Ikhithi yokuxilonga ye-25-hydroxy Vitamin D (i-fluorescence immunochromatographic assay)
Ikhithi yokuxilonga ye-25-hydroxy Vitamin D(ukuhlolwa kwe-fluorescence immunochromatographic)
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-25-hydroxy Vitamin D (fluorescence immunochromatographic assay) i-fluorescence immunochromatographic assay yokutholwa kobuningi be-25-hydroxy Vitamin D (25-(OH) VD) ku-serum yomuntu noma i-plasma, esetshenziswa kakhulu ukuhlola amazinga. kavithamini D. Kuyi-axiliary diagnosis reagent. Wonke amasampula amahle kufanele aqinisekiswe ngezinye izindlela. Lokhu kuhlolwa kuhloselwe ukusetshenziswa ngochwepheshe bezempilo kuphela.
ISIFINYEZO
I-Vitamin D iyivithamini futhi iyi-hormone ye-steroid, ikakhulukazi ehlanganisa i-VD2 ne-VD3, imiyalelo yayo efana kakhulu. I-Vitamin D3 kanye ne-D2 iguqulwa ibe yi-25 hydroxyl vitamin D (kuhlanganise ne-25-dihydroxyl vitamin D3 kanye ne-D2). I-25-(OH) VD emzimbeni womuntu, ukufundisa okuzinzile, ukugxila okuphezulu. I-25-(OH) VD ibonisa inani eliphelele likavithamini D , kanye nekhono lokuguqulwa likavithamini D, ngakho-ke i-25-(OH)VD ibhekwa njengenkomba engcono kakhulu yokuhlola izinga likavithamini D. Ikhithi Yokuxilongwa isekelwe i-immunochromatography futhi inganikeza umphumela kungakapheli imizuzu eyi-15.
ISIMISO SENKQUBO
I-membrane yedivayisi yokuhlola ihlanganiswe ne-conjugate ye-BSA kanye ne-25-(OH)VD endaweni yokuhlola kanye ne-anti-rabbit IgG ye-antibody yembuzi endaweni yokulawula. Iphedi lomaka limbozwe nge-fluorescence mark anti-25-(OH)VD antibody kanye ne-IgG yonogwaja kusengaphambili. Lapho kuhlolwa isampula, i-25-(OH)VD kusampula ihlangana ne-fluorescence ephawulwe ukuthi i-anti 25-(OH)VD antibody, bese yenza ingxube yamasosha omzimba. Ngaphansi kwesenzo se-immunochromatography, ukugeleza okuyinkimbinkimbi kubheke ephepheni elimuncayo, lapho okuyinkimbinkimbi kudlula isifunda sokuhlola, Umaka we-fluorescent wamahhala uzohlanganiswa no-25-(OH)VD kulwelwesi.Ukuhlushwa okungu-25-(OH) I-VD iwukuhlobana okunegethivu kwesignali ye-fluorescence, futhi ukugxila kwe-25-(OH)VD kusampula kungatholwa nge-fluorescence immunoassay assay.
AMA-REAGENTS KANYE NEZINTO EZINIKEZELWAYO
25T izingxenye zephakheji:
.Iphepha lokuhlola ngalinye elifakwe esikhwameni nge-desiccant 25T
.Isixazululo 25T
.B isixazululo 1
.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
Inqubo yokuhlola yensimbi bheka imanuwali ye-immunoanalyzer. Inqubo yokuhlola i-reagent imi kanje
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.Faka i-30μL serum noma isampula ye-plasma ku-A, bese uxuba kahle.
7.Faka isixazululo esingu-50μL B kule ngxube engenhla, bese uxuba kahle.
8.Shiya ingxube imizuzu engu-15.
9.Yengeza ingxube engu-80μL ukuze usampula kahle ikhadi.
10.Chofoza inkinobho ethi "standard test", emva kwemizuzu eyi-10, ithuluzi lizothola ngokuzenzakalelayo ikhadi lokuhlola, lingakwazi ukufunda imiphumela esikrinini sokubonisa sensimbi, futhi lirekhode/liphrinte imiphumela yokuhlolwa.
11.Bheka umyalelo we-Portable Immune Analyzer(WIZ-A101).
IZIMALI EZILINDELEKILE
25-(OH)VD ibanga elijwayelekile:30-100ng/mL
Kutuswa ukuthi ilabhorethri ngayinye isungule ububanzi bayo obujwayelekile obumelela isiguli sayo.
IMIPHUMELA YOKUHLOLA NOKUTOLIZWA
.Le datha engenhla isikhawu sereferensi esisungulwe kudatha yokuthola yale khithi, futhi kuphakanyiswa ukuthi ilabhorethri ngayinye kufanele isungule isikhawu senkomba ngokubaluleka komtholampilo okufanelekile kwenani labantu kulesi sifunda.
.Ukugxiliswa kwe-25-(OH)VD kungaphezulu kohlu lwereferensi, futhi izinguquko zomzimba noma impendulo yokucindezeleka kufanele ikhishwe.Ngempela okungavamile, kufanele kuhlanganise ukuhlonzwa kwezimpawu zomtholampilo.
.Imiphumela yale ndlela isebenza kuphela ebangeni lesithenjwa elisungulwe yile ndlela, futhi imiphumela ayiqhathanisi ngokuqondile nezinye izindlela.
.Ezinye izici zingaphinda zibangele amaphutha emiphumeleni yokuthola, okuhlanganisa izizathu zobuchwepheshe, amaphutha okusebenza nezinye izici zesampula.
ISITOREJI NOKUZInza
.Ikhithi iyishelufu yezinyanga eziyi-18 kusukela ngosuku eyakhiwa ngalo. Gcina amakhithi angasetshenzisiwe ku-2-30°C. UNGAQISHI. Ungasebenzisi ngale kosuku lokuphelelwa yisikhathi.
.Ungavuli isikhwama esivaliwe kuze kube yilapho usulungele ukwenza isivivinyo, futhi ukuhlola ukusetshenziswa kanye kuyaphakanyiswa ukuthi kusetshenziswe ngaphansi kwendawo edingekayo (izinga lokushisa elingu-2-35℃, umswakamo 40-90%) phakathi kwemizuzu engu-60 ngokushesha kungenzeka.
.I-diluent eyisampula 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 anenombolo ehlukile yenombolo..
.UNGAphinde usebenzise amakhadi okuhlola nanoma yiziphi izisekeli ezilahlwayo.
.Ukungasebenzi kahle, isampula eliningi noma elincane lingaholela ekuphambukeni kwemiphumela.
LUKULINGISA
.Njenganoma isiphi isilingo sisebenzisa amasosha omzimba egundane, kungenzeka ukuthi kuphazanyiswa 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
Umugqa | 5 ng/mL ukuya ku-120 ng/mL | ukuchezuka okuhlobene: -15% kuya +15%. |
I-coefficient yokuhlobana komugqa:(r)≥0.9900 | ||
Ukunemba | Izinga lokubuyisela kufanele libe phakathi kwama-85% - 115%. | |
Ukuphindaphinda | I-CV≤15% | |
Ukucaciswa (Azikho izinto ekuhlolweni kwesiphazamiso eziphazamise ukuhlolwa) | Ukugxambukela | Ukugxilisa ingqondo |
IHemoglobin | 200μg/mL | |
i-transferrin | 100μg/mL | |
I-peroxidase yamahhashi | 2000μg/mL | |
I-Vitamin D3 | 50mg/mL | |
Ivithamini D | 50mg/mL |
REFERENCES
1.Hansen JH,et al.HAMA Ukuphazamisa Nge-Murine Monoclonal Antibody-Based Immunoassays[J].J ye-Clin Immunoassay,1993,16:294-299.
2.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
Ikheli:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China
Ucingo: +86-592-6808278
Ifeksi:+86-592-6808279