Igitabo Cyuzuye Kuri Covid - 19 Kwipimisha Antibody Kubaguzi Bisi

Kugerageza kugura Covid - ibizamini 19 bya antibody wumva ari nko gukundana kumurongo: amahitamo menshi, ibirango bitesha umutwe, kandi ntushobora kumenya neza uwo wizera kugeza bitinze kandi bije yawe yamaze kuba mubucuti bwiyemeje.

Aka gatabo kagabanya akaduruvayo, gasobanura ubwoko bwibizamini, ibipimo ngenderwaho, hamwe nimpamyabumenyi, kandi bikwereka uburyo bwo kugenzura abatanga isoko wizewe ukoresheje urutonde rusobanutse n’ibipimo nyabyo, bishyigikiwe na raporo nk’ubuyobozi bwa OMS bwo gupima serologiya.hano.

Gusobanukirwa Covid - 19 Antibodies: IgM, IgG, Kutabogama Antibodies Byasobanuwe

Covid - 19 kwipimisha antibody ifasha abaguzi kwisi gusuzuma kwandura kwashize, ubudahangarwa bw'umubiri, n'imikorere y'inkingo. Kumenya IgM, IgG, no kutabuza antibodies bifasha kugura ubwenge no gufata ibyemezo byubuvuzi.

Nibyiza - byateguwe na antibody test portfolios akenshi ikubiyemo ibicuruzwa bifitanye isano nkaMonkeypox Igg / igm Ikizamini,Igituntu IgG / IgM Igikoresho Cyipimisha Byihuse (Amaraso Yuzuye / Serumu / Plasma), naChikungunya IgM Cassette (WB - S - P)kubaka ibice byuzuye byanduye.

1. Ibyo IgM Antibodies Yerekana

Antibodies za IgM zigaragara mbere nyuma yo kwandura. Batanga igitekerezo cya vuba cyangwa gikomeje Covid - 19 yerekanwe no kuyobora kwigunga, gushakisha amakuru, hamwe nigihe gito - ibyemezo byubuvuzi.

• Haguruka kare, hanyuma ugabanuke
• Nibyiza mugupima indwara zikaze
• Akenshi uhujwe na IgG kubisubizo bisobanutse

2. Ibyo Antibodies IgG Yerekana

Antibodiyite ya IgG ikora nyuma kandi ikaramba. Bafasha kwemeza kwandura cyangwa gukingira inkingo no gushyigikira abaturage - ubushakashatsi bwubudahangarwa.

• Erekana igihe kirekire - ijambo kwibuka immunite
• Akenshi bikoreshwa mugukurikirana - hejuru kwipimisha
• Urufunguzo rwo kwiga seroprevalence

3. Kutabogama Antibodies no Kurinda

Kutabogama antibodies zibuza virusi kwinjira mu ngirabuzimafatizo. Ibizamini bibareba bigereranya uburinzi bushobora kwandura indwara nindwara zikomeye.

• Wibande kubikorwa bikora, ntabwo uhari gusa
• Ni ingirakamaro mu gusuzuma inkingo
• Akenshi laboratoire - ishingiye, igoye cyane

4. Guhuza Ubwoko bwa Antibody Kubushishozi bwiza

Ikibaho gipima IgM, IgG, hamwe no kutabuza antibodi hamwe gutanga ibisobanuro byuzuye byigihe cyo kwandura ndetse n’ubudahangarwa bw'umubiri.

Ibipimo ngenderwaho mpuzamahanga n’amabwiriza ya Covid - Ibizamini 19 bya Antibody

Abaguzi ku isi bagomba kugenzura iyubahirizwa ry’ubuyobozi bwa OMS n’inzego nkuru zishinzwe kugenzura. Kwemererwa neza bigabanya ingaruka zemewe n'amategeko kandi bizamura ikizere cyamavuriro.

Wibande kumikorere yanditse, sisitemu nziza, hamwe ninganda zikurikiranwa. Buri gihe usabe hejuru - kugeza - ibyemezo byitariki na raporo yo kwemeza kubatanga isoko.

1. OMS nubuyobozi bwisi yose

Ishami ry'Umuryango w'Abibumbye ryita ku Buzima ritanga ubuyobozi ku isuzuma, intego zikorwa, no gukoresha imanza. Ibihugu byinshi bihuza amategeko y’ibanze n’ibyifuzo bya OMS.

• Ntarengwa ibyiyumvo byihariye kandi byihariye
• Amabwiriza yo gukoresha mugukurikirana
• Ibikorwa byo kwemeza ibyigisho

2. CE Kumenyekanisha nibisabwa na EU

Muri EU, Covid - ibizamini 19 bya antibody biri munsi ya IVDR. Ikimenyetso cya CE cyerekana guhuza umutekano, imikorere, hamwe namategeko.

• Inyandiko ya tekiniki
• Imikorere yubuvuzi
• Inyandiko - gahunda yo kugenzura isoko

3. FDA nizindi nzego zigihugu

Amerika FDA, UK MHRA, nabandi bagenzuzi bakoresha inzira zihutirwa cyangwa zisanzwe. Abaguzi bagomba kwemeza ibimenyetso byemewe.

4. Isesengura ryerekana isoko ku baguzi

Ibisabwa byahindutse bivuye mubyihutirwa - gusa bikoreshwa mugihe kirekire - kugenzura igihe kirekire nubuzima bwakazi, hamwe nibyifuzo byinshi byukuri kandi byanditse.

Gereranya Laboratoire na Covid yihuta - 19 Uburyo bwo Kwipimisha Antibody

Covid - 19 yo gupima antibody ikubiyemo byinshi - byinjira muri sisitemu ya laboratoire na point - ya - kwita kubizamini byihuse. Buri buryo bukwiranye nubunini butandukanye, bije, hamwe nubuvuzi.

1. Laboratoire - Ibizamini bya Antibody

Ibizamini bya laboratoire, nka CLIA na ELISA, bitanga ibicuruzwa byinshi kandi byuzuye. Bikwiranye na laboratoire nkuru hamwe na gahunda nini yo gusuzuma.

• Ubukangurambaga bukabije kandi bwihariye
• Saba ibikoresho n'abakozi bahuguwe
• Igihe kirekire

2. Ibizamini byihuta byihuta

Ibizamini byihuse ukoreshe urutoki cyangwa uduce duto twamaraso hanyuma utange ibisubizo muminota, nibyiza kumavuriro, ahantu kure, no kwisuzumisha.

• Ibikorwa byoroshye, ibikoresho bike
• Ifite akamaro muke - igenamiterere ry'umutungo
• Akenshi ubuziranenge cyangwa igice - ingano

3. Guhitamo Uburyo bukwiye ku Isoko ryawe

Abaguzi bagomba guhuza uburyo bwo gukoresha urubanza, ibikorwa remezo, nibisabwa kugirango bagabanye ingengo yimibare iteganijwe.

✅ Nigute wasuzuma ubuziranenge bwikizamini no kwizerwa: Hitamo Laihe Biotech

Covid Yizewe - Ibizamini 19 bya antibody bigomba kwerekana ukuri gukomeye, inyandiko zisobanutse, hamwe ninganda zihamye. Laihe Biotech yibanze kuri ibi bintu bikomeye.

1. Gusubiramo amakuru yimikorere yubuvuzi

Reba kwemeza byigenga, ibyiyumvo, umwihariko, hamwe nicyizere intera. Baza amakuru muburyo butandukanye hamwe nabantu bakingiwe mugihe bishoboka.

• Urungano - rwasuzumye ubushakashatsi aho buhari
• Isuzuma ryinshi
• Nukuri - incamake yimikorere yisi

2. Gusuzuma Sisitemu Neza na Impamyabumenyi

Reba ISO 13485, GMP, hamwe no kugenzura neza. Sisitemu nziza yubuziranenge hasi hasi - kugeza - itandukaniro ryinshi nibiciro byo kurega.

• Ibyangombwa QC yo kurekura
• Gukurikirana ibikoresho fatizo
• Hindura - uburyo bwo kugenzura

3. Impamvu Abaguzi Bose Bafatanyabikorwa na Laihe Biotech

Laihe Biotech itanga Covid yemewe - 19 yipimishije antibody, menyisi yindwara zandura, hamwe ninkunga yizewe yibikoresho byisi yose kubagabuzi nabatanga ubuvuzi.

Kubika, Gutwara, no Gukemura Ibisabwa kuri Covid - 19 Ibikoresho byo Kwipimisha Antibody

Kubika neza no gufata neza birinda imikorere ya kit. Abaguzi kwisi bagomba kugenzura imiterere mbere yo koherezwa kandi amaherezo - ibikoresho byabakoresha.

1. Kugenzura Ubushyuhe nubushuhe

Ibikoresho byinshi bisaba kubika 2–30 ° C, kure yubushyuhe bukabije, ubukonje, nubushuhe. Gukomeza gukurikirana bigabanya ibyago byo gutakaza imikorere.

• Koresha amakuru yinjira muri transit
• Irinde gukonjesha keretse bisobanuwe neza
• Komeza ibimera bifunze

2. Gupakira ibintu hamwe nubuzima bwa Shelf

Reba neza ko gupakira birwanya ihungabana n'ubushyuhe. Buri gihe wemeze ubuzima bwa tekinike kuri label hanyuma uzenguruke ububiko (ubanza - kurangira - ubanza - hanze).

• Ikarito ikomeye
• Kuraho icyiciro hamwe nibirango birangiye
• Amakuru ahamye kubisabwa

3. Amahugurwa yo Gukora no Gukoresha

Abakoresha ba nyuma bagomba gukurikira IFU hafi, harimo ubwoko bw'icyitegererezo, igihe, no gusobanura. Amahugurwa magufi atezimbere cyane - ukuri kwisi.

Umwanzuro

Covid - 19 kwipimisha antibody bikomeje kuba ngombwa mugukurikirana ubudahangarwa, kuyobora politiki, no gushyigikira ubuvuzi. Abaguzi kwisi bagomba gusobanukirwa antibodies, amabwiriza, hamwe nikoranabuhanga ryo kugerageza kubaka portfolio ikomeye.

Mugushimangira ubuziranenge bwemewe, amakuru akomeye, hamwe nibikoresho bikwiye, no guhitamo abafatanyabikorwa nka Laihe Biotech, abaguzi barashobora gutanga ibisubizo nyabyo, byizewe kwisi yose.

Ibibazo bikunze kubazwa kuri Covid - 19 Kwipimisha Antibody

1. Ibizamini bya antibody birashobora gusuzuma kwandura Covid - 19?

Oya. Ibizamini bya Antibody byerekana ahanini kwandura cyangwa gukingira indwara. Kwandura gukomeye, abaguzi n'abaganga bagomba gukoresha ibizamini bya molekile cyangwa antigen.

2. Mugihe gito nyuma yo kwandura antibodi zishobora kumenyekana?

IgM ikunze kugaragara kumunsi wa 5-7 nyuma yibimenyetso, mugihe IgG igaragara nyuma yiminsi 10-14. Ibihe birashobora gutandukana kubantu no kubitandukanye.

3. Ese antibodiyite nziza zisobanura kurinda byuzuye kutongera kugaruka?

Ntabwo buri gihe. Antibodies zerekana urwego runaka rwokwirinda, ariko imbaraga zo gukingira nigihe ziratandukanye. Gutesha agaciro amakuru ya antibody atanga ubushishozi bwiza.

4. Ibizamini bya antibody byihuse birahagije kuri gahunda nini?

Ikizamini cyo hejuru - cyiza cyihuse hamwe no kwemeza gukomeye birashobora gukora neza mugusuzuma no kugenzura. Abaguzi bagomba kwemeza amakuru yimikorere nuburyo bugenzurwa.

5.Ni izihe nyandiko nshobora gusaba mu kizamini - utanga ibikoresho?

Baza IFU, CE / FDA cyangwa ibyemezo byaho, ibyemezo bya ISO, incamake yimikorere yubuvuzi, amakuru ahamye, nibisobanuro bisobanutse kububiko no gutwara.