COVID-19 Anti-2019-nCoV China New Coronavirus

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COVID-19 Anti-2019-nCoV China New Coronavirus

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Zvinotsanangurwa

[WACHASHANDISWA]
Iyo AMRDT100 IgG/IgM Rapid Test Cassette ndeye lateral kuyerera chromatographic immunoassay yemhando yekuonekwa kwemasoja ekudzivirira chirwere (IgG neIgM) kune Novel coronavirus mumunhu Wese Ropa/Serum/Plasma.
Inopa rubatsiro mukuongororwa kwehutachiona neNovel coronavirus.

[SUMMARY]
Kutanga kwaNdira 2020, novel coronavirus (SARS-CoV-2, yaimbozivikanwa se2019-nCoV) yakaonekwa seyakatapukira ichikonzera kubuda kwehutachiona hwepneumonia muWuhan, China, uko nyaya dzekutanga dzakatanga zviratidzo muna Zvita 2019.
MaCoronaviruses mavhairasi akafukidzwa eRNA ayo anoparadzirwa zvakafara pakati pevanhu, zvimwe mhuka dzinoyamwisa, neshiri uye anokonzera zvirwere zvekufema, enteric, hepatic, uye neurologic. Mhando nhanhatu dzekoronavirus dzinozivikanwa kuti dzinokonzera chirwere chevanhu.Mavhairasi mana-229E, OC43, NL63, uye HKU1 akapararira uye anowanzo kukonzera zviratidzo zvinotonhora muvanhu vasina simba.Mamwe maviri aya akanyanya acute respiratory syndrome coronavirus (SARS-CoV) uye Middle East Respiratory Syndrome coronavirus (MERS-CoV) ane zoonotic mumavambo uye akabatanidzwa kune dzimwe nguva chirwere chinouraya.
Coronaviruses i zoonotic, zvichireva kuti inotapurirana pakati pemhuka nevanhu.Zviratidzo zvinowanzoonekwa zvehutachiona zvinosanganisira zviratidzo zvekufema, fivha, chikosoro, kutadza kufema uye kunetseka kufema.Muzviitiko zvakanyanya kuipa, hutachiona hunogona kukonzera mabayo, yakanyanya acute respiratory syndrome, kutadza kweitsvo uye kunyange kufa.
Zvinokurudzirwa kudzivirira kupararira kwehutachiona zvinosanganisira kugara uchigeza maoko, kuvhara muromo nemhino kana uchikosora nekuhotsira, kunyatsobika nyama nemazai.Dzivisa kuswedera pedyo nemunhu wese anoratidza zviratidzo zvechirwere chekufema senge kukosora nekuhotsira.

[PRINCIPLE]
Iyo AMRDT100IgG/IgM Rapid Test Cassette imhando yemembrane strip yakavakirwa immunoassay yekuonekwa kwemasoja ekudzivirira chirwere (IgG neIgM) kune Novel coronavirus mumunhu Wese Ropa/Serum/Plasma.Iyo bvunzo kaseti ine: 1) burgundy colored conjugate pad ine Novel coronavirus recombinant envelope antigens yakasanganiswa neColloid goridhe (Novel coronavirus conjugates), 2) nitrocellulose membrane strip ine mitsara miviri yebvunzo (IgG uye IgM mitsara) uye tambo yekudzora ( C line).Mutsetse weIgM wakafanoputirwa neMouse anti-Human IgM antibody, IgG mutsetse wakavharwa neMouse anti-Human IgG antibody.Kana vhoriyamu yakakwana yebvunzo yemuenzaniso yaiswa mumuenzaniso tsime rebvunzo kaseti, mufananidzo wacho unotama necapillary chiito kuyambuka kaseti.IgM anti-Novel coronavirus, kana iripo mumuenzaniso, inosunga kune Novel coronavirus conjugates.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 kana iripo mumuenzaniso inosunga kune Novel coronavirus conjugates.Iyo immunocomplex inozobatwa neiyo reagent yakavharwa paIgG mutsara, ichigadzira burgundy yemavara IgG mutsara, ichiratidza Novel coronavirus IgG yakanaka bvunzo mhedzisiro.Kusavapo kwechero T mitsara (IgG neIgM) inoratidza mhedzisiro yakaipa.Kuti ishande senzira yekudzora, mutsara weruvara unogara uchionekwa munzvimbo yekutonga inoratidza kuti vhoriyamu yakakodzera yemuenzaniso yakawedzerwa uye membrane wicking yakaitika.

[YAMBIRO UYE ZVOKUCHENGEDZA]
Kune vashandi vehutano uye nyanzvi panzvimbo dzekuchengetedza nzvimbo.
Usashandise mushure mekupera kwezuva.
Ndokumbira uverenge ruzivo rwese rwuri pakapepa rino usati waita bvunzo.
Kaseti yebvunzo inofanira kuramba iri muhomwe yakavharwa kusvika yashandiswa.
Yese mienzaniso inofanirwa kutariswa ingangove ine njodzi uye inobatwa nenzira imwechete seanotapukira.
Iyo yakashandiswa bvunzo kaseti inofanirwa kuraswa zvinoenderana nemubatanidzwa, nyika uye yemuno mirau.

[COMPOSITION]
Muedzo uyu une membrane strip yakavharwa neMouse anti-Human IgM antibody uye Mouse anti-Human IgG antibody pamutsetse webvunzo, uye dhayi padhi ine colloidal goridhe rakasanganiswa neNovel coronavirus recombinant antigen.
Huwandu hwebvunzo hwakadhindwa pamalebula.
Zvinhu Zvakagoverwa
Yedza kasetiPackage isa
Buffer
Zvinhu Zvinodiwa Asi Zvisina Kugoverwa
Sayenzi yekuunganidza mudziyoTimer

[KUCHENGA UYE KUTIRIRA]
Chengetedza seyakaputirwa muhomwe yakavharwa patembiricha (4-30 ℃ kana 40-86 ℉).Iyo kit yakagadzikana mukati menguva yekupera yakadhindwa pane iyo yakanyorwa.
Kana wangovhura homwe, bvunzo dzinofanirwa kushandiswa mukati meawa imwe.Kugara kwenguva refu kunzvimbo inopisa uye ine mwando kunokonzera kukanganisa kwechigadzirwa.
Iyo LOT uye zuva rekupera kwayo zvakadhindwa pane iyo yakanyorwa.

[ZVIRI MUKATI]
Muedzo unogona kushandiswa kuyedza Yese Ropa/Serum/Plasma samples.
Kutora ropa rakazara, serum kana plasma zvienzaniso zvichitevera maitiro enguva dzose ekiriniki murabhoritari.
Kuparadzanisa serum kana plasma kubva muropa nekukurumidza sezvinobvira kudzivirira hemolysis.Shandisa chete yakajeka isina-hemolyzed specimens.
Chengetedza zvienzaniso pa2-8℃ (36-46℉) kana zvisina kuongororwa nekukasira.Chengetedza sampuli pa2-8 ℃ kusvika kumazuva manomwe.Mienzaniso inofanira kuiswa muchando
-20 ℃ (-4 ℉) yekuchengetedza kwenguva refu.Usaomesa sampuli dzeropa rose.
Dzivisa akawanda kutonhora-kunyorova kutenderera.Usati waedza, hunza zvimedu zvakaomeswa nechando kune tembiricha yekamuri zvishoma nezvishoma uye sanganisa zvinyoro.Mienzaniso ine zvinhu zvinooneka zvinofanira kujekeswa ne centrifugation isati yaedzwa.
Usashandise sampuli dzinoratidza gross lipemia, gross hemolysis kana turbidity kuitira kudzivirira kukanganisa pakududzira kwemhedzisiro.

[TEST PROCEDURE]
Bvumira mudziyo wekuyedza uye zvienzaniso kuti zvienzane netembiricha (15-30 ℃ kana 59-86 ℉) isati yaedzwa.
1.Bvisa kaseti yebvunzo kubva muhomwe yakavharwa.
2.Bata dropper vertically uye kuendesa 1 donho remuenzaniso kune specimen well(S) ye test device, wobva wawedzera madonhwe maviri e buffer (inenge 70μl) uye tanga timer.Ona mufananidzo uri pasi apa.
3.Mirira kuti mitsetse ine mavara ionekwe.Dudzira mhinduro dzebvunzo mumaminitsi gumi nemashanu.Usaverenge mhinduro mushure memaminitsi makumi maviri.

[DUDZIRIRO YEMIZVO]
Positive: Kudzora mutsara uye kanenge mutsara webvunzo unoonekwa pane membrane.Kuonekwa kweIgG bvunzo mutsara kunoratidza kuvepo kweNovel coronavirus chaiyo IgG masoja ekudzivirira chirwere.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 munzvimbo yekudzora (C) .Hapana mutsara weruvara unooneka unoonekwa munharaunda yebvunzo.
Haisiyo: Mutsetse wekudzora watadza kuoneka.Kusakwana specimen vhoriyamu kana zvisirizvo maitiro emaitiro ndizvo zvinonyanya zvikonzero zvekutadza kwekudzora mutsara.Wongorora maitiro uye dzokorora bvunzo nekaseti nyowani yekuyedza.Kana dambudziko rikaramba riripo, regedza kushandisa test kit nekukasira uye ubate mushambadzi wenzvimbo yako.

[QUALITY CONTROL]
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.

[ZVIMWE ZVIMWE
Iyo AMRDT100 IgG/IgM Rapid Test Cassette inogumira kuti ipe hunhu hwekuonekwa.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.
Mhedzisiro isina kunaka yebvunzo inoratidza kuti masoja ekudzivirira chirwere kuNovel coronavirus angave asiripo kana pamazinga asingaonekwe nemuyedzo.

[PERFORMANCE CHARACTERISTICS]
Kururama
Kuenzanisa-padivi-parutivi kwakaitwa pachishandiswa Novel coronavirus IgG/IgM Rapid Test uye inotungamira yekutengesa PCR.120 makiriniki emuenzaniso kubva kuProfessional Point of Care site akaongororwa.Migumisiro inotevera inorongwa kubva kuzvidzidzo zvekiriniki izvi:
Kuenzanisa kwenhamba kwakaitwa pakati pemigumo ichipa kunzwisiswa kwe90.00%, chaiyo ye97.78% uye huchokwadi hwe95.83%.
Muchinjikwa-Reactivity uye Kupindira
1.Zvimwe zvakajairika causative agents zvezvirwere zvinotapukira zvakaongororwa pamuchinjikwa reactivity pamwe nemuedzo.Mimwe mienzaniso yakanaka yezvimwe zvirwere zvinotapukira zvakaiswa muNovel coronavirus yakanaka uye isina kunaka mienzaniso uye yakaedzwa zvakasiyana.Hapana muchinjikwa reactivity wakaonekwa nezvienzaniso kubva kuvarwere vane HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV uye TP.
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.Zvibvumirano zve intra-assay zvaive 100%.Chibvumirano chepakati-saiti chaive 100%.

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