Ikhithi yokuxilonga ye-D-Dimer (i-fluorescence immunochromatographic assay)

incazelo emfushane:


  • Isikhathi sokuhlola:10-15 imizuzu
  • Isikhathi esivumelekile:Izinyanga ezingama-24
  • Ukunemba:Ngaphezu kuka-99%
  • Ukucaciswa:1/25 ukuhlolwa/ibhokisi
  • Izinga lokushisa lesitoreji :2℃-30℃
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    Ikhithi yokuxilonga ye-D-Dimer(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-D-Dimer(i-fluorescence immunochromatographic assay) i-fluorescence immunochromatographic assay yokutholwa komthamo we-D-Dimer (DD) ku-plasma yomuntu, isetshenziselwa ukuhlonza i-venous thrombosis, isabalalisa i-intravascular coagulation, kanye nokuqapha i-thrombosis. Ukwelashwa .Wonke amasampula amahle kufanele aqinisekiswe ngezinye izindlela. Lokhu kuhlolwa kuhloselwe ukusetshenziswa ngochwepheshe bezempilo kuphela.

    ISIFINYEZO
    I-DD ikhombisa umsebenzi we-fibrinolytic.Izizathu zokwanda kwe-DD:1.I-hyperfibrinolysis yesibili, efana ne-hypercoagulation, ukuhlangana kwe-intravascular coagulation, isifo sezinso, ukwenqatshwa kokufakelwa kwesitho, ukwelashwa kwe-thrombolytic, njll. ; 3. I-myocardial infarction, i-cerebral infarction, i-pulmonary embolism, i-venous thrombosis, ukuhlinzwa, isimila, ukubola kwe-intravascular coagulation, ukutheleleka kanye ne-tissue necrosis, njll.

    ISIMISO SENKQUBO
    I-membrane yedivayisi yokuhlola ihlanganiswe ne-anti DD antibody endaweni yokuhlola kanye ne-anti-rabbit IgG ye-IgG yembuzi endaweni yokulawula. Iphedi elilebula limbozwa nge-fluorescence ebhalwe ukuthi i-anti DD antibody kanye ne-rabbit IgG kusengaphambili. Lapho kuhlolwa isampula elihle, i-DD antigen kusampula ihlangana ne-fluorescence ebhalwe ukuthi i-anti DD antibody, bese yenza ingxube yamasosha omzimba. Ngaphansi kwesenzo se-immunochromatography, ukugeleza okuyinkimbinkimbi kubheke ephepheni elimuncayo, lapho inkimbinkimbi idlula isifunda sokuhlola, ihlangene ne-anti DD coating antibody, yakha inkimbinkimbi entsha. Izinga le-DD lihlotshaniswa kahle nesignali ye-fluorescence, futhi ukugxila kwe-DD kusampula kungatholwa nge-fluorescence immunoassay assay.

    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
    .Amasampula ahloliwe angaba i-heparin anticoagulant plasma noma i-EDTA anticoagulant plasma.

    .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.
    .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.Yengeza i-40μL serum 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
    DD <0.5mg/L

    Kutuswa ukuthi ilabhorethri ngayinye isungule ububanzi bayo obujwayelekile obumelela isiguli sayo.

    IMIPHUMELA YOKUHLOLA NOKUTOLIZWA
    .Le datha engenhla ingumphumela wokuhlolwa kwe-DD, futhi kuphakanyiswa ukuthi ilabhorethri ngayinye kufanele isungule uhla lwamanani okuthola i-DD 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
    I-1.Ikhithi kufanele ivalwe futhi ivikelwe kumswakama.

    2.Zonke izibonelo ezinhle zizoqinisekiswa ngezinye izindlela.
    3.Zonke izifanekiso zizophathwa njengezingcolisa izinto ezingase zibe khona.
    4.UNGAsebenzisi i-reagent ephelelwe yisikhathi.
    5.UNGAshintshi ama-reagents phakathi kwamakhithi anenombolo ehlukile.
    6.UNGAWUSEBENZISI kabusha amakhadi okuhlola nanoma yiziphi izesekeli ezilahlwayo.
    I-7.I-Misoperation, isampula eningi noma encane ingaholela 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

    Umugqa 0.2mg/L kuya ku-10mg/L ukuchezuka okuhlobene: -15% kuya +15%.
    I-coefficient yokuhlobana komugqa:(r)≥0.9900
    Ukunemba Izinga lokubuyisela lizoba phakathi kwama-85% - 115%.
    Ukuphindaphinda I-CV≤15%
    Ukucaciswa(Azikho izinto ekuhlolweni kwesiphazamiso eziphazamise ukuhlolwa)

    Ukugxambukela

    Ukugxilisa ingqondo

    I-FDP

    120mg/L

    VC

    2000mg/L

    I-Barbituric acid

    100mg/L

    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:

     t11-1 In Vitro Diagnostic Medical Device
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     tt-4 Ungaphinde Usebenzise
     tt-5 ISEXWAYISO
     tt-6 Bheka Imiyalo Yokusetshenziswa

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