Inkampani yethu igcizelela ukuphatha, ukwethulwa kwabasebenzi abanekhono, kanye nokwakhiwa kwesakhiwo sabasebenzi, izama kanzima ukuthuthukisa ikhwalithi kanye nokuqaphela umthwalo wemfanelo wabasebenzi. Inkampani yethu ithole ngempumelelo Isitifiketi se-IS9001 kanye Nesitifiketi Se-European CE Samanani Aphansi Isifo Esibulalayo Intengo Engcono Kakhulu Ikhasethi le-HCV HIV Hbsag Rapid Tests Kit, Siyakwamukela ukuze sakhe ukusebenzelana kwebhizinisi elimile kahle kakhulu neningi nenhlangano yethu ukuze senze uhambo olude oluhle ndawonye. ubumnandi bamakhasimende wumsebenzi wethu waphakade!
Inkampani yethu igcizelela ukuphatha, ukwethulwa kwabasebenzi abanekhono, kanye nokwakhiwa kwesakhiwo sabasebenzi, izama kanzima ukuthuthukisa ikhwalithi kanye nokuqaphela umthwalo wemfanelo wabasebenzi. Inkampani yethu ithole ngempumelelo Isitifiketi se-IS9001 kanye Nesitifiketi se-European CE seChina Rapid Test, I-Hp-ab Rapid Diagnostic Test, Ikhasethi lokuhlola ngokushesha, Sithanda ukumema amakhasimende aphesheya ukuze axoxisane nathi ngebhizinisi. Singanikeza amaklayenti ethu izinto zekhwalithi ephezulu kanye nenkonzo enhle kakhulu. Siqinisekile ukuthi sizoba nobudlelwano obuhle bokusebenzisana futhi senze ikusasa eliqhakazile kuzo zombili izinhlangothi.
Ikhithi yokuxilonga ye-Antibody kuya ku-Helicobacter Pylori(I-Fluorescence Immunochromatographic Assay)
Ukusetshenziswa kwe-in vitro diagnostic kuphela
Sicela ufunde le phakheji ngokucophelela ngaphambi kokuyisebenzisa futhi ulandele ngokuqinile imiyalelo. Ukuthembeka kwemiphumela yokuhlolwa akunakuqinisekiswa uma kukhona ukuchezuka emiyalweni ekule kokufakwa kwephakheji.

UKUSETSHENZISWA OKUHLOSIWE
Ikhithi Yokuxilonga Ye-Antibody kuya ku-Helicobacter Pylori (i-Fluorescence Immunochromatographic Assay) iwukuhlolwa kwe-fluorescence immunochromatographic ukuze kutholwe inani le-antibody ye-HP ku-serum yomuntu noma i-plasma. okuyinani elibalulekile lokuxilonga izifo zesisu.Wonke amasampula amahle kufanele aqinisekiswe ngezinye izindlela. Lokhu kuhlolwa kuhloselwe ukusetshenziswa ngochwepheshe bezempilo kuphela.

ISIFINYEZO
Ukutheleleka kwe-gastric helicobacter pylori kuhlobene eduze ne-gastritis engapheli, isilonda sesisu, i-adenocarcinoma yesisu, i-gastric mucosa ehambisana ne-lymphoma, izinga lokutheleleka kwe-Hp ylori cishe ngama-90% ku-gastritis, isilonda sesisu, isilonda se-duodenal kanye neziguli zomdlavuza wesisu. I-WHO ihlonze i-h. pylori njengohlobo lokuqala lwesici esidala umdlavuza.isici esiyingozi somdlavuza wesisu.Ukutholwa kwe-H.pylori kunenani elikhulu ekuxilongweni kwe-h. ukutheleleka kwe-pylori.

ISIMISO SENKQUBO
I-membrane yedivayisi yokuhlola imbozwe nge-HP antigen endaweni yokuhlola kanye ne-anti-rabbit IgG ye-antibody yembuzi endaweni yokulawula. Iphedi elilebula limbozwa nge-fluorescence ebhalwe ukuthi HP antigen kanye ne-rabbit IgG kusengaphambili. Lapho kuhlolwa isampula elihle, i-antibody ye-HP kusampula ihlangana ne-fluorescence enelebuli ye-HP antigen, bese yakhe ingxube yokuzivikela komzimba. Ngaphansi kwesenzo se-immunochromatography, ukugeleza okuyinkimbinkimbi kubheke ephepheni elimuncayo, lapho inkimbinkimbi idlula indawo yokuhlola, ihlanganiswe ne-HP coating antigen, yakha inkimbinkimbi entsha.Izinga le-HP-Ab lihlotshaniswa kahle nesignali ye-fluorescence, kanye nokugxila I-HP-Ab kusampula ingatholwa ngokuhlolwa kwe-fluorescence immunoassay

AMA-REAGENTS KANYE NEZINTO EZINIKEZELWAYO

25T izingxenye zephakheji:
Ikhadi lokuhlola i-foil ngayinye efakwe esikhwameni se-desiccant 25T
Isampula ye-diluent 25T
Faka iphakheji 1

IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE
Isitsha seqoqo lesampula, isibali sikhathi

UKUQOQWA KANYE NESIGCINISO ESAMPULA
1.Amasampula ahloliwe angaba i-serum, i-heparin anticoagulant plasma noma i-EDTA anticoagulant plasma.
2.Ngokwezinqubo ezijwayelekile qoqa isampula. I-Serum noma isampula ye-plasma ingagcinwa efrijini ku-2-8℃ izinsuku ezingu-7 kanye nokugcinwa kwe-cryopreservation ngaphansi -15°C izinyanga ezingu-6.
3.Wonke amasampula agwema imijikelezo yokuncibilika kweqhwa.

INQUBO YOKUHLOLA
Sicela ufunde imanuwali yokusebenza kwezinsimbi kanye nokufakwa kwephakheji ngaphambi kokuhlola.
1.Beka eceleni wonke ama-reagents namasampuli ekamelweni lokushisa.
2.Vula i-Portable Immune Analyzer(WIZ-A101), faka ukungena ngemvume kwephasiwedi ye-akhawunti ngokwendlela yokusebenza yethuluzi, bese ufaka isixhumi esibonakalayo sokubona.
3.Skena ikhodi yokuhlonza ukuze uqinisekise into yokuhlola.
4.Khipha ikhadi lokuhlola esikhwameni se-foil.
5.Faka ikhadi lokuhlola endaweni yekhadi, skena ikhodi ye-QR, bese unquma into yokuhlola.
6.Engeza i-serum engu-20μL noma isampula ye-plasma ukuze uyisampula ye-diluent, bese uxuba kahle.
7.Engeza isisombululo sesampula esingu-80μL ukuze uthole isampula yomthombo wekhadi.
8.Chofoza inkinobho ethi "standard test", ngemva kwemizuzu engu-15, ithuluzi lizobona ngokuzenzakalelayo ikhadi lokuhlola, lingakwazi ukufunda imiphumela esikrinini sokubonisa sensimbi, futhi lirekhode / liphrinte imiphumela yokuhlolwa.
9.Bheka umyalelo we-Portable Immune Analyzer(WIZ-A101).

IZIMALI EZILINDELEKILE
I-HP-Ab<10
Kutuswa ukuthi ilabhorethri ngayinye isungule ububanzi bayo obujwayelekile obumelela isiguli sayo.

IMIPHUMELA YOKUHLOLA NOKUTOLIZWA
.Idatha engenhla ingumphumela wokuhlolwa kwe-HP-Ab reagent, futhi kuphakanyiswa ukuthi ilabhorethri ngayinye kufanele isungule uhla lwamanani okutholwa kwe-HP-Ab afanele abantu bakulesi sifunda. Imiphumela engenhla ingeyereferensi kuphela.
.Imiphumela yale ndlela isebenza kuphela kububanzi bereferensi obusungulwe kule ndlela, futhi akukho ukuqhathaniswa okuqondile nezinye izindlela.
.Ezinye izici zingaphinda zibangele amaphutha emiphumeleni yokuthola, okuhlanganisa izizathu zobuchwepheshe, amaphutha okusebenza nezinye izici zesampula.

UKUGCINWA NOKUZInza
1.Ikhithi iyimpilo yeshelufu yezinyanga eziyi-18 kusukela ngosuku lokukhiqizwa kwayo. Gcina amakhithi angasetshenzisiwe ku-2-30°C. UNGAQISHI. Ungasebenzisi ngale kosuku lokuphelelwa yisikhathi.
2.Ungasivuli isikhwama esivaliwe kuze kube yilapho usulungele ukwenza isivivinyo, futhi ukuhlolwa okukodwa kuphakanyiswa ukuthi kusetshenziswe ngaphansi kwendawo edingekayo (izinga lokushisa elingu-2-35℃, umswakama 40-90%) phakathi kwemizuzu engama-60 ngokushesha. ngangokunokwenzeka.
I-3.I-diluent yesampula isetshenziswa ngokushesha ngemva kokuvulwa.

IZIXWAYISO NEZIQINISEKISO
.Ikhithi kufanele ivalwe futhi ivikelwe emswakameni.
.Zonke izibonelo ezinhle zizoqinisekiswa ngezinye izindlela.
.Zonke izifanekiso zizophathwa njengamandla angcolisayo.
.UNGAsebenzisi i-reagent ephelelwe yisikhathi.
.UNGAshintshisani ama-reagents phakathi kwamakhithi anendawo ehlukile No..
.UNGAphinde usebenzise amakhadi okuhlola nanoma yiziphi izisekeli ezilahlwayo.
.Ukungasebenzi kahle, isampula eliningi noma elincane lingaholela ekuphambukeni kwemiphumela.

LUKULINGISA
.Njenganoma yikuphi ukulinganisa okusebenzisa amasosha omzimba egundane, kungenzeka ukuthi kuphazamiseke amasosha omzimba alwa namagundane (HAMA) esibonelweni. Izibonelo zeziguli ezithole amalungiselelo e-monoclonal antibodies ukuze zixilongwe noma zelashwe zingaqukatha i-HAMA. Izibonelo ezinjalo zingadala imiphumela engemihle noma engemihle engamanga.
.Lo mphumela wokuhlolwa ngowenkomba yomtholampilo kuphela, akufanele usebenze njengesisekelo sokuxilongwa nokwelashwa kweziguli, ukuphathwa komtholampilo kweziguli kufanele kucatshangelwe ngokugcwele kuhlanganiswe nezimpawu zayo, umlando wezokwelapha, okunye ukuhlolwa kwaselabhorethri, impendulo yokwelashwa, i-epidemiology kanye nolunye ulwazi. .
.Lesi siphehli sisetshenziswa kuphela ekuhlolweni kwe-serum ne-plasma. Ingase ingatholi umphumela onembile uma isetshenziselwa amanye amasampula afana namathe nomchamo nokunye.

IZIMPAWU ZOKUSEBENZA

REFERENCES
1.Shao,JL&F.Wu.Intuthuko yakamuva ezindleleni zokuthola i-Helicobacter pylori[J].Iphephabhuku Le-Gastroenterology and Hepatology,2012,21(8):691-694
2.Hansen JH,et al.HAMA Ukuphazamisa Nge-Murine Monoclonal Antibody-Based Immunoassays[J].J ye-Clin Immunoassay,1993,16:294-299.
3.Levinson SS.Imvelo Yama-Heterophilic Antibodies kanye Neqhaza Ekuphazamisekeni Kwe-Immunoassay[J].J ye-Clin Immunoassay,1992,15:108-114.
Ukhiye wezimpawu ezisetshenzisiwe:

	In Vitro Diagnostic Medical Device
	Umkhiqizi
	Gcina ku-2-30 ℃
	Usuku lokuphelelwa isikhathi
	Ungaphinde Usebenzise
	ISEXWAYISO
	Bheka Imiyalo Yokusetshenziswa

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