Monitoring methods and devices for use therein
First Claim
1. A test kit for use in monitoring an ovulation cycle of a female mammal, which kit consists essentially of a plurality of disposable testing devices for sampling and testing a body fluid, and providing readable signals indicative of the concentrations of at least two different analytes in said body fluid, together with an electronic reader/monitor for reading and interpreting said readable signals to provide the user with an indication of the fertility status of said cycle, wherein:
- a) said readable signals are read while one of said testing devices is located within a receiving means of said reader/monitor;
b) said readable signals are created by concentrating a first detectable material in a first detection zone of a porous carrier within said testing device and by concentrating a second detectable material in a second detection zone of said porous carrier, while said sampled body fluid is flowing through said porous carrier, wherein said flowing body fluid contacts said first detection zone and said second detection zone sequentially;
c) said first detection zone signal being the result of a sandwich-format specific binding reaction and thereby being directly indicative of the body fluid concentration of a first analyte which first analyte exhibits a detectable concentration change closely associated with the time of actual ovulation;
d) said second detection zone signal being the result of a competition-format specific binding reaction and thereby is indicative of the body fluid concentration of a second analyte, which second analyte exhibits a detectable concentration change after menses but in advance of the time of actual ovulation;
e) said second detection zone being downstream from said first detection zone relative to a receiving portion of said testing device which is contacted with said body fluid to initiate said tests, said first detection zone containing an immobilized anti-LH antibody and said second detection zone containing immobilized hapten or an analog thereof;
f) said readable signals are read by optical transmission through said testing device using pulsed diffuse light; and
g) the reader/monitor comprising;
(1) a source of pulsed diffuse light having a wavelength that is strongly absorbed by said detectable materials;
(2) a sensing means for sensing incident light from said source;
(3) a receiving means for receiving and holding said testing device with each of said detection zones in a light path between said source and said sensor; and
(4) an electronic means for deriving detectable material concentration, said electronic means being connected to said sensing means, said electronic means being programmed to derive from sensed incident light a measure of the extend to which detectable material has become concentrated in each of said detection zones.
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0 Petitions
Accused Products
Abstract
Methods, devices and test kits for monitoring the ovulation cycle, involve testing the body fluid, e.g. urinary, concentration of one or more analytes. Preferably estrone-3-glucuronide and luteinizing hormone are both measured, and a reference concentration for E3G is established at about day 6 of the current cycle. Preferably, disposable testing devices are used, in conjunction with a relatively permanent electronic reader/monitor. The number of “daily” tests required per month can be minimized.
168 Citations
11 Claims
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1. A test kit for use in monitoring an ovulation cycle of a female mammal, which kit consists essentially of a plurality of disposable testing devices for sampling and testing a body fluid, and providing readable signals indicative of the concentrations of at least two different analytes in said body fluid, together with an electronic reader/monitor for reading and interpreting said readable signals to provide the user with an indication of the fertility status of said cycle, wherein:
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a) said readable signals are read while one of said testing devices is located within a receiving means of said reader/monitor;
b) said readable signals are created by concentrating a first detectable material in a first detection zone of a porous carrier within said testing device and by concentrating a second detectable material in a second detection zone of said porous carrier, while said sampled body fluid is flowing through said porous carrier, wherein said flowing body fluid contacts said first detection zone and said second detection zone sequentially;
c) said first detection zone signal being the result of a sandwich-format specific binding reaction and thereby being directly indicative of the body fluid concentration of a first analyte which first analyte exhibits a detectable concentration change closely associated with the time of actual ovulation;
d) said second detection zone signal being the result of a competition-format specific binding reaction and thereby is indicative of the body fluid concentration of a second analyte, which second analyte exhibits a detectable concentration change after menses but in advance of the time of actual ovulation;
e) said second detection zone being downstream from said first detection zone relative to a receiving portion of said testing device which is contacted with said body fluid to initiate said tests, said first detection zone containing an immobilized anti-LH antibody and said second detection zone containing immobilized hapten or an analog thereof;
f) said readable signals are read by optical transmission through said testing device using pulsed diffuse light; and
g) the reader/monitor comprising;
(1) a source of pulsed diffuse light having a wavelength that is strongly absorbed by said detectable materials;
(2) a sensing means for sensing incident light from said source;
(3) a receiving means for receiving and holding said testing device with each of said detection zones in a light path between said source and said sensor; and
(4) an electronic means for deriving detectable material concentration, said electronic means being connected to said sensing means, said electronic means being programmed to derive from sensed incident light a measure of the extend to which detectable material has become concentrated in each of said detection zones. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification