Methods and reagents for zika virus immunoassays
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsSai Patibandla, Krishna Singh
Life of this patent
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Abstract
Disclosed herein are immunoassay methods and reagents for detecting anti-Zika IgM antibody in a biological sample from a subject and/or diagnosing Zika virus infection in a subject. Also disclosed are algorithms for implementing the disclosed methods. The disclosed immunoassay methods, reagents, and algorithms enable efficient and reliable qualitative detection of anti-Zika virus antibodies and rapid determination of presumptive positive results for Zika virus infection in human subjects.
Claims36
A method of detecting an anti-Zika virus IgM antibody in a biological sample from a human subject, the method comprising a first immunoassay and, optionally, a second immunoassay, wherein the first immunoassay comprises:
- a) incubating the biological sample with
- an anti-human IgG Fc antibody,
- a labeled Zika virus antigen, and
- a solid support comprising an anti-human IgM antibody,
- wherein, in the presence of an anti-Zika virus IgG antibody, an anti-Zika virus IgM antibody, or an anti-Zika virus IgG antibody and an anti-Zika virus IgM antibody in the biological sample, a complex I is formed, the complex I comprising (i) the anti-Zika virus IgG antibody, the anti-Zika virus IgM antibody, or the anti-Zika virus IgG antibody and the anti-Zika virus IgM antibody, (ii) the labeled Zika virus antigen, and (iii) the solid support comprising the anti-human IgM antibody;
- and
- b) detecting the complex I, the presence of which indicates the presence of the anti-Zika virus IgM antibody, the anti-Zika virus IgG antibody, or the anti-Zika virus IgG antibody and the anti-Zika virus IgM antibody in the biological sample, and if the complex I is detected, performing the second immunoassay, comprising:
- c) incubating the biological sample with
- a solid support comprising an anti-human IgM antibody, and
- a labeled Zika virus antigen,
- wherein, in the presence of an anti-Zika virus IgM antibody in the biological sample, a complex II is formed, the complex II comprising (i) the solid support comprising the anti-human IgM antibody, (ii) the anti-Zika virus IgM antibody, and (iii) the labeled Zika virus antigen;
- and
- d) detecting the complex II, the presence of which indicates the presence of the anti-Zika virus IgM antibody in the biological sample.
A method of detecting antibodies to Zika virus in a human subject, the method comprising performing a first immunoassay comprising:
- a) incubating a biological sample from the subject with:
- a solid support comprising an anti-human IgM antibody,
- an anti-human IgG Fc antibody, and
- a labeled Zika virus antigen,
- wherein, in the presence of an anti-Zika virus IgG antibody, an anti-Zika virus IgM antibody, or an anti-Zika virus IgG antibody and an anti-Zika virus IgM antibody in the biological sample, a complex I is formed, the complex I comprising (i) the solid support comprising the anti-human IgM antibody, (ii) the anti-Zika virus IgG antibody, the anti-Zika virus IgM antibody, or the anti-Zika virus IgG antibody and the anti-Zika virus IgM antibody, and (iii) the labeled Zika virus antigen;
- b) detecting the complex I, and
- bi) if the complex I is not detected, determining that the subject is negative for antibodies to Zika virus;
- or
- bii) if the complex I is detected, determining that the subject is positive for anti-Zika virus antibodies.
A kit comprising:
- a solid support,
- an anti-human IgM antibody,
- an anti-human IgG Fc antibody, and
- a labeled Zika virus antigen.
A kit comprising reagents for a first immunoassay and reagents for a second immunoassay,
- wherein the reagents for the first immunoassay comprise:
- a solid support,
- an anti-human IgM antibody,
- an anti-human IgG Fc antibody, and
- a labeled Zika virus antigen;
- and
- wherein the reagents for the second immunoassay comprise:
- a solid support,
- an anti-human IgM antibody, and
- a labeled Zika virus antigen.
Dependencies are inferred from the claim text.