COVID-19 IgG/IgM Rapid Test Cassette

Kwa akatswiri komanso mu vitro diagnostic ntchito kokha.

ZOFUNIKA KUGWIRITSA NTCHITO

TheCOVID-19 IgG/IgM Rapid Test Cassettendi lateral flow immunoassay yopangidwira kuzindikira kwamtundu wa ma antibodies a IgG ndi IgM ku kachilombo ka SARS-CoV-2 m'magazi athunthu, seramu kapena plasma zitsanzo kuchokera kwa anthu omwe akuwaganizira kuti ali ndi kachilombo ka COVID -19 ndi wothandizira zaumoyo wawo.

Mayeso a CO VID-19 IgG/IgM Rapid ndi chithandizo chozindikiritsa odwala omwe akuganiziridwa kuti ali ndi kachilombo ka SARS -CoV-2 molumikizana ndikuwonetsa zachipatala komanso zotsatira za mayeso ena a labotale. Amalangizidwa kuti agwiritse ntchito ngati chizindikiritso chowonjezera cha milandu yomwe akuwakayikira omwe ali ndi mayeso a nucleic acid ya novel coronavirus kapena kugwiritsidwa ntchito limodzi ndi mayeso a nucleic acid pamilandu yomwe akuwakayikira. Zotsatira zochokera pakuyezetsa ma antibody siziyenera kugwiritsidwa ntchito ngati njira yokhayo yodziwira kapena kupatula matenda a SARS -CoV-2 kapena kudziwitsa za matendawa.

Zotsatira zoyipa sizimaletsa matenda a SARS -CoV-2, makamaka kwa omwe adakumana ndi anthu odziwika omwe ali ndi kachilomboka kapena m'malo omwe ali ndi matenda ambiri. Kuyezetsa kotsatira ndi kufufuza kwa maselo kuyenera kuganiziridwa kuti kuthetse matenda mwa anthuwa.

Zotsatira zabwino zitha kukhala chifukwa cha matenda am'mbuyomu kapena apano omwe si a SARS-CoV-2 coronavirus strains.

Mayesowa amapangidwa kuti azigwiritsidwa ntchito m'ma laboratories azachipatala kapena ogwira ntchito yazachipatala pamalo osamalira, osati kugwiritsidwa ntchito kunyumba. Kuyezetsa kuyenera kugwiritsidwa ntchito powunika magazi omwe aperekedwa.

CHIDULE

Novel coronaviruses ndi a p genus.COVID 19ndi pachimake kupuma matenda opatsirana. Nthawi zambiri anthu amavutika. Pakadali pano, odwala omwe ali ndi kachilombo ka coronavirus ndiye gwero lalikulu la matenda; jekeseni wa asymptomatic amathanso kukhala gwero lopatsirana. Malingana ndi kafukufuku wamakono wa epidemiological, nthawi yoyamwitsa ndi masiku 1 mpaka 14, makamaka masiku 3 mpaka 7. The mawonetseredwe aakulu monga malungo, kutopa ndi youma chifuwa. Kutsekeka kwa mphuno, mphuno, zilonda zapakhosi, myalgia ndi kutsekula m'mimba zimapezeka nthawi zingapo.

Kachilombo ka SARS-CoV2 kakalowa m'thupi, RNA, chibadwa cha kachilomboka, ndiye chizindikiro choyamba chomwe chitha kuzindikirika. Mbiri ya virus ya SARS-CoV-2 ndi yofanana ndi chimfine, chomwe chimafika pachimake nthawi yazizindikiro, kenako ndikuyamba kuchepa. Ndi chitukuko cha matendawa pambuyo pa matenda, chitetezo cha mthupi cha munthu chidzatulutsa ma antibodies, omwe IgM ndi antibody yoyambirira yopangidwa ndi thupi pambuyo pa matenda, kusonyeza gawo lalikulu la matenda. Ma antibodies a IgG opita ku SARS-CoV2 amatha kuzindikirika pambuyo pa matenda. Zotsatira zabwino za IgG ndi IgM zitha kuchitika pambuyo pa matenda ndipo zitha kuwonetsa matenda owopsa kapena aposachedwa. IgG ikuwonetsa gawo lokhazikika la matenda kapena mbiri ya matenda am'mbuyomu.

Komabe, onse a IgM ndi IgG amakhala ndi nthawi yazenera kuchokera ku matenda a virus kupita kukupanga ma antibody, IgM imatsala pang'ono kuwoneka matenda atayamba masiku angapo, kotero kuti kuzindikira kwawo nthawi zambiri kumatsalira kumbuyo kwa nucleic acid kuzindikira ndipo sikumva bwino kwambiri kuposa kuzindikira kwa nucleic acid. Ngati mayeso a nucleic acid amplification alibe ndipo pali ulalo wamphamvu wa miliri ku matenda a COVID-19, zitsanzo za seramu zophatikizika (mugawo lachiwopsezo ndi kuchira) zitha kuthandizira kuzindikira.

MFUNDO

COVID-19 IgG/IgM Rapid Test Cassette(WB/S/P) ndi njira yoyeserera 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 coiyugate yokhala ndi Novel coronavirus recombinant envelopu antigens coi^yokhala ndi golide wa Colloid (Novel coronavirus c两ugates), 2) mzere wa membrane wa nitrocellulose wokhala ndi mizere iwiri yoyesera (mizere ya IgG ndi IgM) ndi mzere wowongolera (C mzere). Mzere wa IgM udakutidwa kale ndi Mouse anti-Human IgM antibody, mzere wa IgG umakutidwa ndi anti-Human IgG antibody, pomwe kuchuluka kokwanira kwa kaseti kakang'ono kumaperekedwa mu chitsime cha kaseti yoyesera. Chitsanzocho chimayenda ndi capillary action kudutsa makaseti. IgM anti-Novel coronavirus, ngati ilipo pachitsanzocho, ilumikizana ndi Novel coronavirus coiyugates. Immunocomplex imatengedwa ndi reagent yomwe idakutidwa kale pa IgM band, ndikupanga mzere wamtundu wa IgM wamtundu wa burgundy, kuwonetsa zotsatira za mayeso a Novel coronavirus IgM. IgG anti-Novel coronavirus yomwe ikupezeka pachitsanzo ichi idzalumikizana ndi Novel coronavirus conjugates. Immunocomplex imatengedwa ndi reagent yomwe idakutidwa pamzere wa Lhe IgG, ndikupanga mzere wa IgG wamtundu wa burgundy, kuwonetsa zotsatira za mayeso a Novel coronavirus IgG. Kusakhalapo kwa mizere ya T (IgG ndi IgM) kumasonyeza a

zotsatira zoipa. 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 in vitro diagnostic ntchito kokha.
• Kwa akatswiri azaumoyo ndi akatswiri malo osamalirako.

•Musagwiritse ntchito tsiku lotha ntchito litatha.

• chonde werengani zonse zomwe zili mu kapepalaka musanapange mayeso. •Kaseti yoyesera ikhalebe muthumba lomata mpaka itagwiritsidwa ntchito.

•Zitsanzo zonse ziyenera kuonedwa ngati zowopsa ndikusamalidwa mofanana ndi mankhwala opatsirana.

•Kaseti yoyeserera yomwe yagwiritsidwa ntchito iyenera kutayidwa molingana ndi malamulo aboma, boma komanso mdera lanu.

COMPOSITION

Mayesowa ali ndi kamzere kakang'ono kamene kakutidwa ndi Mouse anti-Human IgM antibody ndi Mouse anti-Human IgG antibody pa.

test line, ndi utoto wopaka utoto womwe uli ndi golide wa colloidal wophatikizidwa ndi Novel corona virus recombinant antigen. Kuchuluka kwa mayeso kunasindikizidwa pa zolembera.

Zida Zoperekedwa

• Kaseti yoyesera • Ikani phukusi
• Chotchinga • Chotsitsa
• Lancet

Zinthu Zofunika Koma Zosaperekedwa

•Chotengera chosonkhanitsira zitsanzo • Chowerengera nthawi

KUSINTHA NDI KUKHALA

•Sungani Monga Chopakidwa muthumba lomata pa kutentha (4-30″Cor 40-86°F). Zidazi ndi zokhazikika mkati mwa tsiku lotha ntchito lomwe lasindikizidwa pacholembacho.

•Mukatsegula thumbalo, thumbalo liyenera kugwiritsidwa ntchito pasanathe ola limodzi. Kusungidwa kwanthawi yayitali kumalo otentha ndi achinyezi kungayambitse kuwonongeka kwa zinthu.

•LOT ndi tsiku lotha ntchito zidasindikizidwa pa chizindikiro cha SPECIMEN

•Kuyezetsako kungagwiritsidwe ntchito kuyesa magazi athunthu/Serum/Magazi a m'magazi.

•Kutenga magazi athunthu, seramu kapena madzi a m'magazi a m'magazi potsatira ma labotale achipatala.

•Alekanitse madzi a m'magazi kapena madzi a m'magazi mwamsanga kuti mupewe magazi. Gwiritsani ntchito zitsanzo zomveka bwino zopanda hemolyzed.

•Sungani zitsanzo pa 2-8 °C (36-46T) ngati sizinayesedwe mwamsanga. Sungani zitsanzo pa 2-8 °C mpaka masiku 7. Zitsanzozi ziyenera kuzizira pa -20 ° C (-4 ° F) kuti zisungidwe nthawi yayitali. Osaundana magazi athunthu,

• Pewani maulendo angapo oundana, musanayese, bweretsani zitsanzo zozizira kutentha pang'onopang'ono ndikusakaniza mofatsa.

Zitsanzo zomwe zili ndi tinthu tating'onoting'ono tating'onoting'ono tikuyenera kufotokozedwa ndi centrifugation musanayesedwe.

•Musagwiritse ntchito zitsanzo zosonyeza gross lipemia gross hemolysis kapena turbidity pofuna kupewa kusokonezedwa ndi kutanthauzira kwa zotsatira.

NJIRA YOYESA

Lolani chipangizo choyesera ndi zitsanzo kuti zigwirizane ndi kutentha (15-30 C kapena 59-86 T) musanayesedwe.

1. Chotsani Kaseti yoyeserera m'thumba lomata.
2. Gwirani chotsitsacho molunjika ndikusamutsa dontho limodzi (pafupifupi 10 ul) la chitsanzo kumtunda kwa chitsime cha chitsanzo (S) ndikuwonetsetsa kuti palibe thovu la mpweya. Kuti mumvetsetse bwino, tumizani chitsanzo ndi pipette yomwe imatha kutulutsa 10 ul ya voliyumu. Onani chithunzi pansipa.
3. Kenako, onjezerani madontho awiri (pafupifupi 70 ul) a buffer nthawi yomweyo mu chitsime cha chitsanzo (S).
4. Yambitsani chowerengera.
5. kuti mizere yamitundu iwonekere. Tanthauzirani zotsatira za mayeso pa mphindi khumi ndi zisanu. Osawerenga zotsatira pakadutsa mphindi 20.

Malo a Chitsanzo

(Chithunzichi ndi chongofotokozera zokha, chonde onani zinthu zakuthupi.)

KUMASULIRIDWA KWA ZOTSATIRA

ma antibodies. 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 umodzi wachikuda umapezeka m'chigawo chowongolera (C), Palibe mzere wowoneka bwino wamtundu womwe umapezeka m'chigawo choyesera.

Zosavomerezeka:Mzere wowongolera ukulephera kuwonekera. Kusakwanira kwa kuchuluka kwa zitsanzo kapena njira zolakwika ndizomwe zimapangitsa kuti fbr control linefailure. 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.

ZOPHUNZITSA

• Makaseti a COVID-19 IgG/IgM Rapid Test (WB/S/P) ali ndi malire kuti apereke mawonekedwe abwino

kuzindikira. 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 zosonyeza kuti ma antibodies ku Novel coronavirus sapezeka kapena ali pamlingo womwe sunawonekere pakuyezetsa.

ZINTHU ZOCHITIKA

Kulondola

Chidule cha Mayeso a CO VID-19 IgG/IgM Rapid monga pansipa

Ponena za kuyezetsa kwa IgG, tawerengera kuchuluka kwa odwala 82 panthawi yomwe akuchira.

COVID-19 IgG:

Zotsatira zomwe zimapereka chidwi cha 97.56%

Ponena za mayeso a IgM, kuyerekeza kwa zotsatira ndi RT-PCR.

COVID-19 IgM:

Kuyerekeza kwachiwerengero kunapangidwa pakati pa zotsatira zomwe zimapereka chidwi cha 88.61%, kutsimikizika kwa 97.67% ndi kulondola kwa 93.33%

Cross-Reactivity ndi Kusokoneza

1 .Zina zodziwika bwino zoyambitsa matenda opatsirana zidawunikidwa kuti zitha kuyambiranso ndi mayeso. Zitsanzo zina zabwino za matenda ena opatsirana zidalowetsedwa mu Novel coronavirus zabwino ndi zoyipa zomwe zidayesedwa padera. Palibe kuyanjananso komwe kunawonedwa ndi zitsanzo za odwala omwe ali ndi kachilombo ka HIV, HA ^ HBsAg, HCV TP, HTIA ^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

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%.