Herpes simplex virus diagnostics
AssigneeChiron Corporation
InventorsRae Lyn Burke, D'Anna Alexander
Life of this patent
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Abstract
Novel methods and immunodiagnostic test kits for diagnosing herpes simplex virus (HSV) infection are disclosed. The methods and kits employ both type-specific and type-common antigens, in a single-step assay format, to provide for highly accurate results. The methods discriminate between HSV-1 and HSV-2 infection so that an accurate diagnosis can be performed.
Claims46
A method of detecting the presence of antibodies to herpes simplex virus (HSV) comprising:
- (a) providing a biological sample from a human suspected of containing antibodies to HSV type 1 (HSV-1) and/or HSV type 2 (HSV-2);
- (b) contacting said biological sample with one or more purified type-specific HSV-1 polypeptides bound to a solid support, one or more purified type specific HSV-2 polypeptides bound to a solid support, and one or more purified type-common HSV polypeptides bound to a solid support, under conditions which allow HSV antibodies, when present in the biological sample, to bind to said type-specific and/or said type-common polypeptides;
- and
- (c) detecting the presence or absence of bound antibodies from step (b) as an indication of the presence or absence of HSV, wherein said detecting is done using one or more detectably labeled anti-human immunoglobulin antibodies.
A method for distinguishing between herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in a human serum sample suspected of containing antibodies to HSV-1 and/or HSV-2, said method comprising:
- (a) immobilizing one or more purified type-specific HSV-1 polypeptides, one or more purified type-specific HSV-2 polypeptides and one or more purified type-common HSV polypeptides in discrete positions on a nitrocellulose strip, wherein said one or more purified type-specific HSV-1 polypeptides are selected from the group consisting of an HSV-1 glycoprotein G (gG1) polypeptide and a type-specific epitope of HSV-1 glycoprotein B (gB1) comprising an amino acid sequence corresponding to amino acids 1-47 of HSV gB1, numbered with reference to the mature gB1 molecule, and further wherein said one or more purified type-specific HSV-2 polypeptides comprise a type-specific HSV-2 glycoprotein G (gG2) polypeptide;
- (b) contacting said nitrocellulose strip from step (a) with said human serum sample under conditions which allow anti-HSV-1 and anti-HSV-2 antibodies, when present in the biological sample, to bind to said type-specific and/or said type-common HSV polypeptides;
- (c) contacting a detectably labeled anti-human immunoglobulin antibody with bound antibodies of step (b) to form labeled antibody/anti-human immunoglobulin antibody complexes;
- and
- (d) detecting the labeled complexes of step (c),
- thereby distinguishing between HSV-1 and HSV-2 in said biological sample.
An immunodiagnostic test kit for detecting herpes simplex virus (HSV) antibodies in a human serum sample, said test kit comprising one or more purified type-specific HSV type 1 (HSV-1) polypeptides bound to a solid support wherein said one or more purified type-specific HSV-1 polypeptides are selected from the group consisting of an HSV-1 glycoprotein G (gG1) polypeptide and a type-specific epitope of HSV-1 glycoprotein B (gB1) comprising an amino acid sequence corresponding to amino acids 1-47 of HSV gB1, numbered with reference to the mature gB1 molecule, a purified type-specific HSV type 2 (HSV-2) polypeptide bound to a solid support wherein said purified type-specific HSV-2 polypeptide is an HSV-2 glycoprotein G (gG2) polypeptide, and one or more purified type-common HSV polypeptides bound to a solid support, and instructions for conducting the immunodiagnostic test.
Dependencies are inferred from the claim text.