COVID-19 IgM/IgG Antibody Detection Kit

COVID-19 IgM/IgG Antibody Detection Kit

(Colloidal Gold Immunochromatography Method) Product Manual

【PRODUCT NAME】COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold Immunochromatography Method) 【PACKAGING SPECIFICATIONS】 1 Test/Kit, 10 Tests/Kit

【ABSTRACT】

Cov kab mob tshiab coronaviruses yog nyob rau β genus. COVID-19 yog tus kab mob ua pa nyuaj. Tib neeg feem ntau raug mob. Tam sim no, cov neeg mob kis los ntawm tus kabmob tshiab no yog qhov tseem ceeb ntawm kev kis tus kabmob; Cov neeg mob asymptomatic kuj tuaj yeem yog qhov kis tau. Raws li kev tshawb nrhiav kev kis kabmob tam sim no, lub sijhawm incubation yog 1 txog 14 hnub, feem ntau yog 3 txog 7 hnub. Cov tsos mob tseem ceeb muaj xws li kub taub hau, qaug zog thiab hnoos qhuav. Qhov ntswg congestion, los ntswg qhov ntswg, mob caj pas, myalgia thiab raws plab yog pom nyob rau hauv ob peb kis.

【EXPECTED USAGE】

Cov khoom siv no tsim nyog rau kev kuaj pom zoo ntawm COVID-19 los ntawm kev kuaj 2019- nCoV IgM/IgG cov tshuaj tiv thaiv hauv tib neeg cov ntshav, ntshav, lossis ntshav tag nrho. Cov cim qhia ntawm tus kab mob 2019-nCoV muaj xws li cov tsos mob ua pa, ua npaws, hnoos, ua tsis taus pa, thiab ua tsis taus pa. Hauv cov mob hnyav dua, kev kis kab mob tuaj yeem ua rau mob ntsws, mob ua pa hnyav, mob raum tsis ua haujlwm, thiab txawm tias tuag taus. 2019 nCoV tuaj yeem raug tso tawm los ntawm kev ua pa tawm los yog kis los ntawm cov kua hauv qhov ncauj, txham, sib cuag lub cev, thiab los ntawm cov tee dej.

【PRINCIPLES OF THE PROCEDURE】

Lub hauv paus ntsiab lus ntawm immunochromatography ntawm cov khoom siv no: kev sib cais ntawm cov khoom sib xyaw ua ke los ntawm qhov nruab nrab uas siv lub zog capillary thiab qhov tshwj xeeb thiab nrawm ntawm cov tshuaj tiv thaiv rau nws cov antigen. Qhov kev ntsuam xyuas no muaj ob lub cassette, ib qho IgG cassette thiab IgM cassette.

For YXI-CoV- IgM&IgG- 1 and YXI-CoV- IgM&IgG- 10:In the IgM cassette, it is a dry medium that has been coated cais with 2019-nCoV recombinant antigen (“T” test line) and tshis anti-nas. polyclonal antibodies ("C" kab tswj). Cov tshuaj tiv thaiv kab mob colloidal kub-labeled, nas los tiv thaiv tib neeg IgM (mIgM) yog nyob rau hauv qhov tso tawm pad seem.Ib zaug diluted cov ntshav, ntshav, lossis cov ntshav tag nrho raug siv rau cov qauv ntaub qhwv seem (S), cov tshuaj tiv thaiv mIgM yuav khi rau 2019- nCoV IgM antibodies yog tias muaj, tsim cov mIgM-IgM complex. Lub mIgM-IgM complex yuav txav mus thoob plaws lub lim dej nitrocellulose (NC lim) ntawm kev ua haujlwm capillary. Yog tias 2019-nCoV IgM antibody muaj nyob rau hauv cov qauv, cov kab xeem (T) yuav raug khi los ntawm mIgM-IgM complex thiab tsim xim. Yog tias tsis muaj 2019-nCoV IgM cov tshuaj tiv thaiv kab mob hauv cov qauv, mIgM dawb yuav tsis khi rau kab ntsuas (T) thiab tsis muaj xim yuav tsim. Qhov pub dawb mIgM yuav khi rau txoj kab tswj hwm (C); Cov kab tswj no yuav tsum tau pom tom qab qhov kev tshawb pom cov kauj ruam raws li qhov no lees paub tias cov khoom siv ua haujlwm zoo.Hauv IgG cassette, nws yog qhov nruab nrab qhuav uas tau coated nyias nrog nas los tiv thaiv tib neeg IgG ("T" kab xeem) thiab luav. antichicken IgY antibody ("C" kab tswj). Lub colloidal kub-labeled antibodies, 2019-nCoV recombinant antigen thiab nqaij qaib IgY antibody yog nyob rau hauv qhov tso tawm pad seem. Thaum diluted cov ntshav, ntshav, lossis ntshav tag nrho raug siv rau hauv cov qauv ntaub qhwv (S), cov

colloidalgold-2019-nCoV recombinant antigen yuav khi rau 2019-nCoV IgG antibodies yog tias lawv muaj, tsim cov colloidalgold-2019-nCoV recombinant antigen-IgG complex. Lub complex yuav txav mus thoob plaws lub lim dej nitrocellulose (NC lim) ntawm kev ua haujlwm capillary. Yog tias 2019-nCoV IgG antibody muaj nyob rau hauv cov qauv, cov kab xeem (T) yuav raug khi los ntawm colloidalgold-2019-nCoV recombinant antigen-IgG complex thiab tsim xim. Yog tias tsis muaj 2019-nCoV IgG antibody nyob rau hauv cov qauv, dawb colloidalgold-2019-nCoV recombinant antigen yuav tsis khi rau cov kab xeem (T) thiab tsis muaj xim yuav tsim. Cov dawb colloidal kub- qaib IgY antibody yuav khi rau cov kab tswj (C); cov kab tswj no yuav tsum pom tom qab cov kauj ruam tshawb pom vim qhov no lees paub tias cov khoom siv ua haujlwm zoo.

For For YXI-CoV- IgM&IgG-02- 1 and YXI-CoV- IgM&IgG-02- 10: Lub hauv paus ntsiab lus ntawm immunochromatography ntawm cov khoom siv no: kev sib cais ntawm cov khoom hauv ib qho sib tov los ntawm nruab nrab siv capillary force thiab kev khi tshwj xeeb thiab nrawm ntawm antibody rau nws antigen. Cov Khoom Siv Tshuaj Tiv Thaiv Kab Mob Khaus Viv-19 IgM/IgG Antibody Detection Kit yog cov khoom siv tshuaj tiv thaiv kab mob zoo raws li cov tshuaj tiv thaiv kab mob rau kev kuaj pom IgG thiab IgM cov tshuaj tiv thaiv kab mob rau SARS-CoV-2 hauv cov ntshav, ntshav lossis ntshav kuaj. Qhov kev sim no muaj ob yam, ib qho IgG tivthaiv thiab ib qho IgM tivthaiv. Hauv IgG tivthaiv, tiv thaiv tib neeg IgG yog coated hauv cheeb tsam IgG xeem kab. Thaum lub sij hawm kuaj, cov qauv no tshwm sim nrog SARS-CoV-2 antigen-coated particles nyob rau hauv lub test cassette. Cov sib tov ces tsiv mus nyob tom qab ntawm daim nyias nyias chromatographically los ntawm capillary kev ua thiab reacts nrog antihuman IgG nyob rau hauv lub cheeb tsam IgG xeem kab, yog hais tias tus qauv muaj IgG tshuaj tiv thaiv rau SARSCoV-2. Ib kab xim xim yuav tshwm sim hauv cheeb tsam IgG kuaj kab vim qhov no. Ib yam li ntawd, cov tshuaj tiv thaiv tib neeg IgM yog coated nyob rau hauv cheeb tsam IgM kuaj kab thiab yog tias cov qauv muaj IgM cov tshuaj tiv thaiv rau SARS-CoV-2, cov qauv sib xyaw ua ke ua rau cov tshuaj tiv thaiv IgM. Ib kab xim xim tshwm nyob rau hauv cheeb tsam IgM kuaj kab raws li qhov tshwm sim. Yog li, yog tias cov qauv muaj SARS-CoV-2 IgG cov tshuaj tiv thaiv kab mob, kab xim xim yuav tshwm sim hauv cheeb tsam IgG kuaj kab. Yog tias cov qauv muaj SARS-CoV-2 IgM cov tshuaj tiv thaiv kab mob, kab xim xim yuav tshwm sim hauv cheeb tsam IgM kuaj kab. Yog tias cov qauv tsis muaj SARS-CoV-2 cov tshuaj tiv thaiv, tsis muaj kab xim yuav tshwm sim hauv ib cheeb tsam ntawm cov kab xeem, qhia txog qhov tsis zoo. Txhawm rau ua raws li kev tswj hwm txheej txheem, cov kab xim xim yuav ib txwm tshwm sim hauv cheeb tsam tswj kab, qhia tias qhov ntim zoo ntawm cov qauv tau muab ntxiv thiab membrane wicking tau tshwm sim.

【MAIN COMPONENTS】

Lus Cim : Cov khoom hauv cov khoom siv sib txawv tsis tuaj yeem sib xyaw lossis sib hloov.

【MATERIALS TO BE PROVIDED BY USER】

• Cawv ncoo

• koob txhaj ntshav

【STXOJ CAI THIAB EXPIRAWSION】

Khaws cov khoom siv hauv qhov chaw txias thiab qhuav ntawm 2 - 25 ° C.

Tsis txhob khov.

Cov khoom siv khaws cia kom raug siv tau rau 12 lub hlis.

【SAMPLE REQUIREMENTS】

Assay yog tsim rau tib neeg cov ntshav, ntshav, lossis ntshav kuaj tag nrho. Cov qauv yuav tsum tau siv sai li sai tau tom qab sau. Kev sau ntshav thiab ntshav plasma: Ntshav thiab ntshav ntshav yuav tsum tau muab cais kom sai li sai tau tom qab sau cov ntshav kom tsis txhob hemolysis.

【SAMPLE PRESERVATION】

Ntshav thiab ntshav ntshav yuav tsum tau siv sai li sai tau tom qab sau thiab khaws cia ntawm 2-8 ° C rau 7 hnub yog tias tsis siv tam sim ntawd. Yog tias yuav tsum tau khaws cia ntev, thov khaws cia ntawm -20 ° C rau lub sijhawm tsawg dua 2 lub hlis. Tsis txhob rov khov thiab thawing.

Tag nrho cov ntshav los yog peripheral yuav tsum tau kuaj tsis pub dhau 8 teev tom qab sau.

Hemolysis hnyav thiab lipid kuaj ntshav yuav tsum tsis txhob siv los kuaj xyuas.

【TESTING METHOD】

For YXI-CoV- IgM&IgG- 1 and YXI-CoV- IgM&IgG- 10:

Ua tib zoo nyeem cov lus qhia ua ntej siv. Nqa cov Test strip, Sample diluent tube, thiab coj mus kuaj rau chav sov ua ntej kuaj.

1. Ntxiv 50 µl ntawm Tag Nrho lossis peripheral ntshav los yog 20 µl Ntshav thiab ntshav rau hauv Sample diluent raj thiab sib tov kom huv si. Ntxiv 3-4 tee rau hauv qhov piv txwv pad seem.

2. Tawm ntawm chav tsev kub li 5 feeb los soj ntsuam cov txiaj ntsig. Cov txiaj ntsig ntsuas tom qab 5 feeb tsis raug thiab yuav tsum muab pov tseg. For YXI-CoV- IgM&IgG-02- 1 and YXI-CoV- IgM&IgG-02- 10:

Ua tib zoo nyeem cov lus qhia ua ntej siv. Nqa cov Test strip, Sample diluent tube, thiab coj mus kuaj rau chav sov ua ntej kuaj.

1. Ntxiv 25µl ntawm Tag Nrho lossis peripheral ntshav lossis 10µl Cov Ntshav thiab ntshav rau hauv Sample diluent raj thiab sib tov kom huv si. Ntxiv 4 tee rau hauv cov qauv ntaub qhwv

ntu.

2. Tawm ntawm chav tsev kub li 5 feeb los soj ntsuam cov txiaj ntsig. Cov txiaj ntsig ntsuas tom qab 5 feeb tsis raug thiab yuav tsum muab pov tseg.

【[INTERPRETATION OF TEST RESULTS】