Nrog peb cov thev naus laus zis nyob rau tib lub sijhawm raws li peb lub siab ntawm kev tsim kho tshiab, kev sib koom tes, cov txiaj ntsig thiab kev txhim kho, peb yuav tsim kom muaj kev vam meej yav tom ntej nrog ib leeg nrog koj lub lag luam zoo rau Tuam Tshoj HCV Rapid Test Sawb / Cassette Enterprise Standard, Ua ib lub koom haum hluas nce, peb yuav tsis zoo tshaj plaws, tab sis peb tau sim peb qhov zoo tshaj plaws los ua koj tus khub zoo heev.
Nrog peb cov thev naus laus zis nyob rau tib lub sijhawm raws li peb lub siab ntawm kev tsim kho tshiab, kev sib koom tes, cov txiaj ntsig thiab kev txhim kho, peb tab tom tsim kom muaj kev vam meej yav tom ntej nrog ib leeg nrog koj lub tuam txhab hwm rauAnti-HCV-Ns, Suav Hepatitis C Virus, Peb ib txwm hais rau kev tswj hwm tenet ntawm "Zoo yog thawj zaug, Technology yog lub hauv paus, Honesty thiab Innovation".
Rau kev kuaj mob hauv vitro nkaus xwb

Thov nyeem cov pob no kom zoo ua ntej siv thiab ua raws li cov lus qhia nruj me ntsis. Kev ntseeg siab ntawm cov txiaj ntsig kev ntsuas tsis tuaj yeem lav tau yog tias muaj kev sib txawv ntawm cov lus qhia hauv pob no.

YUAV TSUM SIV

Diagnostic Kit for Hepatitis C Virus Antibody (Fluorescence Immunochromatographic Assay) yog ib qho tshuaj fluorescence immunochromatographic assay rau kev kuaj kom muaj nuj nqis ntawm HCV antibody hauv tib neeg cov ntshav los yog ntshav, uas yog ib qho tseem ceeb pab kuaj tus nqi rau kev kis kab mob siab C.Tag nrho cov qauv zoo yuav tsum tau lees paub. txheej txheem. Qhov kev sim no yog npaj rau kev siv kho mob nkaus xwb

1. Tso tag nrho cov reagents thiab cov qauv mus rau chav tsev kub.
2.Qhib lub Portable Immune Analyzer (WIZ-A101), nkag mus rau tus account password tus ID nkag mus raws li txoj kev ua haujlwm ntawm lub cuab yeej, thiab nkag mus rau qhov kev kuaj pom.
3.Scan lub dentification code kom paub meej tias cov khoom kuaj.
4. Tshem tawm daim ntawv xeem los ntawm lub hnab ntawv ci.
5.Insert daim npav xeem rau hauv daim npav, luam theej duab QR code, thiab txiav txim siab cov khoom xeem.
6.Ntxiv 20μL cov ntshav los yog cov ntshav plasma coj mus kuaj diluent, thiab sib tov zoo ..
7.Ntxiv 80μL cov qauv tshuaj rau cov qauv zoo ntawm daim npav.
8.Nias lub pob "standard test", tom qab 15 feeb, lub ntsuas yuav cia li ntes daim ntawv xeem, nws tuaj yeem nyeem cov txiaj ntsig ntawm lub vijtsam zaub ntawm lub ntsuas, thiab sau / luam cov txiaj ntsig kev xeem.
9.Saib cov lus qhia ntawm Portable Immune Analyzer (WIZ-A101).

TSEEM CEEB

Tus kab mob siab C (HCV) yog ib lub hnab ntawv, ib qho kev nkag siab zoo RNA (9.5 kb) tus kab mob uas yog tsev neeg ntawm Flaviviridae. Rau qhov loj genotypes thiab series ntawm subtypes ntawm HCV tau raug txheeb xyuas. Cais tawm xyoo 1989, HCV tam sim no tau lees paub tias yog qhov ua rau kev hloov pauv tsis yog-A, tsis-B kab mob siab. Tus kab mob yog tus yam ntxwv nrog mob thiab mob ntev. Ntau tshaj 50% ntawm cov neeg muaj tus kab mob no muaj mob hnyav, ua rau lub neej hem kab mob siab nrog rau daim siab cirrhosis thiab hepatocellular carcinomas. Txij li thaum cov kev taw qhia nyob rau hauv 1990 ntawm anti-HCV tshuaj ntsuam xyuas ntawm cov ntshav pub dawb, qhov tshwm sim ntawm tus kab mob no nyob rau hauv cov neeg tau txais kev txhaj tshuaj tau txo qis. Cov kev tshawb fawb soj ntsuam pom tau hais tias qhov tseem ceeb ntawm HCV cov neeg mob tsim cov tshuaj tiv thaiv rau NS5 cov protein uas tsis yog qauv ntawm tus kab mob. Rau qhov no, cov kev ntsuam xyuas muaj xws li antigens los ntawm NS5 cheeb tsam ntawm tus kab mob genome ntxiv rau NS3 (c200), NS4 (c200) thiab Core (c22).

TSEV KAWM NTAWV NO

Lub daim nyias nyias ntawm cov cuab yeej kuaj yog coated nrog HCV antigen ntawm thaj tsam kuaj thiab tshis anti luav IgG antibody ntawm thaj tsam tswj. Lable ncoo yog coated los ntawm fluorescence sau HCV antigen thiab luav IgG ua ntej. Thaum kuaj cov qauv zoo, HCV cov tshuaj tiv thaiv hauv cov qauv ua ke nrog cov tshuaj fluorescence sau tias HCV antigen, thiab tsim cov tshuaj tiv thaiv kab mob. Nyob rau hauv qhov kev txiav txim ntawm lub immunochromatography, complex ntws nyob rau hauv cov kev taw qhia ntawm absorbent daim ntawv, thaum complex dhau lub xeem cheeb tsam, nws ua ke nrog HCV antigen txheej antigen, cov ntaub ntawv tshiab complex.HCV antibody qib yog zoo correlated nrog fluorescence teeb liab, thiab cov concentration ntawm HCV antibody hauv cov qauv tuaj yeem kuaj pom los ntawm fluorescence immunoassay assay

REAGENTS THIAB KHOOM PLIG

25T pob khoom:
.Test card ib tus zuj zus daim ntawv ntim nrog lub desiccant
.Sample diluents
.Package insert

Cov khoom yuav tsum tau tab sis tsis muab
Sample ntim thawv, timer
SAMPLE COLLECTION THIAB STORAGE
1.Cov qauv kuaj tau tuaj yeem yog ntshav, heparin anticoagulant plasma lossis EDTA anticoagulant plasma.
2.Raws li cov txheej txheem txheej txheem sau cov qauv. Cov ntshav los yog cov ntshav ntshav tuaj yeem khaws cia hauv tub yees ntawm 2-8 ℃ rau 7 hnub thiab khaws cia hauv qab -15 ° C rau 6 lub hlis
3.Txhua tus qauv tsis txhob khov-thaw mus.

TSEEM CEEB
Thov nyeem phau ntawv ntsuas kev ua haujlwm thiab pob ntim ua ntej kuaj.
.Qhov kev ntsuam xyuas no tsuas yog siv rau kev soj ntsuam xwb, yuav tsum tsis txhob ua lub hauv paus rau kev kuaj mob thiab kev kho mob nkaus xwb, cov neeg mob kev tswj xyuas kev kho mob yuav tsum muaj kev txiav txim siab ua ke nrog nws cov tsos mob, keeb kwm kev kho mob, lwm yam kev kuaj mob, kev kho mob teb, kab mob sib kis thiab lwm yam ntaub ntawv. .
.Qhov reagent no tsuas yog siv rau kev kuaj ntshav thiab ntshav. Tej zaum nws yuav tsis tau txais txiaj ntsig zoo thaum siv rau lwm cov qauv xws li qaub ncaug thiab zis thiab lwm yam.

TXOJ CAI TSHIAB

REFERENCES
1.Post ntshav kab mob siab. In: Moore SB, ed. Transfusion-transmitted Viral Diseases. Alington, VA. Am. Assoc. Cov txhab nyiaj ntshav, p. 53-38.
2.Hansen JH, thiab al.HAMA cuam tshuam nrog Murine Monoclonal Antibody-Based Immunoassays[J].J ntawm Clin Immunoassay,1993,16:294-299.
3.Levinson SS.Qhov Xwm ntawm Heterophilic Antibodies thiab Lub Luag Haujlwm hauv Immunoassay Interference[J].J ntawm Clin Immunoassay,1992,15:108-114.
4.Alter HJ., Purcell RH, Holland PV, et al. (1978) Transmissible agent in non-A, non-B hepatitis. Ib: 459-463.
5.Choo QL, Weiner AJ, Overby LR, Kuo G, Houghton M. (1990) Kab mob siab C: tus kab mob loj tshaj plaws ntawm tus kab mob uas tsis yog-A, tsis-B kab mob siab. Br Med Bull 46: 423-441 .
6.Engvall E, Perlmann P. (1971) Enzyme linked immunosorbent assay (ELISA): Kev soj ntsuam zoo ntawm IgG. Immunochemistry 8: 871-874.

TXOJ CAI ZOO

HCV-Ab <0.02

Nws raug pom zoo tias txhua lub chaw kuaj mob tsim nws tus kheej ib txwm sawv cev rau nws cov neeg mob.

TEST RESULTS THIAB INTERPRETATION

• Cov ntaub ntawv saum toj no yog qhov tshwm sim ntawm HCV-Ab reagent test, thiab nws tau pom tias txhua lub chaw kuaj mob yuav tsum tsim kom muaj ntau yam ntawm HCV-Ab nrhiav kom tau qhov zoo rau cov pej xeem hauv cheeb tsam no. Cov txiaj ntsig saum toj no tsuas yog siv rau kev siv xwb.
• Cov txiaj ntsig ntawm txoj kev no tsuas yog siv tau rau cov kev siv ntau yam tsim los ntawm cov qauv no, thiab tsis muaj kev sib piv ncaj qha nrog lwm txoj hauv kev.
• Lwm yam tseem ceeb kuj tuaj yeem ua rau muaj qhov yuam kev hauv kev tshawb pom, suav nrog cov laj thawj kev, kev ua haujlwm tsis raug thiab lwm yam qauv.

KHOOM THIAB STABILITY

1. Cov khoom siv yog 18 lub hlis txee-lub neej txij li hnub tsim khoom. Khaws cov khoom siv tsis siv ntawm 2-30 ° C. TSIS PUB DAWB. Tsis txhob siv dhau hnub tas sij hawm.
2. Tsis txhob qhib lub hnab ntim kom txog thaum koj npaj txhij los ua qhov kev sim, thiab qhov kev sim siv ib zaug tau pom zoo kom siv nyob rau hauv ib puag ncig uas yuav tsum tau ua (kub 2-35 ℃, av noo 40-90%) hauv 60 mins kom sai li sai tau .
3. Sample diluent yog siv tam sim ntawd tom qab qhib.

CEEB TOOM THIAB KEV TIV THAIV
.Cov khoom siv yuav tsum tau muab kaw thiab tiv thaiv kom tsis txhob ya raws.
.Txhua cov qauv zoo yuav tsum raug lees paub los ntawm lwm cov txheej txheem.
.Tag nrho cov qauv yuav tsum raug kho raws li cov pa phem.
.Tsis txhob siv cov reagent tas sij hawm.
.TSIS TXHOB hloov cov tshuaj reagents ntawm cov khoom siv sib txawv No..
.Tsis txhob rov siv cov ntawv xeem thiab cov khoom siv pov tseg.
.Kev ua haujlwm tsis raug, ntau dhau los lossis me me tuaj yeem ua rau muaj qhov sib txawv.

LIMITATION
.Raws li nrog txhua qhov kev ntsuam xyuas uas siv cov tshuaj tiv thaiv nas, muaj peev xwm tshwm sim rau kev cuam tshuam los ntawm tib neeg cov tshuaj tiv thaiv nas (HAMA) hauv cov qauv. Cov qauv ntawm cov neeg mob uas tau txais kev npaj ntawm monoclonal antibodies rau kev kuaj mob lossis kev kho mob yuav muaj HAMA. Cov qauv zoo li no tuaj yeem ua rau cov txiaj ntsig tsis zoo lossis tsis muaj tseeb.
Ntsiab rau cov cim siv:

	Hauv Vitro Diagnostic Medical Device
	Chaw tsim tshuaj paus
	Khaws ntawm 2-30 ℃
	Hnub Kawg
	Tsis txhob rov siv dua
	CEEB TOOM
	Tshawb xyuas cov lus qhia rau kev siv