COVID-19 IgG/IgM Rapid Test Cassette

Don masu sana'a da kuma in vitro bincike kawai amfani.

AMFANI DA NUFIN

TheCOVID-19 IgG/IgM Rapid Test CassetteImmunoassay ne mai gudana na gefe wanda aka tsara don gano ingantattun ƙwayoyin rigakafin IgG da IgM ga ƙwayar cuta ta SARS-CoV-2 a cikin jini gabaɗaya, samfuran jini ko samfuran plasma daga waɗanda ake zargi da kamuwa da cutar COVID-19 ta hanyar mai ba da lafiyar su.

Gwajin gaggawa na CO VID-19 IgG/IgM taimako ne a cikin gano marasa lafiya da ake zargi da kamuwa da cutar SARS-CoV-2 tare da gabatarwar asibiti da sakamakon sauran gwaje-gwajen dakin gwaje-gwaje. An ba da shawarar yin amfani da azaman ƙarin nunin gwaji don shari'o'in da ake tuhuma tare da gwajin ƙwayar ƙwayar ƙwayar cuta na novel coronavirus ko amfani da shi tare da gwajin nucleic acid a cikin abubuwan da ake zargi. Ba za a yi amfani da sakamakon gwajin rigakafin ƙwayar cuta a matsayin tushen kawai don ganowa ko ware kamuwa da cutar SARS-CoV-2 ko sanar da matsayin kamuwa da cuta ba.

Sakamako mara kyau baya kawar da kamuwa da cutar ta SARS-CoV-2, musamman a cikin waɗanda suka yi hulɗa da sanannun mutanen da suka kamu da cutar ko kuma a wuraren da ke da yawan kamuwa da cuta. Ya kamata a yi la'akari da gwajin gwaji tare da binciken kwayoyin don kawar da kamuwa da cuta a cikin waɗannan mutane.

Kyakkyawan sakamako na iya kasancewa saboda kamuwa da cuta na baya ko na yanzu tare da nau'ikan coronavirus marasa SARS-CoV-2.

An yi nufin yin amfani da gwajin a dakunan gwaje-gwaje na asibiti ko kuma ta ma'aikatan kiwon lafiya a wurin kulawa, ba don amfanin gida ba. Kada a yi amfani da gwajin don tantance jinin da aka bayar.

TAKAITACCEN

Novel coronaviruses na cikin jinsin p.CUTAR COVID 19cuta ce mai saurin kamuwa da numfashi. Mutane gabaɗaya suna da sauƙi. A halin yanzu, marasa lafiya da suka kamu da cutar sankara ta coronavirus sune babban tushen kamuwa da cuta; allurar asymptomatic kuma na iya zama tushen kamuwa da cuta. Dangane da binciken cututtukan cututtuka na yanzu, lokacin shiryawa shine kwanaki 1 zuwa 14, galibi daga kwanaki 3 zuwa 7. Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari. Ana samun cunkoso na hanci, hanci, ciwon makogwaro, myalgia da gudawa a wasu lokuta.

Lokacin da kwayar cutar SARS-CoV2 ta cutar da kwayoyin halitta, RNA, kwayoyin halittar kwayar cutar, ita ce alamar farko da za a iya ganowa. Siffofin lodin hoto na SARS-CoV-2 yayi kama da na mura, wanda ke hauhawa a kusan lokacin bayyanar cututtuka, sannan ya fara raguwa. Tare da haɓaka yanayin cutar bayan kamuwa da cuta, tsarin garkuwar jikin ɗan adam zai samar da ƙwayoyin rigakafi, daga cikinsu IgM shine farkon rigakafin da jiki ke samarwa bayan kamuwa da cuta, wanda ke nuna babban lokacin kamuwa da cuta. Kwayoyin rigakafin IgG zuwa SARS-CoV2 sun zama abin ganowa daga baya bayan kamuwa da cuta. Kyakkyawan sakamako na duka IgG da IgM na iya faruwa bayan kamuwa da cuta kuma yana iya zama alamar kamuwa da cuta mai tsanani ko kwanan nan. IgG yana nuna ƙarshen lokacin kamuwa da cuta ko tarihin kamuwa da cuta da ya gabata.

Duk da haka, duka IgM da IgG suna da lokacin taga daga kamuwa da kwayar cutar zuwa samar da kwayoyin cuta, IgM kusan ya bayyana bayan bayyanar cututtuka da yawa kwanaki, don haka gano su sau da yawa yana bayan gano nucleic acid kuma ba shi da hankali fiye da gano nucleic acid. A cikin lokuta inda gwaje-gwajen haɓakar acid nucleic ba su da kyau kuma akwai ƙaƙƙarfan hanyar haɗin gwiwa zuwa kamuwa da cuta ta COVID-19, samfuran serum ɗin da aka haɗe (a cikin matsanancin lokaci da haɓaka) na iya tallafawa ganewar asali.

KA'IDA

COVID-19 IgG/IgM Rapid Test Cassette(WB/S/P) ingantaccen tsiri ne mai tushen immunoassay don gano ƙwayoyin rigakafi (IgG da IgM) zuwa Novel coronavirus a cikin Dukan Jini / Serum / Plasma. Kaset ɗin gwajin ya ƙunshi:1) wani kushin coiyugate mai launin burgundy mai ɗauke da Novel coronavirus recombinant envelope antigens coi^ugated with Colloid gold (Novel coronavirus c)两ugates), 2) nitrocellulose membrane tsiri mai dauke da layin gwaji guda biyu (Layin IgG da IgM) da layin sarrafawa (layin C). An riga an lulluɓe layin IgM tare da rigakafin Mouse anti-Human IgM, layin IgG yana da rufin linzamin kwamfuta anti-Human IgG antibody, lokacin da isasshen ƙarar ƙira don kada a bazu cikin rijiyar samfurin kaset ɗin gwaji. 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 coiyugates. 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 wanda yake gabatarwa a cikin samfurin zai ɗaure ga haɗin gwiwar Novel coronavirus. 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 a

mummunan sakamako. 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.

GARGADI DA TSIRA

• Don bincikar in vitro amfani kawai.
• Don ƙwararrun kiwon lafiya da ƙwararrun wuraren wuraren kulawa.

•Kada a yi amfani da bayan ranar karewa.

• da fatan za a karanta duk bayanan da ke cikin wannan takarda kafin yin gwajin. •Kaset ɗin gwajin ya kasance a cikin jakar da aka rufe har sai an yi amfani da shi.

Yakamata a yi la'akari da duk samfuran masu haɗari kuma a sarrafa su kamar yadda masu kamuwa da cuta suke.

•Ya kamata a yi watsi da kaset ɗin gwajin da aka yi amfani da shi bisa ga dokokin tarayya, jihohi da na gida.

KYAUTA

Gwajin yana ƙunshe da tsit ɗin membrane wanda aka lulluɓe da Mouse anti-Human IgM antibody da Mouse anti-Human IgG antibody akan

layin gwaji, da kushin rini wanda ke ƙunshe da gwal na colloidal haɗe da Novel corona virus recombinant antigen. An buga adadin gwaje-gwaje akan lakabin.

An Samar da Kayayyakin

• Gwajin kaset • Saka fakiti
• Buffer • Dropper
• Lancet

Kayayyakin da ake buƙata Amma Ba a Samar da su ba

• Kwandon tarin samfura • Mai ƙidayar lokaci

AJIYA DA KWANTA

• Ajiye kamar yadda Kunshe a cikin jakar da aka hatimi a zafin jiki (4-30″ Cor 40-86°F) Kit ɗin ya tsaya tsayin daka a cikin ranar karewa da aka buga akan lakabin.

•Da zarar an bude jakar, yakamata a yi amfani da mafi ƙarancin cikin sa'a ɗaya. Tsawaita bayyanawa ga yanayin zafi da ɗanɗano zai haifar da lalacewar samfur.

• An buga LOT da ranar karewa a kan alamar SPECIMEN

Za a iya amfani da gwajin don gwada samfuran Jini/Serum/Plasma gabaɗaya.

•Don tattara cikakken jini, jini ko samfuran plasma bin hanyoyin gwajin asibiti na yau da kullun.

•A ware ruwan magani ko plasma da jini da wuri-wuri don gujewa ciwon jini. Yi amfani da kawai bayyanannun samfuran marasa hemolyzed.

• Ajiye samfurori a 2-8 ° C (36-46T) idan ba a gwada su nan da nan ba. Ajiye samfurori a 2-8 ° C har zuwa kwanaki 7. Ya kamata a daskarar da samfuran a -20 ° C (-4°F) don dogon ajiya. Kada a daskare duka samfuran jini,

•A guji hawan daskarewa 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.

•Kada a yi amfani da samfuran da ke nuna babban lipemia babban hemolysis ko turbidity don guje wa tsangwama kan fassarar sakamako.

HANYAR GWADA

Bada na'urar gwaji da samfurori don daidaitawa zuwa zafin jiki (15-30 C ko 59-86 T) kafin gwaji.

1. Cire kaset ɗin gwajin daga jakar da aka hatimce.
2. Riƙe digo a tsaye kuma canja wurin digo 1 (kimanin 10 ul) na samfur zuwa cikin babban yankin samfurin da kyau(S) tabbatar da cewa babu kumfa mai iska. Don ingantacciyar madaidaici, canja wurin samfur ta pipette mai ikon isar da 10 ul na girma. Dubi hoton da ke ƙasa.
3. Sa'an nan, ƙara digo 2 (kimanin 70 ul) na buffer nan da nan a cikin samfurin rijiyar (S).
4. Fara mai ƙidayar lokaci.
5. don bayyana layukan launi. Fassara sakamakon gwajin a minti 15. Kar a karanta sakamako bayan mintuna 20.

Wuri don Samfura

(Hoton don tunani ne kawai, da fatan za a koma ga kayan abu.)

FASSARAR SAKAMAKO

maganin rigakafi. 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.

Mara kyau:Layi mai launi ɗaya yana bayyana a 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 dalilan fbr sarrafa gazawar. 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.

KYAUTATA 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.

IYAKA

• COVID-19 IgG/IgM Cassette Rapid Test Cassette (WB/S/P) an iyakance shi don samar da inganci

ganowa. 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 da gwajin ba a iya gano su ba.

HALAYEN YI

Daidaito

Taƙaitaccen bayanan CO VID-19 IgG/IgM Gwajin Saurin gaggawa kamar ƙasa

Game da gwajin IgG, mun ƙidaya ingantaccen adadin marasa lafiya 82 yayin lokacin kwanciyar hankali.

COVID-19 IgG:

Sakamakon yana haifar da hankali na 97.56%

Game da gwajin IgM, kwatancen sakamako zuwa RT-PCR.

COVID-19 IgM:

An yi kwatancen ƙididdiga tsakanin sakamakon da ke haifar da azanci na 88.61 %, ƙayyadaddun 97.67% da daidaito na 93.33%

Rikici-Reactivity da Tsangwama

1 .Sauran abubuwan da ke haifar da cututtuka na yau da kullum an kimanta su don giciye 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 cutar HIV,HA^ HBsAg, HCV TP, HTIA^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

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%.