Ikhithi yokuxilonga ye-Alpha-fetoprotein (i-fluorescence immunochromatographic assay)

inkcazelo emfutshane:


  • Ixesha lovavanyo:10-15 imizuzu
  • Ixesha elisebenzayo:Iinyanga ezingama-24
  • Ukuchaneka:Ngaphezulu kwe-99%
  • Inkcazo:1/25 uvavanyo / ibhokisi
  • Ubushushu bokugcina :2℃-30℃
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Ikhithi yokuxilonga ye-Alpha-fetoprotein(uvavanyo lwe-fluorescence immunochromatographic)
    Ukusetyenziswa kwe-in vitro diagnostic kuphela

    Nceda ufunde le phakheji ifake ngononophelo phambi kokuba uyisebenzise kwaye ulandele ngokungqongqo imiyalelo. Ukuthembeka kweziphumo zovavanyo akunakuqinisekiswa ukuba kukho nakuphi na ukutenxa kwimiyalelo ekweli phakheji.

    UKUSETYENZISWA OKUHLOSIWEYO

    I-Diagnostic Kit ye-Alpha-fetoprotein (i-fluorescence immunochromatographic assay) luvavanyo lwe-fluorescence immunochromatographic yokufumanisa ubungakanani be-Alpha-fetoprotein (AFP) kwi-serum yabantu okanye i-plasma, esetyenziselwa ukuxilongwa kwe-axiliary, isiphumo sonyango kunye nokuxilongwa kwe-hepatocellular carcinoma. Zonke iisampuli ezilungileyo kufuneka ziqinisekiswe ngezinye iindlela. Olu vavanyo lwenzelwe ukusetyenziswa kweengcali zezempilo kuphela.

    USHWANKATHELO

    I-Alpha-fetoprotein (AFP) yenye yeempawu zethumba ezisetyenziswa ngokuqhelekileyo. Yi-glycoprotein enobunzima bemolekyuli obungama-70,000 kunye neswekile eyi-4%. Iiveki ezi-6, ukufikelela kwincopho yeeveki ezili-12 ukuya kwe-15, ukuxinwa kwe-serum ye-1 ukuya kwi-3 g / L, kunye ne-umbilical cord yegazi ekuzalweni kwe-10 ukuya kwi-100 mg / L; 1 ukuya kwiminyaka emi-2 emva kokuzalwa kwinqanaba labantu abadala; Ukukhulelwa okuqhelekileyo kunokufikelela. I-90 ukuya kwi-500 ng / mL embindini;Umxholo we-serum yomntu oqhelekileyo we-AFP uphakathi kwe-2 kunye ne-8 ng / mL, kodwa izifo ezininzi, ngakumbi i-hepatitis, ichaphazela ixabiso le-AFP.

    UMGAQO WENKQUBO

    I-membrane yesixhobo sovavanyo igqunywe nge-anti AFP kwingingqi yovavanyo kunye ne-antibody ye-IgG yebhokhwe kwindawo yolawulo. Iphedi elayibhile iqatywe nge-fluorescence ebhalwe i-anti AFP antibody kunye nomvundla we-IgG kwangaphambili. Xa kuvavanywa isampulu eqinisekileyo, i-antigen ye-AFP kwisampulu idibanisa ne-fluorescence ebhalwe i-anti-AFP antibody, kwaye yenze umxube wokugonyeka. Ngaphantsi kwesenzo se-immunochromatography, ukuhamba okuntsonkothileyo kwicala lephepha elifunxayo, xa i-complex idlula ummandla wovavanyo, idityaniswe ne-anti-AFP yokwambathisa i-antibody, yenza inqanaba elitsha le-complex. kwisampulu inokubonwa ngovavanyo lwe-fluorescence immunoassay.

    IIREGENTS KUNYE NEZINTO EZIBONISWAYO

    Amacandelo ephakheji ye-25T:

    .Ikhadi lovavanyo lwefoyile nganye efakwe kwi-desiccant 25T
    .Iisampulu zediluyinti 25T
    .Fakela ipakethe 1

    IZINTO EZIFUNEKAYO KODWA AKUNIKEZWA
    Isampulu yokuqokelela isitya,ixesha

    UKUQOKELELWA KWEsampuli NOKUGCINWA
    1.Iisampulu ezivavanyiweyo zingaba serum, i-heparin anticoagulant plasma okanye i-EDTA anticoagulant plasma.

    2.Ngokungqinelana neendlela eziqhelekileyo zokuqokelela isampuli. I-Serum okanye isampuli ye-plasma inokugcinwa efrijini kwi-2-8 ℃ ye-7days kunye ne-cryopreservation engaphantsi kwe-15 ° C kwiinyanga ezi-6.
    3.Zonke iisampulu ziphephe imijikelo yokunyibilika komkhenkce.

    INKQUBO YOVAVANYO
    Nceda ufunde incwadi yokusebenza kwesixhobo kunye nokufakwa kwephakheji phambi kovavanyo.

    I-1.Lay eceleni zonke ii-reagents kunye neesampuli kwiqondo lokushisa.
    2.Vula i-Portable Immune Analyzer (WIZ-A101), faka igama lokungena kwi-akhawunti ngokwendlela yokusebenza yesixhobo, kwaye ungenise ujongano lokubona.
    3.Skena ikhowudi yokuchaza ukuze uqinisekise into yovavanyo.
    4.Khupha ikhadi lovavanyo kwibhegi yefoyile.
    5.Faka ikhadi lovavanyo kwi-slot yekhadi, scan ikhowudi ye-QR, kwaye unqume into yovavanyo.
    6.Yongeza i-20μL ye-serum okanye isampuli yeplasma kwisampulu ye-diluent, kwaye udibanise kakuhle.
    7.Yongeza i-80μL yesisombululo sesampulu kwisampulu kakuhle yekhadi.
    8.Cofa iqhosha elithi "standard test", emva kwemizuzu eyi-15, isixhobo siya kubona ngokuzenzekelayo ikhadi lovavanyo, sinokufunda iziphumo kwisikrini sokubonisa isixhobo, kwaye sirekhode / siprinte iziphumo zovavanyo.
    9.Jonga kumyalelo we-Portable Immune Analyzer(WIZ-A101).

    IINDLELA EZILINDELEKILEYO

    AFP:<10ng/mL
    Kucetyiswa ukuba ilabhoratri nganye iseke uluhlu lwayo oluqhelekileyo olumele izigulane zayo.

    IZIPHUMO ZOMVAVANYO KUNYE UTOLIKO
    .Idatha engentla isiphumo sovavanyo lwe-AFP reagent, kwaye kucetyiswa ukuba ibhubhoratri nganye kufuneka imisele uluhlu lwamaxabiso okubona i-AFP afanelekileyo kubemi kulo mmandla. Ezi ziphumo zingentla zezereferensi kuphela.

    .Iziphumo zale ndlela zisebenza kuphela kuluhlu lwereferensi olusekwe kule ndlela, kwaye akukho kuthelekiswa ngokuthe ngqo kunye nezinye iindlela.
    .Ezinye izinto zinokubangela iimpazamo kwiziphumo zokubona, kubandakanywa nezizathu zobugcisa, iimpazamo zokusebenza kunye nezinye izinto zesampulu.

    UKUGCINWA NOZINZI
    1.Ikhithi ziinyanga ezili-18 zobomi beshelufa ukusukela kumhla wokwenziwa. Gcina iikhithi ezingasetyenziswanga kwi-2-30°C. MUSA UKUMKHENZA. Musa ukusebenzisa ngaphaya komhla wokuphelelwa.

    2.Musa ukuvula isingxobo esitywiniweyo de ube ulungele ukwenza uvavanyo, kwaye uvavanyo lokusetyenziswa olunye lucetyiswa ukuba lusetyenziswe phantsi kwendawo efunekayo (iqondo lobushushu 2-35℃, ukufuma 40-90%) ngaphakathi kwemizuzu engama-60 ngokukhawuleza. kangangoko kunokwenzeka.
    I-3.I-diluent yesampuli isetyenziswa ngokukhawuleza emva kokuvulwa.

    IZILUMKISO NEMIGAQO
    .Ikhithi kufuneka itywinwe kwaye ikhuselwe kumswakama.

    .Yonke imizekelo emihle iya kuqinisekiswa ngezinye iindlela.
    .Yonke imizekelo iya kuphathwa njengongcoliseko olunokubakho.
    .USUKU sebenzisa i-reagent ephelelwe lixesha.
    . AKUKHO ukutshintshiselana kwee-reagents phakathi kweekhithi ezineenombolo ezahlukeneyo.
    .USUKU phinda usebenzise amakhadi ovavanyo kunye naziphi na izincedisi ezilahlwayo.
    .I-Misoperation, isampuli eninzi okanye encinci inokukhokelela ekuphambukeni kweziphumo.

    LUKUXELELA
    .Njengalo naluphi na uvavanyo olusebenzisa izilwa-buhlungu zegundane, kunokwenzeka ukuba kukho ukuphazanyiswa yi-anti-mouse antibodies (HAMA) kwi-specimen. Iisampulu ezisuka kwizigulane ezifumene amalungiselelo ee-antibodies ze-monoclonal zokuxilongwa okanye unyango zingaquka i-HAMA. Imizekelo enjalo inokubangela ubuxoki okanye iziphumo ezingalunganga.

    .Esi siphumo sovavanyo kuphela kwireferensi yeklinikhi, akufanele sisebenze njengesiseko kuphela sokuxilongwa kweklinikhi kunye nonyango, izigulane zolawulo lwezonyango kufuneka ziqwalaselwe ngokubanzi kunye neempawu zayo, imbali yonyango, ezinye iimviwo zebhubhoratri, impendulo yonyango, i-epidemiology kunye nolunye ulwazi. .
    .Le reagent isetyenziselwa kuphela iimvavanyo ze-serum kunye ne-plasma. Isenokungafumani ziphumo zichanekileyo xa isetyenziselwa ezinye iisampulu ezinje ngamathe nomchamo, njl.

    IIMPAWU ZOKUSEBENZA

    Umgca I-1ng/mL ukuya kwi-1000ng/mL ukutenxa okuhambelanayo: -15% ukuya +15%.
    Umgca wolungelelwaniso i-coefficient:(r)≥0.9900
    Ukuchaneka Izinga lokubuyisela liya kuba phakathi kwe-85% - 115%.
    Ukuphindaphinda CV≤15%
    Ukuchaneka(Akukho nanye kwizinto ezivavanyiweyo eziye zaphazamisa kuvavanyo)

    Ungenelelo

    Ukugxininiswa kokuphazamiseka

    I-acetaminophen

    1500μg/mL

    Acetylsalicylic acid

    10mg/mL

    CEA

    500μg/mL

    IHemoglobin

    200μg/mL

    transferrin

    100μg/mL

    Ihashe radish peroxidase

    2000μg/mL

    LH

    200mIU/mL

    FSH

    200mIU/mL

    HCG

    20000mIU/mL

    TSH

    200μIU/mL

    BSA

    5mg/mL

    Vinblastine

    500μg/mL

    Cisplatin

    1000μg/mL

    Azathioprine

    30mg/L

    Bleomycin

    100μU/mL

    RIMIZEKELO
    1.Hansen JH, et al.HAMA Ukuphazamiseka kunye ne-Murine Monoclonal Antibody-Based Immunoassays [J] .J ye-Clin Immunoassay, 1993, 16: 294-299.
    2.Levinson SS.Ubume be-Heterophilic Antibodies kunye nendima kwi-Immunoassay Interference[J].J ye-Clin Immunoassay,1992,15:108-114.

    Isitshixo kwiisimboli ezisetyenzisiweyo:

     t11-1 In Vitro Diagnostic Medical Isixhobo
     tt-2 Umenzi
     tt-71 Gcina kwi-2-30 ℃
     tt-3 Umhla WOKUPHELELWA
     tt-4 Musa Ukuphinda Usebenzise
     tt-5 ISILUMKO
     tt-6 Qhagamshelana neMiyalelo yokuSetyenziswa

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