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