| 主权项 |
1. A method for performing a thyroid stimulating hormone (TSH) immunoassay, the method comprising the steps of:
(a) inserting a fluid sample into a device comprising an immunosensor in a conduit, said immunosensor having a capture antibody specific for TSH immobilized thereon; (b) dissolving a signal antibody into said fluid sample; (c) forming a sandwich complex on said immunosensor, said complex comprising said capture antibody, TSH from the fluid sample, and said dissolved signal antibody; (d) washing uncomplexed signal antibody and fluid sample from the immunosensor with a wash fluid in no more than one washing step; and (e) detecting a signal associated with said complexed signal antibody as indicative of a level of TSH in the fluid sample; 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 dissociation constant (Kd) for TSH; wherein the capture antibody Kd for follicle stimulating hormone (FSH), luteinizing hormone (LH) and chorionic gonadotropin (CG) is in the range of from 70 to 1000 nM, 35 to 1000 nM and 40 to 500 nM, respectively; wherein the signal antibody Kd for FSH, LH and CG is in the range of from 70 to 300 nM, 35 to 54 nM and 40 to 45, respectively; wherein the capture antibody Kd for FSH, LH and CG is greater than the signal antibody Kd for FSH, LH and CG; and wherein the capture antibody comprises mouse monoclonal anti-TSH-β antibody 5409 and the signal antibody comprises mouse monoclonal anti-TSH-β antibody M94206. |
