Coronavirus Yihuta Yibikoresho Bipima COVID-19

Ibisobanuro Byihuse

Coronavirus Yihuta Yibikoresho Bipima COVID-19

Gupakira & Gutanga

Ibisobanuro

[UKORESHEJWE]
AMRDT100 IgG / IgM Ikizamini cyihuta Cassette ni immunoassay ikurikira ya chromatografique kugirango igaragaze neza antibodies (IgG na IgM) kuri Novel coronavirus mumaraso Yumuntu / Serum / Plasma.
Itanga ubufasha mugupima kwandura Novel coronavirus.

[INCAMAKE]
Mu ntangiriro za Mutarama 2020, igitabo cyitwa coronavirus (SARS-CoV-2, cyahoze kizwi ku izina rya 2019-nCoV) cyagaragaye ko ari umuntu wanduye utera icyorezo cya virusi i Wuhan mu Bushinwa, aho indwara za mbere zatangiriye ibimenyetso mu Kuboza 2019.
Coronavirus zifunze virusi ya RNA ikwirakwizwa cyane mubantu, izindi nyamaswa z’inyamabere, n’inyoni kandi zitera indwara z’ubuhumekero, iz'inda, iz'umwijima, n’iz'imitsi.Virusi enye-229E, OC43, NL63, na HKU1 ziriganje kandi mubisanzwe bitera ibimenyetso bikonje bikunze kugaragara kubantu badafite ubudahangarwa.Ubundi buryo bubiri bukomeye syndrome de syndrome de coronavirus (SARS-CoV) hamwe na syndrome de coronavirus yo mu burasirazuba bwo hagati (MERS-CoV) ni zoonotic inkomoko kandi bifitanye isano n'indwara rimwe na rimwe zica.
Coronavirus ni zoonotic, bivuze ko yanduza inyamaswa n'abantu.Ibimenyetso bikunze kwandura birimo ibimenyetso byubuhumekero, umuriro, inkorora, guhumeka neza hamwe ningorane zo guhumeka.Mu bihe bikomeye cyane, kwandura bishobora gutera umusonga, syndrome ikabije y'ubuhumekero, kunanirwa kw'impyiko ndetse no gupfa.
Ibyifuzo bisanzwe kugirango wirinde kwandura harimo gukaraba intoki buri gihe, gupfuka umunwa nizuru mugihe ukorora no kwitsamura, guteka neza inyama namagi.Irinde guhura cyane numuntu wese ugaragaza ibimenyetso byindwara zubuhumekero nko gukorora no kwitsamura.

[INGINGO]
AMRDT100IgG / IgM Cassette Yihuta Yihuta ni umurongo wujuje ubuziranenge ushingiye ku immunoassay kugirango hamenyekane antibodies (IgG na IgM) kugeza kuri Novel coronavirus mumaraso Yumuntu / Serum / Plasma.Cassette yikizamini igizwe na: 1) padi yamabara ya burgundy irimo Novel coronavirus recombinant envelope antigens ihujwe na zahabu ya Colloid (Novel coronavirus conjugates), 2) agace ka nitrocellulose karimo imirongo ibiri yikizamini (IgG na IgM) n'umurongo ugenzura ( C umurongo).Umurongo wa IgM wabanje gushyirwaho antibody ya Mouse irwanya Umuntu IgM, umurongo wa IgG ushyizwemo na antibody ya Mouse anti-Human IgG.Iyo ingano ihagije yikigereranyo yatanzwe mu iriba ryikitegererezo cassette yikigereranyo, icyitegererezo cyimuka kubikorwa bya capillary hakurya ya cassette.IgM anti-Novel coronavirus, niba ihari murugero, izahuza na Novel coronavirus conjugates.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 niba ihari murugero izahuza na Novel coronavirus conjugates.Immunocomplex noneho ifatwa na reagent yometse kumurongo wa IgG, ikora umurongo wamabara ya IgG, byerekana ibisubizo bya Novel coronavirus IgG.Kubura imirongo iyo ari yo yose T (IgG na IgM) byerekana ibisubizo bibi.Kugirango ukore igenzura, umurongo wamabara uzahora ugaragara mukarere kayobora umurongo werekana ko ingano ikwiye yikigereranyo yongewemo kandi gukuramo membrane byabayeho.

[UMUBURO N'UBWITONDERWA]
Kubashinzwe ubuzima ninzobere aho barerera.
Ntukoreshe nyuma yitariki yo kurangiriraho.
Nyamuneka soma amakuru yose muriki gitabo mbere yo gukora ikizamini.
Cassette yikizamini igomba kuguma mumufuka ufunze kugeza ikoreshejwe.
Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe nuwanduye.
Cassette yikizamini yakoreshejwe igomba gutabwa hakurikijwe amategeko ya leta, leta ndetse n’ibanze.

[UMURIMO]
Ikizamini kirimo agace kavanze kanditseho antibody ya Mouse anti-Human IgM na Mouse anti-Human IgG antibody ku murongo w’ibizamini, hamwe n’irangi ryirangi ririmo zahabu ya colloidal ifatanije na Novel coronavirus recombinant antigen.
Ingano y'ibizamini yacapishijwe kuri label.
Ibikoresho byatanzwe
Ikizamini cassetteGushyiramo paki
Buffer
Ibikoresho bisabwa ariko ntibitangwa
Ikigereranyo cyo gukusanya ibikoresho

[Ububiko N'UBUHAMYA]
Ubike nkuko bipakiye mu mufuka ufunze ku bushyuhe (4-30 ℃ cyangwa 40-86 ℉).Igikoresho gihamye mugihe cyigihe cyo kurangiriraho cyanditse kuri label.
Umaze gufungura umufuka, ikizamini kigomba gukoreshwa mugihe cyisaha imwe.Kumara igihe kinini ibidukikije bishyushye nubushuhe bizatera ibicuruzwa kwangirika.
LOT n'itariki yo kurangiriraho byacapishijwe kuri label.

[UMUVUGIZI]
Ikizamini kirashobora gukoreshwa mugupima Amaraso Yuzuye / Serumu / Plasma.
Gukusanya amaraso yose, serumu cyangwa plasma ikurikiza uburyo busanzwe bwa laboratoire.
Tandukanya serumu cyangwa plasma mumaraso vuba bishoboka kugirango wirinde hemolysis.Koresha gusa ingero zidasobanutse neza.
Bika ingero kuri 2-8 ℃ (36-46 ℉) niba bitageragejwe ako kanya.Bika ingero kuri 2-8 ℃ kugeza kumunsi 7.Ingero zigomba gukonjeshwa kuri
-20 ℃ (-4 ℉) kubikwa igihe kirekire.Ntugahagarike urugero rwamaraso yose.
Irinde kuzenguruka inshuro nyinshi.Mbere yo kwipimisha, zana ingero zikonje mubushyuhe bwicyumba hanyuma uvange witonze.Ibigereranyo birimo ibintu bigaragara bigomba gusobanurwa na centrifugation mbere yo kwipimisha.
Ntugakoreshe ingero zerekana lipemia nini, hemolysis nini cyangwa imivurungano kugirango wirinde kwivanga mubisobanuro.

UBURYO BWO GUKORA IKIZAMINI]
Emera igikoresho cyikigereranyo hamwe ningero zingana nubushyuhe (15-30 ℃ cyangwa 59-86 ℉) mbere yo kwipimisha.
1.Kuraho cassette yikizamini mumufuka ufunze.
2.Fata igitonyanga gihagaritse kandi wohereze igitonyanga 1 cyikigereranyo kurugero rwiza (S) rwibikoresho byipimisha, hanyuma wongereho ibitonyanga 2 bya buffer (hafi 70μl) hanyuma utangire igihe.Reba ikigereranyo gikurikira.
3.Tegereza imirongo y'amabara igaragara.Sobanura ibisubizo by'ibizamini mu minota 15.Ntusome ibisubizo nyuma yiminota 20.

[GUSOBANURA IBISUBIZO]
Ibyiza: Kugenzura umurongo byibuze umurongo umwe wikizamini ugaragara kuri membrane.Kugaragara kumurongo wikizamini cya IgG byerekana ko hariho antibodiyite ya Novel coronavirus yihariye.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 kayobora (C) .Nta murongo ugaragara wamabara ugaragara mukarere k'ibizamini.
Bitemewe: Umurongo wo kugenzura unanirwa kugaragara.Ingano yikigereranyo idahagije cyangwa tekinike yuburyo bukwiye nimpamvu zishoboka zo kugenzura umurongo kunanirwa.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]
AMRDT100 IgG / IgM Ikizamini cyihuta Cassette igarukira gusa kugirango itange ubuziranenge.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.
Igisubizo kibi cyerekana ko antibodies kuri Novel coronavirus zidahari cyangwa kurwego rutamenyekana nikizamini.

[IMIKORESHEREZE Y’IMIKORESHEREZE]
Ukuri
Kugereranya kuruhande byakozwe hakoreshejwe Novel coronavirus IgG / IgM Rapid Ikizamini hamwe na PCR yubucuruzi ikomeye.Isuzumabumenyi 120 ry’amavuriro yavuye kurubuga rwumwuga.Ibisubizo bikurikira byatanzwe muri ubu bushakashatsi bwubuvuzi:
Kugereranya imibare byakozwe hagati y ibisubizo bitanga sensibilité ya 90.00%, umwihariko wa 97,78% nukuri kuri 95.83%.
Kwambukiranya no Kwivanga
1.Ibindi bintu bisanzwe bitera indwara zandura byasuzumwe kugirango habeho kwipimisha.Bimwe mubintu byiza byizindi ndwara zandura zandujwe muri Novel coronavirus nziza kandi mbi hanyuma bipimwa ukundi.Nta reaction ya cross yagaragaye hamwe n'ingero z'abarwayi banduye virusi itera sida, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV na TP.
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.Amasezerano yo kwisuzumisha yari 100%.Amasezerano hagati yurubuga yari 100%.

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