Kit xét nghiệm kháng nguyên HBs Ag- HBsAg Test Kit

Kit xét nghiệm kháng nguyên HBs Ag Chẩn đoán bệnh Viêm gan B Immuno HBV Rapid Test được dùng để phát hiện định tính kháng nguyên virus viêm gan B Heppatitis B

Immuno HBsAg is a chromatographic immunoassay kit for rapid and qualitative detection of Hepatitis B virus surface antigen (HBsAg) from human serum or plasma. A nitrocellulose membrane is immobilized with mouse monoclonal antibody against HBsAg. Another anti-HBsAg -monoclonal antibody is conjugated to colloidal gold particles. This conjugate is placed on a polyester pad or glass fiber pad as conjugate pad. This test is aimed to the detection of Hepatitis B virus antigen in human serum or plasma. When the specimen is dropped into device, the solubilized conjugate migrates with the sample by passive diffusion and both the conjugate and sample come into contact with the anti-HBsAg antibody that it immobilized onto the nitrocellulose membrane. The result is visible after 10~15 minutes in the form of a red line that develops on the strip. The solution continues to migrate to encounter a control reagent that binds a control conjugate, thereby producing a second red line

MATERIALS PROVIDED
1.      Test devices individually foil-pouched with a desiccant 2.      Instruction manual for use

 

TEST PROCEDURE

 

   PERFORMANCE CHARACTERISTICS

1) Sensitivity and Specificity

Immuno HBsAg has tested with positive and negative clinical samples tested by confimatory assay using PCR.

	Reference		Immuno HBsAg		Total Results
			Positive	Negative
	PCR	Positive	597	0	597
		Negative	0	602	602
	Total Results		597	602	1199

Immuno HBsAg showed >99.9% (597/597) in sensitivity and >99.9% (602/602) in specificity with clinical samples.

2) Precision

(1)        Within run, precision was determined by using 10 replicates of four different specimens containing different concentrations of antibody. The negative and positive values were correctly identified 100% of the time.

(2)        Between run, precision was determined by using the four different specimens containing different concentrations of antibody in 3 different replicates with 3 different lots of test devices. Again negative and positive results were observed 100% of the time.

 

Immuno HBsAg			HBsAg
	Specimen	serum, plasma and whole blood
	Diagnostic target	HBV antibody
	Sensitivity	99.9%
	Specificity	99.9%

 

ORDERING INFORMATION

 

Product name	Cat. No	Type	Packing	Shelf Life
HBsV Ag	HBsAg	Device/Strip	20test/box	24
HbsV Ab	HbsAb	Device/Strip	20test/box	24
HbeV Ag	HbeAg	Device/Strip	20test/box	24
HbeV Ab	HbeAb	Device/Strip	20test/box	24
HBcV Ab	HBcAb	Device/Strip	20test/box	24

Liên hệ : P. Kinh doanh 0902505589

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

Kit xét nghiệm HIV type 1 và type 2 - HIV1/2 3.0 Test Kit

Kit xét nghiệm HIV type 1 và type 2 - HIV1/2 3.0 Test Kit

Immuno HIV1/2 3.0 is a chromatographic immunoassay kit for rapid and qualitative detection of all antibodies (IgG, IgM, IgA) against HIV1 and HIV2 simultaneously, in serum, plasma, and whole blood from human. The nitrocellulose membrane of Immuno is immobilized with HIV1 antigens (p24+gp41) in test line 1 region, with HIV2 antigen (gp36) in test line 2 region, and with rabbit anti-mouse antibodies in the control line. And also, the recombinant HIV antigens (p24+gp41+gp36) are conjugated to the colloidal gold particles. This conjugate is placed on a polyester or glass pad as conjugate pad. When the sample is dropped into the sample well on the device, the solubilized conjugate migrates with the sample by passive diffusion and both the conjugate and sample come into contract with the recombinant antigens that immobilized onto the nitrocellulose. If the sample contains antibodies against HIV1 or HIV2, the result is visible as red line within 20 minutes in the test line 1 or test line 2  on the membrane, respectively. The solution continues to migrate to encounter a control reagent that binds a control conjugate, thereby producing another red  line

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 OF THE TEST

.

Reference		Immuno HIV1/2 3.0		Total Result
Method	Result	Positive	Negative
Commercial Confirm Mehtod	Positive	570	0	570
	Negative	5	2010	2015
Total Result		575	2010	2085

Immuno HIV1/2 3.0			HIV1/2 3.0
	Specimen	serum, plasma and whole blood
	Diagnostic target	HIV1/2 antibody
	Sensitivity	99.90%
	Specificity	95.00%

 

ORDERING INFORMATION

 

Product name	Cat. No	Type	Packing	Shelf Life
HIV1/2 3.0	HIV	Device	20test/box	24

           

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