Patent ID: 7326578

Claim:
A lateral flow device for indirectly determining a threshold concentration of serum Follicle Stimulating Hormone (FSH) in a subject by measuring FSH in a urine sample comprising: (a) an application zone for receiving a urine sample; (b) a labelling zone containing labeled binding partner for the FSH; (c) a detection zone having an immobilized capture reagent for the FSH; and (d) a reference zone having a signal of fixed intensity indicative of the threshold concentration of serum FSH, wherein when the signal in the detection zone is less intense than the signal in the reference zone, the subject has a serum FSH level less than the threshold concentration; and when the signal in the detection zone is more intense than the signal in the reference zone, the subject has a serum FSH level more than the threshold concentration; wherein the threshold concentration in serum is between 5mIU/ml and 20 mIU/ml.