Ukusetshenziswa kwe-in vitro diagnostic kuphela

Sicela ufunde le phakheji ngokucophelela ngaphambi kokuyisebenzisa futhi ulandele ngokuqinile imiyalelo.Ukuthembeka kwemiphumela yokuhlolwa akunakuqinisekiswa uma kukhona ukuchezuka emiyalweni ekule kokufakwa kwephakheji.

UKUSETSHENZISWA OKUHLOSIWE

Ikhithi Yokuhlola I-Hepatitis C Virus Antibody (i-Fluorescence Immunochromatographic Assay) iwukuhlola kwe-fluorescence immunochromatographic ukuze kutholwe inani le-antibody ye-HCV ku-serum yomuntu noma ku-plasma, okubalulekile ukuxilonga okuwusizo ekuthelelekeni ngesifo sokusha kwesibindi kohlobo C. Wonke amasampula amahle kufanele aqinisekiswe ngamanye izindlela.Lokhu kuhlolwa kuhloselwe ukusetshenziswa ngochwepheshe bezempilo kuphela

1.Beka eceleni wonke ama-reagents namasampuli ekamelweni lokushisa.
2.Vula i-Portable Immune Analyzer(WIZ-A101), faka ukungena ngemvume kwephasiwedi ye-akhawunti ngokwendlela yokusebenza yethuluzi, bese ufaka isixhumi esibonakalayo sokubona.
3.Skena ikhodi yokuhlonza ukuze uqinisekise into yokuhlola.
4.Khipha ikhadi lokuhlola esikhwameni se-foil.
5.Faka ikhadi lokuhlola endaweni yekhadi, skena ikhodi ye-QR, bese unquma into yokuhlola.
6.Engeza i-serum engu-20μL noma isampula ye-plasma ukuze uyisampula ye-diluent, bese uxuba kahle.
7.Engeza isisombululo sesampula esingu-80μL ukuze uthole isampula yomthombo wekhadi.
8.Chofoza inkinobho ethi "standard test", ngemva kwemizuzu engu-15, ithuluzi lizothola ngokuzenzakalelayo ikhadi lokuhlola, lingakwazi ukufunda imiphumela esikrinini sokubonisa sensimbi, futhi lirekhode / liphrinte imiphumela yokuhlolwa.
9.Bheka umyalelo we-Portable Immune Analyzer(WIZ-A101).

ISIFINYEZO

I-Hepatitis C virus (HCV) iyimvilophu, igciwane le-RNA (9.5 kb) elilodwa elixhumekile eliyingxenye yomndeni wakwaFlaviviridae.Izinhlobo ze-genotype eziyisithupha ezinkulu kanye nochungechunge lwezinhlobo ezincane ze-HCV zihlonziwe.Ikhishwe yodwa ngo-1989, i-HCV manje iqashelwa njengembangela eyinhloko yokumpontshelwa okuhlobene ne-non-A, non-B hepatitis.Lesi sifo sibonakala ngefomu elibukhali nelingapheli.Bangaphezu kuka-50% abantu abangenwe yileli gciwane abanesifo sokusha kwesibindi esiyingozi esiyingozi esiyingozi esihambisana ne-cirrhosis yesibindi kanye ne-hepatocellular carcinoma.Kusukela ngo-1990 kwethulwa ukuhlolwa kwe-anti-HCV ekunikeleni ngegazi, izehlakalo zalokhu kutheleleka kwabamukela ukumpontshelwa ziye zehla kakhulu.Ucwaningo lwezokwelapha lukhombisa ukuthi inani elibalulekile labantu abangenwe yi-HCV bakha amasosha omzimba ku-NS5 amaprotheni angewona wesakhiwo wegciwane.Kulokhu, ukuhlola kufaka ama-antigens asuka esifundeni se-NS5 se-viral genome ngaphezu kwe-NS3 (c200), NS4 (c200) kanye ne-Core (c22).

ISIMISO SENKQUBO

I-membrane yedivayisi yokuhlola ihlanganiswe ne-HCV antigen endaweni yokuhlola kanye ne-anti-rabbit IgG ye-antibody yembuzi endaweni yokulawula.Iphedi elinelebula limbozwe nge-fluorescence ebhalwe ukuthi i-HCV antigen kanye ne-rabbit IgG kusengaphambili.Lapho kuhlolwa isampula elihle, i-antibody ye-HCV kusampula ihlangana ne-fluorescence enelebuli ye-HCV antigen, bese yakhe ingxube yokuzivikela komzimba.Ngaphansi kwesenzo se-immunochromatography, ukugeleza okuyinkimbinkimbi kubheke ephepheni elimuncayo, lapho inkimbinkimbi idlula indawo yokuhlola, ihlanganiswe ne-HCV antigen coating antigen, yakha i-complex entsha. I-antibody ye-HCV kusampula ingatholwa ngokuhlolwa kwe-fluorescence immunoassay

AMA-REAGENTS KANYE NEZINTO EZINIKEZELWAYO

25T izingxenye zephakheji:
.Ikhadi lokuhlola i-foil ngayinye efakwe esikhwameni se-desiccant
.Izihlanjululi zesampula
.Faka iphakheji

IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE
Isitsha seqoqo lesampula, isibali sikhathi
UKUQOQWA KANYE NESIGCINISO ESAMPULA
1.Amasampula ahloliwe angaba i-serum, i-heparin anticoagulant plasma noma i-EDTA anticoagulant plasma.
2.Ngokwezinqubo ezijwayelekile qoqa isampula.I-Serum noma isampula ye-plasma ingagcinwa efrijini ku-2-8 ℃ izinsuku ezingu-7 kanye nokugcinwa kwe-cryopreservation ngaphansi -15 ° C izinyanga ezingu-6
3.Wonke amasampula agwema imijikelezo yokuncibilika kweqhwa.

INQUBO YOKUHLOLA
Sicela ufunde imanuwali yokusebenza kwezinsimbi kanye nokufakwa kwephakheji ngaphambi kokuhlola.
.Lo mphumela wokuhlolwa ngowenkomba yomtholampilo kuphela, akufanele usebenze njengesisekelo sokuxilongwa nokwelashwa kweziguli kuphela, ukuphathwa komtholampilo kweziguli kufanele kucatshangelwe ngokugcwele kuhlanganiswe nezimpawu zayo, umlando wezokwelapha, okunye ukuhlolwa kwaselabhorethri, impendulo yokwelashwa, i-epidemiology kanye nolunye ulwazi. .
.Lesi siphehli sisetshenziswa kuphela ekuhlolweni kwe-serum ne-plasma.Ingase ingatholi umphumela onembile uma isetshenziselwa amanye amasampula afana namathe nomchamo nokunye.

IZIMPAWU ZOKUSEBENZA

IZIKHOMBISI
1.Post transfusion hepatitis.Ku: Moore SB, ed.Izifo Ezibangelwa Amagciwane Ezithathelwana Ngegazi.Alington, VA.Am.I-Assoc.I-Blood Banks, amakhasi 53-38.
2.Hansen JH,et al.HAMA Ukuphazamisa Nge-Murine Monoclonal Antibody-Based Immunoassays[J].J ye-Clin Immunoassay,1993,16:294-299.
3.Levinson SS.Imvelo Yama-Heterophilic Antibodies kanye Neqhaza Ekuphazamisekeni Kwe-Immunoassay[J].J ye-Clin Immunoassay,1992,15:108-114.
4.Alter HJ., Purcell RH, Holland PV, et al.(1978) I-ejenti edluliselwayo ku-non-A, non-B hepatitis.I-Lancet I: 459-463.
5.Choo QL,Weiner AJ, Overby LR, Kuo G, Houghton M. (1990) I-Hepatitis C Virus: i-agent enkulu eyimbangela ye-viral non-A, non-B hepatitis.Br Med Bull 46: 423-441.
6.Engvall E, Perlmann P. (1971) I-Enzyme ihlotshaniswa ne-immunosorbent assay (ELISA):i-qualitative assay ye-IgG.I-Immunochemistry 8: 871-874.

IZIMALI EZILINDELEKILE

I-HCV-Ab<0.02

Kutuswa ukuthi ilabhorethri ngayinye isungule ububanzi bayo obujwayelekile obumelela isiguli sayo.

IMIPHUMELA YESIVIVINYO NOKUTOLIZWA

• Idatha engenhla ingumphumela wokuhlolwa kwe-HCV-Ab reagent, futhi kuphakanyiswa ukuthi ilabhorethri ngayinye kufanele isungule uhla lwamanani okutholwa kwe-HCV-Ab afanele abantu bakulesi sifunda.Imiphumela engenhla ingeyereferensi kuphela.
• Imiphumela yale ndlela isebenza kuphela kububanzi bereferensi obusungulwe kule ndlela, futhi akukho ukuqhathanisa okuqondile nezinye izindlela.
• Ezinye izici zingabangela amaphutha emiphumeleni yokuthola, okuhlanganisa izizathu zobuchwepheshe, amaphutha okusebenza nezinye izici zesampula.

ISITOREJI NOKUZInza

1. Ikhithi iyisikhathi seshelufu sezinyanga eziyi-18 kusukela ngosuku lokukhiqizwa kwayo.Gcina amakhithi angasetshenzisiwe ku-2-30°C.UNGAQISHI.Ungasebenzisi ngale kosuku lokuphelelwa yisikhathi.
2. Ungavuli isikhwama esivaliwe kuze kube yilapho usulungele ukwenza isivivinyo, futhi ukuhlola ukusetshenziswa kanye kuyaphakanyiswa ukuthi kusetshenziswe ngaphansi kwendawo edingekayo (izinga lokushisa elingu-2-35℃, umswakama 40-90%) phakathi kwemizuzu engama-60 ngokushesha okukhulu. .
3. I-diluent eyisampula isetshenziswa ngokushesha ngemva kokuvulwa.

IZIXWAYISO NEZIQINISEKISO
.Ikhithi kufanele ivalwe futhi ivikelwe kumswakama.
.Zonke izibonelo ezinhle zizoqinisekiswa ngezinye izindlela.
.Zonke izibonelo kufanele zithathwe njengezingcolisa.
.UNGAsebenzisi i-reagent ephelelwe yisikhathi.
.UNGAshintshi ama-reagents phakathi kwamakhithi anendawo ehlukile No..
.UNGAWASENZI futhi amakhadi okuhlola nanoma yiziphi izisekeli ezilahlwayo.
.Ukusebenzisa kabi, isampula eyeqile noma encane ingaholela ekuphambukeni kwemiphumela.

LUKULINGISA
.Njenganoma yikuphi ukuhlola okusebenzisa amasosha omzimba egundane, kungenzeka ukuthi kuphazamiseke amasosha omzimba alwa namagundane (HAMA) esibonelweni.Izibonelo zeziguli ezithole amalungiselelo e-monoclonal antibodies ukuze zixilongwe noma zelashwe zingaqukatha i-HAMA.Izibonelo ezinjalo zingadala imiphumela engemihle noma engemihle engamanga.
Ukhiye wezimpawu ezisetshenzisiwe:

	In Vitro Diagnostic Medical Device
	Umkhiqizi
	Gcina ku-2-30 ℃
	Usuku lokuphelelwa isikhathi
	Ungaphinde Usebenzise
	ISEXWAYISO
	Bheka Imiyalo Yokusetshenziswa