Patent ID: 11959917
Assignee: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Field: Measurement (Instruments)
Classification: CPC G  Y | IPC G

Claim 25:
26. A method of detecting antibodies to Zika virus in a human subject, the method comprising performing a first immunoassay comprising:
a) incubating a first biological sample from the subject with:
a buffer comprising an anti-human IgG Fc antibody and a solid support comprising an anti-human IgM antibody,
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 presence of complex I, and
performing a second immunoassay comprising:
c) incubating a second biological sample from the subject with:
a solid support comprising an anti-human IgM antibody, and
a labeled Zika virus antigen,

wherein anti-human IgG Fc antibody is absent from the second immunoassay,
wherein, in the presence of an anti-Zika virus IgM antibody in the second 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;
d) detecting the presence or absence of complex II, and
di) if the complex II is not detected, determining that the human subject is negative for anti-Zika virus IgM antibodies, or
dii) if the complex II is detected, repeating steps c) and d) at least in duplicate, and
e) if the complex II is detected in the equivalent of at least 2 of 3 replicates, determining that the human subject is positive for anti-Zika virus IgM antibodies.