Ngwa nyocha maka mgbochi ọrịa Helicobacter Pylori (Fluorescence Immunochromatographic Assay)

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    Ngwa nyocha maka mgbochi ọrịa Helicobacter Pylori(Fluorescence Immunochromatographic assay)
    N'ihi na in vitro diagnostic ojiji naanị

    Biko gụọ ihe ngwungwu a nke ọma tupu ejiri ya wee soro ntuziaka ahụ.Enweghị ike ịkwenye ntụkwasị obi nke nsonaazụ nyocha ma ọ bụrụ na ọ dị iche na ntuziaka dị na ntinye ngwugwu a.

    Ezubere iji
    Ngwa nyocha maka mgbochi nke Helicobacter Pylori (Fluorescence Immunochromatographic Assay) bụ nyocha immunochromatographic fluorescence maka nyocha ọnụọgụ nke mgbochi HP na ọbara mmadụ ma ọ bụ plasma.nke dị mkpa inyeaka diagnostic uru maka ọrịa gastric. All nti sample ga-akwado ndị ọzọ methodologies.Ezubere ule a maka naanị ndị ọkachamara ahụike.

    Nchịkọta
    Ọrịa helicobacter pylori nke gastric nwere njikọ chiri anya na gastritis na-adịghị ala ala, ọnya afọ, adenocarcinoma gastric, lymphoma gastric mucosa metụtara, ọnụọgụ ọrịa Hp ylori dị ihe dị ka 90% na gastritis, ọnya afọ, ọnya duodenal na ndị ọrịa cancer gastric.WHO achọpụtala h.pylori dị ka ụdị nke mbụ na-akpata ọrịa kansa.ọ bụ ihe na-ebute ọrịa kansa afọ. Nchọpụta H.pylori bara nnukwu uru na nchọpụta h.pylori ọrịa.

    Ụkpụrụ nke usoro
    A na-ekpuchi akpụkpọ ahụ nke ngwaọrụ ule na HP antigen na mpaghara ule na ewu mgbochi oke bekee IgG na mpaghara nchịkwa.A na-ekpuchi pad lable site na fluorescence nke akpọrọ HP antigen na oke bekee IgG tupu oge eruo.Mgbe a na-anwale nlele dị mma, ihe mgbochi HP dị na nlele na-ejikọta ya na fluorescence akpọrọ HP antigen, wee mepụta ngwakọta mgbochi.N'okpuru omume nke immunochromatography, mgbagwoju eruba na ntụziaka nke absorbent akwụkwọ, mgbe mgbagwoju gafere ule mpaghara, ọ jikọtara na HP mkpuchi antigen, Nleta ọhụrụ complex.HP-Ab larịị na-kwesịrị correlated na fluorescence mgbaàmà, na ịta nke Enwere ike ịchọpụta HP-Ab na nlele site na nyocha immunoassay fluorescence

    Reagent na ihe ndị e nyere

    Ngwa ngwugwu 25T:
    Kaadị ule n'otu n'otu ejiri akpa 25T desiccant tinye ya
    Ihe atụ diluents 25T
    Ntinye ngwugwu 1

    AKWỤKWỌ KWESỊRỊ MA Ọ BỤGHỊ
    Akpa mkpokọta ihe nlele, ngụ oge

    NKWUKWU NA NKWUKWU
    1.The samples nwalere nwere ike ịbụ serum, heparin anticoagulant plasma ma ọ bụ EDTA anticoagulant plasma.

    2.According ọkọlọtọ usoro na-anakọta sample.Enwere ike idowe ihe nlele ọbara ma ọ bụ plasma refrigerated na 2-8 ℃ maka ụbọchị 7 na cryopreservation n'okpuru -15 Celsius maka ọnwa 6.
    3.All sample zere ifriizi-thaw cycles.

    Usoro ASsay
    Biko gụọ akwụkwọ ntuziaka ọrụ akụrụngwa na ntinye ngwugwu tupu ịnwale.

    1.Dịna n'akụkụ niile reagents na sample na ụlọ okpomọkụ.
    2.Mepee Portable Immune Analyzer (WIZ-A101), tinye nbanye paswọọdụ akaụntụ dị ka usoro ọrụ nke ngwá ọrụ si dị, ma tinye interface nchọpụta ahụ.
    3. Nyochaa koodu nyocha iji kwado ihe nlele ahụ.
    4.Wepụ kaadị ule site na akpa foil.
    5.Tinye kaadị ule n'ime oghere kaadị, nyochaa koodu QR, ma chọpụta ihe nlele ahụ.
    6.Add 20μL serum ma ọ bụ plasma sample ka sample diluent, na mix ọma ..
    7.Add 80μL sample ngwọta ka ịlele nke ọma nke kaadị.
    8.Click bọtịnụ "ọkọlọtọ ule", mgbe nkeji iri na ise gachara, ngwa ahụ ga-achọpụta kaadị ule na-akpaghị aka, ọ nwere ike ịgụ ihe si na ihuenyo ngosi nke ngwá ọrụ ahụ, ma dekọọ / bipụta nsonaazụ ule.
    9. Rụtụ aka na ntuziaka nke Portable Immune Analyzer(WIZ-A101).

    Ụkpụrụ echere
    HP-Ab <10

    A na-atụ aro ka ụlọ nyocha ọ bụla guzobe oke nke ya na-anọchite anya ndị ọrịa ya.

    Nsonaazụ ule na ntụgharị asụsụ
    .The n'elu data bụ n'ihi HP-Ab reagent ule, na ọ na-atụ aro na onye ọ bụla laabu kwesịrị guzobe a nso nke HP-Ab nchọpụta ụkpụrụ adabara ndị bi na mpaghara a.Nsonaazụ dị n'elu bụ naanị maka ntụnye aka.

    .Nsonaazụ nke usoro a na-emetụta naanị na nsonye ntụaka nke e guzobere na usoro a, ọ dịghịkwa ihe jikọrọ ya na ụzọ ndị ọzọ.
    .Ihe ndị ọzọ nwekwara ike ime ka njehie na nsonaazụ nchọpụta, gụnyere ihe kpatara teknụzụ, njehie arụmọrụ na ihe nlele ndị ọzọ.

    Nchekwa na Nkwụsi ike
    1.The kit bụ 18 ọnwa shelf-ndụ site na ụbọchị mmepụta.Chekwaa ngwa ndị a na-ejighị ya na 2-30 Celsius.Emela friji.Ejila ụbọchị ngafe gafere.

    2.Do not emepe mechiri emechi obere akpa ruo mgbe ị dị njikere ịrụ a ule, na otu-eji ule na-atụ aro ka a ga-eji n'okpuru chọrọ gburugburu ebe obibi (okpomọkụ 2-35 ℃, iru mmiri 40-90%) n'ime 60 mins ngwa ngwa. dị ka o kwere mee.
    3.Sample diluent na-eji ozugbo emeghere ya.

    Ịdọ aka ná ntị na ịkpachara anya
    .A ga-emechi ngwa ahụ ma chebe ya pụọ ​​​​na mmiri.

    .A ga-eji usoro ndị ọzọ kwado ihe nlere niile dị mma.
    .A ga-ewere ụdịdị niile dị ka ihe nwere ike imetọ.
    Ejila reagenti mebiela
    .AKWỤKWỌ reagents n'etiti ngwa dị iche iche nza No.
    .Ejikwala kaadị ule na ngwa ọ bụla enwere ike ijikwa ọzọ.
    .Misoperation, oke ma ọ bụ obere sample nwere ike iduga n'ihi deviations.

    LNṅomi
    Dị ka ọ dị na nyocha ọ bụla na-eji ọgwụ mgbochi òké eme ihe, ohere dị maka nnyonye anya site na mgbochi mgbochi òké mmadụ (HAMA) n'ụdị.Ihe atụ sitere na ndị ọrịa natara ọgwụ mgbochi monoclonal maka nchoputa ma ọ bụ ọgwụgwọ nwere ike ịnwe HAMA.Ụdị ụdị ahụ nwere ike ịkpata nsonaazụ na-adịghị mma ma ọ bụ ụgha ụgha.

    .Nnwale ule a bụ naanị maka ntụaka ụlọ ọgwụ, ekwesịghị ịbụ naanị ihe ndabere maka nyocha na ọgwụgwọ ụlọ ọgwụ, ndị na-ahụ maka ụlọ ọgwụ na-ahụ maka ndị ọrịa kwesịrị ịdị na-atụgharị uche zuru oke na-ejikọta ya na mgbaàmà ya, akụkọ ahụike ahụike, nyocha ụlọ nyocha ndị ọzọ, nzaghachi ọgwụgwọ, ọrịa na-efe efe na ozi ndị ọzọ. .
    A na-eji reagent naanị maka nyocha ọbara na plasma.O nwere ike ọ gaghị enweta nsonaazụ ziri ezi mgbe ejiri ya mee ihe maka nlele ndị ọzọ dị ka mmiri mmiri na mmamịrị na wdg.

    ÀJỤMỤ ỌRỤ

    Linearity 10-1000 Ngbanwe nke ikwu: -15% ruo +15%.
    Ọnụọgụ njikọ linear:(r)≥0.9900
    Izi ezi Ọnụego mgbake ga-adị n'ime 85% - 115%.
    Nkwagharị ugboro ugboro CV≤15%

    REFERENCES
    1.Shao,JL&F.Wu.Ọganihu ndị na-adịbeghị anya na ụzọ nchọpụta nke Helicobacter pylori[J].Journal of Gastroenterology and Hepatology,2012,21(8):691-694

    2.Hansen JH, et al.HAMA Ntinye aka na Murine Monoclonal Antibody Based Immunoassays[J].J nke Clin Immunoassay,1993,16:294-299.
    3.Levinson SS. Ọdịdị nke Antibodies Heterophilic na Ọrụ dị na Ntinye aka Immunoassay [J].J nke Clin Immunoassay,1992,15:108-114.
    Igodo akara akara ejiri:

     t11-1 Na Vitro Diagnostic Medical Device
     tt-2 Onye nrụpụta
     tt-71 Na-echekwa na 2-30 ℃
     tt-3 Ụbọchị mmebi
     tt-4 Ejighachila ya
     tt-5 kpachara anya
     tt-6 Kpọtụrụ ntuziaka maka ojiji

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