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 kolu fakelo lwephakheji.

UKUSETYENZISWA OKUHLOSIWEYO

Diagnostic Kit for Hepatitis C Virus Antibody (Fluorescence Immunochromatographic Assay) luvavanyo lwe-fluorescence immunochromatographic ukwenzela ubhaqo lwe-antibody ye-HCV kwi-serum yabantu okanye i-plasma, eyona nto ibalulekileyo kwixabiso elincedisayo lokuxilonga usulelo lwe-hepatitis C. Zonke iisampuli ezilungileyo kufuneka ziqinisekiswe ngamanye iindlela.Olu vavanyo lwenzelwe ukusetyenziswa kweengcali zezempilo kuphela

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-20μL ye-serum okanye isampuli yeplasma kwisampulu ye-diluent, kwaye udibanise kakuhle.
7.Yongeza i-80μL yesisombululo sesampulu kwisampulu kakuhle yekhadi.
8.Klikha 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).

USHWANKATHELO

Intsholongwane yeHepatitis C (HCV) yimvulophu, intsholongwane ye-RNA (9.5 kb) engumtya omnye ophuma kusapho lweFlaviviridae.Ii-genotypes ezintandathu eziphambili kunye noluhlu lwee-subtypes ze-HCV ziye zachongwa.Ibekwe yodwa ngo-1989, i-HCV ngoku iqondwa njengoyena nobangela wotofelo-gazi olunxulumene no-non-A, non-B hepatitis.Esi sifo sibonakaliswe ngefom ebukhali kwaye engapheliyo.Ngaphezu kwe-50% yabantu abosulelekileyo bakhula kakhulu, i-hepatitis engapheliyo esongela ubomi kunye ne-cirrhosis yesibindi kunye ne-hepatocellular carcinomas.Ukususela ngowe-1990 kwaqaliswa ukuhlolwa kwe-anti-HCV ekunikeleni ngegazi, iziganeko zolu sulelo kubantu abatofelwa igazi ziye zancitshiswa kakhulu.Uphononongo lwezonyango lubonisa ukuba isixa esibalulekileyo sabantu abosulelwe yi-HCV baphuhlisa izilwa-buhlungu ukuya kwi-NS5 engeyiyo iprotein yentsholongwane.Kule nto, iimvavanyo zibandakanya ii-antigens ezivela kummandla we-NS5 we-genome yentsholongwane ngaphezu kwe-NS3 (c200), i-NS4 (c200) kunye ne-Core (c22).

UMGAQO WENKQUBO

Inwebu yesixhobo sovavanyo igqunywe nge-antigen ye-HCV kwindawo yovavanyo kunye ne-antibody ye-IgG yebhokhwe kwindawo yolawulo.Iphedi elayibhile iqatywe nge-fluorescence ebhalwe i-HCV antigen kunye ne-Rabbit IgG kwangaphambili.Xa uvavanya isampulu eqinisekileyo, i-antibody ye-HCV kwisampulu idibanisa ne-fluorescence ebhalwe i-antigen ye-HCV, kwaye yenze umxube wokuzivikela komzimba.Phantsi kwesenzo se-immunochromatography, ukuhamba okuntsonkothileyo kwicala lephepha elifunxayo, xa intsonkothe ​​iphumelele ummandla wovavanyo, idityaniswe ne-HCV antigen coating antigen, yenza inqanaba elitsha le-antibody. I-antibody ye-HCV kwisampulu inokufunyanwa ngovavanyo lwe-fluorescence immunoassay

IIREGENTS KUNYE NEZINTO EZIBONISWAYO

Amacandelo ephakheji ye-25T:
.Ikhadi lovavanyo lwefoyile nganye efakwe kwi-desiccant
.Iisampulu zokuthambisa
.Fakela ipakethe

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 yeplasma 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.
.Esi siphumo sovavanyo kuphela kwireferensi yeklinikhi, akufanele isebenze njengesiseko kuphela sokuxilongwa kweklinikhi kunye nonyango, izigulane zolawulo lwezonyango kufuneka ziqwalaselwe ngokubanzi kunye neempawu zayo, imbali yezonyango, 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

IZIQINISEKISO
1.Post utofelo-hepatitis.Kwi: Moore SB, ed.Utofelo-gazi lweZifo zeNtsholongwane.Alington, VA.Am.Assoc.Iibhanki Zegazi, iphepha 53-38.
2.Hansen JH, et al.HAMA Ukuphazamiseka kunye ne-Murine Monoclonal Antibody-Based Immunoassays [J] .J ye-Clin Immunoassay, 1993, 16: 294-299.
3.Levinson SS. Ubume be-Heterophilic Antibodies kunye nendima kwi-Immunoassay Interference [J].J ye-Clin Immunoassay, i-1992, 15: 108-114.
4.Alter HJ., Purcell RH, Holland PV, et al.(1978) I-arhente ehambisayo kwi-non-A, i-hepatitis engeyiyo ye-B.ILancet I: 459-463.
I-5.Choo QL, i-Weiner AJ, i-Overby LR, i-Kuo G, i-Houghton M. (1990) i-Hepatitis C Virus: eyona nto ibangela i-viral non-A, i-hepatitis engeyiyo ye-B.Br Med Bull 46: 423-441.
6.Engvall E, Perlmann P. (1971) I-Enzyme edibeneyo yokuvavanya i-immunosorbent (ELISA): uvavanyo olusemgangathweni lwe-IgG.Immunochemistry 8: 871-874.

IINDLELA EZILINDELEKILEYO

HCV-Ab <0.02

Kucetyiswa ukuba ilabhoratri nganye iseke uluhlu lwayo oluqhelekileyo olumele izigulane zayo.

IZIPHUMO ZOMVAVANYO KUNYE UTOLIKO

• Le datha ingasentla sisiphumo sovavanyo lwe-HCV-Ab reagent, kwaye kucetyiswa ukuba ilabhoratri nganye kufuneka iseke uluhlu lwamaxabiso okubona i-HCV-Ab 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. .
3. Isampuli yokuxutywa isetyenziswa ngoko nangoko emva kokuvulwa.

IZILUMKISO NEMIGAQO
.Ikhithi kufuneka itywinwe kwaye ikhuselwe kumswakama.
.Yonke imizekelo emihle iya kuqinisekiswa ngezinye iindlela.
.Yonke imizekelo iya kuphathwa njengento enongcoliseko.
.SUKUSEBENZISA i-reagent ephelelwe lixesha.
.UNGAtshintshi ii-reagents phakathi kweekhithi ezineNombolo eyahlukileyo.
.MUSA ukuphinda usebenzise amakhadi ovavanyo kunye naziphi na izincedisi ezilahlwayo.
.Ukusetyenziswa kakubi, iisampulu egqithisileyo okanye encinci inokukhokelela ekuphambukeni kweziphumo.

LUKUXELELA
.Njengalo naluphi na uvavanyo olusebenzisa izilwa-buhlungu zegundane, kunokwenzeka ukuba kubekho uphazamiseko lwe-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.
Isitshixo kwiisimboli ezisetyenzisiweyo:

	In Vitro Diagnostic Medical Isixhobo
	Umenzi
	Gcina kwi-2-30 ℃
	Umhla WOKUPHELELWA
	Musa Ukuphinda Usebenzise
	ISILUMKO
	Qhagamshelana neMiyalelo yokuSetyenziswa