Ikhithi yokuxilonga ye-Antigen kuya ku-Helicobacter Pylori (I-Fluorescence Immunochromatographic Assay)
I-Diagnostic Kit ye-Antigen 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-Antigen kuya ku-Helicobacter Pylori (i-Fluorescence Immunochromatographic Assay) ifanele ukutholwa kobuningi bobulongwe bomuntu i-HP antigen nge-fluorescence immunochromatographic assay, enenani elibalulekile lokuhlonza insiza yezifo 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. Inhlangano yezempilo emhlabeni isihlonze uh. i-pylori njengohlobo lokuqala lwesici esibangela umdlavuza futhi ngokusobala iyisici esiyingozi somdlavuza wesisu.Ukutholwa kwe-H.pylori kunenani elikhulu ekuxilongweni kwe-h. pylori.Ukuhlolwa okusekelwe kubuchwepheshe bokuhlaziya i-fluorescence immunochromatographic assay, okunganikeza umphumela phakathi nemizuzu engu-15.
ISIMISO SENKQUBO
Umucu une-anti-HP enamathela amasosha omzimba endaweni yokuhlola, eboshelwe ku-chromatography yolwelwesi kusenesikhathi. Iphedi elebula limbozwe i-fluorescence ebhalwe ukuthi i-anti-HP antibody kusengaphambili. Lapho kuhlolwa isampula ephozithivu, i-HP kusampula ingaxutshwa ne-fluorescence ebhalwe ukuthi anti-HP antibody, futhi yakhe ingxube yokuzivikela komzimba. Njengoba ingxube ivunyelwa ukuthi ithuthe eduze komugqa wokuhlola, i-HP conjugate complex ithathwa yi-anti-HP coating antibody kulwelwesi futhi yakha inkimbinkimbi. Amandla e-fluorescence ahlotshaniswa kahle nokuqukethwe kwe-HP. I-HP esesampula ingatholwa nge-fluorescence immunoassay analyzer.
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
Isampula yokuqoqa isitsha, isibali sikhathi
UKUQOQWA KANYE NESIGCINISO ESAMPULA
1.Sebenzisa isitsha esihlanzekile esilahlwayo ukuqoqa isampula yendle entsha, bese ihlolwa ngokushesha. Uma ingeke ihlolwe ngokushesha, sicela igcinwe ku-2-8°C izinsuku ezi-3 noma ngaphansi kuka-15°C izinyanga ezingu-6.
2.Khipha udondolo lwesampula, ulifake esampuleni yobulongwe, phinda isenzo izikhathi ezi-3, thatha izingxenye ezehlukene zesampula yobulongwe isikhathi ngasinye, bese ubuyisela induku yesampula, bopha qini bese uxhawula kahle, Noma usebenzisa isampula yesampula ekhethiwe. cishe isampula lobulongwe elingu-50mg, bese lifaka ishubhu lesampula lobulongwe eliqukethe isampula lokuhlanjululwa, bese liyisikulufa ngokuqinile.
3.Sebenzisa amasampula e-pipette alahlwayo thatha isampula yendle esigulini sohudo, bese wengeza amaconsi ama-3 (cishe u-100µL) eshubhuni lokusampula le-fecal bese unyakazisa kahle.
Amanothi:
1.Gwema imijikelezo yokuqhwaza.
2.Thaw amasampula ekamelweni lokushisa ngaphambi kokusetshenziswa.
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.Khipha ikepisi kushubhu yesampula bese ulahla amathonsi amabili okuqala esampula ehlanjululiwe, engeza amaconsi ama-3 (cishe u-100uL) alikho ibhamuza elihlanjululwe isampula lime mpo futhi kancane ungene emthonjeni wesampula wekhadi eline-dispette enikeziwe.
7.Chofoza inkinobho ethi "standard test", ngemva kwemizuzu engu-15, ithuluzi lizothola ngokuzenzakalelayo ikhadi lokuhlola, lingakwazi ukufunda imiphumela esikrinini sokubonisa sensimbi, futhi lirekhode / liphrinte imiphumela yokuhlolwa.
8.Bheka umyalelo we-Portable Immune Analyzer(WIZ-A101).
IZIMALI EZILINDELEKILE
I-HP-Ag <10
Kutuswa ukuthi ilabhorethri ngayinye isungule ububanzi bayo obujwayelekile obumelela isiguli sayo.
IMIPHUMELA YOKUHLOLA NOKUTOLIZWA
1.I-HP-Ag kusampula ingaphezu kuka-10, futhi kufanele ikhiphe uguquko lwesimo somzimba. Imiphumela ayijwayelekile ngempela futhi kufanele kutholakale ukuthi inezimpawu zomtholampilo.
2.Imiphumela yale ndlela isebenza kuphela kububanzi bereferensi obusungulwe kule ndlela, futhi akukho ukuqhathanisa okuqondile nezinye izindlela.
3.Ezinye izici zingabangela 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 sisebenzi sisetshenziselwa ukuhlola indle kuphela. Ingase ingatholi umphumela onembile uma isetshenziselwa amanye amasampula afana namathe nomchamo nokunye.
IZIMPAWU ZOKUSEBENZA
Umugqa | 10-1000 | ukuchezuka okuhlobene: -15% kuya +15%. |
I-coefficient yokuhlobana komugqa:(r)≥0.9900 | ||
Ukunemba | Izinga lokubuyisela lizoba phakathi kwama-85% - 115%. | |
Ukuphindaphinda | I-CV≤15% |
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 |
I-Xiamen Wiz Biotech CO., LTD
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