Diagnostic Kit yeTesttosterone (fluorescence immunochromatographic assay)
Diagnostic Kit yeTesttosterone(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 yeTesttosterone (fluorescence immunochromatographic assay) inonzi fluorescence immunochromatographic assay ye quantitative yekuona Testosterone (T) mu serum yevanhu kana plasma, iyo inonyanya kushandiswa kuongorora mazinga e Testosterone.Iyo inobatsira kuongororwa reagent.All positive samples inofanira kusimbiswa nedzimwe nzira. Muedzo uyu wakaitirwa kushandiswa nenyanzvi dzezvehutano chete.
SUMMARY
Testosterone (T), iyo ine molecular uremu hwe288.4 D. Muchirongwa chekutenderera, inenge 97% kusvika 99% ye testosterone inosunga kumapuroteni eplasma. Pakati pavo, 60% ye testosterone muropa inosungirirwa kuhomoni yepabonde inosunga globulin ( SHBG), 38% inosungirirwa kualbumin, uye 2% ndeyemahara. Testosterone inosunga muropa haina biologically inoshanda, uye chete testosterone yemahara inogona kupinda mumareki maseru kuti iite maitiro ayo emuviri.
ZVINOTAURWA ZVINOITA
Iyo membrane yechishandiso chekuyedza yakavharwa neiyo conjugate yeBSA neTestosterone padunhu rebvunzo uye mbudzi anti tsuro IgG antibody padunhu rekutonga. Marker pad akaputirwa nefluorescence mark anti Testosterone antibody uye tsuro IgG pamberi. Paunenge uchiyedza sampuli, Testosterone mumuenzaniso inosanganisa nefluorescence yakanyorwa anti Testosterone antibody, uye gadzira musanganiswa wekudzivirira muviri. Pasi pechiito che immunochromatography, iyo yakaoma inoyerera ikananga kune pepa rinopinza, apo yakaoma yakapfuura dunhu rekuedzwa, Iyo yakasununguka fluorescent marker ichabatanidzwa neTesttosterone pa membrane.Kusangana kweTesttosterone kunokanganisa kwakashata kwechiratidzo chefluorescence, uye iyo Kusangana kweTesttosterone mumuenzaniso kunogona kuonekwa ne fluorescence immunoassay assay.
REAGENTS NEZVINHU ZVINOPIWA
25T package zvikamu:
.Kuedza kadhi rimwe nerimwe foil yakaiswa muhomwe ine desiccant 25T
.A mhinduro 25T
.B mhinduro 1
.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
Maitiro ekuyedza echiridzwa ona iyo immunoanalyzer bhuku. Iyo reagent test maitiro ndeaya anotevera
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 30μL serum kana plasma sampuli kuA solution, uye sangana zvakanaka.
7.Wedzera 20μL B mhinduro kumusanganiswa wepamusoro, uye sanganisa zvakanaka.
8.Siya musanganiswa kwemaminitsi makumi maviri.
9.Wedzera 80μL musanganiswa kuti uenzanise zvakanaka wekadhi.
10.Dzvanya bhatani rekuti "standard test", mushure memaminitsi gumi, chiridzwa chinozongoona kadhi rebvunzo, chinogona kuverenga zvabuda kubva pachiratidziro chechiridzwa, uye kurekodha / kudhinda mhinduro dzebvunzo.
11.Tarira kurairo yePortable Immune Analyzer(WIZ-A101).
ZVINOTARISIRWA ZVINOKOSHA
Testosterone yakajairika: Murume: 2.5-10.5ng/mL
Mukadzi: 0.25-1.0ng/mL
Zvinokurudzirwa kuti murabhoritari yega yega imise zera rayo rakajairwa rinomiririra huwandu hwevarwere vayo.
TEST RESULTS UYE DUDZIRIRO
.Iyo data iri pamusoro apa inguva yereferensi yakagadzwa ye data yekuona yekiti iyi, uye zvinokurudzirwa kuti laboratori yega yega inofanira kumisa nguva yereferensi yezvakakoshesesa zvekiriniki zvehuwandu hwevanhu munharaunda ino.
.Kuwanda kweTesttosterone kwakakwirira kudarika mutsara wekutsvaga, uye kuchinja kwehupenyu kana kushushikana kwepfungwa kunofanira kubviswa.Izvo zvisingawanzoitiki, zvinofanira kusanganisa kuongororwa kwechirwere chechirwere.
.Migumisiro yeiyi nzira inongoshanda kune mutsara wekutsvaga wakagadzwa nenzira iyi, uye zvigumisiro hazvifananidzi zvakananga 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 akasiyana lot no..
.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 | 0.5 ng/mL kusvika 20 ng/mL | hama kutsauka: -15% kusvika +15%. |
Linear coefficient yekubatanidza:(r)≥0.9900 | ||
Kururama | Chiyero chekudzorera chichave mukati me85% - 115%. | |
Kudzokorora | CV≤15% | |
Zvakananga(Hapana chimwe chezvinhu pane chakakanganiswa chakaedzwa chakakanganisa muyedzo) | Kupindira | Kuvhiringidza kuisa pfungwa |
E2 | 500ng/mL | |
PROG | 500ng/mL | |
VaK | 500ng/mL | |
E3 | 100ng/mL | |
17β-E2 | 100ng/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