Method for evaluating urine of a subject to estimate the fertile window by evaluating for the presence of analytes of estrogen and progesterone
AssigneeMFB Fertility, Inc.
InventorAmy Beckley
Life of this patent
Estimating the term…
Abstract
Disclosed herein are devices, systems, methods and kits for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive readout of the immunoassay results. The methods disclosed herein may also incorporate steps associated with evaluating the urine of a sample for the presence of an estrogen metabolite and/or luteinizing hormone.
Claims10
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 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,
- a membrane comprising a testing zone,
- the testing zone comprising PdG conjugated to a carrier protein, and further configured to evaluate for the concentration of PdG in the sample of urine,
- the membrane further configured to provide an observable result for the concentration of PdG in the sample of urine, as indicated by the color intensity 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-estrone-3-glucuronide (E3G) antibody conjugated to a visual label,
- a membrane comprising a testing zone,
- the testing zone comprising E3G conjugated to a carrier protein and further configured to evaluate for the presence or absence of E3G in the sample of urine,
- determining that ovulation has occurred and that the fertile window has closed by repeating the collecting and testing steps until a fold change in the concentration of PdG within a single menstrual cycle is observed, and determining that the fertile window has opened by observing a positive result for the presence of E3G at or above the E3G threshold;
- and
- estimating the fertile window dates, 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 E3G at or above the E3G threshold and the fertile window closing date of the subject estimated as the date of the first fold change in the concentration of PdG.
Dependencies are inferred from the claim text.