COVID-19 Anti- 2019-nCoV China New Coronavirus

Cov ntsiab lus ceev

COVID-19 Anti- 2019-nCoV China New Coronavirus

Ntim & Xa

Specifications

[Thov siv]
AMRDT100 IgG / IgM Rapid Test Cassette yog ib qho lateral flow chromatographic immunoassay rau kev kuaj pom zoo ntawm cov tshuaj tiv thaiv kab mob (IgG thiab IgM) rau Novel coronavirus hauv tib neeg Cov Ntshav / Ntshav / Ntshav.
Nws muab kev pabcuam hauv kev kuaj mob ntawm tus kabmob Novel coronavirus.

[SUMMARY]
Thaum lub Ib Hlis Ntuj xyoo 2020, tus kab mob tshiab (SARS-CoV-2, yav tas los hu ua 2019-nCoV) tau raug txheeb xyuas tias yog tus kab mob sib kis uas ua rau muaj kev kis tus kab mob ntsws hauv Wuhan, Tuam Tshoj, qhov chaw thawj kis tau tshwm sim thaum lub Kaum Ob Hlis 2019.
Cov kab mob Coronaviruses yog cov kab mob RNA uas tau muab faib dav rau tib neeg, lwm yam tsiaj tsiaj, thiab noog thiab ua rau cov kab mob ua pa, enteric, hepatic, thiab neurologic kab mob.Siv hom kab mob coronavirus paub tias ua rau tib neeg muaj kab mob.Plaub tus kab mob-229E, OC43, NL63, thiab HKU1 muaj ntau thiab feem ntau ua rau muaj cov tsos mob khaub thuas hauv cov neeg uas muaj kev tiv thaiv kab mob.Ob qhov lwm hom mob hnyav ua pa nyuaj ua pa mob coronavirus (SARS-CoV) thiab Middle East respiratory syndrome coronavirus (MERS-CoV) yog zoonotic hauv keeb kwm thiab tau txuas rau qee zaum mob tuag taus.
Coronaviruses yog zoonotic, txhais tau tias lawv kis ntawm tsiaj thiab tib neeg.Tej yam tshwm sim ntawm tus kab mob muaj xws li cov tsos mob ua pa, ua npaws, hnoos, ua tsis taus pa luv thiab ua tsis taus pa nyuaj.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 tuag.
Cov lus pom zoo los tiv thaiv kev kis tus kab mob xws li ntxuav tes tsis tu ncua, npog qhov ncauj thiab qhov ntswg thaum hnoos thiab txham, ua kom cov nqaij thiab qe.Tsis txhob nyob ze nrog ib tus neeg uas pom cov tsos mob ntawm tus mob ua pa xws li hnoos thiab txham.

[TSEEM CEEB]
AMRDT100IgG/IgM Rapid Test Cassette yog ib qho zoo ntawm daim nyias nyias strip raws li immunoassay rau kev kuaj xyuas cov tshuaj tiv thaiv (IgG thiab IgM) rau Novel coronavirus hauv tib neeg Cov Ntshav / Ntshav / Plasma.Cov ntawv pov thawj muaj xws li: 1) ib lub burgundy xim conjugate ncoo uas muaj Novel coronavirus recombinant hnab ntawv antigens conjugated nrog Colloid kub (Novel coronavirus conjugates), 2) ib tug nitrocellulose membrane strip uas muaj ob kab xeem (IgG thiab IgM kab) thiab ib tug tswj kab ( C kab).IgM kab yog pre-coated nrog nas los tiv thaiv tib neeg IgM tshuaj tiv thaiv kab mob, IgG kab yog coated nrog nas anti-Human IgG tshuaj tiv thaiv.Thaum lub ntim ntim txaus ntawm cov qauv kuaj tau muab xa mus rau hauv cov qauv zoo ntawm cov ntawv xeem, cov qauv txav los ntawm kev txiav txim siab capillary hla lub cassette.IgM anti-Novel coronavirus, yog tias muaj nyob hauv cov qauv, yuav khi rau Novel coronavirus conjugates.Lub immunocomplex yog tom qab ntawd raug ntes los ntawm cov tshuaj reagent pre-coated ntawm IgM band, tsim cov kab burgundy xim IgM, qhia txog Novel coronavirus IgM qhov txiaj ntsig zoo.IgG anti-Novel coronavirus yog muaj nyob rau hauv cov qauv yuav khi rau Novel coronavirus conjugates.Lub immunocomplex yog tom qab ntawd raug ntes los ntawm cov tshuaj reagent coated ntawm kab IgG, tsim cov xim burgundy IgG kab, qhia txog Novel coronavirus IgG qhov kev kuaj pom zoo.Tsis muaj ib kab T (IgG thiab IgM) qhia tias qhov tshwm sim tsis zoo.Txhawm rau ua raws li kev tswj hwm txheej txheem, cov kab xim xim yuav ib txwm tshwm sim ntawm thaj chaw tswj kab uas qhia tias qhov ntim ntawm cov qauv tau muab ntxiv thiab daim nyias nyias tau tshwm sim.

[Kev ceeb toom thiab kev ceeb toom]
Rau cov kws kho mob thiab cov kws tshaj lij ntawm cov chaw kho mob.
Tsis txhob siv tom qab hnub tas sij hawm.
Thov nyeem tag nrho cov ntaub ntawv hauv daim ntawv no ua ntej ua qhov kev xeem.
Lub cassette xeem yuav tsum nyob twj ywm hauv lub hnab kaw kom txog thaum siv.
Tag nrho cov qauv yuav tsum raug suav hais tias muaj peev xwm txaus ntshai thiab ua haujlwm tib yam li tus neeg sawv cev kis.
Cov ntawv xeem siv yuav tsum muab pov tseg raws li tsoomfwv, lub xeev thiab cov cai hauv zos.

[COMPOSITION]
Qhov kev sim no muaj ib daim nyias nyias coated nrog nas los tiv thaiv tib neeg IgM tshuaj tiv thaiv thiab nas los tiv thaiv tib neeg IgG tshuaj tiv thaiv ntawm cov kab xeem, thiab cov ntaub ntawv zas xim uas muaj colloidal kub ua ke nrog Novel coronavirus recombinant antigen.
Qhov ntau ntawm cov ntawv xeem tau luam tawm ntawm daim ntawv lo.
Cov ntaub ntawv muab
Test cassettePackage insert
Tsis pub
Cov ntaub ntawv xav tau tab sis tsis muab
Specimen collection containerTimer

[KHOV CHAW THIAB STABILITY]
Cia li ntim rau hauv lub hnab ntim ntawm qhov kub (4-30 ℃ lossis 40-86 ℉).Cov khoom siv ruaj khov nyob rau hauv hnub tas sij hawm luam tawm ntawm daim ntawv lo.
Thaum qhib lub hnab, qhov kev sim yuav tsum siv li ntawm ib teev.Kev raug kub thiab ntub ib puag ncig ntev yuav ua rau cov khoom tsis zoo.
LOT thiab hnub tas sij hawm tau luam tawm ntawm daim ntawv lo.

[TSEEM CEEB]
Qhov kev kuaj no tuaj yeem siv los kuaj tag nrho Cov Ntshav / Ntshav / Ntshav Ntshav.
Txhawm rau sau tag nrho cov ntshav, ntshav ntshav lossis ntshav plasma raws li cov txheej txheem kuaj mob tsis tu ncua.
Cais cov ntshav los yog ntshav los ntawm cov ntshav kom sai li sai tau kom tsis txhob hemolysis.Siv cov qauv ntshiab uas tsis yog hemolyzed nkaus xwb.
Khaws cov khoom ntawm 2-8 ℃ (36-46 ℉) yog tias tsis kuaj tam sim.Khaws cov qauv ntawm 2-8 ℃ txog 7 hnub.Cov qauv yuav tsum khov rau ntawm
-20 ℃ (-4 ℉) rau kev cia ntev dua.Tsis txhob khov tag nrho cov ntshav.
Zam ntau lub voj voog khov-thaw.Ua ntej kev sim, nqa cov qauv khov rau hauv chav sov maj mam thiab sib tov maj mam.Cov qauv uas muaj qhov pom ntawm qhov teeb meem yuav tsum tau qhia meej los ntawm centrifugation ua ntej kuaj.
Tsis txhob siv cov qauv uas qhia txog tag nrho cov lipemia, tag nrho hemolysis lossis turbidity txhawm rau kom tsis txhob cuam tshuam rau kev txhais lus.

[TEST PROCEDURE]
Tso cai rau cov cuab yeej ntsuas thiab cov qauv ntsuas kom sib npaug rau qhov ntsuas kub (15-30 ℃ lossis 59-86 ℉) ua ntej kuaj.
1. Tshem tawm cov ntawv xeem los ntawm lub hnab kaw.
2.Tuav lub dropper vertically thiab hloov 1 poob ntawm cov hnoos qeev mus rau qhov zoo (S) ntawm cov khoom kuaj, tom qab ntawd ntxiv 2 tee ntawm qhov tsis zoo (kwv yees li 70μl) thiab pib lub sijhawm.Saib cov duab hauv qab no.
3. Tos kom cov kab xim tuaj yeem tshwm.Txhais cov txiaj ntsig kev xeem hauv 15 feeb.Tsis txhob nyeem cov txiaj ntsig tom qab 20 feeb.

[Kev txhais lus ntawm cov txiaj ntsig]
Qhov zoo: Cov kab tswj thiab tsawg kawg yog ib txoj kab kuaj pom ntawm daim nyias nyias.Cov tsos mob ntawm IgG kuaj kab qhia pom muaj Novel coronavirus tshwj xeeb IgG cov tshuaj tiv thaiv.Cov tsos mob ntawm IgM kuaj kab qhia pom muaj Novel coronavirus tshwj xeeb IgM cov tshuaj tiv thaiv.Thiab yog tias ob qho tib si IgG thiab IgM kab tshwm sim, nws qhia tau tias muaj ob qho tib si Novel coronavirus tshwj xeeb IgG thiab IgM cov tshuaj tiv thaiv.
Tsis zoo: Ib kab xim muaj xim tshwm nyob rau hauv cheeb tsam tswj (C).Tsis muaj kab xim xim pom tshwm hauv cheeb tsam kab xeem.
Invalid: Tswj kab tsis tshwm sim.Cov khoom ntim tsis txaus lossis cov txheej txheem tsis raug yog cov laj thawj feem ntau rau kev tswj kab tsis ua haujlwm.Tshawb xyuas cov txheej txheem thiab rov ua qhov kev xeem nrog ib daim ntawv xeem tshiab.Yog tias muaj teeb meem tshwm sim, txiav tawm siv cov khoom kuaj tam sim ntawd thiab tiv tauj koj tus neeg muag khoom hauv zos.

[QHOV TSEEM CEEB]
Cov txheej txheem tswj tau suav nrog hauv qhov kev xeem.Ib kab xim uas tshwm nyob rau hauv cheeb tsam tswj (C) yog suav tias yog kev tswj hwm txheej txheem sab hauv.Nws lees paub qhov ntim cov qauv txaus, tsim nyog daim nyias nyias wicking thiab raug txheej txheem txheej txheem.
Cov qauv tswj tsis tau muab nrog cov khoom siv no.Txawm li cas los xij, nws raug pom zoo tias cov kev tswj xyuas qhov zoo thiab qhov tsis zoo yuav raug kuaj raws li kev sim ua haujlwm zoo kom paub meej tias cov txheej txheem kev xeem thiab xyuas qhov kev xeem kom raug.

[LIMITATIONS]
AMRDT100 IgG/IgM Rapid Test Cassette yog txwv los muab kev kuaj pom zoo.Qhov kev siv ntawm cov kab xeem tsis tas yuav cuam tshuam rau qhov concentration ntawm cov tshuaj tiv thaiv kab mob hauv cov ntshav.
Cov txiaj ntsig tau los ntawm qhov kev sim no yog npaj los pab rau kev kuaj mob nkaus xwb.Txhua tus kws kho mob yuav tsum txhais cov txiaj ntsig ua ke nrog tus neeg mob keeb kwm, kev tshawb pom lub cev, thiab lwm yam kev kuaj mob.
Qhov kev ntsuam xyuas tsis zoo qhia tau hais tias cov tshuaj tiv thaiv kab mob rau Novel coronavirus tsis tshwm sim lossis nyob rau theem tsis tuaj yeem kuaj pom los ntawm kev sim.

[Kev ua tau zoo yam ntxwv]
Qhov tseeb
Kev sib piv ntawm ib sab yog ua los ntawm Novel coronavirus IgG / IgM Rapid Test thiab PCR ua lag luam.120 qhov chaw kuaj mob los ntawm Professional Point of Care tau soj ntsuam.Cov txiaj ntsig hauv qab no yog tabulated los ntawm cov kev tshawb fawb soj ntsuam no:
Kev sib piv cov txheeb cais tau ua los ntawm cov txiaj ntsig tau txais txiaj ntsig ntawm 90.00%, qhov tseeb ntawm 97.78% thiab qhov tseeb ntawm 95.83%.
Hla-Reactivity thiab cuam tshuam
1.Lwm cov kab mob sib kis ntawm cov kab mob sib kis tau raug soj ntsuam rau kev sib cuam tshuam nrog kev sim.Qee cov qauv zoo ntawm lwm cov kab mob sib kis tau kis mus rau Novel coronavirus zoo thiab tsis zoo thiab kuaj cais.Tsis muaj kev cuam tshuam kev sib kis tau pom nrog cov qauv ntawm cov neeg mob uas muaj kab mob HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV thiab TP.
2.Qhov muaj peev xwm hla-reactive endogenous tshuaj suav nrog cov khoom siv hauv cov ntshav, xws li lipids, hemoglobin, bilirubin, tau nce siab ntawm qhov muaj siab rau hauv Novel coronavirus zoo thiab tsis zoo thiab kuaj, cais.Tsis muaj kev cuam tshuam los yog cuam tshuam rau lub cuab yeej.
3.Ib txhia lwm yam kev tshuaj ntsuam kab mob lom tau kis mus rau Novel tus kab mob coronavirus zoo thiab tsis zoo thiab kuaj cais.Tsis muaj kev cuam tshuam tseem ceeb ntawm cov qib uas tau teev tseg hauv cov lus hauv qab no.

Reproducibility
Kev tshawb fawb txog kev rov tsim dua tshiab tau ua rau Novel coronavirus IgG/IgM Rapid Test ntawm peb tus kws kho mob chaw kuaj mob (POL).Rau caum (60) cov qauv kuaj ntshav, 20 qhov tsis zoo, 20 tus ciam teb zoo thiab 20 qhov zoo, tau siv hauv txoj kev tshawb no.Txhua tus qauv tau khiav hauv triplicate rau peb hnub ntawm txhua POL.Cov ntawv cog lus hauv kev ntsuam xyuas yog 100%.Daim ntawv cog lus inter-site yog 100%.

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