COVID-19 IgG / IgM Cassette Yihuta

Kubigize umwuga no muri vitro kwisuzumisha gusa.

UKORESHEJWE

UwitekaCOVID-19 IgG / IgM Cassette Yihutani immunoassay itembera igenewe kumenya neza antibodiyite za IgG na IgM kuri virusi ya SARS-CoV-2 mumaraso yose, serumu cyangwa plasma yabantu bakekwaho kwandura COVID -19 nabashinzwe ubuzima.

Ikizamini cya CO VID-19 IgG / IgM ni ubufasha mu gusuzuma abarwayi bakekwaho kwandura SARS -CoV-2 ifatanije no kwerekana ivuriro n'ibisubizo by'ibindi bizamini bya laboratoire.Birasabwa gukoresha nk'ikigereranyo cy'inyongera ku manza zikekwaho kuba zipimishije aside nucleic aside ya coronavirus nshya cyangwa ikoreshwa ifatanije n'ikizamini cya acide nucleic mu bakekwa.Ibisubizo bivuye muri antibody testi ng ntibigomba gukoreshwa nkibishingiro byonyine byo gusuzuma cyangwa gukuraho indwara ya SARS -CoV-2 cyangwa kumenyesha aho yanduye.

Ibisubizo bibi ntibibuza kwandura SARS -CoV-2, cyane cyane kubantu bahuye n’abanduye bazwi cyangwa mu turere twanduye cyane.Kwipimisha gukurikiranwa hamwe no gusuzuma molekuline bigomba gufatwa kugirango wirinde kwandura muri aba bantu.

Ibisubizo byiza birashobora guterwa no kwandura cyangwa kurubu hamwe na non-SARS- CoV-2 coronavirus.

Ikizamini kigamije gukoreshwa muri laboratoire z’amavuriro cyangwa n’abakozi bashinzwe ubuzima aho -kuvura, ntabwo ari ugukoresha urugo.Ikizamini ntigikwiye gukoreshwa mugupima amaraso yatanzwe.

INCAMAKE

Igitabo coronavirus ni icy'ubwoko bwa p.COVID-19ni indwara ikaze yubuhumekero.Abantu muri rusange birashoboka.Kugeza ubu, abarwayi banduye igitabo cyitwa coronavirus ni isoko nyamukuru yo kwandura;abantu batewe inshinge na bo barashobora kuba isoko yanduza.Ukurikije iperereza ryakozwe muri iki gihe, igihe cyo gukuramo ni iminsi 1 kugeza 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.

Iyo virusi ya SARS-CoV2 yanduye ibinyabuzima, RNA, ibintu bikomoka kuri virusi, ni cyo kimenyetso cya mbere gishobora kumenyekana.Umwirondoro wa virusi ya SARS-CoV-2 urasa na influenze, igera hejuru mugihe cyibimenyetso byatangiye, hanyuma igatangira kugabanuka.Hamwe niterambere ryamasomo yindwara nyuma yo kwandura, sisitemu yumubiri yumuntu izabyara antibodies, muri zo IgM ni antibody yo hambere ikorwa numubiri nyuma yo kwandura, byerekana icyiciro gikaze cyanduye.Antibodies za IgG kuri SARS-CoV2 zimenyekana nyuma yo kwandura.Ibisubizo byiza kuri IgG na IgM bishobora kubaho nyuma yo kwandura kandi birashobora kwerekana kwandura gukabije cyangwa vuba aha.IgG yerekana icyiciro cyo kwandura cyangwa amateka yanduye kera.

Nyamara, IgM na IgG byombi bifite igihe cyamadirishya kuva kwandura virusi kugeza kubyara antibody, IgM igaragara cyane nyuma yindwara imaze iminsi itangiye, bityo kubimenya kwabo bikunze kuba inyuma yibimenyetso bya acide nucleic kandi ntabwo byoroshye cyane kuruta kumenya aside nucleique.Mugihe aho ibizamini byo kongera aside nucleic ari bibi kandi hari isano ikomeye ya epidemiologiyaCOVID-19kwandura, icyitegererezo cya serumu (mugice cya acute na convalescent) gishobora gushyigikira gusuzuma.

IHame

COVID-19 IgG / IgM Cassette Yihuta Yihuta (WB / S / P) ni umurongo wujuje ubuziranenge ushingiye ku immunoassay kugirango hamenyekane antibodies (IgG na IgM) kuri Novel coronavirus mumaraso Yumuntu / Serum / plasma.Ikizamini cassette kigizwe na：)两ugates), 2) umurongo wa nitrocellulose ya membrane irimo imirongo ibiri yikizamini (IgG na IgM imirongo) n'umurongo wo kugenzura (C umurongo).Umurongo wa IgM wabanje gushyirwaho antibody ya Mouse irwanya Umuntu IgM, umurongo wa IgG ushyizwemo antibody yo mu bwoko bwa Mouse anti-Human IgG, mugihe ingano ihagije yikigereranyo itangwa mu iriba ryicyitegererezo cya cassette.Icyitegererezo cyimuka kubikorwa bya capillary hejuru ya cassette.IgM anti-Novel coronavirus, niba ihari murugero, izahuza na Novel coronavirus coiyugates.Immunocomplex noneho ifatwa na reagent yabanje gutwikirwa kumurongo wa IgM, ikora umurongo wa IgM ufite ibara rya burgundy, byerekana ibisubizo bya Novel coronavirus IgM.IgG anti-Novel coronavirus itanga murugero izahuza na Novel coronavirus conjugates.Immunocomplex noneho ifatwa na reagent yashizwe kumurongo wa lhe IgG, igakora umurongo wa amabara ya IgG, byerekana igeragezwa ryiza rya Novel coronavirus IgG.Kubura imirongo iyo ari yo yose T (IgG na IgM) byerekana a

ibisubizo bibi.Kugirango ube igenzura ryikurikiranabikorwa, umurongo wamabara uzahora ugaragara mukarere kayobora umurongo werekana ko ingano ikwiye yikigereranyo yongeweho kandi gukubita membrane byabayeho.

UMUBURO N'UBWITONDERWA

• Kuri vitro kwisuzumisha koresha gusa.
• Kubashinzwe ubuvuzi ninzobere aho bita.

• Ntugakoreshe nyuma yitariki yo kurangiriraho.

• nyamuneka soma amakuru yose muriki gitabo mbere yo gukora ikizamini.• Cassette yikizamini igomba kuguma mu gikapu gifunze kugeza ikoreshejwe.

• Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe nuwanduye.

• Cassette ikoreshwa yikizamini igomba gutabwa hakurikijwe amategeko ya leta, leta ndetse n’ibanze.

UMURYANGO

Ikizamini kirimo ibice bya membrane bisizwe na Mouse anti-Human IgM antibody na Mouse anti-Human IgG antibody kuri

umurongo wo kwipimisha, hamwe n'irangi ryirangi ririmo zahabu ya colloidal hamwe na virusi ya Novel corona recombinant antigen.Ingano y'ibizamini yacapishijwe kuri label.

Ibikoresho byatanzwe

• Ikizamini cassette • Shyiramo paki
• Buffer • Igitonyanga
• Lancet

Ibikoresho bisabwa ariko ntibitangwa

• Kugereranya ibikoresho byo gukusanya • Igihe

Ububiko N'UBUHAMYA

• Ubike nkuko bipakiye mu mufuka ufunze ku bushyuhe (4-30 ″ Cor 40-86 ° F) .Ibikoresho birahagaze neza mugihe cyo kurangiriraho byanditse kuri label.

• Umaze gufungura umufuka, kugirango bitagomba gukoreshwa mu isaha imwe.Kumara igihe kinini ibidukikije bishyushye nubushuhe bizatera ibicuruzwa kwangirika.

• BYINSHI nitariki yo kurangiriraho byacapishijwe kuri label SPECIMEN

• Ikizamini gishobora gukoreshwa mugupima Amaraso yose / Serumu / Plasma.

• Gukusanya amaraso yose, serumu cyangwa plasma ikurikiza uburyo busanzwe bwa laboratoire.

• Tandukanya serumu cyangwa plasma mumaraso byihuse kugirango wirinde hemolysis.Koresha gusa ingero zidasobanutse neza.

• Bika ingero kuri 2-8 ° C (36-46T) niba utageragejwe ako kanya.Bika ingero kuri 2-8 ° C kugeza kuminsi 7.Ingero zigomba gukonjeshwa kuri -20 ° C (-4 ° F) kugirango zibike igihe kirekire.Ntugahagarike urugero rwamaraso yose、

• Irinde kuzenguruka inshuro nyinshi, mbere yo kwipimisha, uzane ingero zikonje mubushyuhe bwicyumba hanyuma uvange witonze.

Ibigereranyo birimo ibintu bigaragara bigomba gusobanurwa na centrifugation mbere yo kwipimisha.

• Ntukoreshe ingero zerekana lipemia ikabije ya hemolysis cyangwa ihungabana kugirango wirinde kwivanga mubisobanuro

UBURYO BWO GUKORA IKIZAMINI

Emera igikoresho cyikigereranyo hamwe ningero zingana nubushyuhe (15-30 C cyangwa 59-86 T) mbere yo kwipimisha.

1. Kuraho ikizamini Cassette mumufuka ufunze.
2. Fata igitonyanga gihagaritse hanyuma wohereze igitonyanga 1 (hafi 10 ul) yikigereranyo mugice cyo hejuru cyurugero rwiza (S) urebe neza ko nta mwuka uhumeka.Kugirango ubone neza, kwimura urugero na pipette ishoboye gutanga 10 ul yubunini.Reba ikigereranyo gikurikira.
3. Noneho, ongeramo ibitonyanga 2 (hafi 70 ul) ya buffer ako kanya murugero rwiza (S).
4. Tangira ingengabihe.
5. kumirongo yamabara kugaragara.Sobanura ibisubizo by'ibizamini mu minota 15.Ntusome ibisubizo nyuma yiminota 20.

Agace k'urugero

(Ishusho niyerekanwa gusa, nyamuneka reba ibintu bifatika.)

GUSOBANURA IBISUBIZO

antibodies.Kugaragara kwa IgM umurongo werekana ko hariho antibodiyite ya Novel coronavirus yihariye.Niba kandi umurongo wa IgG na IgM ugaragara, byerekana ko kuba hariho Novel coronavirus zombi antibodiyite IgG na IgM.

Ibibi:Umurongo umwe wamabara ugaragara mukarere kagenzura (C), Nta murongo ugaragara wamabara ugaragara mukarere ka test.

Ntibyemewe:Igenzura ryananiwe kugaragara.Ingano ntangarugero idahagije cyangwa tekinike yuburyo bukwiye nimpamvu zishoboka cyane fbr kugenzura umurongo.Ongera usuzume inzira hanyuma usubiremo ikizamini hamwe na cassette nshya.Niba ikibazo gikomeje, hagarika guhagarika ibikoresho byikizamini ako kanya hanyuma ubaze abakwirakwiza hafi.

KUGENZURA UMUNTU

Igenzura rikorwa ririmo ikizamini.Umurongo wamabara ugaragara mukarere kayobora (C) ufatwa nkigenzura ryimbere.Yemeza ingano yikigereranyo ihagije, gukuramo membrane ihagije hamwe nubuhanga bukurikirana.Igipimo cyo kugenzura ntabwo gitangwa niki gikoresho.Ariko, birasabwa ko igenzura ryiza kandi ribi ryageragezwa nkigikorwa cyiza cya laboratoire kugirango hemezwe inzira yikizamini no kugenzura imikorere ikwiye.

LIMITATIONS

• COVID-19 IgG / IgM Cassette Yihuta Yikizamini (WB / S / P) igarukira gutanga ubuziranenge

gutahura.Ubwinshi bwumurongo wikizamini ntabwo byanze bikunze bifitanye isano nubunini bwa antibody mumaraso.Ibisubizo byabonetse muri iki kizamini bigamije kuba imfashanyo mugupima gusa.Buri muganga agomba gusobanura ibisubizo afatanije namateka yumurwayi, ibyagaragaye kumubiri, nubundi buryo bwo gusuzuma.

• Ikizamini kibi cyerekana ko antibodies kuri Novel coronavirus zidahari cyangwa kurwego rutamenyekana nikizamini.

IBIKORWA BIKORWA

Ukuri

Incamake yamakuru ya CO VID-19 IgG / IgM Ikizamini cyihuse nkuko bikurikira

Kubijyanye n'ikizamini cya IgG, twabaze igipimo cyiza cy'abarwayi 82 mugihe cyo kuvuka.

COVID-19 IgG:

Ibisubizo bitanga sensibilité ya 97.56%

Kubyerekeye ikizamini cya IgM, kugereranya ibisubizo na RT-PCR.

COVID-19 IgM:

Kugereranya imibare byakozwe hagati y ibisubizo bitanga sensibilité ya 88.61%, umwihariko wa 97.67% nukuri kwa 93.33%

Kwambukiranya no Kwivanga

1 .Ibindi bintu bisanzwe bitera indwara zandura byasuzumwe kugirango habeho kwipimisha hamwe n'ikizamini.Bimwe mubintu byiza byizindi ndwara zandura zandujwe muri Novel coronavirus nziza nibibi d bipimishije ukundi.Nta musaraba wagaragaye ufite ingero z'abarwayi banduye virusi itera sida, HA ^ HBsAg, HCV TP, HTIA ^ CMV FLUA, FLUB, Depite RSy, CP, HPIVs.

2.Ibintu byambukiranya-endogenous endogenous harimo ibice bisanzwe bya serumu, nka lipide, hemoglobine, bilirubin, byatewe hejuru cyane muri Novel coronavirus nziza kandi mbi kandi irageragezwa, ukwayo.

Nta reaction ya cross cyangwa kwivanga byagaragaye kubikoresho.

3.Bimwe mubindi bisesengura biologiya bisanzwe byinjijwe muri Novel coronavirus nziza kandi mbi kandi bipimwa ukundi.Nta kwivanga gukomeye kwagaragaye kurwego rwashyizwe ku mbonerahamwe ikurikira.

Imyororokere

Ubushakashatsi bwimyororokere bwakorewe kuri Novel coronavirus IgG / IgM Rapid Ikizamini cyihuse muri laboratoire y'ibiro bitatu byabaganga (POL).Muri ubu bushakashatsi, mirongo itandatu (60) ya serumu yubuvuzi, 20 mbi, 20 imipaka myiza na 20 nziza.Buri cyitegererezo cyakoreshwaga muri bitatu muminsi itatu kuri buri POL.Imbere-assay yemeye ents yari 100%.Amasezerano hagati yurubuga yari 100%.