Kit ɗin Gwajin Saurin Coronavirus COVID-19

Cikakken Bayani

Kit ɗin Gwajin Saurin Coronavirus COVID-19

Marufi & Bayarwa

Ƙayyadaddun bayanai

[Amfani da niyya]
AMRDT100 IgG/IgM Cassette Rapid Test Cassette shine a gefe guda yana gudana chromatographic immunoassay don gano ingantattun ƙwayoyin rigakafi (IgG da IgM) zuwa Novel coronavirus a cikin Dukan Jini / Serum / Plasma.
Yana ba da taimako don gano kamuwa da cuta tare da Novel coronavirus.

[TAKATAI]
A farkon watan Janairun 2020, an gano wani sabon labari na coronavirus (SARS-CoV-2, wanda aka fi sani da 2019-nCoV) a matsayin mai cutar da ke haifar da barkewar cutar huhu a Wuhan, China, inda cutar ta farko ta fara bayyana a watan Disamba 2019.
Coronaviruses an lullube ƙwayoyin cuta na RNA waɗanda ke yaɗuwa a tsakanin mutane, sauran dabbobi masu shayarwa, da tsuntsaye kuma suna haifar da cututtukan numfashi, ciki, hanta, da cututtukan jijiya. An san nau'ikan coronavirus guda shida suna haifar da cutar ɗan adam.Kwayoyin cuta guda huɗu-229E, OC43, NL63, da HKU1 sun zama ruwan dare kuma galibi suna haifar da alamun mura na gama gari a cikin mutane marasa ƙarfi.Sauran nau'ikan guda biyu masu tsananin matsanancin ciwo na numfashi na coronavirus (SARS-CoV) da coronavirus na numfashi na gabas ta tsakiya (MERS-CoV) asalinsu zoonotic ne kuma ana danganta su da rashin lafiya wani lokaci.
Coronaviruses zoonotic ne, ma'ana ana yada su tsakanin dabbobi da mutane.Alamomin kamuwa da cuta na yau da kullun sun haɗa da alamun numfashi, zazzabi, tari, ƙarancin numfashi da wahalar numfashi.A lokuta masu tsanani, kamuwa da cuta na iya haifar da ciwon huhu, matsanancin ciwo na numfashi, gazawar koda har ma da mutuwa.
Shawarwari na yau da kullun don hana yaduwar kamuwa da cuta sun haɗa da wanke hannu akai-akai, rufe baki da hanci lokacin tari da atishawa, dafa nama da ƙwai sosai.A guji kusanci da duk wanda ke nuna alamun cututtukan numfashi kamar tari da atishawa.

[KA'IDA]
AMRDT100IgG/IgM Cassette Rapid Test Cassette ƙwaƙƙwarar ƙwayar ƙwayar cuta ce ta tushen immunoassay don gano ƙwayoyin rigakafi (IgG da IgM) zuwa Novel coronavirus a cikin Dukan Jini / Serum / Plasma.Kaset ɗin gwajin ya ƙunshi: 1) kushin conjugate mai launin burgundy mai ɗauke da Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates), 2) wani nitrocellulose membrane tsiri mai dauke da layin gwaji guda biyu (IgG da IgM Lines) da layin sarrafawa ( C layi).An riga an lulluɓe layin IgM tare da anti-Human IgM na Mouse, layin IgG an lulluɓe shi da Mouse anti-Human IgG antibody.Lokacin da aka ba da isasshen adadin samfurin gwaji a cikin rijiyar samfurin kaset ɗin, samfurin yana ƙaura ta hanyar aikin capillary a cikin kaset ɗin.IgM anti-Novel coronavirus, idan akwai a cikin samfurin, zai ɗaure ga Novel coronavirus conjugates.Immunocomplex an kama shi da reagent wanda aka riga aka lullube akan rukunin IgM, yana samar da layin IgM mai launin burgundy, yana nuna sakamakon gwajin IgM na Novel coronavirus.IgG anti-Novel coronavirus idan akwai a cikin samfurin zai ɗaure ga Novel coronavirus conjugates.Sa'an nan an kama immunocomplex ta reagent wanda aka lullube akan layin IgG, yana samar da layin IgG mai launin burgundy, yana nuna sakamakon gwajin IgG na Novel coronavirus.Rashin kowane layin T (IgG da IgM) yana nuna sakamako mara kyau.Don yin aiki azaman sarrafa tsari, layi mai launi koyaushe zai bayyana a yankin layin sarrafawa wanda ke nuna cewa an ƙara ƙarar samfurin daidai kuma an sami wicking membrane.

[GARGAƊI DA KIYAYE]
Don ƙwararrun kiwon lafiya da ƙwararru a wuraren wuraren kulawa.
Kada ku yi amfani bayan ranar karewa.
Da fatan za a karanta duk bayanan da ke cikin wannan takarda kafin yin gwajin.
Kaset ɗin gwajin yakamata ya kasance a cikin jakar da aka rufe har sai an yi amfani da shi.
Duk samfuran yakamata a yi la'akari da su masu haɗari kuma ana sarrafa su ta hanya ɗaya da wakili mai kamuwa da cuta.
Ya kamata a jefar da kaset ɗin gwajin da aka yi amfani da shi bisa ga dokokin tarayya, jihohi da na gida.

[HAUKI]
Gwajin yana ƙunshe da ɓangarorin membrane da aka lulluɓe da Mouse anti-Human IgM antibody da Mouse anti-Human IgG antibody akan layin gwajin, da kuma kushin rini wanda ya ƙunshi zinare colloidal haɗe da Novel coronavirus recombinant antigen.
An buga adadin gwaje-gwaje akan lakabin.
An Samar da Kayayyakin
Gwada saka kasetPackage
Buffer
Kayayyakin da ake buƙata Amma Ba a Samar da su ba
Kwangilar tarin samfurTimer

[AJIYA DA KWANTAWA]
Ajiye kamar yadda aka kunshe a cikin jakar da aka rufe a zazzabi (4-30 ℃ ko 40-86 ℉).Kayan ya tsaya tsayin daka a cikin ranar karewa da aka buga akan lakabin.
Da zarar an buɗe jakar, yakamata a yi amfani da gwajin a cikin awa ɗaya.Tsawaita bayyanawa ga yanayin zafi da ɗanɗano zai haifar da lalacewar samfur.
An buga LOT da ranar karewa akan lakabin.

[SPECIMEN]
Za a iya amfani da gwajin don gwada Jini duka/Magunguna/Plasma.
Don tattara cikakken jini, jini ko samfuran plasma bin hanyoyin gwajin asibiti na yau da kullun.
Rarrabe ruwan magani ko plasma daga jini da wuri-wuri don guje wa hemolysis.Yi amfani da kawai bayyanannun samfuran marasa hemolyzed.
Ajiye samfurori a 2-8 ℃ (36-46 ℉) idan ba a gwada su nan da nan ba.Ajiye samfurori a 2-8 ℃ har zuwa kwanaki 7.Ya kamata a daskare samfuran a
-20 ℃ (-4℉) don dogon ajiya.Kada a daskare duka samfuran jini.
Kauce wa daskare-daskare da yawa.Kafin gwaji, kawo daskararrun samfurori zuwa zafin daki a hankali kuma a gauraya a hankali.Ya kamata a fayyace samfuran da ke ɗauke da ɓangarorin ɓangarorin da ke bayyane ta hanyar centrifugation kafin gwaji.
Kar a yi amfani da samfuran da ke nuna babban lipemia, babban hemolysis ko turbidity don guje wa tsangwama kan fassarar sakamako.

[TSARAR GWAJI]
Bada na'urar gwaji da samfurori don daidaitawa zuwa zafin jiki (15-30 ℃ ko 59-86 ℉) kafin gwaji.
1.Cire kaset ɗin gwaji daga jakar da aka rufe.
2. Rike digo a tsaye kuma canja wurin digo 1 na samfurin zuwa samfurin da kyau (S) na na'urar gwaji, sannan ƙara digo 2 na buffer (kimanin 70μl) kuma fara mai ƙidayar lokaci.Dubi hoton da ke ƙasa.
3. Jira Lines masu launin su bayyana.Fassara sakamakon gwajin a cikin mintuna 15.Kar a karanta sakamako bayan mintuna 20.

[FASARAR SAKAMAKO]
Tabbatacce: Layin sarrafawa kuma aƙalla layin gwaji ɗaya ya bayyana akan membrane.Bayyanar layin gwajin IgG yana nuna kasancewar Novel coronavirus takamaiman ƙwayoyin rigakafin IgG.Bayyanar layin gwajin IgM yana nuna kasancewar Novel coronavirus takamaiman ƙwayoyin rigakafin IgM.Kuma idan duka layin IgG da IgM sun bayyana, yana nuna cewa kasancewar duka Novel coronavirus takamaiman IgG da IgM rigakafi.
Korau: Layi mai launi ɗaya ya bayyana a cikin yankin sarrafawa (C) .Babu wani layi mai launi da ya bayyana a yankin layin gwaji.
Ba daidai ba: Layin sarrafawa ya kasa bayyana.Rashin isassun samfurin ƙira ko dabarun ƙa'ida ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafawa.Bita tsarin kuma maimaita gwajin tare da sabon kaset na gwaji.Idan matsalar ta ci gaba, daina amfani da kayan gwajin nan da nan kuma tuntuɓi mai rarrabawa na gida.

[KAMAKIYAR KYAUTA]
An haɗa tsarin sarrafawa a cikin gwajin.Layi mai launi da ke bayyana a cikin yankin sarrafawa (C) ana ɗaukar tsarin kulawa na ciki.Yana tabbatar da isassun ƙarar samfuri, isassun wicking membrane da ingantaccen dabarar tsari.
Ba a samar da matakan sarrafawa tare da wannan kit ɗin.Koyaya, ana ba da shawarar cewa a gwada ingantattun sarrafawa da mara kyau azaman kyakkyawan aikin dakin gwaje-gwaje don tabbatar da tsarin gwajin da kuma tabbatar da aikin gwajin da ya dace.

[LIMITATIONS]
An iyakance kaset gwajin gaggawa na AMRDT100 IgG/IgM don samar da gamo mai inganci.Ƙarfin layin gwajin ba lallai ba ne ya dace da tattarawar antibody a cikin jini.
Sakamakon da aka samu daga wannan gwajin ana nufin su zama taimako a cikin ganewar asali kawai.Dole ne kowane likita ya fassara sakamakon tare da tarihin mai haƙuri, binciken jiki, da sauran hanyoyin bincike.
Sakamakon gwaji mara kyau yana nuna cewa ƙwayoyin rigakafi ga Novel coronavirus ko dai ba sa nan ko kuma a matakan gwajin da ba a iya gano su ba.

[Halayen Aiki]
Daidaito
An gudanar da kwatancen gefe-gefe ta amfani da Novel coronavirus IgG/IgM Gwajin Sauri da babban PCR na kasuwanci.An ƙididdige samfurori 120 na asibiti daga wurin Ƙwararrun Ƙwararrun Kulawa.An tsara sakamako masu zuwa daga waɗannan binciken na asibiti:
An yi kwatancen ƙididdiga tsakanin sakamakon da ke haifar da azanci na 90.00%, ƙayyadaddun 97.78% da daidaito na 95.83%.
Rikici-Reactivity da Tsangwama
1.Wasu na kowa causative jamiái na cututtuka da aka kimanta domin giciye reactivity tare da gwajin.Wasu samfurori masu inganci na sauran cututtukan gama gari an zuga su cikin Novel coronavirus tabbatacce kuma samfuran marasa kyau kuma an gwada su daban.Ba a lura da aikin giciye tare da samfurori daga marasa lafiya da suka kamu da HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV da TP.
2. Yiwuwar abubuwan da ke haifar da haɓakawa da suka haɗa da abubuwan haɗin jini na gama gari, kamar su lipids, hemoglobin, bilirubin, an spiked a babban taro a cikin Novel coronavirus tabbatacce kuma munanan samfuran kuma an gwada su daban.Ba a ga sake kunnawa ko tsangwama ga na'urar ba.
3. Wasu sauran nazarce-nazarcen halittu na gama gari an zuga su cikin Novel coronavirus tabbatacce kuma samfuran marasa kyau kuma an gwada su daban.Ba a sami tsangwama mai mahimmanci ba a matakan da aka jera a teburin da ke ƙasa.

Maimaituwa
An yi karatun sake haifuwa don Novel coronavirus IgG/IgM Gwajin gaggawa a dakunan gwaje-gwajen ofisoshin likitoci uku (POL).Sittin (60) samfurori na asibiti, 20 korau, 20 tabbataccen iyaka da 20 tabbatacce, an yi amfani da su a cikin wannan binciken.An gudanar da kowane samfurin sau uku na kwanaki uku a kowane POL.Yarjejeniyar intra-assay sun kasance 100%.Yarjejeniyar tsakanin rukunin yanar gizon ta kasance 100%.

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