Ikhithi yokuDinga iCardiac Troponin I (i-fluorescence immunochromatographic assay)
Ikhithi yokuxilonga yeCardiac Troponin I(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 for Cardiac Troponin I(fluorescence immunochromatographic assay) luvavanyo lwe-fluorescence immunochromatographic yokufumanisa ubungakanani beCardiac Troponin I (cTnI) kwiserum yomntu okanye kwiplasma, isetyenziselwa ukuxilongwa kwe-AMI (Acute Myocardial Infar). Zonke iisampuli ezilungileyo kufuneka ziqinisekiswe ngezinye iindlela. Olu vavanyo lwenzelwe ukusetyenziswa kweengcali zezempilo kuphela.
USHWANKATHELO
Amanqanaba e-cTnI anyuke kwiiyure ezininzi emva kokuba i-Myocardial infarction yenzeke, iphakamileyo kwiiyure ze-12-16, kwaye yahlala iphakamileyo kwiintsuku ze-4-9 emva kwe-Myocardial infarction. Inkcazo yehlabathi jikelele ye-myocardial infarction yesithathu ngo-2012: I-biomarker-cTn (I okanye i-T) ekhethiweyo ekhethiweyo, inomsebenzi ophezulu we-myocardial tissue kunye novelwano oluphezulu lwekliniki. Utshintsho kugxininiso lwe-cTn lubalulekile ekuxilongweni kwe-AMI
UMGAQO WENKQUBO
Inwebu yesixhobo sovavanyo igqunywe nge-anti-cTnI ye-antibody kwindawo yovavanyo kunye ne-antibody ye-IgG yebhokhwe kwindawo yolawulo. Iphedi elayibhile iqatywe nge-fluorescence ebhalwe anti cTnI antibody kunye nomvundla IgG kwangaphambili. Xa kuvavanywa isampulu eqinisekileyo, i-antigen ye-cTnI kwisampulu idibanisa ne-fluorescence ebhalwe i-anti-cTnI antibody, kwaye yenze umxube wokuzikhusela. Ngaphantsi kwesenzo se-immunochromatography, ukuhamba okuntsonkothileyo kwicala lephepha elifunxayo, xa intsonkothe iphumelele ummandla wovavanyo, idityaniswe ne-anti cTnI yokugquma i-antibody, yenza inqanaba elitsha elintsonkothileyo.cTnI linxibelelene kakuhle nesiginali ye-fluorescence, kunye noxinzelelo lwe-cTnI. kwisampulu inokubonwa ngovavanyo lwe-fluorescence immunoassay.
IIREGENTS KUNYE NEZINTO EZIBONISWAYO
Amacandelo ephakheji ye-25T:
Ikhadi lokuvavanya ifoyile nganye efakwe kwi-desiccant 25T
Isampulu yediluyinti 25T
Faka ipakethi 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
Nceda ufunde incwadi yokusebenza kwesixhobo kunye nokufakwa kwephakheji phambi kovavanyo.
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-40μL ye-serum okanye isampuli yeplasma kwisampulu ye-diluent, kwaye udibanise kakuhle.
7.Yongeza i-80μL yesisombululo sesampulu kwisampulu kakuhle yekhadi.
8.Cofa iqhosha elithi "standard test", emva kwemizuzu eyi-15, isixhobo siya kubona ngokuzenzekelayo ikhadi lovavanyo, sinokufunda iziphumo kwisikrini sokubonisa isixhobo, kwaye sirekhode / siprinte iziphumo zovavanyo.
9.Jonga kumyalelo we-Portable Immune Analyzer(WIZ-A101).
IINDLELA EZILINDELEKILEYO
cTnI <0.3ng/mL
Kucetyiswa ukuba ilabhoratri nganye iseke uluhlu lwayo oluqhelekileyo olumele izigulane zayo.
IZIPHUMO ZOMVAVANYO KUNYE UTOLIKO
.Le datha ingentla sisiphumo sovavanyo lwe-reagent ye-cTnI, kwaye kucetyiswa ukuba ilabhoratri nganye kufuneka iseke uluhlu lwamaxabiso okubona i-cTnI alungele abemi kulo mmandla. Ezi ziphumo zingentla zezereferensi kuphela.
.Iziphumo zale ndlela zisebenza kuphela kuluhlu lwereferensi olusekwe kule ndlela, kwaye akukho kuthelekiswa ngokuthe ngqo kunye 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 ukutshintshanisa iirejenti phakathi kweekhithi ezineqashiso ezahlukeneyo No..
.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 | 0.1ng/mL ukuya ku-40ng/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 |
sTnI | 1000μg/L | |
cTnT | 1000μg/L | |
ABP | 1000μg/L | |
CK-MB | 1000μg/L | |
cTnC | 1000μg/L | |
I-sTnT | 1000μg/L | |
MYO | 1000μg/L |
RIMIZEKELO
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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