kwipimisha.

1. Kuraho cassette yikizamini mu mufuka wafunze kandi uyikoreshe mu minota 15.Ibisubizo byiza bizagerwaho niba isuzuma ryakozwe ako kanya nyuma yo gufungura umufuka wa file.

2. Shyira Tube ya Extraction muri sitasiyo yakazi. Shyira icupa rya reagent icupa hejuru hejuru uhagarike.Kanda icupa hanyuma ureke igisubizo cyose (Hafi, 250μL) kigwe mumiyoboro ikuramo kubuntu udakoze ku nkombe yigituba kugeza kuri Extraction. Itiyo.

3. Shira icyitegererezo cya swab muri Extraction Tube. Ongera uhindure swab hafi amasegonda 10 mugihe ukanda umutwe imbere imbere yigituba kugirango urekure antigen muri swab.

4.Kuraho swab mugihe ukanda umutwe wa swab imbere imbere ya Extraction Tube mugihe uyikuyemo kugirango wirukane amazi menshi ashoboka shiraho swab. Fata swab ukurikije protocole yawe yo guta imyanda ya biohazard.

5.Huza igitonyanga hejuru yigitereko gikuramo. Shyira cassette yikizamini hejuru yisuku kandi iringaniye.

6. Ongeraho ibitonyanga 2 byumuti (hafi, 65μL) kurugero rwiza hanyuma utangire igihe. Soma ibisubizo byerekanwe muminota 20-30, ibisubizo bisomwe nyuma yiminota 30 ntibyemewe.

GUSOBANURA IBISUBIZO

Umurongo umwe wamabara ugaragara mukarere kayobora umurongo (C).Nta murongo ugaragara mu karere k'ibizamini (T) .Ibisubizo bibi byerekana ko antigen ya SARS-CoV-2 idahari, cyangwa iri munsi y'urwego rushobora kugaragara.

POSITIVEIGISUBIZO:

Imirongo ibiri igaragara.umurongo umwe wamabara ugomba kuba mukarere kayobora (C) naho undi murongo ugaragara wamabara ugomba kuba mukarere kizamini (T) .Igisubizo cyiza cyerekana ko SARS-CoV-2 yagaragaye murugero.

IBISUBIZO BIDASANZWE:

Umurongo wo kugenzura unanirwa kugaragara.Ubunini bwikigereranyo budahagije cyangwa tekinike yuburyo bukwiye nimpamvu zishoboka zo kugenzura umurongo kunanirwa.Ongera usuzume inzira hanyuma usubiremo ikizamini hamwe nikizamini gishya.Niba ikibazo gikomeje, hagarika guhagarika ibikoresho byikizamini ako kanya hanyuma ubaze abakwirakwiza hafi.

ICYITONDERWA:

Ubwinshi bwamabara mukarere ka test (T) buratandukana bitewe nubunini bwa SARS-CoV-2 Antigen igaragara murugero.Kubwibyo, igicucu icyo aricyo cyose cyamabara mukarere kizamini (T) kigomba gufatwa nkicyiza.

KUGENZURA UMUNTU

• Igenzura rikorwa ririmo ikizamini.Umurongo wamabara ugaragara mukarere kayobora (C) ufatwa nkigenzura ryimbere.Byemeza neza ibyerekezo bihagije.
• Igipimo cyo kugenzura ntabwo gitangwa niki gikoresho;icyakora, birasabwa ko igenzura ryiza kandi ribi ryageragezwa nkigikorwa cyiza cya laboratoire kugirango hemezwe inzira yikizamini no kugenzura imikorere ikwiye.

LIMITATIONSCY'IKIZAMINI

1. UwitekaSARS-CoV-2 Antigen yihuta ya Cassetteni iyumwuga mugukoresha vitro isuzumwa gusa.Ikizamini kigomba gukoreshwa mugushakisha SARS-CoV-2 Antigen muri Oropharyngeal Swab.Nta gaciro k'umubare cyangwa igipimo cyo kwiyongera kwa SARS-CoV-2 ntigishobora kugenwa niyi miterere. ikizamini.
2. Ikizamini cyukuri giterwa nubwiza bwikitegererezo cya swab.Ibibi bibi bishobora kuvamo uburyo bwo kubika icyitegererezo kidakwiye.
3. Cassette ya SARS-CoV-2 Antigen Yihuta Yerekana Ikizamini cyerekana gusa ko SARS-CoV-2 iri mu cyitegererezo kiva muri SARS-CoV-2 ya coronavirus.
4. Kimwe nibizamini byose byo gusuzuma, ibisubizo byose bigomba gusobanurwa hamwe nandi makuru yubuvuzi aboneka kwa muganga.
5. Igisubizo kibi cyabonetse muri iki gikoresho kigomba kwemezwa na PCR.Ibisubizo bibi birashobora kuboneka mugihe intumbero ya SARS-CoV-2 igaragara muri swab idahagije cyangwa iri munsi yurwego rushobora kugaragara.
6. Amaraso menshi cyangwa mucus birenze urugero rwa swab birashobora kubangamira imikorere kandi bishobora gutanga umusaruro mubi.
7. Igisubizo cyiza kuri SARS-CoV-2 ntikibuza kwandura kwanduye kwanduza virusi.Kubwibyo rero, bishoboka ko bishoboka kwandura indwara ya bagiteri idahwitse.
8. Ibisubizo bibi ntibibuza kwandura SARS-CoV-2, cyane cyane ku bahuye na virusi.Kwipimisha gukurikiranwa hamwe no gusuzuma molekuline bigomba gufatwa kugirango wirinde kwandura muri aba bantu.
9. Ibisubizo byiza bishobora guterwa no kwandura kwanduye hamwe na coronavirus itari SARS-CoV-2, nka coronavirus HKU1, NL63, OC43, cyangwa 229E.
10. Ibisubizo bivuye mu gupima antigen ntibigomba gukoreshwa nkishingiro ryonyine ryo gusuzuma cyangwa gukuraho ubwandu bwa SARS-CoV-2 cyangwa kumenyesha aho bwanduye.
11. Gukuramo reagent bifite ubushobozi bwo kwica virusi, ariko ntibishobora kwanduza 100% virusi.Uburyo bwo kudakora virusi bushobora kwerekanwa: ni ubuhe buryo busabwa na OMS / CDC, cyangwa bushobora gukemurwa hakurikijwe amabwiriza yaho.

IBIKORWA BIKORWA

IbyiyumvonaUmwihariko

Cassette ya SARS-CoV-2 Antigen Rapid Ikizamini Cassette yasuzumwe hamwe n'ingero zabonetse ku barwayi.PCR ikoreshwa nk'uburyo bwo gukoresha Cassette ya SARS-CoV-2 Antigen Rapid Ikizamini.

Ibyiyumvo bifitanye isano: 95.0% (95% CI *: 83.1% -99.4%)

Umwihariko ugereranije: 99.2% (95% CI *: 97,6% -99.8%)

Intera y'icyizere

Imipaka ntarengwa

Iyo ibirimo virusi birenze 400TCID₅₀/ ml, igipimo cyiza cyo gutahura kirenze 95%.Iyo ibirimo virusi bitarenze 200TCID₅₀/ ml, igipimo cyiza cyo kumenya kiri munsi ya 95%, bityo igipimo ntarengwa cyo kumenya ibicuruzwa ni 400TCID₅₀/ ml.

Icyitonderwa

Ibice bitatu bikurikiranye bya reagent byageragejwe neza.Ibice bitandukanye bya reagent byakoreshejwe mugupima icyitegererezo kimwe inshuro 10 zikurikiranye, kandi ibisubizo byose byari bibi.Ibice bitandukanye bya reagent byakoreshejwe mugupima icyitegererezo cyiza inshuro 10 zikurikiranye, kandi ibisubizo byose byari byiza.

INGARUKA

Iyo virusi iri murugero igomba gupimwa igera kuri 4.0 * 10⁵TCID₅₀/ ml, ibisubizo byikizamini biracyerekana ingaruka ZIKURIKIRA.

Kwambukiranya ibintu

Isuzuma ryambukiranya Kit ryarasuzumwe.Ibisubizo byerekanaga ko nta musaraba wongeyeho hamwe nibi bikurikira.

Interfering Ibintu

Ibisubizo by'ibizamini ntibibangamiwe nibintu bikurikira:

IBIBLIOGRAPHY

1.Weiss SR, Leibowitz JZ.Coronavirus pathogenez.Avoka Virus Res 2011; 81: 85-164
2.Cui J, Li F, Shi ZL.Origin nihindagurika rya coronavirus itera indwara. Nat Rev Microbiol 2019; 17: 181-192.
3.Su S, Wong G, Shi W, nibindi. Epidemiologiya, recombination genetique, hamwe na patogenezi ya coronavirus.InziraMicrobiol 2016; 24: 490-502.