Claims for Patent: 5,721,095

Summary for Patent: 5,721,095

Title:	HIV-1/HIV-2 viral detection kit and method
Abstract:	A method for producing an improved solid phase antigenic reagent useful in an immunoassay for detecting antibodies specific for a virus, such as the human immunodeficiency virus, is disclosed which comprising the addition to a natural viral lysate a synthetic or recombinant viral protein or peptide. Also provided is an improved immunoassay utilizing the solid phase antigenic reagent.
Inventor(s):	Chan; Lily (Singapore, SG), Sum; Yoke Wah (Jurong Town, SG), Yin; May Fong (Singapore, SG), Lim; Lee Fang (Singapore, SG)
Assignee:	Genelabs Diagnostics Pte Ltd. (Singapore, SG)
Application Number:	08/486,837
Patent Claims:	1. A method for detecting HIV infection in a human blood sample, comprising adding the sample to a solid phase support having bound thereto (i) electrophoretically separated HIV-1 viral lysate proteins, (ii) an HIV-2-specific peptide antigen having the sequence LNSWGCAFRQVCHTTVPW, and (iii) a human immunoglobulin capture reagent; detecting the pattern of binding of serum antibodies in said sample to said HIV-1 proteins and to said HIV-2 antigen; and determining from said pattern, the presence in the serum sample of (i) HIV-1 infection, (ii) HIV-2 infection, (iii) lack of HIV infection, or (iv) indeterminate HIV-cross-reactivity. 2. The method of claim 1, wherein said human immunoglobulin capture reagent is anti-human immunoglobulin G (IgG) antibody. 3. The method of claim 1, which further includes, bound to the solid support, a synthetic HIV-1-specific viral envelope protein-derived antigen, said detecting of said pattern of binding further includes detection of binding to said HIV-1 specific antigen, and said determining further includes confirming the presence of HIV-1 infection in a weakly HIV-1 immunoreactive serum sample. 4. An immunoassay for detecting HIV infection in a human blood sample, comprising a solid phase support having bound thereto (i) electrophoretically separated HIV-1 viral lysate proteins, (ii) an HIV-2-specific peptide antigen having the sequence LNSWGCAFRQVCHTTVPW, and (iii) a human immunoglobulin capture reagent; and means for detecting the pattern of binding of serum antibodies in said sample to said HIV-1 proteins and to said HIV-2 antigen; wherein from said pattern, the presence in the serum sample of (i) HIV-1 infection, (ii) HIV-2 infection, (iii) lack of HIV infection, or (iv) indeterminate HIV-cross-reactivity is determined. 5. The immunoassay of claim 4, wherein said anti-human immunoglobulin capture reagent is anti-human immunoglobulin G (IgG) antibody. 6. The immunoassay of claim 4, which further includes, bound to the solid support, a synthetic HIV-1-specific viral envelope protein-derived antigen, said means for detecting means for detection of binding to said HIV-1 specific antigen, and from said pattern is further confirmed the presence of HIV-1 infection in a weakly HIV-1 immunoreactive serum sample.

Details for Patent 5,721,095

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2015-02-24
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2015-02-24
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2015-02-24