Kit xét nghiệm Kháng thển HCV

Kit xét nghiệm HCV Ab -Chẩn đoán bệnh Viêm gan siêu vi C

One Step Detection Kit for Hepatitis C Virus Antibody

Immuno HCV Rapid Test được dùng để phát hiện định tính kháng thể kháng HCV 

Hepatitis C virus now us recognized as a major agent of chronic hepatitis, transfusion-acquired non-A, non-B hepatitis and liver disease throughout the world. HCV is an enveloped positive-sense, single-stranded RNA virus. Clinical diagnostic issues related to HCV is the detection of HCV antibodies in human serum or plasma by immunoassay. We have constructed HCV genes for the expression of recombinant antigens in bacterium systems such as E.coli and focused on structural and non-structural regions of HCV encoded polyprotein, which are definitely immunogenic. The major immunoreactive antigens of these proteins have been reported as core, NS3, NS4 and NS5 regions of HCV genome, which are known to be highly immunodominant regions. For diagnosis of HCV infection, these recombinant proteins were used as capture materials of a immunochromatographic test. Compared to the first generation HCV test using single recombinant antigens, multiple antigens using recombinant proteins have been added in new serologic tests to avoid non-specific cross reactivity and to increase the sensitivity of the HCV antibody test. Immuno HCV is a immunochromatographic test for the qualitative detection of antibodies specific to HCV in human serum, plasma, and whole blood. The Immuno HCV kit contains a membrane strip, which is pre-coated with recombinant HCV capture antigens (core, NS3, NS4, NS5) in the test line (T). The protein A-colloid gold conjugate and specimen moves along the membrane chromatographically to the test region (T) and forms a visible line coming from the antigen-antibody-protein A colloid gold particle complex with high degree of sensitivity and specificity.

MATERIALS PROVIDED
1.      Test devices individually foil-pouched with a desiccant 2.      Disposable dropper 3.      Buffer Assay 4.      Instruction manual for use

TEST PROCEDURE

                                                                                    

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

Immuno HCV have tested with positive and negative clinical samples tested by confimatory assay using RT-PCR.

	n=2.305		Immuno HCV		Total Results
	RT-PCR		Positive	Negative
		Positive	234	2	236
		Negative	9	2,060	2,069
	Total Results		243	2,062	2,305

Immuno HCV rapid test showed 99.15% (234/236) in sensitivity and 99.56% (2,060/2,069) in specificity with clinical samples.

 

Immuno HCV			HCV
	Specimen	serum, plasma and whole blood
	Diagnostic target	HCV antibody
	Sensitivity	99.15%
	Specificity	99.56%

 

ORDERING INFORMATION

 

Product name	Cat. No	Type	Packing	Shelf Life
HCV Ab	HCV	Device	20test/box	24