Diagnostic Kit yeAlpha-fetoprotein (fluorescence immunochromatographic assay)
Diagnostic Kit yeAlpha-fetoprotein(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 yeAlpha-fetoprotein (fluorescence immunochromatographic assay) ndeye fluorescence immunochromatographic assay yehuwandu hwekuonekwa kweAlpha-fetoprotein (AFP) muserum yevanhu kana plasma, iyo inonyanya kushandiswa kubatsiridza kuongororwa, kurapa mhedzisiro uye prognosis yekutanga hepatocellular carcinoma. Yese yakanaka sampuli inofanirwa kusimbiswa nedzimwe nzira. Muedzo uyu wakaitirwa kushandiswa nenyanzvi dzezvehutano chete.
SUMMARY
Alpha-fetoprotein (AFP) ndechimwe chezvinonyanya kushandiswa zviratidzo zvebundu.Iglycoprotein ine huremu hwe70,000 uye shuga inosvika 4%.Inonyanya kugadzirwa nechiropa che "fetus",chizotevera yolk sac.Fetus yakatanga kugadzirwa Masvondo matanhatu, kusvika panhongonya yemavhiki gumi nemaviri kusvika gumi nemashanu, serum concentration ye1 kusvika 3 g/L, uye ruvhuvhu ropa pakuzvarwa 10 kusvika 100 mg/L; makore 1 kusvika 2 mushure mekuzvarwa kusvika padanho revakuru; Kubata pamuviri kwakajairika kunogona kusvika. 90 kusvika 500 ng/mL pakati;Zvakajairwa serum yemunhu AFP zviri pakati pe2 ne8 ng/mL,asi zvirwere zvakawanda, kunyanya hepatitis, zvinokanganisa kukosha kweAFP.
ZVINOTAURWA ZVINOITA
Iyo membrane yechishandiso chekuyedza yakavharwa neanti AFP antibody padunhu rekuyedza uye mbudzi anti tsuro IgG antibody panzvimbo yekutonga. Lable pad yakaputirwa nefluorescence yakanyorwa anti AFP antibody uye tsuro IgG pamberi. Paunenge uchiyedza sampuli yakanaka, iyo AFP antigen mumuenzaniso inosanganisa nefluorescence yakanyorwa anti AFP antibody, uye gadzira musanganiswa wekudzivirira muviri. Pasi pechiito che immunochromatography, iyo yakaoma inoyerera munzira yeinonyudza bepa, apo yakaoma yakapfuura dunhu rekuyedzwa, yakasanganiswa neAFP coating antibody, inoumba nyowani yakaoma. mumuenzaniso inogona kuonekwa ne fluorescence immunoassay assay.
REAGENTS NEZVINHU ZVINOPIWA
25T package zvikamu:
.Kuedza kadhi rimwe nerimwe foil yakaiswa 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 yekadhi, tarisai QR code, uye sarudza chinhu chekuedza.
6.Wedzera 20μL serum kana plasma sampuli kuti sampuli diluent, uye sanganisa zvakanaka.
7.Wedzera 80μL sampuli mhinduro kuti uenzanise zvakanaka wekadhi.
8.Click "standard test" bhatani, mushure memaminitsi e15, chiridzwa chichangoona kadhi rekuedza, rinogona kuverenga migumisiro kubva pachiratidziro chechiratidzo chechiridzwa, uye nyora / kudhinda mhinduro dzekuedza.
9.Rejera kune rairo yePortable Immune Analyzer(WIZ-A101).
ZVINOTARISIRWA ZVINOKOSHA
AFP: <10ng/mL
Zvinokurudzirwa kuti murabhoritari yega yega imise zera rayo rakajairwa rinomiririra huwandu hwevarwere vayo.
TEST RESULTS UYE DUDZIRIRO
.Iyo data iri pamusoro apa mhedzisiro yeAFP reagent test, uye zvinokurudzirwa kuti laboratori yega yega inofanira kumisa huwandu hweAFP yekuona maitiro akakodzera 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 KUTSIGIRA
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.
. HASI kuchinjana mareagents pakati pekiti ane akasiyana lot 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 yekurapa, 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
Linearity | 1ng/mL kusvika 1000ng/mL | hama kutsauka: -15% kusvika +15%. |
Linear coefficient yekubatanidza:(r)≥0.9900 | ||
Kururama | Chiyero chekudzorera chichave mukati me85% - 115%. | |
Kudzokorora | CV≤15% | |
Kunyatsojeka (Hapana chimwe chezvinhu pane chinopindira chakaedzwa chakakanganisa muyedzo) | Kupindira | Kuvhiringidza kuisa pfungwa |
Acetaminophen | 1500μg/mL | |
Acetylsalicylic acid | 10mg/mL | |
CEA | 500μg/mL | |
Hemoglobin | 200μg/mL | |
transferrin | 100μg/mL | |
Horse radish peroxidase | 2000μg/mL | |
LH | 200mIU/mL | |
FSH | 200mIU/mL | |
HCG | 20000mIU/mL | |
TSH | 200μIU/mL | |
BSA | 5mg/mL | |
Vinblastine | 500μg/mL | |
Cisplatin | 1000μg/mL | |
Azathioprine | 30mg/L | |
Bleomycin | 100μU/mL |
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