Ikhithi yokuxilonga yeTestosterone (i-fluorescence immunochromatographic assay)
Diagnostic Kit for Testosterone(uvavanyo lwe-fluorescence immunochromatographic)
Ukusetyenziswa kwe-in vitro diagnostic kuphela
Nceda ufunde le phakheji ifake ngononophelo phambi kokuba uyisebenzise kwaye ulandele ngokungqongqo imiyalelo. Ukuthembeka kweziphumo zovavanyo akunakuqinisekiswa ukuba kukho nakuphi na ukutenxa kwimiyalelo ekweli phakheji.
UKUSETYENZISWA OKUHLOSIWEYO
I-Diagnostic Kit ye-Testosterone (i-fluorescence immunochromatographic assay) yi-fluorescence immunochromatographic assay yokufumanisa ubuninzi be-Testosterone (T) kwi-serum yabantu okanye i-plasma, esetyenziselwa ukuvavanya amanqanaba e-Testosterone. kufuneka ziqinisekiswe ngezinye iindlela. Olu vavanyo lwenzelwe ukusetyenziswa kweengcali zezempilo kuphela.
USHWANKATHELO
I-Testosterone (T), enesisindo se-molecular ye-288.4 D. Kwinkqubo yokujikeleza, malunga ne-97% ukuya kwi-99% ye-testosterone ibophelela kwiiprotheni ze-plasma. Phakathi kwabo, i-60% ye-testosterone egazini ibophelelwe kwi-hormone yesini ebopha i-globulin ( SHBG), i-38% ibotshelelwe kwi-albumin, kwaye i-2% isimahla. I-testosterone ebophelelayo egazini ayisebenzi ngokwebhayoloji, kwaye kuphela i-testosterone yasimahla inokungena kwiiseli zerake ukuze yenze iziphumo zayo zomzimba.
UMGAQO WENKQUBO
I-membrane yesixhobo sokuvavanya ifakwe kwi-conjugate ye-BSA kunye ne-Testosterone kummandla wovavanyo kunye nebhokhwe yokulwa nomvundla we-IgG kwingingqi yokulawula. Iphedi yokumakisha iqatywe nge-fluorescence uphawu lwe-anti-Testosterone antibody kunye nomvundla we-IgG kwangaphambili. Xa kuvavanywa isampulu, i-Testosterone kwisampulu idibanisa kunye ne-fluorescence ephawulwe nge-anti-Testosterone antibody, kwaye yenze umxube wokugonyeka. Ngaphantsi kwesenzo se-immunochromatography, ukuhamba okuyinkimbinkimbi kwindlela yephepha elithathayo, xa i-complex idlulisa ummandla wokuvavanya, I-marker ye-fluorescent yamahhala iya kudibaniswa ne-Testosterone kwi-membrane. Uxinzelelo lwe-Testosterone kwisampulu lunokubonwa ngovavanyo lwe-fluorescence immunoassay.
IIREGENTS KUNYE NEZINTO EZIBONISWAYO
Amacandelo ephakheji ye-25T:
.Ikhadi lovavanyo lwefoyile nganye efakwe kwi-desiccant 25T
.Isisombululo 25T
.B isisombululo 1
.Fakela ipakethe 1
IZINTO EZIFUNEKAYO KODWA AKUNIKEZWA
Isampulu yokuqokelela isitya,ixesha
UKUQOKELELWA KWEsampuli NOKUGCINWA
1.Iisampulu ezivavanyiweyo zingaba serum, i-heparin anticoagulant plasma okanye i-EDTA anticoagulant plasma.
2.Ngokungqinelana neendlela eziqhelekileyo zokuqokelela isampuli. I-Serum okanye isampuli ye-plasma inokugcinwa efrijini kwi-2-8 ℃ ye-7days kunye ne-cryopreservation engaphantsi kwe-15 ° C kwiinyanga ezi-6.
3.Zonke iisampulu ziphephe imijikelo yokunyibilika komkhenkce.
INKQUBO YOVAVANYO
Inkqubo yovavanyo yesixhobo bona incwadana ye-immunoanalyzer. Inkqubo yovavanyo lwe-reagent ngolu hlobo lulandelayo
I-1.Lay eceleni zonke ii-reagents kunye neesampuli kwiqondo lokushisa.
2.Vula i-Portable Immune Analyzer (WIZ-A101), faka igama lokungena kwi-akhawunti ngokwendlela yokusebenza yesixhobo, kwaye ungenise ujongano lokubona.
3.Skena ikhowudi yokuchaza ukuze uqinisekise into yovavanyo.
4.Khupha ikhadi lovavanyo kwibhegi yefoyile.
5.Faka ikhadi lovavanyo kwi-slot yekhadi, scan ikhowudi ye-QR, kwaye unqume into yovavanyo.
6.Yongeza i-30μL serum okanye isampuli yeplasma kwisisombululo, kwaye udibanise kakuhle.
7.Yongeza isisombululo se-20μL B kumxube ongentla, kwaye udibanise kakuhle.
8.Shiya umxube imizuzu engama-20.
9.Yongeza i-80μL umxube kwisampulu yequla lekhadi.
10.Cofa iqhosha elithi “standard test”,emva kwemizuzu eli-10, isixhobo siya kubona ngokuzenzekelayo ikhadi lovavanyo, siyakwazi ukufunda iziphumo kwiscreen sokubonisa sesixhobo, kwaye sirekhode/siprinte iziphumo zovavanyo.
11.Jonga kumyalelo we-Portable Immune Analyzer (WIZ-A101).
IINDLELA EZILINDELEKILEYO
Uluhlu oluqhelekileyo lweTestosterone: Indoda: 2.5-10.5ng / mL
Owasetyhini: 0.25-1.0ng/mL
Kucetyiswa ukuba ilabhoratri nganye iseke uluhlu lwayo oluqhelekileyo olumele izigulane zayo.
IZIPHUMO ZOMVAVANYO KUNYE UTOLIKO
.Le datha ingentla lithuba lereferensi elisekwe kwidatha yobhaqo yale khithi, kwaye kucetyiswa ukuba ilabhoratri nganye kufuneka iseke isithuba sesalathiso sokubaluleka kwezonyango olufanelekileyo lwabemi kulo mmandla.
.Uxinzelelo lwe-Testosterone luphezulu kunoluhlu lwereferensi, kwaye utshintsho lwe-physiological okanye impendulo yoxinzelelo kufuneka lungabandakanyi.Ngokuqinisekileyo engaqhelekanga, kufuneka idibanise ukuxilongwa kweempawu zeklinikhi.
.Iziphumo zale ndlela zisebenza kuphela kuluhlu lwereferensi olusekwe yile ndlela, kwaye iziphumo azifani ngokuthe ngqo nezinye iindlela.
.Ezinye izinto zinokubangela iimpazamo kwiziphumo zokubona, kubandakanywa nezizathu zobugcisa, iimpazamo zokusebenza kunye nezinye izinto zesampulu.
UKUGCINWA NOZINZI
1.Ikhithi ziinyanga ezili-18 zobomi beshelufa ukusukela kumhla wokwenziwa. Gcina iikhithi ezingasetyenziswanga kwi-2-30°C. MUSA UKUMKHENZA. Musa ukusebenzisa ngaphaya komhla wokuphelelwa.
2.Musa ukuvula isingxobo esitywiniweyo de ube ulungele ukwenza uvavanyo, kwaye uvavanyo lokusetyenziswa olunye lucetyiswa ukuba lusetyenziswe phantsi kwendawo efunekayo (iqondo lobushushu 2-35℃, ukufuma 40-90%) ngaphakathi kwemizuzu engama-60 ngokukhawuleza. kangangoko kunokwenzeka.
I-3.I-diluent yesampuli isetyenziswa ngokukhawuleza emva kokuvulwa.
IZILUMKISO NEMIGAQO
.Ikhithi kufuneka itywinwe kwaye ikhuselwe kumswakama.
.Yonke imizekelo emihle iya kuqinisekiswa ngezinye iindlela.
.Yonke imizekelo iya kuphathwa njengongcoliseko olunokubakho.
.USUKU sebenzisa i-reagent ephelelwe lixesha.
. MUSA ukutshintshiselana ngeerejenti phakathi kweekhithi ezinenombolo eyahlukileyo.
.USUKU phinda usebenzise amakhadi ovavanyo kunye naziphi na izincedisi ezilahlwayo.
.I-Misoperation, isampuli eninzi okanye encinci inokukhokelela ekuphambukeni kweziphumo.
LUKUXELELA
.Njengalo naluphi na uvavanyo olusebenzisa izilwa-buhlungu zegundane, kunokwenzeka ukuba kukho ukuphazanyiswa yi-anti-mouse antibodies (HAMA) kwi-specimen. Iisampulu ezisuka kwizigulane ezifumene amalungiselelo ee-antibodies ze-monoclonal zokuxilongwa okanye unyango zingaquka i-HAMA. Imizekelo enjalo inokubangela ubuxoki okanye iziphumo ezingalunganga.
.Esi siphumo sovavanyo kuphela kwireferensi yeklinikhi, akufanele sisebenze njengesiseko kuphela sokuxilongwa kweklinikhi kunye nonyango, izigulane zolawulo lwezonyango kufuneka ziqwalaselwe ngokubanzi kunye neempawu zayo, imbali yonyango, ezinye iimviwo zebhubhoratri, impendulo yonyango, i-epidemiology kunye nolunye ulwazi. .
.Le reagent isetyenziselwa kuphela iimvavanyo ze-serum kunye ne-plasma. Isenokungafumani ziphumo zichanekileyo xa isetyenziselwa ezinye iisampulu ezinje ngamathe nomchamo, njl.
IIMPAWU ZOKUSEBENZA
Umgca | I-0.5 ng / mL ukuya kwi-20 ng / mL | ukutenxa okuhambelanayo: -15% ukuya +15%. |
Umgca wolungelelwaniso i-coefficient:(r)≥0.9900 | ||
Ukuchaneka | Izinga lokubuyisela liya kuba phakathi kwe-85% - 115%. | |
Ukuphindaphinda | CV≤15% | |
Ukuchaza ngokuthe ngqo(Akukho nanye kwizinto ezivavanyiweyo eziye zaphazamisa kuvavanyo) | Ungenelelo | Ukugxininiswa kokuphazamiseka |
E2 | 500ng/mL | |
INKQUBO | 500ng/mL | |
Kor | 500ng/mL | |
E3 | 100ng/mL | |
17β-E2 | 100ng/mL |
IZIQINISEKISO
1.Hansen JH, et al.HAMA Ukuphazamiseka kunye ne-Murine Monoclonal Antibody-Based Immunoassays [J] .J ye-Clin Immunoassay, 1993, 16: 294-299.
2.Levinson SS.Ubume be-Heterophilic Antibodies kunye nendima kwi-Immunoassay Interference[J].J ye-Clin Immunoassay,1992,15:108-114.
Isitshixo kwiisimboli ezisetyenzisiweyo:
In Vitro Diagnostic Medical Isixhobo | |
Umenzi | |
Gcina kwi-2-30 ℃ | |
Umhla WOKUPHELELWA | |
Musa Ukuphinda Usebenzise | |
ISILUMKO | |
Qhagamshelana neMiyalelo yokuSetyenziswa |
Xiamen Wiz Biotech CO.,LTD
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