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COVID-19 IgM/IgG Antibody Detection Kit

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    COVID-19 IgM/IgG Antibody Detection Kit

    (Colloidal Gold Immunochromatography Method) Product Manual

     

    PRUDUCT NAME】 COVID- 19 IgM/IgG Kayan Ganewar Jikin Jiki (Tsarin Immunochromatography Colloidal Gold) 【PACKAGING SPECIFICATIONS】 Gwaji 1/Kit , Gwaji 10/Kit

    ABSTRACT

    Novel coronaviruses na cikin nau'in β. COVID-19 cuta ce mai saurin kamuwa da numfashi. Mutane gabaɗaya suna da sauƙi. A halin yanzu, marasa lafiya da suka kamu da cutar sankara ta coronavirus sune babban tushen kamuwa da cuta; Mutanen da suka kamu da asymptomatic suma suna iya zama tushen kamuwa da cuta. Dangane da binciken cututtukan cututtuka na yanzu, lokacin shiryawa shine kwanaki 1 zuwa 14, galibi daga kwanaki 3 zuwa 7. Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari. Ana samun cunkoso na hanci, hanci, ciwon makogwaro, myalgia da gudawa a wasu lokuta.

    EXPECTED USAGE

    Wannan kit ɗin ya dace don gano ƙimar COVID-19 ta hanyar gano ƙwayoyin rigakafin 2019-nCoV IgM/IgG a cikin jini, plasma, ko duka jini. Alamomin kamuwa da cuta na yau da kullun tare da 2019-nCoV sun haɗa da alamun numfashi, zazzabi, tari, gajeriyar numfashi, da dyspnea. A cikin lokuta masu tsanani, kamuwa da cuta na iya haifar da ciwon huhu, matsanancin ciwo na numfashi, gazawar koda, har ma da mutuwa. Ana iya fitar da 2019 nCoV ta hanyar ɓoyewar numfashi ko kuma yada ta ta hanyar ruwa na baki, atishawa, saduwa ta jiki, da ta digon iska.

    PRINCIPLES OF THE PROCEDURE

    Ka'idar immunochromatography na wannan kit: rabuwa da aka gyara a cikin cakuda ta hanyar matsakaici ta hanyar amfani da ƙarfin capillary da ƙayyadaddun da sauri dauri na antigen zuwa antigen. Wannan gwajin ya ƙunshi kaset guda biyu, kaset na IgG da kaset na IgM.

    Don YXI-CoV- IgM&IgG-1 da YXI-CoV- IgM&IgG- 10: A cikin kaset na IgM, busassun matsakaici ne wanda aka lulluɓe shi daban tare da layin gwaji na 2019-nCoV (layin gwajin “T”) da goat anti-mouse. polyclonal antibodies (layin kula da "C"). The colloidal zinariya-labeled antibodies, linzamin kwamfuta anti-human IgM (mIgM) ne a cikin saki pad sashe. Da zarar diluted serum, plasma, ko dukan jini aka shafa a sample pad sashe (S), mIgM antibody zai ɗaure zuwa 2019- nCoV IgM rigakafi idan suna nan, suna samar da hadaddun mIgM-IgM. Hadaddiyar mIgM-IgM daga nan za ta wuce ta tace nitrocellulose (NC filter) ta hanyar aikin capillary. Idan 2019-nCoV IgM antibody yana nan a cikin samfurin, layin gwajin (T) za a ɗaure shi da hadaddun mIgM-IgM kuma ya haɓaka launi. Idan babu maganin rigakafi na 2019-nCoV IgM a cikin samfurin, mIgM kyauta ba zai ɗaure layin gwajin (T) kuma babu launi da zai haɓaka. MIgM na kyauta zai ɗaure zuwa layin sarrafawa (C); wannan layin sarrafawa ya kamata a bayyane bayan matakin ganowa kamar yadda wannan ya tabbatar da cewa kit ɗin yana aiki da kyau.A cikin kaset na IgG, busassun matsakaici ne wanda aka lulluɓe shi daban tare da linzamin kwamfuta anti-human IgG (layin gwajin "T") da Rabbit. antichicken IgY antibody (layin sarrafawa "C"). Kwayoyin rigakafi masu alamar zinari, 2019-nCoV antigen da kaji IgY antibody suna cikin sashin kushin saki. Da zarar an diluted serum, plasma, ko duka jini ana shafa shi a sashin kushin samfurin (S), da

    colloidalgold-2019-nCoV recombinant antigen zai ɗaure ga 2019-nCoV IgG antibodies idan suna nan, samar da colloidalgold-2019-nCoV recombinant antigen-IgG hadaddun. Sa'an nan hadaddun zai matsa a kan nitrocellulose filter (NC filter) ta hanyar aikin capillary. Idan 2019-nCoV IgG antibody yana cikin samfurin, layin gwajin (T) za a ɗaure shi ta colloidalgold-2019-nCoV recombinant antigen-IgG hadaddun da haɓaka launi. Idan babu 2019-nCoV IgG antibody a cikin samfurin, free colloidalgold-2019-nCoV antigen recombinant ba zai ɗaure da gwajin line (T) kuma babu wani launi da zai tasowa. The free colloidal zinariya-kaza antibody IgY zai ɗaure zuwa kula line (C); wannan layin sarrafawa ya kamata a bayyane bayan matakin ganowa saboda wannan yana tabbatar da cewa kit ɗin yana aiki yadda yakamata.

    Don YXI-CoV-IgM&IgG-02-1 da YXI-CoV- IgM&IgG-02-10: Ka'idar immunochromatography na wannan kit: Rarraba abubuwan da aka haɗa a cikin cakuda ta hanyar matsakaici ta hanyar amfani da ƙarfin capillary da ƙayyadaddun da sauri dauri na antigen zuwa antigen. Kit ɗin Ganewar rigakafin COVID-19 IgM/IgG shine ingantaccen rigakafin rigakafi na tushen membrane don gano ƙwayoyin IgG da IgM ga SARS-CoV-2 a cikin jini gaba ɗaya, jini ko samfuran plasma. Wannan gwajin ya ƙunshi abubuwa biyu, bangaren IgG da bangaren IgM. A cikin ɓangaren IgG, an rufe IgG anti-dan Adam a cikin yankin layin gwajin IgG. Yayin gwaji, samfurin yana amsawa da ƙwayoyin antigen-mai rufi na SARS-CoV-2 a cikin kaset ɗin gwajin. Cakuda sannan ya yi ƙaura ta gefe tare da membrane chromatographically ta hanyar aikin capillary kuma yana amsawa tare da IgG na ɗan adam a cikin layin gwajin IgG, idan samfurin ya ƙunshi ƙwayoyin rigakafi na IgG zuwa SARSCoV-2. Layi mai launi zai bayyana a yankin layin gwajin IgG sakamakon wannan. Hakazalika, an rufe IgM na ɗan adam a cikin yankin layin gwajin IgM kuma idan samfurin ya ƙunshi ƙwayoyin rigakafi na IgM zuwa SARS-CoV-2, hadaddun samfurin haɗin gwiwar yana amsawa da IgM na ɗan adam. Layi mai launi ya bayyana a yankin layin gwajin IgM a sakamakon haka. Don haka, idan samfurin ya ƙunshi ƙwayoyin rigakafin SARS-CoV-2 IgG, layin launi zai bayyana a yankin layin gwajin IgG. Idan samfurin ya ƙunshi ƙwayoyin rigakafin SARS-CoV-2 IgM, layin launi zai bayyana a yankin layin gwajin IgM. Idan samfurin bai ƙunshi ƙwayoyin rigakafin SARS-CoV-2 ba, babu wani layi mai launi da zai bayyana a cikin ɗayan layin gwajin, yana nuna mummunan sakamako. Don yin aiki azaman tsarin sarrafawa, layi mai launi koyaushe zai bayyana a cikin yankin layin sarrafawa, yana nuna cewa an ƙara ƙarar samfurin da ya dace kuma wicking membrane ya faru.

     

    MAIN COMPONENTS

     

     

    Cat. No. YXI-CoV-IgM&IgG-1  YXI-CoV-IgM&IgG-10 YXI-CoV-IgM&IgG-02-1 YXI-CoV-IgM&IgG-02-10  

     

     

    Components

     

    Product Pic.

    Name Specification Quantity Quantity Quantity Quantity
    gwajin tsiri na 1 1 gwaji/jakar / / 1 10 Nitrocellulose membrane, dauri pad, samfurin kushin, jini tacewa membrane, absorbent takarda, PVC
    gwaji nau'in 2 1 gwaji/jakar 1 10 / / Nitrocellulose membrane, dauri pad, samfurin kushin, jini tacewa membrane, absorbent takarda, PVC
    samfurin diluent tube 100 μL / gwangwani 1 10 1 10 Phosphate, Tween-20
    desiccant guda 1 1 10 1 10 silicon dioxide
    dropper guda 1 1 10 1 10 Filastik

    Lura: Abubuwan da ke cikin kayan batch daban-daban ba za a iya haɗa su ko musanya su ba.

     

    MATERIALS TO BE PROVIDE BY USER

    •Tashin barasa

    •Alurar shan jini

    STARBIYYA KUMA EXPIRATION

    Ajiye kayan a cikin sanyi da bushe wuri a 2 - 25 ° C.

    Kar a daskare.

    Kayan da aka adana da kyau suna aiki na tsawon watanni 12.

    SAMPLE REQUIREMENTS

    Assay ya dace da jinin mutum, plasma, ko duka samfuran jini. Ya kamata a yi amfani da samfurori da wuri-wuri bayan tattarawa. Tarin jini da jini: Ya kamata a rabu da jini da plasma da wuri-wuri bayan an tattara jini don guje wa hemolysis.

    SAMPLE PRESERVATION

    Ya kamata a yi amfani da jini da plasma da wuri-wuri bayan tattarawa kuma a adana su a 2-8 ° C na kwanaki 7 idan ba a yi amfani da su nan da nan ba. Idan ana buƙatar ajiya na dogon lokaci, da fatan za a adana a -20 ° C na lokaci ƙasa da watanni 2. A guji maimaita daskarewa da narkewa.

    Ya kamata a gwada samfurin jini gabaɗaya ko na gefe a cikin sa'o'i 8 bayan tattarawa.

    Ba za a yi amfani da haemolysis mai tsanani da samfuran jinin lipid ba don ganowa.

    TESTING METHOD

    Don YXI-CoV- IgM&IgG- 1 da YXI-CoV- IgM&IgG- 10:

    Karanta umarnin a hankali kafin amfani. Kawo tsiri na Gwaji, Samfurin diluent bututu, da samfurin zuwa zafin daki kafin gwaji.

    1. Ƙara 50 µl na Jini gabaɗaya ko na gefe ko 20 µl Serum da plasma zuwa Samfurin diluent tube sannan a gauraya sosai. Ƙara 3-4 saukad da zuwa sashin kushin samfurin.

    2. Bar a dakin da zafin jiki na minti 5 don lura da sakamakon. Sakamako da aka auna bayan mintuna 5 basu da inganci kuma yakamata a jefar dasu. Don YXI-CoV- IgM&IgG-02- 1 da YXI-CoV- IgM&IgG-02- 10:

    Karanta umarnin a hankali kafin amfani. Kawo tsiri na Gwaji, Samfurin diluent bututu, da samfurin zuwa zafin daki kafin gwaji.

    1. Ƙara 25µl na Duka ko jini na gefe ko 10µl Serum da plasma zuwa Samfurin diluent tube kuma gauraya sosai. Ƙara 4 saukad da zuwa samfurin kushin

     

     

    sashe.

    2. Bar a dakin da zafin jiki na minti 5 don lura da sakamakon. Sakamako da aka auna bayan mintuna 5 basu da inganci kuma yakamata a jefar dasu.

     

    [INTERPRETATION OF GWADA RESULTS

     

     

    YXI-CoV- IgM&IgG-1 kuma YXI-CoV- IgM&IgG-10 YXI-CoV- IgM&IgG-02-1 kuma YXI-CoV- IgM&IgG-02-10
    ★IgG KYAU: Layi biyu sun bayyana.Layi mai launi ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), kuma layin launi yana bayyana a yankin layin gwajin IgG. Sakamakon yana da kyau ga 2019- nCoV takamaiman-IgG antibodies. ★lgM KYAU: Layuka biyu sun bayyana. Layi mai launi ɗaya ya kamata ya kasance a cikin yankin layin sarrafawa (C), kuma layin launi ya bayyana a yankin layin gwajin lgM. Sakamakon yana da kyau ga 2019- nCoV takamaiman-lgM antibodies.★IgG da lgM POSITIVE: Dukan layin gwajin ( T) da layin kula da ingancin (C) masu launi a cikin kaset na IgG da kaset na lgM.

    ★NAGATIVE: Ƙarya mai launi ɗaya ta bayyana a yankin sarrafawa (C) .Babu wani layi mai launi da ya bayyana a yankin gwajin lgG ko lgM (T).

     

     

    ★INVALID: Layin sarrafawa ya kasa bayyana.Rashin isasshen samfurin samfurin ko dabarun tsarin da ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafawa.Bita tsarin kuma maimaita gwajin tare da sabon kaset na gwaji.Idan matsalar ta ci gaba, daina amfani da kayan gwajin nan da nan. kuma tuntuɓi mai rabawa na gida.

     

     

    ★IgG KYAU: Layuka biyu sun bayyana. Layi mai launi ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), kuma layin launi yana bayyana a yankin layin gwajin IgG. Sakamakon yana da inganci ga ƙwayoyin rigakafin SARS-CoV-2 takamaiman-IgG. ★IgM POSITIVE: Layuka biyu sun bayyana. Layi mai launi ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), kuma layin launi yana bayyana a yankin layin gwajin IgM. Sakamakon yana da inganci ga ƙwayoyin rigakafin SARS-CoV-2 takamaiman-IgM. ★IgG da IgM POSITIVE: Layuka uku sun bayyana. Layi mai launi ɗaya ya kamata ya kasance a cikin yankin layin sarrafawa (C), kuma layin launi biyu yakamata su bayyana a yankin layin gwajin IgG da yankin layin gwajin IgM.

    ★MAGANCI: Layi mai launi ɗaya ya bayyana a yankin sarrafawa (C). A'a

    layin launi na fili yana bayyana a yankin gwajin IgG ko IgM (T).

     

    ★INVALID: Layin sarrafawa ya kasa bayyana. Rashin isassun samfurin ƙira ko dabarun ƙa'ida ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafawa. Bita tsarin kuma maimaita gwajin tare da sabon kaset na gwaji. Idan matsalar ta ci gaba, daina amfani da kayan gwajin nan da nan kuma tuntuɓi mai rarrabawa na gida.

     

     

     

     

    LIMITATION OF GANEION METHOD

    a. An ƙirƙiri samfurin ne kawai don amfani tare da maganin ɗan adam, plasma, samfuran jini duka don gano ƙimar 2019 -nCoV IgM da rigakafin IgG.

    b. Kamar yadda yake a cikin duk gwaje-gwajen bincike, ƙayyadaddun ganewar asibiti bai kamata ya dogara da sakamakon gwajin guda ɗaya ba amma ya kamata a yi shi bayan an kimanta duk binciken asibiti kuma ya kamata a tabbatar da shi ta wasu hanyoyin ganowa na al'ada.

    c. Mara kyau na ƙarya na iya faruwa idan adadin 2019-nCoV IgM ko IgG antibody yana ƙasa da matakin gano kayan.

    d. Idan samfurin ya jike kafin amfani, ko an adana shi ba daidai ba, yana iya haifar da sakamako mara kyau.

    e. Gwajin don gano ingancin 2019-nCoV IgM ko IgG antibody a cikin jini, plasma ko samfurin jini kuma baya nuna adadin ƙwayoyin rigakafi.

    KYAUTATAIONS

    a. Kar a yi amfani da kayan da suka ƙare ko lalace.

    b. Yi amfani da abin da ya dace kawai a cikin fakitin kit. Diluents daga kuri'a na kit daban-daban ba za a iya haɗa su ba.

    c. Kada a yi amfani da ruwan famfo, ruwa mai tsafta ko ruwa mai tsafta azaman iko mara kyau.

    d. Ya kamata a yi amfani da gwajin a cikin awa 1 bayan buɗewa. Idan yanayin zafin jiki ya fi 30 ℃, ko kuma yanayin gwajin yana da ɗanɗano, yakamata a yi amfani da kaset ɗin Gano nan take.

    e. Idan babu motsin ruwan bayan daƙiƙa 30 na fara gwajin, ya kamata a ƙara ƙarin digo na maganin samfurin.

    f. Kula don hana yuwuwar kamuwa da cuta yayin tattara samfuran. Saka safar hannu, abin rufe fuska, da sauransu, sannan a wanke hannayenka daga baya.

    g. An tsara wannan katin gwajin don amfani guda ɗaya, lokaci ɗaya. Bayan amfani, katin gwajin da samfuran ya kamata a ɗauki su azaman sharar lafiya tare da haɗarin kamuwa da ƙwayoyin cuta da zubar da su yadda ya kamata daidai da ƙa'idodin ƙasa masu dacewa.




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