Patent ID: 8802427

Claim:
A device for detecting Follicle Stimulating Hormone (FSH) present in a liquid sample at a concentration relative to a predetermined level, wherein the device comprises: A) a sample application member for receiving the liquid sample; B) a first portion comprising a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of FSH; and C) a second portion comprising (i) a single test site having immobilized thereon a capture component capable of directly or indirectly binding with a second epitope of the FSH, the device further including a scavenger component in an amount sufficient to bind FSH present in the sample below the predetermined level, the scavenger component being located between the sample application member and the test site, such that a signal indicating binding of FSH at the test site only occurs when FSH is present in the liquid sample at a concentration above the predetermined level and no signal at the test site indicates any FSH in the liquid sample is present at a concentration below the predetermined level and (ii) a control site having immobilized thereon a capture component comprising a binding member that binds labeled conjugate.