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TSH antibodies for point-of-care immunoassay formats

  • US 9,199,234 B2
  • Filed: 11/29/2011
  • Issued: 12/01/2015
  • Est. Priority Date: 05/27/2011
  • Status: Expired due to Fees
First Claim
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1. A device for performing an immunoassay for thyroid stimulating hormone (TSH) in a fluid sample, the device comprising an immunosensor in a conduit, said immunosensor having a capture antibody specific for TSH immobilized thereon, and said conduit having a dry reagent coating disposed therein, the dry reagent coating comprising a signal antibody configured to dissolve into said fluid sample;

  • wherein the capture antibody has a first dissociation constant (Kd) ratio, Kd (follicle stimulating hormone (FSH));

    Kd(TSH), that ranges from 1500 to 10000, and the signal antibody has a second Kd ratio, Kd(FSH);

    Kd(TSH), that ranges from 1500 to 3750;

    wherein the first Kd ratio is greater than the second Kd ratio;

    wherein the capture antibody and the signal antibody are epitope-compatible antibodies;

    wherein the capture antibody and the signal antibody, respectively, are capable of binding to at least two different epitopes on a TSH-β

    subunit of TSH;

    wherein the capture antibody and the signal antibody each have a Kd for TSH of between 0.08 and 0.1 nM; and

    wherein the capture antibody is mouse monoclonal anti-TSH-β

    antibody 5409 and the signal antibody is mouse monoclonal anti-TSH-β

    antibody M94206.

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