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AssigneeChiron Diagnostics Corporation
InventorsDeborah Lynn Parkes, Stephen Ralph Coates
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Disclosed are recombinant, synthetically and otherwise biologically produced novel proteins and polypeptides which are encoded by the DNA sequence for HSV-2 glycoprotein G (gG) or fragments of said gG sequence particularly by the unique sequence for gG or portions of said unique sequence. The unique sequence proteins and polypeptides are serologically active, can be produced easily and safely at low cost, are useful as diagnostic reagents for HSV-2 and as vaccines against HSV-2. Further disclosed are serological assays based on such unique sequence gG proteins and polypeptides that diagnose the presence of herpes simplex virus type 2 (HSV-2) specific antibodies and can differentiate between HSV-2 and herpes simplex virus type 1 (HSV-1) specific antibodies. Such assays are useful to diagnose genital infections, to detect for exposure to HSV-2 and to screen pregnant women to protect newborns from neonatal HSV-2 infection. Also disclosed are antibodies to such gG proteins and polypeptides which are useful therapeutically diagnostically and for affinity purification. Further, disclosed are purified and isolated DNA molecules which can be used as probes specific for HSV-2 DNA.
A method of testing human body fluids for the presence of HSV-2 type-specific antibodies which comprises contacting a composition containing a recombinantly produced nonglycosylated protein with a sample of a human body fluid and determining whether said nonglycosylated protein binds to HSV-2 antibodies in said sample, wherein said nonglycosylated protein is selected from the group consisting of an unique sequence HSV-2 gG protein which has the amino acid sequence from amino acid 16 to amino acid 462 as shown in FIG. 2;
A test kit for testing human body fluids for the presence of HSV-2 type-specific antibodies comprising
Dependencies are inferred from the claim text.