HBsAg and HCV 2 in 1 Rapid Test

Intended Use

HBsAg and HCV 2 in 1 Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of anti-HCV antibodies and HBsAg, antibodies in human whole blood, serum or plasma specimens. HBsAg and HCV 2 in 1 Rapid Test is intended for use as an aid in the diagnosis of HCV and HBV infections.

Introduction

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibodies to HCV are found in over 80% of patients with well-documented non-A, non-B hepatitis[1,2]. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to first generation HCV EIAs using single recombinant antigens, new serologic tests include multiple antigens using recombinant protein and/or synthetic peptides to avoid nonspecific cross-reactivity and to increase sensitivity[3,4].

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in the lipid envelope of this small DNA virus. During the replicative phase of the virus, this surface antigen is produced in excess and is detectable in the blood of the infected. The incubation period of HBV is 6 weeks to 6 months[5].

HBV and HCV is a bloodborne virus transmitted through direct contact with the blood of an infected person.

Test Procedure

Interpretation 0f Results

	HCV+ HBsAg POSITIVE: one colored band appears in the control region (C), and two colored bands appear in both HCV and HBsAg region.
	HCV POSITIVE: one colored band appears in the control region (C), and one colored band appears in HCV region.
	HBsAg POSITIVE: one colored band appears in the control region (C), and one colored band appears in HBsAg region.
	Negative: one colored band appears in the control region (C). No line appears in HCV or HBsAg or HIV regions.
	INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

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