COVID-19 IgG/IgM Rapid Test Cassette

Yehunyanzvi uye in vitro diagnostic kushandiswa chete.

ZVIRI KUSHANDISA

TheCOVID-19 IgG/IgM Rapid Test Cassetteis a lateral flow immunoassay yakagadzirirwa kutariswa kwemhando yeIgG neIgM masoja ekudzivirira chirwere kuSARS-CoV-2 hutachiona muropa rose, serum kana plasma mienzaniso kubva kuvanhu vanofungidzirwa kuti vane hutachiona hweCCIDID-19 nemupi wehutano.

CO VID-19 IgG/IgM Rapid Test rubatsiro mukuongororwa kwevarwere vane hutachiona hweSARS -CoV-2 pamwe chete nekuratidzwa kwekiriniki uye mhedzisiro yekumwe ongororo murabhoritari.Zvinokurudzirwa kushandisa seyekuwedzera bvunzo chiratidzo cheanofungidzirwa nyaya dzine negative nucleic acid bvunzo yenovel coronavirus kana kushandiswa pamwe chete neiyo nucleic acid bvunzo mune dzinofungidzirwa nyaya.Mibairo kubva mukuongororwa kwemasoja ekudzivirira chirwere haifanirwe kushandiswa seyo chete hwaro hwekuongorora kana kusabvisa hutachiona hweSARS -CoV-2 kana kuzivisa mamiriro ehutachiona.

Mhedzisiro yakaipa haitore hutachiona hweSARS -CoV-2, kunyanya kune avo vanga vachisangana nevanhu vanozivikanwa vane hutachiona kana munzvimbo dzine huwandu hwehutachiona hunoshanda.Kuongororwa kwekutevera nekuongorora kwema molecular kunofanirwa kutariswa sekutonga kunze kwehutachiona muvanhu ava.

Mhedzisiro yakanaka inogona kunge yakakonzerwa nehutachiona hwekare kana hwazvino neasiri SARS-CoV-2 coronavirus strains.

Muedzo uyu unoitirwa kuti ushandiswe kumakiriniki marabhoritari kana nevashandi vehutano panguva yekutarisira, kwete kushandiswa kumba.Ongororo iyi haifanirwe kushandiswa kuongororwa ropa rakapihwa.

SUMMARY

Iyo novel coronaviruses ndeye p genus.COVID 19chirwere chekufema chinotapukira.Vanhu vanowanzo batwa nedambudziko iri.Parizvino, varwere vakatapukirwa neinoveli coronavirus ndiyo honzeri yehutachiona;asymptomatic jekiseni vanhu 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.

Kana hutachiona hweSARS-CoV2 hwabata chipenyu, RNA, iyo genetic zvinhu zvehutachiona, ndiyo yekutanga chiratidzo chinogona kuonekwa.Iyo hutachiona hwehuwandu hweSARS-CoV-2 hwakafanana neiyo furuwenza, iyo inokwira panguva yekutenderera kwechiratidzo, uye yobva yatanga kudzikira.Nekuvandudzwa kwechirwere chekosi mushure mekutapukirwa, immune system yemunhu inoburitsa masoja ekudzivirira chirwere, pakati pawo IgM ndiyo yekutanga antibody inogadzirwa nemuviri mushure mekutapukirwa, ichiratidza chikamu chakaoma chehutachiona.IgG masoja ekudzivirira chirwere kuSARS-CoV2 anozoonekwa gare gare mushure mekutapukirwa.Mhedzisiro yakanaka yeIgG neIgM inogona kuitika mushure mekutapukirwa uye inogona kuratidza hutachiona hwakanyanya kana huchangobva kuitika.IgG inoratidza danho rekupora rehutachiona kana nhoroondo yehutachiona hwekare.

Nekudaro, zvese IgM neIgG zvine nguva yehwindo kubva kuhutachiona hwehutachiona kusvika pakugadzirwa kwemasoja ekudzivirira chirwere, IgM inoda kuoneka mushure mekutanga kwechirwere mazuva akati wandei, saka kuonekwa kwavo kunowanzo kusaririra kuseri kwekuonekwa kweiyo nucleic acid uye haina kusimba pane kuona nucleic acid.Muzviitiko apo nucleic acid amplification bvunzo haina kunaka uye kune yakasimba epidemiological link kuneCOVID 19hutachiona, paired serum samples (muacute uye convalescent phase) inogona kutsigira kuongororwa.

PRINCIPLE

COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) imhando yemembrane strip based immunoassay yekuonekwa kwemasoja ekudzivirira chirwere (IgG neIgM) kuNovel coronavirus muRopa Rese remunhu/Serum/plasma.The test cassette ine:1) burgundy colored coiyugate pad ine Novel coronavirus recombinant envelope antigens两ugates), 2) nitrocellulose membrane strip ine mitsara miviri yekuedza (IgG uye IgM mitsara) uye mutsara wekutonga (C mutsara).Mutsara weIgM wakafanoputirwa neMouse anti-Human IgM antibody, IgG mutsara wakavharwa Mouse anti-Human IgG antibody, kana huwandu hwakakwana hwemuenzaniso huchiiswa mumuenzaniso mutsime wekaseti yekuyedza.Muenzaniso wacho unotama necapillary chiito pane kaseti.IgM anti-Novel coronavirus, kana iripo mumuenzaniso, inosunga kune Novel coronavirus coiyugates.Iyo immunocomplex inozobatwa neiyo reagent pre-yakaputirwa paIgM bhendi, ichigadzira burgundy yemavara IgM mutsara, ichiratidza Novel coronavirus IgM yakanaka bvunzo mhedzisiro.IgG anti-Novel coronavirus iyo iripo mumuenzaniso inosunga kune Novel coronavirus conjugates.Iyo immunocomplex inozobatwa neiyo reagent yakavharwa palhe IgG mutsara, ichigadzira burgundy yemavara IgG mutsara, ichiratidza Novel coronavirus IgG yakanaka bvunzo mhedzisiro.Kusavapo kwechero T mitsara (IgG neIgM) inoratidza a

negative result.Kushanda senzira yekutonga, mutsara wemavara unogara uchionekwa panzvimbo yekutonga inoratidza kuti vhoriyamu yakakodzera yemuenzaniso yakawedzerwa uye membrane wicking yakaitika.

YAMBIRO UYE CHENJERERO

• Yekushandisa in vitro diagnostic chete.
• Kune vashandi vehutano uye nyanzvi nzvimbo dzekuchengetedza nzvimbo.

• Usashandise mushure mekupera kwezuva.

• ndapota verenga ruzivo rwese rwuri pakapepa rino usati waita bvunzo.•Kaseti yebvunzo inofanira kuramba iri muhomwe yakavharwa kusvika yashandiswa.

• Mienzaniso yese inofanirwa kutorwa seine njodzi uye inobatwa nenzira imwechete seanotapurira utachiona.

•Kaseti yebvunzo yakashandiswa inofanirwa kuraswa zvinoenderana nemubatanidzwa, yenyika uye nemirairo yemuno.

COMPOSITION

Muedzo uyu une membrane strip yakavharwa neMouse anti-Human IgM antibody uye Mouse anti-Human IgG antibody pane.

test line, uye padhi yedhayi ine colloidal goridhe yakasanganiswa neNovel corona virus recombinant antigen.Huwandu hwebvunzo hwakadhindwa pamalebula.

Zvinhu Zvakagoverwa

• Kaseti yekuedza • Isai pakiti
• Buffer • Drop
• Lancet

Zvinhu Zvinodiwa Asi Zvisina Kugoverwa

•Mucherechedzo wekuunganidza mudziyo • Timer

KUCHENGA UYE KUgadzikana

•Chengetedza Sezvakarongedzerwa muhomwe yakavharwa patembiricha(4-30″Cor 40-86°F). Kiti yacho inogadzikana mukati memazuva ekupera kwenguva yakadhindwa pamazita.

• Kana wangovhura homwe, iyo isinga shandiswe mukati meawa imwe chete.Kugara kwenguva refu kunzvimbo inopisa uye ine mwando kunokonzera kukanganisa kwechigadzirwa.

•Roti uye zuva rekupera basa zvakadhindwa pachinyorwa chinonzi SPECIMEN

•Muedzo unogona kushandiswa kuyedza sampuli dzeRopa/Serum/Plasma.

•Kutora ropa rakazara, serum kana plasma zvienzaniso zvichitevedza maitirwo emurabhoritari ekiriniki.

•Kuparadzanisa serum kana plasma kubva muropa nokukurumidza sezvinobvira kudzivirira hemolysis.Shandisa chete yakajeka isina-hemolyzed specimens.

•Chengeta zvimedu pa2-8 °C (36-46T) kana zvisina kuongororwa nekukasika.Chengetedza sampuli pa2-8 °C kusvika kumazuva manomwe.Zviyereso zvinofanirwa kuomeswa nechando pa -20 °C (-4°F) kuitira kuchengetedza kwenguva refu.Usaomesa sampuli dzeropa rose,

•Dzivisa kutenderera kwakawanda kwechando-kunyungudika, usati waedzwa, unza zvienzaniso zvakaomeswa nechando kune tembiricha yekamuri zvishoma nezvishoma uye sanganisa zvinyoro.

Mienzaniso ine zvinhu zvinooneka zvinofanira kujekeswa ne centrifugation isati yaedzwa.

• Usashandise masamples anoratidza gross lipemia gross hemolysis kana turbidity kuitira kudzivirira kukanganiswa pakududzirwa kwemhedzisiro.

TEST PROCEDURE

Bvumira chishandiso chekuyedza uye zvienzaniso kuti zvienzane netembiricha (15-30 C kana 59-86 T) isati yaedzwa.

1. Bvisa Cassette yebvunzo kubva muhomwe yakavharwa.
2. Bata chinodonhedza chakatwasuka uye wotamisa 1 donho (inenge gumi ul) yemuenzaniso munzvimbo yepamusoro yemuenzaniso zvakanaka (S) uchiita chokwadi chekuti hapana mabhuru emhepo.Kuti zvive nani, shandura muenzaniso nepipette inokwanisa kuendesa 10 ul yehuwandu.Ona mufananidzo uri pasi apa.
3. Wobva wawedzera madonhwe maviri (anenge makumi manomwe ul) e buffer nekukasira mumuenzaniso mutsime(S).
4. Tanga timer.
5. kuti mitsetse ine mavara ioneke.Dudzira mhinduro dzebvunzo pamaminitsi gumi nemashanu.Usaverenge mhinduro mushure memaminitsi makumi maviri.

Nzvimbo yeSpecimen

(Mufananidzo ndewekungotaura chete, ndapota tarisa kune icho chinhu.)

DUDZIRIRO YEMIZVO

antibodies.Kuonekwa kweIgM bvunzo mutsara kunoratidza kuvepo kweNovel coronavirus chaiyo IgM masoja ekudzivirira chirwere.Uye kana zvese IgG neIgM mutsara zvikaonekwa, zvinoratidza kuti kuvapo kweNovel coronavirus chaiyo IgG uye IgM masoja ekudzivirira chirwere.

Negative:Mutsara mumwe weruvara unoonekwa munharaunda yekudzora (C), Hapana mutsara unooneka weruvara unoonekwa munharaunda yebvunzo.

Hazvina basa:Mutsetse wekudzora watadza kuoneka.Kusakwana specimen vhoriyamu kana zvisirizvo maitiro emaitiro ndizvo zvinonyanya zvikonzero fbr control linefailure.Wongorora maitiro uye dzokorora bvunzo nekaseti nyowani yekuyedza.Kana dambudziko rikaramba riripo, regedza kushandisa test kit nekukasira uye ubate mushambadzi wenzvimbo yako.

HUNHU KUDZORERA

A procedural control inosanganisirwa muyedzo.Mutsara weruvara unoonekwa munharaunda yekutonga (C) unoonekwa seyemukati maitiro ekudzora.Iyo inosimbisa yakakwana yemuenzaniso vhoriyamu, yakakwana membrane wicking uye inogadzirisa maitiro maitiro.Kudzora zviyero hazvina kupihwa nekiti iyi.Nekudaro, zvinokurudzirwa kuti zvidzore zvakanaka uye zvisina kunaka zviongororwe seyakanaka marabhoritari tsika yekusimbisa maitiro ebvunzo uye kuona kwakaringana kuita kwebvunzo.

ZVIKATAURWA

• COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) inogumira pakupa hunhu

kuonekwa.Kusimba kwemutsetse webvunzo hakurevi hazvo kuenderana nehuwandu hwemasoja ekudzivirira chirwere muropa.Mhedzisiro yakawanikwa kubva pabvunzo iyi inotarisirwa kuve rubatsiro mukuongororwa chete.Chiremba mumwe nomumwe anofanira kududzira migumisiro pamwe chete nenhoroondo yemurwere, zvakawanikwa mumuviri, uye mamwe maitiro ekuongorora.

•Muedzo usina kunaka unoratidza kuti masoja ekudzivirira chirwere eNovel coronavirus angave asiripo kana kuti ari pamazinga asingaonekwe nebvunzo.

PERFORMANCE CHARACTERISTICS

Kururama

Pfupiso data yeCO VID-19 IgG/IgM Yekukurumidza Kuongororwa sezviri pazasi

Nezve IgG bvunzo, takaverenga mwero wakanaka wevarwere makumi masere nevaviri panguva yekupora.

COVID-19 IgG:

Mhedzisiro inoburitsa kunzwa kwe97.56%

Nezve IgM bvunzo, mhedzisiro yekuenzanisa neRT-PCR.

COVID-19 IgM:

Kuenzanisa kwenhamba kwakaitwa pakati pemigumo ichipa kunzwisiswa kwe88.61%, chaiyo ye97.67% uye huchokwadi hwe93.33%

Muchinjikwa-Reactivity uye Kupindira

1 .Zvimwe zvinowanzoitika zvinokonzera zvirwere zvinotapukira zvakaongororwa kuti zvive nemuchinjikwa reactivity nemuedzo.Mimwe mienzaniso yakanaka yezvimwe zvirwere zvinotapukira zvakaiswa muNovel coronavirus yakanaka uye yakaipa mienzaniso uye yakaedzwa zvakasiyana.Hapana muchinjika reactivity wakaonekwa nezvienzaniso kubva kuvarwere vane HIV, HA ^ HBsAg, HCV TP, HTIA ^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

2. Zvinogona kuyambuka-reactive endogenous zvinhu zvinosanganisira zvakajairika serum zvinoumba, senge lipids, hemoglobin, bilirubin, zvakakwizwa pakakwirira muNovel coronavirus yakanaka uye isina kunaka sampuli uye yakaedzwa, zvakasiyana.

Hapana muchinjikwa reactivity kana kukanganisa kwakaonekwa kune mudziyo.

3.Vamwe vakajairwa biological analytes vakapinzwa muNovel coronavirus yakanaka uye yakaipa mienzaniso uye vakaedzwa zvakasiyana.Hapana kupindira kwakakosha kwakaonekwa pamatanho akanyorwa mutafura iri pazasi.

Reproducibility

Reproducibility zvidzidzo zvakaitirwa Novel coronavirus IgG/IgM Rapid Test pamarabhoritari matatu ehofisi yechiremba (POL).Makumi matanhatu (60) ekiriniki serum samples, 20 negative, 20 borderline positive uye 20 positive, zvakashandiswa muchidzidzo ichi.Imwe neimwe muenzaniso yaiitwa katatu kwemazuva matatu paPOL yega yega.Iyo intra-assay chibvumirano chaive 100%.Chibvumirano chepakati-saiti chaive 100%.