Ikhithi yokuFumana i-COVID-19 ye-IgM/IgG ye-Antibody
COVID-19 IgM/IgG Antibody Detection Kit
(Colloidal Gold Immunochromatography Method) Product Manual
【PI-RODUCT NAME】I-COVID-19 ye-IgM/IgG ye-Antibody yokubona iKhiti (iNdlela yeGolide yeColloidal Immunochromatography) 【PACKAGING SPECIFICATIONS】 Uvavanyo olu-1/Ikhithi, iimvavanyo ezili-10/iKhithi
【ABSIPHEPHA】
Inoveli coronaviruses yeyodidi lwe-β. I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla. Ngokuqhelekileyo abantu basengozini. Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo; abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo. Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7. Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo. Ukuxinana kweempumlo, impumlo evuzayo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.
【EXPECTED USAGE】
Le khithi ilungele ukufunyaniswa okusemgangathweni kwe-COVID-19 ngokufumanisa izilwa-buhlungu ze-2019-nCoV IgM/IgG kwiserum yomntu, kwiplasma, okanye igazi lilonke. Iimpawu eziqhelekileyo zosulelo ngo-2019-nCoV ziquka iimpawu zokuphefumla, umkhuhlane, ukukhohlela, ukuphefumla, kunye ne-dyspnea. Kwiimeko ezinzima ngakumbi, usulelo lunokubangela inyumoniya, isifo sokuphefumla esiqatha, ukusilela kwezintso, kwanokufa. I-nCoV ka-2019 inokukhutshelwa ngokukhutshwa kokuphefumla okanye isasazwe ngolwelo lomlomo, ukuthimla, ukudibana nomzimba, kunye namathontsi omoya.
【PRINCIPLES OF THE PI-ROCEI-DURE】
Umgaqo we-immunochromatography wale khithi: ukwahlukana kwamacandelo kumxube ngokusebenzisa i-medium capillary force kunye nokubopha okuthe ngqo kunye nokukhawuleza kwe-antibody kwi-antigen yayo. Olu vavanyo luneekhasethi ezimbini, i-IgG cassette kunye ne-IgM cassette.
Kwi-YXI-CoV- IgM&IgG- 1 kunye ne-YXI-CoV- IgM&IgG- 10:Kwikhasethi ye-IgM, sisixhobo esomileyo esigqunywe ngokwahlukeneyo nge-2019-nCoV recombinant antigen (“T” test line) kunye nebhokhwe echasene nempuku. i-polyclonal antibodies ("C" umgca wokulawula). I-antibodies ye-colloidal ebhalwe ngegolide, i-mouse anti-human IgM (mIgM) ikwicandelo lephedi yokukhupha. Emva kokuba i-serum ehlanjululweyo, i-plasma, okanye igazi elipheleleyo lisetyenziswe kwicandelo lesampula (S), i-antibody ye-mIgM iya kubophelela kwi-2019- Izilwa-buhlungu ze-nCoV IgM ukuba zikhona, zenza i-mIgM-IgM complex. I-mIgM-IgM complex iya kuthi emva koko ihambe ngapha kwe-nitrocellulose filter(NC filter) nge-capillary action. Ukuba i-antibody ye-2019-nCoV IgM ikhona kwisampuli, umgca wovavanyo (T) uya kubotshwa yi-mIgM-IgM eyinkimbinkimbi kwaye iphuhlise umbala. Ukuba akukho 2019-nCoV IgM antibody kwisampulu, i-mIgM yasimahla ayiyi kubophelela kumgca wovavanyo (T) kwaye akukho mbala uya kukhula. I-mIgM yasimahla iya kubophelela kumgca wolawulo (C); lo mgca wolawulo kufuneka ubonakale emva kwesinyathelo sokubhaqa njengoko oku kuqinisekisa ukuba ikiti isebenza ngokufanelekileyo.Kwikhasethi ye-IgG, yindawo eyomileyo ehlanganiswe ngokwahlukileyo kunye ne-mouse anti-human IgG ("T" umgca wokuvavanya) kunye noMvundla. i-antichicken IgY antibody ( "C" umgca wokulawula). Ii-antibodies ezibhalwe ngegolide ye-colloidal, i-2019-nCoV recombinant antigen kunye ne-antibody yenkukhu ye-IgY zikwicandelo lephedi yokukhupha. Emva kokuba i-serum ehlanjululweyo, iplasma, okanye igazi elipheleleyo ligalelwe kwisampulu yecandelo (ii-S), i
colloidalgold-2019-nCoV recombinant antigen iya kubophelela 2019-nCoV IgG antibodies ukuba zikhona, ukwenza colloidalgold-2019-nCoV recombinant antigen-IgG complex. I-complex iya kuthi emva koko ihambe ngapha kwe-nitrocellulose filter (NC filter) nge-capillary action. Ukuba i-antibody ye-2019-nCoV IgG ikhona kwisampulu, umgca wovavanyo (T) uya kubotshwa yi-colloidalgold-2019-nCoV recombinant antigen-IgG complex kunye nokuphuhlisa umbala. Ukuba akukho 2019-nCoV IgG antibody kwisampulu, free colloidalgold-2019-nCoV recombinant antigen ayiyi kubophelela kumgca wovavanyo (T) kwaye akukho mbala uya kuphuhlisa. I-antibody ye-colloidal yegolide-yenkukhu ye-IgY yamahhala iya kubophelela kumgca wokulawula (C); lo mgca wolawulo kufuneka ubonakale emva kwesinyathelo sokubhaqa njengoko oku kuqinisekisa ukuba ikiti isebenza kakuhle.
Ye-YXI-CoV- IgM&IgG-02- 1 kunye ne-YXI-CoV- IgM&IgG-02- 10: Umgaqo we-immunochromatography wale khithi: ukwahlukana kwamacandelo kumxube ngokusebenzisa i-medium usebenzisa amandla e-capillary kunye nokubopha okuthe ngqo kunye nokukhawuleza i-antibody kwi-antigen yayo. I-COVID-19 IgM/IgG Antibody Detection Kit luvavanyo olusemgangathweni olusekwe kwimembrane ukuze kufunyanwe izilwa-buhlungu ze-IgG kunye ne-IgM kwi-SARS-CoV-2 egazini lonke, kwiserum okanye kwisampulu zeplasma. Olu vavanyo lunamacandelo amabini, icandelo le-IgG kunye necandelo le-IgM. Kwicandelo le-IgG, i-IgG echasene nomntu ifakwe kwindawo yovavanyo lwe-IgG. Ngexesha lovavanyo, umzekelo uphendula kunye ne-SARS-CoV-2 yamasuntswana e-antigen-coated kwikhasethi yovavanyo. Umxube ke ufudukele ecaleni kwenwebu yechromatographical ngesenzo se-capillary kwaye udibana ne-IgG echasene nobuntu kwindawo yovavanyo lwe-IgG, ukuba umfuziselo unezilwa-buhlungu ze-IgG kwi-SARSCoV-2. Umgca onemibala uya kubonakala kwingingqi yovavanyo lwe-IgG ngenxa yoku. Ngokukwanjalo, i-IgM echasene nomntu igqunywe kumgca wovavanyo we-IgM kwaye ukuba umfuziselo une-antibodies ye-IgM kwi-SARS-CoV-2, i-conjugate specimen complex isabela nge-antihuman IgM. Umgca onemibala uvela kwindawo yovavanyo lwe-IgM njengesiphumo. Ke ngoko, ukuba lo mzekelo une-SARS-CoV-2 IgG antibodies, umgca onemibala uya kuvela kwindawo yovavanyo lwe-IgG. Ukuba umzekelo uqulethe izilwa-buhlungu ze-SARS-CoV-2 IgM, umgca onemibala uya kuvela kwindawo yovavanyo lwe-IgM. Ukuba lo mzekelo awuqulathanga izilwa-buhlungu ze-SARS-CoV-2, akukho mgca unemibala uya kuvela kuyo nayiphi na imimandla yovavanyo, ebonisa iziphumo ezibi. Ukuze usebenze njengolawulo lwenkqubo, umgca onemibala uya kuhlala ubonakala kummandla wolawulo, obonisa ukuba umthamo ofanelekileyo we-specimen wongeziwe kwaye i-membrane wicking yenzeke.
【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 | |
| uvavanyo strip uhlobo 1 | 1 uvavanyo / ingxowa | / | / | 1 | 10 | Nitrocellulose inwebu, iphedi yokubopha, iphedi yesampulu, inwebu yokuhluza igazi, iphepha elifunxayo, iPVC |
| uvavanyo strip uhlobo 2 | 1 uvavanyo / ingxowa | 1 | 10 | / | / | Nitrocellulose inwebu, iphedi yokubopha, iphedi yesampulu, inwebu yokuhluza igazi, iphepha elifunxayo, iPVC |
| ityhubhu yesampula yediluent | 100 μL/ibhotyana | 1 | 10 | 1 | 10 | Phosphate, Phakathi-20 |
| desiccant | Iqhekeza eli-1 | 1 | 10 | 1 | 10 | i-silicon dioxide |
| idropha | Iqhekeza eli-1 | 1 | 10 | 1 | 10 | Iplastiki |
Qaphela : Amalungu kwiikhithi zebhetshi ezahlukeneyo azinakuxutywa okanye zitshintshwe .
【MATERIALS TO BE PROVII-DED BY USER】
•Iphedi yotywala
•inaliti yokuthatha igazi
【SUKUHLELA KUNYE EXPII-RATION】
Gcina iikiti kwindawo epholileyo neyomileyo kwi-2 - 25°C.
Musa ukuba ngumkhenkce.
Iikiti ezigcinwe kakuhle zisebenza iinyanga ezili-12.
【SAMPLE REQUIREMENTS】
Uvavanyo lufanelekile kwiserum yomntu, iplasma, okanye iisampulu zegazi elipheleleyo. Iisampulu kufuneka zisetyenziswe ngokukhawuleza emva kokuqokelela. I-Serum kunye ne-plasma collection: I-Serum kunye ne-plasma kufuneka ihlulwe ngokukhawuleza emva kokuqokelela igazi ukuphepha i-hemolysis.
【SAMPLE NGAPHAMBILISI-ERVATION】
I-Serum kunye ne-plasma kufuneka isetyenziswe ngokukhawuleza emva kokuqokelela kwaye igcinwe kwi-2-8 ° C kwiintsuku ze-7 ukuba ingasetyenziswa ngokukhawuleza. Ukuba ugcino lwexesha elide luyafuneka, nceda ugcine kwi -20 °C ngamaxesha angaphantsi kweenyanga ezi-2. Kuphephe ukukhenkceza okuphindaphindiweyo kunye nokunyibilika.
Iisampulu yegazi epheleleyo okanye yomda kufuneka ivavanywe kwiiyure ezisi-8 emva kokuba iqokelelwe.
I-hemolysis enzima kunye neesampuli zegazi ze-lipid aziyi kusetyenziselwa ukuchongwa.
【TESTING METHOD】
YeYXI-CoV- IgM&IgG- 1 kunye neYXI-CoV- IgM&IgG- 10:
Funda imiyalelo ngononophelo phambi kokuba uyisebenzise. Yiza nomtya woVavanyo, ityhubhu yesampulu yokuxutywa, kunye nesampulu kwiqondo lobushushu begumbi phambi kovavanyo.
1. Yongeza i-50 µl yegazi Elipheleleyo okanye elikwi-peripheral okanye i-20 µl ISerum kunye neplasma kwiSampuli yetyhubhu yokuxuba kwaye uxube kakuhle. Yongeza i-3- 4 yehla kwicandelo lesampula lephedi.
2. Shiya kwiqondo lokushisa kwimizuzu emi-5 ukujonga iziphumo. Iziphumo ezilinganiswe emva kwemizuzu emi-5 azikho mthethweni kwaye kufuneka zilahlwe. YeYXI-CoV- IgM&IgG-02- 1 kunye neYXI-CoV- IgM&IgG-02- 10:
Funda imiyalelo ngononophelo phambi kokuba uyisebenzise. Yiza nomtya woVavanyo, ityhubhu yesampulu yokuxutywa, kunye nesampulu kwiqondo lobushushu begumbi phambi kovavanyo.
1. Yongeza i-25µl yegazi eliPheleleyo okanye elikwi-peripheral okanye i-10µl iSerum kunye neplasma kwiSampuli yetyhubhu yokuxuba kwaye uxube kakuhle. Yongeza amaconsi ama-4 kwisampula yesampula
icandelo.
2. Shiya kwiqondo lokushisa kwimizuzu emi-5 ukujonga iziphumo. Iziphumo ezilinganiswe emva kwemizuzu emi-5 azikho mthethweni kwaye kufuneka zilahlwe.
【[INTERPRETATION OF UVAVANYO RESULTS】
| YXI-CoV- IgM&IgG-1 kwaye YXI-CoV- IgM&IgG-10 | YXI-CoV- IgM&IgG-02-1 kwaye YXI-CoV- IgM&IgG-02-10 |
| ★IgG POSITIVE: Imigca emibini ibonakala.Umgca omnye onemibala kufuneka ube kwindawo yokulawula umgca (C), kwaye umgca onemibala ubonakala kwindawo yovavanyo lwe-IgG.Isiphumo silungile kwi-2019- nCoV ethile-i-IgG antibodies. ★lgM OKUHLE: kuvela imigca emibini. Umgca omnye onemibala kufuneka ube kwindawo yokulawula umgca (C), kwaye umgca onemibala ubonakala kwindawo yovavanyo lwe-lgM. Isiphumo silungile kwi-2019- nCoV specific-lgM antibodies.★ IgG kunye ne-lgM POSITIVE: Zombini umgca wovavanyo ( T) kunye nomgca wokulawula umgangatho (C) zinemibala kwikhasethi ye-IgG kunye nekhasethi ye-lgM. ★ OKUBI: Ubuxoki obunye obunemibala buvela kummandla wolawulo (C) .Akukho mgca wombala obonakalayo ovela kummandla wovavanyo we-lgG okanye we-lgM (T).
★OKUNGENAKUMBI: Umgca wokulawula awuphumeleli ukuvela.Umthamo wesampulu engonelanga okanye iindlela ezingalunganga zenkqubo zezona zizathu zinokwenzeka zokungaphumeleli komgca wolawulo.Jonga kwakhona inkqubo kwaye uphinde uvavanyo ngekhasethi entsha yovavanyo.Ukuba ingxaki iyaqhubeka,yeka ukusebenzisa ikhithi yovavanyo kwangoko. kwaye uqhagamshelane nomthengisi wendawo yakho.
| ★IgG POSITIVE: Imigca emibini ibonakala. Umgca omnye onemibala kufuneka ube kwindawo yokulawula umgca (C), kwaye umgca onemibala ubonakala kwindawo yovavanyo lwe-IgG. Iziphumo zilungile kwii-antibodies ze-SARS-CoV-2 ezikhethekileyo-IgG. ★IgM OKUHLE: kuvela imigca emibini. Umgca omnye onemibala kufuneka ube kwindawo yokulawula umgca (C), kwaye umgca onemibala ubonakala kwindawo yovavanyo lwe-IgM. Iziphumo zilungile kwii-antibodies ze-SARS-CoV-2 ezikhethekileyo-IgM. ★IgG kunye ne-IgM POSITIVE: Imigca emithathu ibonakala. Umgca omnye onemibala kufuneka ube kwindawo yokulawula umgca (C), kwaye imigca emibini enemibala kufuneka ibonakale kwingingqi yovavanyo lwe-IgG kunye nommandla wovavanyo we-IgM. ★ ENGALUNGILEYO: Umgca omnye onemibala ubonakala kwindawo yokulawula (C). Hayi Umgca ombala obonakalayo uvela kummandla wovavanyo we-IgG okanye we-IgM (T).
★ AYILUNGILEYO: Umgca wolawulo uyasilela ukuvela. Umthamo wesampulu engonelanga okanye ubuchule benkqubo obungachanekanga zezona zizathu zinokwenzeka zokungaphumeleli komgca wolawulo. Hlaziya inkqubo kwaye uluphinde uvavanyo ngekhasethi entsha yovavanyo.
|
【LIMITATION OF FUMANAION METHOD】
a. Imveliso yenzelwe kuphela ukusetyenziswa kunye ne-serum yabantu, iplasma, iisampulu zegazi elipheleleyo ukuze kufunyanwe umgangatho we-2019 -nCoV IgM kunye ne-IgG antibody.
b. Njengazo zonke iimvavanyo zokuxilonga, ukuxilongwa kweklinikhi ecacileyo akufanele kusekelwe kwisiphumo sovavanyo olunye kodwa kunoko kufuneka kwenziwe emva kokuba zonke iziphumo zonyango ziye zavavanywa kwaye kufuneka ziqinisekiswe ngezinye iindlela zokubona eziqhelekileyo.
c. I-negative engeyiyo inokwenzeka ukuba isixa se-2019-nCoV IgM okanye i-IgG antibody singaphantsi kwinqanaba lokubhaqa lekhithi.
d. Ukuba imveliso iba manzi ngaphambi kokusetyenziswa, okanye igcinwe ngokungafanelekanga, inokubangela iziphumo ezingalunganga.
e. Uvavanyo lolokufumana umgangatho we-2019-nCoV IgM okanye i-antibody ye-IgG kwiserum yomntu, kwiplasma okanye kwisampulu yegazi kwaye ayibonisi ubungakanani bezithinteli-zifo.
【PRECAUTIONS】
a. Musa ukusebenzisa iimveliso eziphelelwe lixesha okanye ezonakalisiweyo.
b. Sebenzisa kuphela i-diluent ehambelanayo kwiphakheji yekhithi. Iidiluyinti ezivela kwiikhithi ezahlukeneyo azinakuxutywa.
c. Musa ukusebenzisa amanzi etephu, amanzi acociweyo okanye amanzi adibeneyo njengolawulo olubi.
d. Uvavanyo kufuneka lusetyenziswe kwiyure eli-1 emva kokuvulwa. Ukuba ubushushu be-ambient bungaphezulu kwe-30 ℃, okanye imeko-bume yovavanyo ifumile, iCassette yokuFumana kufuneka isetyenziswe ngokukhawuleza.
e. Ukuba akukho ntshukumo yolwelo emva kwemizuzwana engama-30 yokuqalisa uvavanyo, ithontsi elongezelelweyo lesisombululo sesampulu kufuneka longezwe.
f. Lumka ukuthintela ukuba nokwenzeka kosulelo lwentsholongwane xa uqokelela iisampulu. Nxiba iiglavu ezilahlwayo, iimaski, njalo njalo, kwaye uhlambe izandla zakho emva koko.
g. Eli khadi lovavanyo lenzelwe usetyenziso lwexesha elinye. Emva kokusetyenziswa, ikhadi lovavanyo kunye neesampulu kufuneka zithathwe njengenkunkuma yezonyango kunye nomngcipheko wosulelo lwebhayoloji kwaye ilahlwe ngokufanelekileyo ngokuhambelana nemimiselo yesizwe efanelekileyo.
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