Diagnostic Kit yeCardiac Troponin I(fluorescence immunochromatographic assay)
Yekushandisa in vitro diagnostic chete
Ndokumbira uverenge iyi pasuru isa nekungwarira usati washandisa uye kunyatsotevera mirairo.Kuvimbika kwemhedzisiro yeassay hakugone kuvimbiswa kana paine chero kutsauka kubva kune mirairo mune ino pasuru yekuisa.

ZVIRI KUSHANDISA
Diagnostic Kit yeCardiac Troponin I(fluorescence immunochromatographic assay) ndeye fluorescence immunochromatographic assay yehuwandu hwekuonekwa kweCardiac Troponin I (cTnI) muserum yemunhu kana plasma, inoshandiswa pakubatsira kuongororwa kweAMI (Acute Myocardial Infar).Yese yakanaka sampuli inofanirwa kusimbiswa nedzimwe nzira.Muedzo uyu wakaitirwa kushandiswa nenyanzvi dzezvehutano chete.

SUMMARY
cTnI mazinga akawedzera maawa akawanda mushure mekunge Myocardial infarction yakaitika, yakakwira pamaawa 12-16, uye yakaramba yakasimudzwa 4-9 mazuva mushure mokunge Myocardial infarction yaitika.Tsanangudzo yepasirese yeyechitatu myocardial infarction muna 2012: Iyo inosarudzika biomarker-cTn (I kana T), ine yakakwira myocardial tishu chaiyo uye yakakwirira yekiriniki yekunzwa.Shanduko muhuwandu hwecTn hwakakosha pakuongororwa kweAMI

ZVINOTAURWA ZVINOITA
Iyo membrane yechishandiso chekuyedza yakavharwa neanti cTnI antibody padunhu rekuyedza uye mbudzi anti tsuro IgG antibody padunhu rekutonga.Lable pad yakaputirwa nefluorescence yakanyorwa anti cTnI antibody uye tsuro IgG pamberi.Paunenge uchiyedza sampuli yakanaka, iyo cTnI antigen mumuenzaniso inosanganisa nefluorescence yakanyorwa anti cTnI antibody, uye inogadzira musanganiswa wekudzivirira muviri.Pasi pechiito che immunochromatography, iyo yakaoma kuyerera munzira yeanononzva bepa, apo yakaoma yakapfuura dunhu rekuyedzwa, yakasanganiswa ne anti cTnI coating antibody, inoumba nyowani yakaoma.cTnI nhanho inoenderana neiyo fluorescence chiratidzo, uye kuwanda kwecTnI. mumuenzaniso inogona kuonekwa ne fluorescence immunoassay assay.

REAGENTS NEZVINHU ZVINOPIWA

25T package zvikamu:
Kadhi rekuyedza rimwe nerimwe foil rakaiswa muhomwe ine desiccant 25T
Sample diluents 25T
Package isa 1

ZVINHU ZVINODIWA ASI ZVISINA KUPIWA
Sample yekuunganidza mudziyo, timer

SAMPLE KUCHENGA UYE KUCHENGA
1.Mienzaniso yakaedzwa inogona kuva serum, heparin anticoagulant plasma kana EDTA anticoagulant plasma.
2.According to standard techniques unganidza sampuli.Serum kana plasma sampuli inogona kuchengetwa firiji pa 2-8 ℃ kwemazuva 7 uye cryopreservation pazasi -15 ° C kwemwedzi mitanhatu.
3.Yese sampuli inodzivirira kutonhora-kunyungudika kutenderera.

ASAY PROCEDURE
Ndokumbira uverenge bhuku rekushandisa chekushandisa uye pasuru isa usati waedza.
1.Kuisa parutivi zvose reagents uye samples kune tembiricha yekamuri.
2.Vhura iyo Portable Immune Analyzer (WIZ-A101), isa iyo password password login maererano nenzira yekushanda yechiridzwa, uye pinda iyo yekuona interface.
3.Scan dentification code kuti usimbise chinhu chekuedza.
4.Bvisa kadhi rekuedza kubva mubhegi refoil.
5.Isai kadhi rekuedza mukadhi kadhi, tarisai QR code, uye sarudza chinhu chekuedza.
6.Wedzera 40μL serum kana plasma sampuli kuti sampuli diluent, uye sanganisa zvakanaka.
7.Wedzera 80μL sampuli mhinduro kuti uenzanise zvakanaka wekadhi.
8.Dzvanya bhatani re "standard test", mushure memaminitsi e15, chiridzwa chichangoona kadhi rekuedza, rinogona kuverenga migumisiro kubva pachiratidziro chechiridzwa chechiridzwa, uye nyora / kudhinda mhinduro dzekuedza.
9.Rejera kune rairo yePortable Immune Analyzer(WIZ-A101).

ZVINOTARISIRWA ZVINOKOSHA
cTnI <0.3ng/mL
Zvinokurudzirwa kuti murabhoritari yega yega imise zera rayo rakajairwa rinomiririra huwandu hwevarwere vayo.

TEST RESULTS UYE DUDZIRIRO
.Iyo data iri pamusoro apa imhedzisiro yecTnI reagent test, uye zvinokurudzirwa kuti laboratori yega yega inofanira kumisa huwandu hwe cTnI yekuona kukosha kwakakodzera kune vanhu munharaunda ino.Mibairo iri pamusoro ndeyekutarisa chete.
.Migumisiro yeiyi nzira inoshandiswa chete kune zvinyorwa zvinotaridzirwa zvakasimbiswa nenzira iyi, uye hapana kuenzaniswa kwakananga nedzimwe nzira.
.Zvimwe zvikonzero zvinogonawo kukonzera kukanganisa mumigumisiro yekuona, kusanganisira zvikonzero zvehutano, zvikanganiso zvekushanda uye zvimwe zvinhu zvemuenzaniso.

KUCHENGA UYE KUgadzikana
1.Ikiti ndeye 18 mwedzi pasherufu-hupenyu kubva pazuva rekugadzirwa.Chengetedza makiti asina kushandiswa pa2-30°C.MUSAIZE.Usashandise kupfuura zuva rekupera.
2.Usavhura homwe yakavharwa kusvika wagadzirira kuita bvunzo, uye bvunzo-yekushandisa imwe chete inokurudzirwa kushandiswa pasi penzvimbo inodiwa (tembiricha 2-35 ℃, humidity 40-90%) mukati me60 mins nekukurumidza. sezvinobvira.
3.Sample diluent inoshandiswa pakarepo mushure mekuvhurwa.

YAMBIRO UYE CHENJERERO
.Ikiti inofanira kuvharwa uye kuchengetedzwa kubva pakunyorova.
.Yese mienzaniso yakanaka ichasimbiswa nedzimwe nzira.
.Mienzaniso yese ichabatwa sezvingango svibisa.
.USA shandisa expired reagent.
.USACHINANA mareagents pakati pemakiti ane akawanda akawanda Nha.
.USAshandise zvakare makadhi ebvunzo uye chero zvinhu zvinoraswa.
.Misoperation, yakawandisa kana sampuli shoma inogona kutungamirira kumhedzisiro yekutsauka.

LIMITATION
.Sezvinoita chero muyedzo unoshandisa masoja ekudzivirira embeva, mukana uripo wekukanganiswa nemasoja ekudzivirira mbeva (HAMA) mumuenzaniso.Mienzaniso kubva kuvarwere vakagamuchira gadziriro dzemonoclonal antibodies yekuongorora kana kurapwa inogona kunge iine HAMA.Mienzaniso yakadaro inogona kukonzera nhema dzakanaka kana nhema dzisina kunaka.
.Iyi mhedzisiro yebvunzo ndeyekuongororwa kwekiriniki chete, haifanire kushanda seyo chete hwaro hwekuongororwa kwekiriniki uye kurapwa, varwere vekiriniki manejimendi vanofanirwa kutarisisa kwakadzama kusanganiswa nezviratidzo zvayo, nhoroondo yezvekurapa, imwe ongororo yerabhoritari, mhinduro yekurapa, epidemiology uye mamwe mashoko. .
.Iri reagent rinoshandiswa chete serum uye plasma tests.Iyo inogona kusawana mhedzisiro chaiyo kana ichishandiswa kune mamwe masampuli senge mate uye weti uye nezvimwe.

PERFORMANCE CHARACTERISTICS

REFERENCES

1.Hansen JH, et al.HAMA Kupindira neMurine Monoclonal Antibody-Based Immunoassays[J].J yeClin Immunoassay,1993,16:294-299.
2.Levinson SS.Mamiriro eHeterophilic Antibodies uye Basa muImmunoassay Interference[J].J yeClin Immunoassay,1992,15:108-114.

Kiyi yezviratidzo zvakashandiswa:

	In Vitro Diagnostic Medical Device
	Mugadziri
	Chengetedza pa2-30 ℃
	Zuva rekupera
	Usashandisezve
	KUCHENJERA
	Bvunza Mirayiridzo Yekushandisa

Xiamen Wiz Biotech CO., LTD
Kero:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China
Tel:+86-592-6808278
Fax:+86-592-6808279