Method for evaluating urine of a subject to estimate the fertile window

A method for evaluating urine of a subject to estimate the fertile window, comprising:

• collecting a single sample of urine,
• testing the single sample of urine with one or both of a first lateral flow assay and a second lateral flow assay,
• the first lateral flow assay comprising:
• a sample pad configured to receive the urine sample,
• a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate comprising an anti-PdG antibody conjugated to a visual label in a concentration selected from the range inclusive of 1-10 μg/ml,
• a membrane comprising a testing zone,
• the testing zone comprising PdG conjugated to a carrier protein that binds PdG antigens at 8-32 molecules per carrier protein, and
• further configured to evaluate for the presence or absence of PdG at or above a PdG threshold, the PdG threshold selected from within the range inclusive of 3-20 μg/ml,
• the membrane further configured to provide an observable positive result for the presence of PdG in the sample of urine at the PdG threshold as indicated by the absence of the color of the visual label in the testing zone following the operation of the first lateral flow assay,
• the second lateral flow assay comprising:
• a sample pad configured to receive the urine sample,
• a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate, the conjugate comprising an anti-LH antibody conjugated to a visual label,
• a membrane comprising a testing zone,
• the testing zone comprising LH conjugated to a carrier protein and further configured to evaluate for the presence or absence of LH at a LH threshold of no less than 20 ml U/ml,
• the membrane configured to provide an observable positive result for the presence of LH in the sample of urine at a LH threshold as indicated by the presence of the color of the visual label in the testing zone following the operation of the second lateral flow assay
• determining that ovulation has occurred and that the fertile window has closed by a positive result for the presence of PdG at the PdG threshold or determining that the fertile window has opened by observing a positive result for the presence of LH at or above the LH threshold, and
• estimating the fertile window dates, optionally by repeating the collecting, testing and determining steps, the fertile window opening date of the subject estimated as the date of the first positive result in a menstrual cycle of the subject for the presence of LH at or above the LH threshold and the fertile window closing date of the subject estimated as the date of the first positive result in the menstrual cycle for the presence of PdG at the PdG threshold, following the evaluation of at least one result for the presence or absence of LH at or above the LH threshold and at least one result for the presence or absence of PdG at the PdG threshold during the menstrual cycle.