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 Miedzo/Kit,10 Miedzo/Kit
【ABSTRACT】
Iyo novel coronaviruses ndeye β genus. COVID-19 chirwere chekufema chinotapukira. Vanhu vanowanzo batwa nedambudziko iri. Parizvino, varwere vakatapukirwa neinoveli coronavirus ndiyo honzeri yehutachiona; asymptomatic vanhu vane hutachiona vanogona zvakare kuve nehutachiona sosi. Zvichienderana neazvino epidemiological kuferefeta, iyo incubation nguva ndeye 1 kusvika 14 mazuva, kazhinji 3 kusvika 7 mazuva. Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma. Nasal congestion, runny mhino, kurwadziwa kwehuro, myalgia uye manyoka zvinowanikwa mune zvishoma.
【EXPECTED USAGE】
Kiti iyi yakakodzera kutariswa kwemhando yeCCIDID-19 nekuona 2019-nCoV IgM/IgG masoja ekudzivirira chirwere muserum yevanhu, plasma, kana ropa rose. Zviratidzo zvakajairika zvehutachiona ne2019-nCoV zvinosanganisira zviratidzo zvekufema, fivha, kukosora, kupfupika kwekufema, uye dyspnea. Muzviitiko zvakaipisisa, utachiona hunogona kukonzera mabayo, yakanyanya acute respiratory syndrome, kusashanda zvakanaka kweitsvo, uye kunyange rufu. 2019 nCoV inogona kuburitswa kuburikidza nekufema kwekuvhara kana kutapurirwa kuburikidza nemvura yemumuromo, kuhotsira, kubata muviri, uye kuburikidza nemadonhwe emhepo.
【PRINCIPLES OF THE PROCEDURE】
Nheyo ye immunochromatography yekiti iyi: kupatsanurwa kwezvikamu mumusanganiswa kuburikidza nepakati uchishandisa capillary simba uye chaiyo uye nekukurumidza kusunga kweantibody kune antigen yayo. Muedzo uyu une makaseti maviri, IgG kaseti uye IgM kaseti.
YeYXI-CoV- IgM&IgG- 1 uye YXI-CoV- IgM&IgG- 10:Mukaseti yeIgM, isvikiro rakaoma rakaputirwa zvakasiyana ne2019-nCoV recombinant antigen (“T” test line) uye mbudzi anti-mbeva. polyclonal antibodies ("C" control line). Iyo colloidal goridhe-yakanyorwa masoja ekudzivirira chirwere, mbeva anti-human IgM (mIgM) iri muchikamu chekuburitsa padhi. Kana serum yakanyungudutswa, plasma, kana ropa rese raiswa pasample pad chikamu(S), mIgM antibody inosunga ku2019- nCoV IgM masoja ekudzivirira chirwere kana aripo, achigadzira mIgM-IgM yakaoma. Iyo mIgM-IgM yakaoma inozofamba ichiyambuka iyo nitrocellulose sefa (NC sefa) kuburikidza necapillary chiito. Kana 2019-nCoV IgM antibody iripo mumuenzaniso, mutsara wekuyedza (T) unosungwa nemIgM-IgM yakaoma uye gadzira ruvara. Kana pasina 2019-nCoV IgM antibody mumuenzaniso, mIgM yemahara haisungirire kumutsetse webvunzo (T) uye hapana ruvara ruchakura. Iyo yemahara mIgM inosunga kumutsara wekutonga (C); iyi mutsara wekutonga unofanirwa kuonekwa mushure mekutsvaga danho sezvo izvi zvichisimbisa kuti kititi iri kushanda zvakanaka.Mukaseti yeIgG, inzvimbo yakaoma yakaputirwa zvakasiyana ne mouse anti-human IgG ("T" test line) uye Rabbit. antichicken IgY antibody ( "C" control line). Iyo colloidal goridhe-yakanyorwa masoja ekudzivirira chirwere, 2019-nCoV recombinant antigen uye huku IgY antibody ari muchikamu chekuburitsa padhi. Kamwe serum yakanyungudutswa, plasma, kana ropa rose rinoiswa kuchikamu chemuenzaniso pad (S), iyo
colloidalgold-2019-nCoV recombinant antigen inosunga kune 2019-nCoV IgG masoja ekudzivirira chirwere kana aripo, achigadzira colloidalgold-2019-nCoV recombinant antigen-IgG yakaoma. Iyo yakaoma inozofamba ichiyambuka iyo nitrocellulose sefa (NC sefa) kuburikidza necapillary chiito. Kana 2019-nCoV IgG antibody iripo mumuenzaniso, mutsara wekuyedza (T) unosungwa necolloidalgold-2019-nCoV recombinant antigen-IgG yakaoma uye inovandudza ruvara. Kana pasina 2019-nCoV IgG antibody mumuenzaniso, yemahara colloidalgold-2019-nCoV recombinant antigen haingasungiri kumutsara webvunzo (T) uye hapana ruvara ruchakura. Iyo yemahara colloidal yegoridhe-huku IgY antibody inosunga kune yekudzora mutsara (C); iyi mutsara wekutonga inofanira kuonekwa mushure mekutsvaga danho sezvo izvi zvinosimbisa kuti kititi iri kushanda zvakanaka.
YeYXI-CoV- IgM&IgG-02- 1 uye YXI-CoV- IgM&IgG-02-10: Nheyo ye immunochromatography yekiti iyi: kupatsanurwa kwezvikamu mumusanganiswa kuburikidza nepakati uchishandisa capillary simba uye chaiyo uye nekukurumidza kusunga kwe. antibody kune antigen yayo. Iyo COVID-19 IgM/IgG Antibody Detection Kit ndeyemhando yepamusoro membrane-based immunoassay yekuonekwa kweIgG neIgM masoja ekudzivirira chirwere kuSARS-CoV-2 muropa rakazara, serum kana plasma mienzaniso. Muedzo uyu une zvikamu zviviri, IgG chikamu uye IgM chikamu. Muchikamu cheIgG, anti-human IgG yakaputirwa munharaunda yeIgG yebvunzo. Munguva yekuyedzwa, iyo specimen inopindirana neSARS-CoV-2 antigen-yakavharwa zvimedu muyedzo kaseti. Musanganiswa wacho unobva wafamba nechemberi uchitevedza membrane chromatographically necapillary chiito uye unopindirana neantihuman IgG munharaunda yeIgG yebvunzo mutsara, kana sampuli ine IgG masoja ekudzivirira chirwere kuSARSCoV-2. Mutsetse weruvara uchaonekwa muIgG bvunzo mutsara dunhu nekuda kweizvi. Saizvozvo, anti-munhu IgM yakavharwa munharaunda yeIgM yebvunzo uye kana sampuli ine IgM masoja ekudzivirira chirwere kuSARS-CoV-2, iyo conjugate specimen complex inopindirana neantihuman IgM. Mutsetse weruvara unoonekwa munharaunda yeIgM yebvunzo mutsara semhedzisiro. Naizvozvo, kana iyo specimen iine SARS-CoV-2 IgG masoja ekudzivirira chirwere, mutsara weruvara uchaonekwa mudunhu reIgG bvunzo. Kana iyo specimen iine SARS-CoV-2 IgM masoja ekudzivirira chirwere, mutsara weruvara uchaonekwa mudunhu reIgM bvunzo mutsara. Kana iyo specimen isina SARS-CoV-2 masoja ekudzivirira chirwere, hapana mutsara weruvara unozoonekwa mune imwe yematunhu ebvunzo, zvichiratidza mhedzisiro. Kuti ishande sekutonga kwemaitiro, mutsara wemavara unogara uchionekwa munharaunda yekutonga, zvichiratidza kuti chiyero chakakodzera chemuenzaniso chakawedzerwa uye membrane wicking yakaitika.
【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 | |
| test strip type 1 | 1 bvunzo/bhegi | / | / | 1 | 10 | Nitrocellulose membrane, binding pad, sample pad, blood filtration membrane, absorbent paper, PVC |
| test strip type 2 | 1 bvunzo/bhegi | 1 | 10 | / | / | Nitrocellulose membrane, binding pad, sample pad, blood filtration membrane, absorbent paper, PVC |
| sampuli diluent chubhu | 100 μL / bhodhoro | 1 | 10 | 1 | 10 | Phosphate, Pakati-20 |
| desiccant | 1 chidimbu | 1 | 10 | 1 | 10 | silicon dioxide |
| dropper | 1 chidimbu | 1 | 10 | 1 | 10 | Plastiki |
Ongorora: Izvo zvikamu zviri mubatch kits zvakasiyana hazvigone kusanganiswa kana kuchinjana.
【MATERIALS TO BE PROVIDED BY USER】
•Doro pedhi
•Kutora ropa tsono
【STORAGE UYE EXPIRATION】
Chengetedza makiti munzvimbo inotonhorera uye yakaoma pa2 - 25 ° C.
Usaomesa nechando.
Makiti akachengetwa zvakanaka anoshanda kwemwedzi gumi nemiviri.
【SAMPLE REQUIREMENTS】
Assay inokodzera serum yevanhu, plasma, kana sampuli dzeropa rose. Mienzaniso inofanira kushandiswa nokukurumidza sezvinobvira mushure mekuunganidza. Serum uye plasma muunganidzwa: Serum uye plasma inofanira kupatsanurwa nekukurumidza sezvinobvira mushure mekuunganidzwa kweropa kudzivirira hemolysis.
【SAMPLE PRESERVATION】
Serum uye plasma inofanira kushandiswa nokukurumidza sezvinobvira mushure mekuunganidza uye kuchengetwa pa 2-8 ° C kwemazuva manomwe kana isingashandisi pakarepo. Kana kuchengetedza kwenguva refu kuchidikanwa, ndapota chengeta pa -20 °C kwenguva isingasviki mwedzi miviri. Dzivisa kuomesa nechando kakawanda uye kunyunguduka.
Yese kana peripheral ropa samples inofanirwa kuongororwa mukati memaawa masere mushure mekuunganidzwa.
Yakanyanya hemolysis uye lipid ropa samples haifanirwe kushandiswa pakuona.
【TESTING METHOD】
ZveYXI-CoV- IgM&IgG- 1 uye YXI-CoV- IgM&IgG- 10:
Verenga mirayiridzo zvakanyatsonaka usati washandisa. Huya neTest strip, Sample diluent chubhu, uye sampuli kune tembiricha yekamuri usati waedzwa.
1. Wedzera 50 µl yeropa Rakazara kana reparutivi kana 20 µl Serum neplasma kuSample diluent chubhu wonyatsosanganisa. Wedzera 3- 4 madonhwe kune chikamu chemuenzaniso pad.
2. Siya pamhepo tembiricha kwemaminetsi mashanu kuti uone zvabuda. Mibairo yakayerwa mushure memaminitsi mashanu haina basa uye inofanira kuraswa. YeYXI-CoV- IgM&IgG-02- 1 uye YXI-CoV- IgM&IgG-02- 10:
Verenga mirayiridzo zvakanyatsonaka usati washandisa. Huya neTest strip, Sample diluent chubhu, uye sampuli kune tembiricha yekamuri usati waedzwa.
1. Wedzera 25µl yeropa rose kana peripheral kana 10µl Serum ne plasma kuSample diluent chubhu uye nyatsosanganisa. Wedzera madonhwe mana kune sampuli pad
chikamu.
2. Siya pamhepo tembiricha kwemaminetsi mashanu kuti uone zvabuda. Mibairo yakayerwa mushure memaminitsi mashanu haina basa uye inofanira kuraswa.
【[INTERPRETATION OF TEST RESULTS】
| YXI-CoV- IgM&IgG-1 uye YXI-CoV- IgM&IgG-10 | YXI-CoV- IgM&IgG-02-1 uye YXI-CoV- IgM&IgG-02-10 |
| ★IgG POSITIVE: Mitsara miviri inooneka.Mutsara weruvara umwechete unofanira kunge uri munharaunda yekutonga (C), uye mutsara une ruvara unoonekwa muIgG test line region.Chigumisiro chakanaka kune 2019- nCoV chaiyo-IgG antibodies. ★lgM POSITIVE: Mitsetse miviri inooneka. Mutsara mumwe weruvara unofanirwa kunge uri munharaunda yekudzora mutsara (C), uye mutsara weruvara unoonekwa munzvimbo yelgM test line. Mhedzisiro yacho yakanaka kune 2019- nCoV chaiyo-lgM masoja ekudzivirira chirwere.★IgG uye lgM POSITIVE: Ose mutsetse webvunzo ( T) uye mutsara wekutonga wemhando (C) ane mavara muIgG kaseti uye nelgM kaseti. ★NEGATIVE: Imwe nhema yemavara inoonekwa munharaunda yekudzora (C) .Hapana mutsara weruvara unooneka unoonekwa mulgG kana LGM test region(T).
★INVALID: Mutsetse wekudzora watadza kuoneka.Kusakwana vhoriyamu yemuenzaniso kana nzira dzisiridzo dzemaitiro ndizvo zvikonzero zvinonyanya kukonzeresa kutadza kwemutsara.Ongorora maitiro uye dzokorora bvunzo nekaseti nyowani yekuedzwa.Kana dambudziko rikaramba richienderera, rega kushandisa test kit nekukasika. uye ubate nemugovera wepanzvimbo yako.
| ★IgG POSITIVE: Mitsetse miviri inooneka. Mutsara mumwe weruvara unofanirwa kunge uri munharaunda yekudzora mutsara (C), uye mutsara weruvara unoonekwa munzvimbo yeIgG yebvunzo mutsara. Mhedzisiro yacho yakanaka kune SARS-CoV-2 chaiyo-IgG masoja ekudzivirira chirwere. ★IgM POSITIVE: Mitsetse miviri inooneka. Mutsara mumwe weruvara unofanirwa kunge uri munharaunda yekudzora mutsara (C), uye mutsara weruvara unoonekwa munzvimbo yeIgM yebvunzo mutsara. Mhedzisiro yacho yakanaka kune SARS-CoV-2 chaiyo-IgM masoja ekudzivirira chirwere. ★IgG uye IgM POSITIVE: Mitsetse mitatu inooneka. Mutsetse mumwe weruvara unofanirwa kunge uri munharaunda yekudzora mutsara (C), uye mitsetse miviri ine mavara inofanirwa kuoneka muIgG bvunzo mutsara dunhu uye IgM bvunzo mutsara dunhu. ★NEGATIVE: Mutsara mumwe wemavara unoonekwa munharaunda yekutonga (C). Aihwa mutsara weruvara unoonekwa muIgG kana IgM dunhu rekuyedza (T).
★INVALID: Mutsara wekudzora watadza kuoneka. Kusakwana sampuli vhoriyamu kana zvisirizvo maitiro emaitiro ndizvo zvinonyanya zvikonzero zvekutadza kutonga mutsara. Ongorora maitiro uye dzokorora bvunzo nekaseti nyowani yebvunzo. Kana dambudziko rikaramba riripo, rega kushandisa kit yebvunzo nekukasika wobva wabata mushambadzi wenzvimbo yako.
|
【LIMITATION OF DETECTION METHOD】
a. Chigadzirwa chacho chakagadzirirwa chete kushandiswa neserum yemunhu, plasma, masampuli eropa rose kuti aonekwe emhando ye2019 -nCoV IgM uye IgG antibody.
b. Sezvinei zvese zvekuongororwa kwekuongorora, chirevo chekiriniki chekuongorora hachifanirwe kubva pamugumisiro wekuedzwa kumwe chete asi kunofanira kuitwa mushure mokunge zvose zvinowanikwa mumakiriniki zvaongororwa uye zvinofanira kusimbiswa nedzimwe nzira dzinowanzoonekwa.
c. Kunyepa kwenhema kunogona kuitika kana huwandu hwe2019-nCoV IgM kana IgG antibody huri pazasi pezinga rekuona rekiti.
d. Kana chigadzirwa chacho chikanyorova chisati chashandiswa, kana kuti chakachengetwa zvisina kunaka, chinogona kukonzera mhedzisiro isiriyo.
e. Muedzo uyu ndewekuonekwa kwemhando ye2019-nCoV IgM kana IgG antibody muserum yemunhu, plasma kana sampu yeropa uye hairatidze huwandu hwemasoja ekudzivirira chirwere.
【PRECAUTIONS】
a. Usashandise zvakapera kana zvakakuvadzwa zvigadzirwa.
b. Shandisa chete diluent inoenderana mune kit package. Diluents kubva kune akasiyana kit lots haigone kusanganiswa.
c. Usashandise mvura yepombi, mvura yakacheneswa kana mvura yakasvibiswa sezvinodzora zvisina kunaka.
d. Muedzo unofanirwa kushandiswa mukati meawa imwe mushure mekuvhurwa. Kana tembiricha yakadzikama yakakwira kupfuura 30 ℃, kana kuti nharaunda yekuyedza yakanyorova, Detection Cassette inofanirwa kushandiswa nekukurumidza.
e. Kana pasina kufamba kwemvura mushure memasekonzi makumi matatu ekutanga bvunzo, imwe donho remhinduro yemuenzaniso rinofanira kuwedzerwa.
f. Chenjerera kudzivirira mukana wekutapukirwa nehutachiona paunenge uchitora samples. Pfeka magurovhosi anoraswa, masks, nezvimwe, uye geza maoko ako mushure.
g. Iri kadhi rekuyedza rakagadzirirwa kushandiswa kamwe chete, kamwe chete. Mushure mekushandiswa, kadhi rekuyedza uye masampuli anofanirwa kutorwa semarara ekurapa ane njodzi yehutachiona hwehutachiona uye kuraswa nemazvo zvinoenderana nemitemo yenyika.
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