Zambiri Zachangu
COVID-19 Anti-2019-nCoV China New Coronavirus
Kupaka & Kutumiza
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Zofotokozera
[ZOFUNIKA KUGWIRITSA NTCHITO]
AMRDT100 IgG/IgM Rapid Test Cassette ndi lateral flow chromatographic immunoassay yowunikira ma antibodies (IgG ndi IgM) kupita ku Novel coronavirus mu Magazi Onse / Seramu / Plasma.
Amapereka chithandizo pakuzindikira matenda a Novel coronavirus.
[CHIDULE]
Kumayambiriro kwa Januware 2020, buku la coronavirus (SARS-CoV-2, lomwe kale limadziwika kuti 2019-nCoV) lidadziwika kuti ndi kachilombo komwe kamayambitsa kufalikira kwa chibayo ku Wuhan, China, komwe milandu yoyamba idayamba mu Disembala 2019.
Ma Coronaviruses ndi ma virus okhala ndi RNA omwe amagawidwa mokulira pakati pa anthu, zoyamwitsa, ndi mbalame ndipo omwe amayambitsa matenda a kupuma, enteric, hepatic, and neurologic. Mitundu isanu ndi umodzi ya coronavirus imadziwika kuti imayambitsa matenda a anthu.Ma virus anayi-229E, OC43, NL63, ndi HKU1 ndi ofala ndipo nthawi zambiri amayambitsa zizindikiro za chimfine mwa anthu omwe alibe chitetezo chokwanira.Mitundu ina iwiri ya acute kupuma kwapamtima coronavirus (SARS-CoV) ndi Middle East Respiratory Syndrome (MERS-CoV) ndi zoonotic kochokera ndipo nthawi zina amalumikizidwa ndi matenda oopsa.
Coronaviruses ndi zoonotic, kutanthauza kuti amafalikira pakati pa nyama ndi anthu.Zizindikiro zodziwika bwino za matenda ndi monga kupuma, kutentha thupi, chifuwa, kupuma movutikira komanso kupuma movutikira.Zikavuta kwambiri, matenda amatha kuyambitsa chibayo, chifuwa chachikulu cha kupuma, kulephera kwa impso ngakhale kufa.
Malangizo oletsa kufalikira kwa matenda ndi monga kusamba m'manja nthawi zonse, kutseka pakamwa ndi mphuno pokhosomola ndi kuyetsemula, kuphika bwino nyama ndi mazira.Pewani kuyandikira pafupi ndi aliyense amene ali ndi zizindikiro za matenda opuma monga kutsokomola ndi kuyetsemula.
[MFUNDO]
Kaseti ya AMRDT100IgG/IgM Rapid Test Cassette ndi njira yoyeserera yoyeserera ya ma antibodies (IgG ndi IgM) ku Novel coronavirus mu Magazi Onse / Seramu / Plasma.Kaseti yoyesera imakhala ndi: 1) pad yamtundu wa burgundy yokhala ndi ma antigen a Novel coronavirus recombinant envelopu yolumikizidwa ndi golide wa Colloid (Novel coronavirus conjugates), 2) chingwe cha nitrocellulose chokhala ndi mizere iwiri yoyesa (mizere ya IgG ndi IgM) ndi mzere wowongolera ( C mzere).Mzere wa IgM udakutidwa kale ndi Mouse anti-Human IgM antibody, mzere wa IgG wokutidwa ndi Mouse anti-Human IgG antibody.Pamene chiwerengero chokwanira cha chitsanzo choyesera chaperekedwa mu chitsime cha chitsanzo cha kaseti yoyesera, chitsanzocho chimasuntha ndi capillary action kudutsa kaseti.IgM anti-Novel coronavirus, ngati ilipo pachitsanzocho, ilumikizana ndi Novel coronavirus conjugates.Immunocomplex imatengedwa ndi reagent yomwe idakutidwa kale pa band ya IgM, ndikupanga mzere wamtundu wa IgM wamtundu wa burgundy, kuwonetsa zotsatira za mayeso a Novel coronavirus IgM.IgG anti-Novel coronavirus ngati ilipo pachitsanzoyo ilumikizana ndi Novel coronavirus conjugates.Immunocomplex imatengedwa ndi reagent yomwe idakutidwa pamzere wa IgG, ndikupanga mzere wa IgG wamtundu wa burgundy, kuwonetsa zotsatira za mayeso a Novel coronavirus IgG.Kusowa kwa mizere ya T (IgG ndi IgM) kukuwonetsa zotsatira zoyipa.Kuti ikhale yoyang'anira njira, mzere wachikuda udzawonekera nthawi zonse pagawo la mzere wosonyeza kuti chiwerengero choyenera cha chitsanzo chawonjezeredwa ndipo kupukuta kwa membrane kwachitika.
[CHENJEZO NDI CHENJEZO]
Kwa akatswiri azaumoyo ndi akatswiri pa malo osamalira.
Osagwiritsa ntchito pambuyo pa tsiku lotha ntchito.
Chonde werengani zonse zomwe zili mu kapepalaka musanapange mayeso.
Kaseti yoyesera iyenera kukhala muthumba lomata mpaka itagwiritsidwa ntchito.
Zitsanzo zonse ziyenera kuonedwa ngati zowopsa ndikusamalidwa mofanana ndi mankhwala opatsirana.
Kaseti yoyeserera yogwiritsidwa ntchito iyenera kutayidwa molingana ndi malamulo aboma, aboma komanso akumaloko.
[COMPOSITION]
Mayesowa ali ndi kansalu kakang'ono kamene kakutidwa ndi Mouse anti-Human IgM antibody ndi Mouse anti-Human IgG antibody pamzere woyesera, ndi utoto wopaka utoto womwe uli ndi golide wa colloidal wophatikizidwa ndi Novel coronavirus recombinant antigen.
Kuchuluka kwa mayeso kunasindikizidwa pa zolembera.
Zida Zoperekedwa
Yesani makasetiPackage Ikani
Bafa
Zinthu Zofunika Koma Zosaperekedwa
Chotengera chosonkhanitsira zitsanzoTimer
[KUSINTHA NDI KUKHALA]
Sungani monga mmatumba mu thumba losindikizidwa pa kutentha (4-30 ℃ kapena 40-86 ℉).Zidazi ndi zokhazikika mkati mwa tsiku lotha ntchito lomwe lidasindikizidwa.
Mukatsegula thumba, mayesowo ayenera kugwiritsidwa ntchito mkati mwa ola limodzi.Kusungidwa kwanthawi yayitali kumalo otentha ndi achinyezi kungayambitse kuwonongeka kwa zinthu.
LOT ndi tsiku lotha ntchito zidasindikizidwa pazolembapo.
[MFUNDO]
Kuyezetsako kungagwiritsidwe ntchito kuyesa zitsanzo za Magazi Onse / Seramu / Plasma.
Kutenga magazi athunthu, seramu kapena plasma toyesa kutsatira njira zachipatala za labotale.
Olekanitsa seramu kapena plasma m'magazi mwachangu momwe mungathere kuti mupewe hemolysis.Gwiritsani ntchito zitsanzo zomveka bwino zopanda hemolyzed.
Sungani zitsanzo pa 2-8 ℃ (36-46 ℉) ngati sizinayesedwe nthawi yomweyo.Sungani zitsanzo pa 2-8 ℃ mpaka masiku 7.Zitsanzo ziyenera kusungidwa mufiriji
-20 ℃ (-4 ℉) posungirako nthawi yayitali.Osaundana magazi athunthu.
Pewani maulendo angapo oundana.Musanayambe kuyezetsa, bweretsani zitsanzo zowundana ku kutentha pang'ono ndikusakaniza mofatsa.Zitsanzo zomwe zili ndi tinthu tating'onoting'ono tating'onoting'ono tikuyenera kufotokozedwa ndi centrifugation musanayesedwe.
Osagwiritsa ntchito zitsanzo zosonyeza gross lipemia, gross hemolysis kapena turbidity kuti mupewe kusokonezedwa pakutanthauzira zotsatira.
[NJIRA YOYESA]
Lolani chipangizo choyesera ndi zitsanzo kuti zigwirizane ndi kutentha (15-30 ℃ kapena 59-86 ℉) musanayesedwe.
1.Chotsani makaseti oyesera m'thumba lomata.
2.Gwirani dontho molunjika ndi kusamutsa dontho limodzi la chitsanzo ku chitsime cha chitsanzo (S) cha chipangizo choyesera, kenaka yikani madontho awiri a buffer (pafupifupi 70μl) ndikuyamba chowerengera.Onani chithunzi pansipa.
3.Dikirani kuti mizere yamitundu iwonekere.Tanthauzirani zotsatira za mayeso mu mphindi khumi ndi zisanu.Osawerenga zotsatira pakadutsa mphindi 20.
[KUMASULIRIDWA KWA ZOTSATIRA]
Zabwino: Mzere wowongolera ndi mzere umodzi woyeserera umawonekera pa nembanemba.Mawonekedwe a mzere woyeserera wa IgG akuwonetsa kukhalapo kwa ma antibodies a Novel coronavirus enieni a IgG.Mawonekedwe a mzere woyeserera wa IgM akuwonetsa kukhalapo kwa ma antibodies a Novel coronavirus enieni a IgM.Ndipo ngati mzere wa IgG ndi IgM ukuwonekera, zikuwonetsa kuti kupezeka kwa ma antibodies a Novel coronavirus enieni a IgG ndi IgM.
Zoipa: Mzere wachikuda umodzi umapezeka m'chigawo cholamulira (C) .
Zosavomerezeka: Mzere wowongolera ukulephera kuwonekera.Kusakwanira kwa kuchuluka kwa zitsanzo kapena njira zolakwika ndizo zifukwa zomwe zimalepheretsa mzere wowongolera.Unikaninso ndondomekoyi ndikubwereza mayesowo ndi kaseti yatsopano yoyeserera.Vuto likapitilira, siyani kugwiritsa ntchito zida zoyeserera nthawi yomweyo ndipo funsani wofalitsa wapafupipafupi.
[KUKHALA KWAKHALIDWE]
Kuwongolera kwadongosolo kumaphatikizidwa muyeso.Mzere wachikuda womwe ukuwoneka m'chigawo chowongolera (C) umatengedwa ngati njira yoyendetsera mkati.Imatsimikizira kuchuluka kokwanira kwa sampuli, kupukuta kokwanira kwa membrane ndi njira yoyenera.
Zowongolera siziperekedwa ndi zida izi.Komabe, tikulimbikitsidwa kuti zowongolera zabwino ndi zoyipa ziyesedwe ngati machitidwe abwino a labotale kuti atsimikizire njira yoyezera ndikuwonetsetsa kuti mayesowo achita bwino.
[MALIRE]
Makaseti a AMRDT100 IgG/IgM Rapid Test Cassette ali ndi malire kuti azitha kuzindikira bwino.Kuchulukira kwa mzere woyesera sikumayenderana kwenikweni ndi kuchuluka kwa antibody m'magazi.
Zotsatira zomwe zapezedwa kuchokera ku mayesowa zimapangidwira kuti zikhale zothandizira pozindikira matenda okha.Dokotala aliyense ayenera kutanthauzira zotsatira zake mogwirizana ndi mbiri ya wodwalayo, zomwe apeza, ndi njira zina zowunikira.
Zotsatira zoyipa zoyesa zikuwonetsa kuti ma antibodies ku Novel coronavirus mwina palibe kapena pamlingo wosadziwika ndi mayeso.
[ZINTHU ZOCHITIKA]
Kulondola
Kuyerekeza mbali ndi mbali kunachitika pogwiritsa ntchito Novel coronavirus IgG/IgM Rapid Test komanso PCR yotsogola yamalonda.Zitsanzo zachipatala 120 zochokera patsamba la Professional Point of Care zidawunikidwa.Zotsatira zotsatirazi zalembedwa kuchokera mu maphunziro azachipatala awa:
Kuyerekeza kwachiwerengero kunapangidwa pakati pa zotsatira zomwe zimapangitsa chidwi cha 90.00%, chodziwika bwino cha 97.78% ndi kulondola kwa 95.83%.
Cross-Reactivity ndi Kusokoneza
1.Zinthu zina zomwe zimayambitsa matenda opatsirana zidawunikidwa kuti zitha kuyambiranso ndi mayeso.Zitsanzo zina zabwino zamatenda opatsirana omwe wamba zidalowetsedwa mu Novel coronavirus zitsanzo zabwino komanso zoyipa ndikuyesedwa padera.Palibe reactivity ya mtanda yomwe inawonedwa ndi zitsanzo kuchokera kwa odwala omwe ali ndi kachilombo ka HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV ndi TP.
2. Zinthu zomwe zimatha kugwira ntchito mopitilira muyeso kuphatikiza zigawo zodziwika bwino za seramu, monga lipids, hemoglobin, bilirubin, zidakwezedwa mozama kwambiri mu Novel coronavirus zitsanzo zabwino ndi zoyipa ndikuyesedwa, padera.Palibe kuwoloka kapena kusokoneza komwe kunawonedwa pa chipangizocho.
3. Ofufuza ena odziwika bwino a zamoyo adalowetsedwa mu Novel coronavirus zitsanzo zabwino komanso zoyipa ndikuyesedwa padera.Palibe kusokoneza kwakukulu komwe kunawonedwa pamagulu omwe alembedwa mu tebulo ili m'munsimu.
Kuberekanso
Maphunziro obwerezabwereza adachitidwa pa Novel coronavirus IgG/IgM Rapid Test m'malo atatu azachipatala (POL).Zitsanzo za seramu zachipatala makumi asanu ndi limodzi (60), 20 zoipa, 20 za m'malire zabwino ndi 20 zabwino, zinagwiritsidwa ntchito mu phunziroli.Chitsanzo chilichonse chinayendetsedwa katatu kwa masiku atatu pa POL iliyonse.Mapangano a intra-assay anali 100%.Chigwirizano chapakati pa malo chinali 100%.
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