Method of evaluating corpus luteum function by recurrently evaluating progesterone non-serum bodily fluids on multiple days

A method for evaluating a series of samples of a non-serum bodily fluid sample of a subject, each sample of the series collected daily during a period of at least three and not more than four consecutive days during the timeframe of 7-10 days past the ovulation date, to evaluate corpus luteum function by estimating the levels of progesterone, comprising:

• predicting the timeframe of 7-10 days past the ovulation date to optimally conduct testing for progesterone or a progesterone metabolite by a step selected from the group consisting of:
• a. testing urine with a lateral flow assay test configured to evaluate urine for the presence of luteinizing hormone to determine the ovulation date;
• b. measuring a rise in basal body temperature of at least 0.5 degrees Fahrenheit to determine the ovulation date;
• c. utilizing a menstrual cycle tracking application operating on a mobile device configured to determine the ovulation date;
• and
• d. sampling cervical mucus to determine the ovulation date,
• collecting a non-serum bodily fluid sample daily for at least three and not more than four consecutive days during the timeframe of 7-10 days past the ovulation date;
• for each fluid sample collected on each of the consecutive days, testing for the presence of progesterone or a metabolite of progesterone by a step selected from the group consisting of:
• a. evaluating urine with a specially configured lateral flow assay, the specially configured lateral flow assay comprising:
• a sample pad configured to receive each urine sample,
• a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate of an anti-PdG antibody conjugated to a visual label at a concentration of 1-10 μg/ml, and
• a membrane comprising a testing zone,
• the testing zone comprising a PdG conjugated to a carrier protein that binds PdG antigens at 8-32 molecules per carrier protein and 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, and
• an adsorbent pad at an end of the specially configured lateral flow assay opposite from the sample pad;
• b. evaluating a saliva sample with the aid of a diagnostic test system, the diagnostic test system comprising:
• an assay device comprising at least one testing region configured to evaluate an applied saliva sample for the presence of progesterone or a progesterone analyte,
• a port for receiving an assay device,
• a reader comprising one or more light sources for illuminating the testing region,
• a data analyzer configured to receive optical signals and determine an amount of an analyte present in the saliva sample, and transmit a result as an output;
• and
• evaluating saliva with a lateral flow test device for quantitatively detecting an analyte in a saliva sample configured to quantitatively detect progesterone at or above a threshold value selected from the range of 90-300 pg/ml;
• observing the result for the presence of progesterone or a metabolite of progesterone;
• following the first result indicating the presence of progesterone or a metabolite of progesterone above the PdG threshold in the tested non-serum bodily fluid sample or the first fold change, repeating the collecting step and the testing step for three days or until the first result indicating progesterone or a metabolite of progesterone is below the PdG threshold;
• and
• recording the total number of days the presence of progesterone is indicated or a metabolite of progesterone is indicated above the PdG threshold during the timeframe of 7-10 days past the ovulation date, or the total number of days the presence of progesterone is indicated or a metabolite of progesterone is indicated above the PdG threshold prior to the first result indicating progesterone is absent or a metabolite of progesterone is below the PdG threshold.

A method for evaluating a single non-serum bodily fluid sample of a subject to assess corpus luteum functionality, comprising:

• collecting the single non-serum bodily fluid sample;
• testing the single non-serum bodily fluid sample with a single test in the form of a lateral flow assay, the lateral flow assay comprising:
• a sample pad configured to receive a non-serum bodily fluid sample,
• a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate consisting of an anti-progesterone antibody or anti-progesterone metabolite antibody conjugated to colloidal gold, a fluorescent dye or colored latex beads,
• a test line within a membrane, the test line comprising a progesterone or a progesterone metabolite conjugated to a carrier protein and configured to evaluate for the presence of the progesterone metabolite at or above a threshold, the threshold selected from within the range inclusive of 3-20 μg/ml, or the presence of progesterone at or above a threshold selected from the range inclusive of 90-300 pg/ml, and
• an adsorbent pad at an end of the specially configured lateral flow assay opposite from the sample pad;
• repeating the collecting step and the testing step, for at least three days during the timeframe of 7-10 days past ovulation or until the first indication that the progesterone metabolite or progesterone is below the threshold of a single test, the first indication obtained by observing a label generated by operation of the single test and observable on the single test representing a negative result for the presence of the progesterone metabolite or progesterone at or above a threshold,
• recording the total number of days the presence of the progesterone metabolite or progesterone is indicated at or above the threshold of the single test prior to the first negative single test signaling that the progesterone metabolite or progesterone is below the threshold of the single test;
• and
• determining whether ovulation has occurred by evaluating for the presence of at least one positive result obtained by operation of the single test performed once daily during the timeframe of 7-10 days past ovulation for a progesterone metabolite or progesterone at the threshold of the single test as indicated by at least one single test.

A method for evaluating a series of samples of urine of a subject, each sample of the series collected daily during a period of at least three consecutive days during the timeframe of 7-10 days past the ovulation date, to evaluate corpus luteum function by estimating the levels of progesterone, comprising:

• predicting the three consecutive days to optimally conduct testing by a step from the group consisting of:
• a. testing urine with a lateral flow assay test configured to evaluate urine for the presence of luteinizing hormone to determine the ovulation date;
• b. measuring a rise in basal body temperature of at least 0.5 degrees Fahrenheit to determine the ovulation date;
• c. utilizing a menstrual cycle tracking application operating on a mobile device configured to determine the ovulation date;
• and
• d. sampling cervical mucus to determine the ovulation date;
• collecting a urine sample daily for three consecutive days during the timeframe of 7-10 days past the ovulation date;
• for each urine sample collected on each of the three consecutive days, testing for the presence of a metabolite of progesterone by evaluating the urine sample with a specially configured lateral flow assay, the specially configured lateral flow assay comprising:
• a sample pad configured to receive each urine sample,
• a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate consisting of an anti-progesterone metabolite antibody conjugated to a label,
• a test line within a membrane, the test line comprising a progesterone metabolite conjugated to a carrier protein and configured to evaluate for the presence or absence of the progesterone metabolite in the urine sample at or above a threshold, the threshold selected from within the range inclusive of 3-20 μg/ml, and further configured to generate an observable result by operation of the specially configured lateral flow assay by depicting a color within the test line if the progesterone metabolite is absent at the threshold in the urine sample or depicting a reduced or absent color within the test line if the progesterone metabolite is present at the threshold in the urine sample following the application of the urine sample, and
• an adsorbent pad at an end opposite from the sample pad;
• observing each test result obtained by operation of each specially configured lateral flow assay and demonstrated by the test line of the specially configured lateral flow assay, the test result indicating whether the urine sample contains an amount of the progesterone metabolite at or above the threshold;
• following the first indication of the presence of the progesterone metabolite at a concentration at or above the threshold in the urine sample on a performed specially configured lateral flow assay, repeating the collecting step and the testing step for each day during the timeframe of 7-10 days past the ovulation date;
• and
• recording the total number of days that the presence of the progesterone metabolite is indicated at or above the threshold during the timeframe of 7-10 days past the ovulation date.