Ikhithi Yokuthola Umuntu We-COVID-19 IgM/IgG
COVID-19 IgM/IgG Antibody Detection Kit
(Colloidal Gold Immunochromatography Method) Product Manual
【PI-RODUCT NAME】Ikhithi Yokuthola Amasosha E-COVID-19 IgM/IgG (Indlela Ye-Colloidal Gold Immunochromatography) 【PI-ACKAGING I-SPECIFICATIONS】 1 Izivivinyo/Ikhithi, Izivivinyo eziyi-10/Ikhithi
【ABSTRACT】
Ama-coronavirus anoveli awohlobo lwe-β. I-COVID-19 yisifo esithathelwanayo sokuphefumula esiyingozi. Ngokuvamile abantu bayathinteka. Njengamanje, iziguli ezingenwe yi-coronavirus yenoveli ziwumthombo oyinhloko wokutheleleka; abantu abane-asymptomatic abangenwe yileli gciwane bangaba umthombo othathelwanayo. Ngokusekelwe ophenyweni lwamanje lwe-epidemiological, isikhathi sokufukamela siyizinsuku ezi-1 kuya kweziyi-14, kakhulukazi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile. Ukucinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.
【EXPECTED USAGE】
Le khithi ifanele ukutholwa kwekhwalithi ye-COVID-19 ngokuthola amasosha omzimba angama-2019-nCoV IgM/IgG ku-serum yomuntu, i-plasma, noma igazi lonke. Izimpawu ezijwayelekile zokutheleleka nge-2019-nCoV zifaka izimpawu zokuphefumula, umkhuhlane, ukukhwehlela, ukuphelelwa umoya, kanye ne-dyspnea. Ezimweni ezimbi kakhulu, ukutheleleka kungabangela inyumoniya, isifo sokuphefumula esinamandla kakhulu, ukwehluleka kwezinso, ngisho nokufa. I-2019 nCoV ingakhishwa ngoketshezi lokuphefumula noma idluliselwe ngoketshezi lomlomo, ukuthimula, ukuthintana ngokomzimba, kanye namaconsi omoya.
【PRINCIPLES OF THE PI-ROCEI-DURE】
Umgomo we-immunochromatography wale khithi: ukuhlukaniswa kwezingxenye zengxube ngokusebenzisa i-capillary force kanye nokubopha okuqondile nokusheshayo kwe-antibody ku-antigen yayo. Lokhu kuhlola kunamakhasethi amabili, ikhasethi le-IgG kanye nekhasethi le-IgM.
Okwe-YXI-CoV- IgM&IgG- 1 kanye ne-YXI-CoV- IgM&IgG- 10:Kukhasethi le-IgM, iwumshini owomile ohlanganiswe ngokuhlukene nge-2019-nCoV recombinant antigen (umugqa wokuhlola "T") kanye ne-anti-gundwane yembuzi. amasosha omzimba e-polyclonal (umugqa wokulawula "C"). Amasosha omzimba anelebula legolide le-colloidal, i-mouse anti-human IgM (mIgM) asesigabeni sephedi yokukhipha. Uma i-serum ehlanjululiwe, i-plasma, noma igazi eliphelele lisetshenziswa esigabeni sesampula sephedi(S), i-antibody ye-mIgM izobophezela ku-2019- Amasosha omzimba e-nCoV IgM uma ekhona, enza inkimbinkimbi ye-mIgM-IgM. I-mIgM-IgM complex izobe isihamba yonkana isihlungi se-nitrocellulose(NC filter) ngesenzo se-capillary. Uma i-antibody ye-2019-nCoV IgM ikhona kusampula, umugqa wokuhlola (T) uzoboshwa inkimbinkimbi ye-mIgM-IgM futhi uthuthukise umbala. Uma lingekho i-antibody ye-2019-nCoV IgM kusampula, i-mIgM yamahhala ngeke ibophezele kulayini wokuhlola (T) futhi awukho umbala ozovela. I-mIgM yamahhala izobophezela kulayini wokulawula (C); lo mugqa wokulawula kufanele ubonakale ngemva kwesinyathelo sokutholwa njengoba lokhu kuqinisekisa ukuthi ikhithi isebenza kahle.Kukhasethi le-IgG, iwumshini owomile ohlanganiswe ngokuhlukana kwegundane elilwa ne-IgG (“T” test line) kanye noRabbit. i-antichicken IgY antibody (umugqa wokulawula "C"). Amasosha omzimba anelebula legolide le-colloidal, i-2019-nCoV recombinant antigen kanye ne-chicken IgY antibody asesigabeni sephedi yokukhulula. Uma i-serum ehlanjululiwe, i-plasma, noma igazi eliphelele lisetshenziswa engxenyeni yesampula yephedi (S), i-
I-colloidalgold-2019-nCoV recombinant antigen izobophezela kumasosha omzimba we-2019-nCoV IgG uma ekhona, yakhe inkimbinkimbi ye-colloidalgold-2019-nCoV recombinant antigen-IgG. I-complex izobe isihamba yonkana isihlungi se-nitrocellulose (isihlungi se-NC) ngesenzo se-capillary. Uma i-antibody ye-2019-nCoV IgG ikhona kusampula, umugqa wokuhlola (T) uzoboshwa yi-colloidalgold-2019-nCoV recombinant antigen-IgG complex futhi uthuthukise umbala. Uma lingekho i-antibody ye-2019-nCoV IgG kusampula, i-colloidalgold-2019-nCoV recombinant antigen yamahhala ngeke ibophe umugqa wokuhlola (T) futhi awukho umbala ozovela. I-antibody yamahhala ye-colloidal gold-chicken IgY izobophezela kulayini wokulawula (C); lo mugqa wokulawula kufanele ubonakale ngemva kwesinyathelo sokuthola njengoba lokhu kuqinisekisa ukuthi ikhithi isebenza kahle.
Okwe-YXI-CoV- IgM&IgG-02- 1 kanye ne-YXI-CoV- IgM&IgG-02- 10:Umgomo we-immunochromatography wale khithi: ukuhlukaniswa kwezingxenye kwingxube ngokusebenzisa i-medium usebenzisa amandla e-capillary kanye nokubopha okuqondile nokusheshayo kwe i-antibody ku-antigen yayo. I-COVID-19 IgM/IgG Antibody Detection Kit iyi-immunoassay esekwe kulwelwesi esezingeni ukuze kutholwe amasosha omzimba e-IgG ne-IgM ku-SARS-CoV-2 egazini lonke, i-serum noma izibonelo ze-plasma. Lokhu kuhlola kuqukethe izingxenye ezimbili, ingxenye ye-IgG kanye nengxenye ye-IgM. Engxenyeni ye-IgG, i-IgG ephikisana nomuntu ihlanganiswe esifundeni somugqa wokuhlola we-IgG. Ngesikhathi sokuhlolwa, isifanekiso siphendula ngezinhlayiya ze-SARS-CoV-2 antigen-coated kukhasethi lokuhlola. Ingxube ibe isihamba ilandelana eduze kolwelwesi lwe-chromatographical ngesenzo se-capillary futhi isabela nge-IgG ephikisana nomuntu endaweni yokuhlola i-IgG, uma isifanekiso siqukethe amasosha omzimba e-IgG aye ku-SARSCoV-2. Ulayini onombala uzovela esifundeni somugqa wokuhlola we-IgG ngenxa yalokhu. Ngokufanayo, i-IgM ephikisana nomuntu ihlanganiswe endaweni yokuhlola i-IgM futhi uma isifanekiso siqukethe amasosha omzimba e-IgM ku-SARS-CoV-2, i-conjugate specimen complex isabela nge-antihuman IgM. Umugqa onombala uvela endaweni yomugqa wokuhlola we-IgM njengomphumela. Ngakho-ke, uma isifanekiso siqukethe amasosha omzimba akwa-SARS-CoV-2 IgG, kuzovela umugqa onemibala endaweni yokuhlola i-IgG. Uma isifanekiso siqukethe amasosha omzimba akwa-SARS-CoV-2 IgM, kuzovela umugqa onemibala endaweni yokuhlola i-IgM. Uma isifanekiso singaqukethe amasosha omzimba akwa-SARS-CoV-2, awukho umugqa onemibala ozovela kunoma yisiphi isifunda somugqa wokuhlola, okhombisa umphumela ongemuhle. Ukuze usebenze njengokulawula kwenqubo, umugqa onemibala uzovela njalo endaweni yokulawula, okubonisa ukuthi umthamo ofanele we-specimen ungeziwe futhi i-membrane wicking yenzekile.
【MAIN COMPOI-NENTS】
| 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 | |
| test strip uhlobo 1 | 1 ukuhlolwa/isikhwama | / | / | 1 | 10 | I-Nitrocellulose membrane, iphedi yokubopha, iphedi yesampula, ulwelwesi lokuhlunga igazi, iphepha elimuncayo, i-PVC |
| test strip uhlobo 2 | 1 ukuhlolwa/isikhwama | 1 | 10 | / | / | I-Nitrocellulose membrane, iphedi yokubopha, iphedi yesampula, ulwelwesi lokuhlunga igazi, iphepha elimuncayo, i-PVC |
| isampula ye-diluent tube | 100 μL/ibhodlela | 1 | 10 | 1 | 10 | I-Phosphate, i-Tween-20 |
| i-desiccant | 1 isiqephu | 1 | 10 | 1 | 10 | i-silicon dioxide |
| i-dropper | 1 isiqephu | 1 | 10 | 1 | 10 | Ipulasitiki |
Qaphela : Izingxenye kumakhithi eqoqo ahlukene azikwazi ukuxutshwa noma ukushintshaniswa .
【MI-ATERIALS TO BE PROVII-DED BY USER】
•Iphedi lotshwala
•inaliti yokuthatha igazi
【SI-TORAGE KANYE EXPII-RATION】
Gcina amakhithi endaweni epholile neyomile eku-2 - 25°C.
Ungaqandi.
Amakhithi agcinwe kahle asebenza izinyanga eziyi-12.
【SAMPLE REQUIREMENTS】
I-Assay ifanele i-serum yomuntu, i-plasma, noma amasampula egazi lonke. Amasampula kufanele asetshenziswe ngokushesha ngangokunokwenzeka ngemva kokuqoqwa. Ukuqoqwa kwe-Serum ne-plasma: I-Serum ne-plasma kufanele kuhlukaniswe ngokushesha ngangokunokwenzeka ngemva kokuqoqwa kwegazi ukuze kugwenywe i-hemolysis.
【SAMPLE PRESI-ERVATION】
I-Serum ne-plasma kufanele isetshenziswe ngokushesha ngangokunokwenzeka ngemva kokuqoqwa futhi igcinwe ku-2-8 ° C izinsuku ezingu-7 uma ingasetshenziswa ngokushesha. Uma kudingeka isitoreji sesikhathi eside, sicela ugcine ku -20 °C izikhathi ezingaphansi kwezinyanga ezi-2. Gwema ukuqhwaza okuphindaphindiwe nokuncibilika.
Isampula yegazi eliphelele noma le-peripheral kufanele lihlolwe phakathi kwamahora angu-8 ngemva kokuqoqwa.
Amasampula egazi le-hemolysis kanye ne-lipid egazini akufanele asetshenziselwe ukutholwa.
【TESTING METHOD】
Okwe-YXI-CoV- IgM&IgG- 1 kanye ne-YXI-CoV- IgM&IgG- 10:
Funda imiyalelo ngokucophelela ngaphambi kokuyisebenzisa. Letha umugqa Wokuhlola, Isampula yeshubhu le-diluent, nesampula ekamelweni lokushisa ngaphambi kokuhlolwa.
1. Engeza u-50 µl wegazi Eliphelele noma le-peripheral noma u-20 µl Serum kanye ne-plasma eshubhuni lesampula le-diluent bese uxuba kahle. Engeza amaconsi angu-3-4 engxenyeni yesampula yephedi.
2. Shiya ekamelweni lokushisa imizuzu emi-5 ukuze ubuke imiphumela. Imiphumela elinganiswa ngemva kwemizuzu emi-5 ayivumelekile futhi kufanele ilahlwe. Okwe-YXI-CoV- IgM&IgG-02- 1 kanye ne-YXI-CoV- IgM&IgG-02-10:
Funda imiyalelo ngokucophelela ngaphambi kokuyisebenzisa. Letha umugqa Wokuhlola, Isampula yeshubhu le-diluent, nesampula ekamelweni lokushisa ngaphambi kokuhlolwa.
1. Engeza u-25µl wegazi Eliphelele noma le-peripheral noma i-10µl Serum ne-plasma eshubhuni le-diluent yesampuli bese uxuba kahle. Engeza amaconsi angu-4 kuphedi yesampula
ingxenye.
2. Shiya ekamelweni lokushisa imizuzu emi-5 ukuze ubuke imiphumela. Imiphumela elinganiswa ngemva kwemizuzu emi-5 ayivumelekile futhi kufanele ilahlwe.
【[INTERPRETATION OF TEST RESULTS】
| YXI-CoV- IgM&IgG-1 futhi YXI-CoV- IgM&IgG-10 | YXI-CoV- IgM&IgG-02-1 futhi YXI-CoV- IgM&IgG-02-10 |
| ★IgG POSITIVE: Kuvela imigqa emibili.Umugqa owodwa onombala kufanele ube esifundeni somugqa wokulawula (C), bese umugqa onombala uvela endaweni yokuhlola ye-IgG.Umphumela ulungile kumasosha omzimba ka-2019-nCoV ethize-IgG. ★lgM OKUHLE: Kuvela imigqa emibili. Umugqa owodwa onombala kufanele ube esifundeni somugqa wokulawula(C), futhi ulayini onombala uvela endaweni yomugqa wokuhlola we-lgM. Umphumela ulungile kumasosha omzimba ka-2019- nCoV specific-lgM.★IgG kanye ne-lgM POSITIVE: Kokubili umugqa wokuhlola ( T)kanye nomugqa wokulawula ikhwalithi (C)kunemibala ekhasethini le-IgG kanye nekhasethi le-lgM. ★OKUBI: Amanga anombala owodwa avela endaweni yokulawula (C).Awukho umugqa onombala obonakalayo ovela endaweni yokuhlola ye-lgG noma i-lgM(T).
★OKUNGAMALI: Ulayini wokulawula awubonakali.Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile yizona zizathu okungenzeka kakhulu zokuhluleka komugqa wokulawula.Buyekeza inqubo bese uphinda ukuhlola ngekhasethi elisha lokuhlola.Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha. futhi uxhumane nomsabalalisi wangakini.
| ★IgG POSITIVE: Imigqa emibili ivela. Umugqa owodwa onombala kufanele ube esifundeni somugqa wokulawula (C), futhi umugqa onemibala uvela esifundeni somugqa wokuhlola we-IgG. Umphumela uba muhle kuma-antibodies e-SARS-CoV-2 ethize-IgG. ★IgM OKUHLE: Imigqa emibili ivela. Umugqa owodwa onombala kufanele ube esifundeni somugqa wokulawula (C), futhi umugqa onemibala uvela esifundeni somugqa wokuhlola we-IgM. Umphumela uba muhle kuma-antibodies e-SARS-CoV-2 ethize-IgM. ★IgG kanye IgM POSITIVE: Imigqa emithathu ivela. Umugqa owodwa onombala kufanele ube esifundeni somugqa wokulawula (C), futhi imigqa emibili enemibala kufanele ivele esifundeni somugqa wokuhlola we-IgG kanye nesifunda somugqa wokuhlola we-IgM. ★ NEGATIVE: Umugqa owodwa onombala uvela endaweni yokulawula (C). Cha umugqa onemibala ebonakalayo uvela endaweni yokuhlola ye-IgG noma ye-IgM (T).
★OKUNGAMALI: Ulayini wokulawula uyehluleka ukuvela. Ivolumu yesampula enganele noma amasu enqubo angalungile yizona zizathu okungenzeka kakhulu zokuhluleka komugqa wokulawula. Buyekeza inqubo bese uphinda ukuhlola ngekhasethi elisha lokuhlola. Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha bese uthintana nomsabalalisi wangakini.
|
【LIMITATION OF THOLAION METHOD】
a. Umkhiqizo uklanyelwe kuphela ukusetshenziswa ne-serum yomuntu, i-plasma, amasampula egazi lonke ukuze kutholwe ikhwalithi ye-2019 -nCoV IgM ne-IgG antibody.
b. Njengakuzo zonke izivivinyo zokuxilonga, ukuxilongwa okuqondile komtholampilo akufanele kusekelwe kumphumela wokuhlolwa okukodwa kodwa kufanele kwenziwe ngemva kokuba konke okutholwe emitholampilo sekuhloliwe futhi kufanele kuqinisekiswe ezinye izindlela zokuthola ezivamile.
c. Kungase kwenzeke i-negetive negative uma inani le-2019-nCoV IgM noma i-IgG antibody lingaphansi kwezinga lokutholwa lekhithi.
d. Uma umkhiqizo uba manzi ngaphambi kokusetshenziswa, noma ugcinwe ngendlela engafanele, kungase kubangele imiphumela engalungile.
e. Ukuhlolwa okokuthola ikhwalithi ye-antibody engu-2019-nCoV IgM noma ye-IgG ku-serum yomuntu, i-plasma noma isampula yegazi futhi akubonisi inani lamasosha omzimba.
【PRECAUTIONS】
a. Ungasebenzisi imikhiqizo ephelelwe yisikhathi noma eyonakele.
b. Sebenzisa kuphela i-diluent efanayo ephaketheni lekhithi. Ama-Diluent avela kukhithi ehlukene awakwazi ukuxutshwa.
c. Ungasebenzisi amanzi ompompi, amanzi ahlanzekile noma amanzi agayiwe njengezilawuli ezingezinhle.
d. Ukuhlolwa kufanele kusetshenziswe phakathi nehora elingu-1 ngemva kokuvulwa. Uma izinga lokushisa le-ambient lingaphezu kuka-30 ℃, noma indawo yokuhlola inomswakama, Ikhasethi Lokutholwa kufanele lisetshenziswe ngokushesha.
e. Uma kungekho ukunyakaza koketshezi ngemva kwemizuzwana engu-30 yokuqala isivivinyo, kufanele kwengezwe ukwehla okwengeziwe kwesixazululo sesampula.
f. Qaphela ukuvikela amathuba okutheleleka ngegciwane lapho uqoqa amasampula. Gqoka amagilavu alahlwayo, imaski, njll., bese ugeza izandla zakho ngemva kwalokho.
g. Leli khadi lokuhlola lenzelwe ukusetshenziswa kanye, kanye. Ngemva kokusetshenziswa, ikhadi lokuhlola namasampula kufanele kubhekwe njengemfucuza yezokwelapha esengozini yokutheleleka ngebhayoloji futhi ilahlwe ngendlela efanele ngokuvumelana nemithetho kazwelonke efanele.
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