Ikizamini cya titerine yinkingo: COVID-19 Kutabogama ibikoresho bya Antibody
IRIBURIRO RIGufi
Ikizamini cyihuse kuriUbwiza cyangwa ubwinshi gutahura antibodiyite zidafite aho zibogamiye kuri SARS-CoV-2 cyangwa inkingo zayo mumaraso yose, serumu, cyangwa plasma.
Kubanyamwuga muri vitro yo gusuzuma gusa.
Amapaki Specification: 40 T / kit, 20 T / kit, 10 T / kit, 1 T / kit.
IHame
SARS-CoV-2 Kutabogama Antibody Yihuta (COVID-19 Ab) ni iyo kumenya antibodiyite kuri SARS-CoV-2 cyangwa inkingo zayo. Ingirabuzimafatizo ya selile angiotensin ihindura enzyme-2 (ACE2) yashyizwe mu karere k'ibizamini hamwe na recombinant reseptor-binding domain (RBD) ihujwe n'ibice byerekana. Mugihe cyo kwipimisha, niba hari SARS-CoV-2 itabuza antibodiyite murugero, yakwitwara hamwe na poroteyine RBD-agace ka conjugate kandi ntigire icyo ikora hamwe na poroteyine ACE2 yabanje gushyirwaho. Uruvange noneho rwimuka hejuru kuri membrane chromatografique hamwe na capillary action kandi ntabwo byafatwa na antigen yabanje gutwikwa.
SARS-CoV-2 Kutabogama Antibody Yihuta (COVID-19 Ab) irimo proteine RBD yuzuye ibice. Poroteyine ACE2 yubatswe mu karere k'ibizamini.
Yemerewe impamyabumenyi
- CE / ISO13485
- Urutonde rwera
GUKORANYA BIDASANZWE NO GUTEGURA
SARS-CoV-2 Kutabogama Antibody Yihuta (COVID-19 Ab) (Amaraso Yuzuye / Serumu / Plasma) irashobora gukorwa hakoreshejwe amaraso yose. Amaraso Yombi Yintoki Yuzuye na Venipuncture Amaraso Yose arashobora gukoreshwa.
Gukusanya Urutoki Amaraso Yuzuye:
- Karaba ikiganza cy'umurwayi ukoresheje isabune n'amazi ashyushye cyangwa usukure hamwe n'inzoga. Emera gukama.
- Kanda ukuboko udakoze ku kibanza cyacumiswe ukanda hasi ukuboko werekeza ku rutoki rwagati cyangwa urutoki.
- Gutobora uruhu ukoresheje lancet sterile. Ihanagura ikimenyetso cya mbere cyamaraso.
- Koresha buhoro buhoro ukuboko kuva ku kuboko kugera ku kiganza kugera ku rutoki kugira ngo ukore igitonyanga cy'amaraso hejuru y'ahantu hacitse.
- Ongeraho urugero kubikoresho byo kwipimisha ukoreshejea micropipette ipima intera 10-100uL.
Tandukanya serumu cyangwa plasma mumaraso byihuse kugirango wirinde hemolysis. Koresha gusa ingero zisobanutse, zitari hemolyzed.
Ikizamini kigomba gukorwa ako kanya nyuma yo gukusanya ingero. Ntugasige ingero zubushyuhe bwicyumba igihe kirekire. Amaraso yose yakusanyijwe na venipuncture agomba kubikwa kuri 2-8 ° C niba ikizamini kigomba gukorwa muminsi 2 yo gukusanya. Kubikwa igihe kirekire, ingero zigomba kubikwa munsi ya -20 ° C. Amaraso yose yakusanyijwe na Fingerstick agomba guhita apimwa.
Zana ingero mubushyuhe bwicyumba mbere yo kwipimisha. Ingero zikonje zigomba gukonjeshwa rwose no kuvangwa neza mbere yo kwipimisha. Ingero ntizigomba gukonjeshwa no gukonjeshwa inshuro zirenze eshatu.
Niba ingero zigomba koherezwa, zigomba gupakirwa hubahirijwe amabwiriza y’ibanze akubiyemo ubwikorezi bwa etiologic.
CINGINGO
Kuri serumu cyangwa plasma (quantitative)
Ibikoresho byatanzwe
1) Amapaki yuzuye, hamwe na cassettes zipimisha
2) Ikarita ya Calibator
3) Amabwiriza yo gukoresha
Ibikoresho bisabwa ariko ntibitangwa
1) Micropipette ninama
2) Igihe
Kanda urutoki amaraso yose (igice-cyuzuye cyangwa cyujuje ubuziranenge)
Ibikoresho byatanzwe
1) Amapaki yuzuye, hamwe na cassettes zipimisha
2) Ikarita ya Calibator
3) Suzuma buffer
4) Lancet
5) Iyode swab
6) Amabwiriza yo gukoresha
Ibikoresho bisabwa ariko ntibitangwa
1) Mocropipette ninama(Kuriicya kabiri gusa)
2) Igihe
UBURYO BWO GUKORA IKIZAMINI
Emera igikoresho, ikigereranyo, buffer, na / cyangwa igenzura kuringaniza ubushyuhe bwicyumba (15-30 ° C) mbere yo kwipimisha.
- Zana umufuka mubushyuhe bwicyumba mbere yo gufungura. Kuraho igikoresho cyo kwipimisha mumufuka ufunze hanyuma ukoreshe vuba bishoboka.
- Shira igikoresho cyikizamini hejuru yisuku kandi itambitse.
A.Kubera Serumu cyangwa Plasma (umubare):
Koresha umuyoboro wo gukusanya serumu cyangwa plasma. Koresha umuyoboro kugirango wohereze hafi 100 mL yikigereranyo mu cyitegererezo cyiza (S) cyibikoresho byipimisha. Tangira ingengabihe.
B.KuberaUrutokiAmaraso Yuzuye (ingano, ibintu bya dilution ni 4):
Gukoresha amicroumuyoboro: Komeza umuyoboro uhagaritse kurubuga rwacumita, na ikibanza hafi 50 µL yamaraso yose murugero rwiza (S) rwibikoresho bipimisha, hanyuma ongerahonezaly 50 uL ya buffer mu cyitegererezo neza hanyuma utangire ingengabihe. Reba ingero zikurikira.
C.KuberaUrutokiAmaraso Yuzuye (ubuziranenge):
Gukoresha igitonyanga cya capillary: Fata igitonyanga uhagaritse kurubuga rwacumita, hanyuma wohereze ibitonyanga 5 byamaraso yose (hafi 50 µL) mumuriba wikigereranyo (S) wibikoresho bipimisha, hanyuma wongereho1 igitonyanga cya buffer (hafi40-50 uL) hanyuma utangire igihe. Reba ingero zikurikira.
3.Tegereza umurongo (amabara) ugaragara. Soma ibisubizo muminota 10. Ntugasobanure ibisubizo nyuma yiminota 15.
UMUSOMYI W'IKIZAMINI CYIZA
1. Kanda kandi ufate buto yera yo gutangira amasegonda 2 ~ 3 kugirango utangire imashini
2. Ihanagura iikarita ya kalibateri onto ikarita yo gusoma, kumenyekanisha kalibrasi yumurongo mubasomyi.
3. Shyiramo ikarita yikizamini mumwanya wo kumenya umusomyi Kuri iburyo ruhande. Menya neza ko idirishya ryikarita mugihe icyitegererezo neza.
4. Soma ibisubizo Kwerekana Umusomyi.
GUSOBANURA IBISUBIZO
- Ibyiza (+): Gusa C umurongo ugaragara, cyangwa T umurongo uhwanye na C umurongo cyangwa intege nke kurenza umurongo C. Irerekana ko hariho SARS-CoV-2 itabuza antibodiyite murugero.
- Ibibi (-): Byombi T umurongo na C umurongo ugaragara, iyo ubukana bwumurongo wa T bukomeye kuruta umurongo wa C. Irerekana ko nta SARS-CoV-2 itabuza antibodiyite mu cyitegererezo, cyangwa ubundi titer ya SARS-CoV-2 itabuza antibodiyite ziri murwego rwo hasi cyane.
- Ntibyemewe: Igenzura ryananiwe kugaragara. Ingano yikigereranyo idahagije cyangwa tekinike yuburyo bukwiye nimpamvu zishoboka zo kugenzura umurongo kunanirwa. Ongera usuzume inzira hanyuma usubiremo ikizamini hamwe nikizamini gishya. Niba ikibazo gikomeje, hagarika ako kanya ukoresheje ibikoresho byipimisha ako kanya hanyuma ubaze abakwirakwiza hafi.
Ibisubizo BiteganijweGukingira.
Igisubizos if gutwara urukingo rwa COVID-19 byitezwe kumera hepfo.
- Mbere yikinini cya mbere: Ibibi byikizamini cyihuse
- Ibyumweru 3 nyuma yikinini cya mbere: intege nke cyangwa nziza
- Icyumweru 1 nyuma yikigereranyo cya kabiri: hagati cyangwa nziza nziza
- Ibyumweru 2 nyuma yikinini cya kabiri: hagati cyangwa nziza
Icyunvikiro cyibisubizo byuzuye kandi byujuje ubuziranenge.
Ubwiza (gereranya ubukana bwumurongo wa T n'umurongo wa C) | Agaciro kerekana (Quantitative) | |
Ibibi | Umurongo T wijimye kurenza umurongo C. | Nab <50ng / ml |
Umutwe muto | Umurongo T uringaniye cyangwa woroshye gato kurenza umurongo C. | 50ng / ml ≤ Nab ≤ 300ng / ml |
Hagati ya titer | Umurongo T biragaragara yoroshye kuruta umurongo C. | 300ng / ml |
Umutwe muremure | Umurongo T ni cyane urumuri cyangwa ibara | Nab> = 1000ng / ml |
IBIKORWA BIKORWA
1. Ibyiyumvo bifitanye isano, umwihariko nukuri
SARS-CoV-2 Kutabogama Antibody Yihuta (COVID-19 Ab) yasuzumwe hamwe ningero zabonetse mubaturage bafite ingero nziza kandi mbi. Ibisubizo byemejwe nubucuruzi SARS-CoV-2 Kutabogama Antibody Detection Kit (ELISA kit, guhagarika 30% kubuza ibimenyetso).
Uburyo | Ubucuruzi SARS-CoV-2 Kutabogama Antibody Detection Kit (ELISA kit) | Ibisubizo Byose | ||
SARS-CoV-2 Kutabogama Antibody Ikizamini Cyihuse (COVID-19 Ab) | Ibisubizo | Ibyiza | Ibibi | |
Ibyiza | 32 | 0 | 32 | |
Ibibi | 1 | 167 | 168 | |
Igisubizo Cyuzuye | 33 | 167 | 200 |
Ibyiyumvo bifitanye isano: 96.97%(95% CI:83.35%~99,99%)
Umwihariko ugereranije: 100.00%(95% CI:97.29%~100.00%)
Ukuri: 99,50%(95% CI:96,94%~99,99%)
2.Kumenya imipaka
Gukata:100ng / ml
Urutonde:50 ~ 5000ng / ml
3.Guhinduranya