Inverness Medical Switzerland Gmbh

Other

Unilever Patent Holdings B.v.

Unipath Limited

Michael Catt

Michael Evans Prior

Paul James Davis

John Coley

Carole R Cunningham

Stewart Wilson

Zhi G Zhang

Keith May

Paul Henry Mundill

Peter Lenko

Paul H C Mundill

Michael T Pearson

Andrew Peter Phelan

Nicholas Andrew Morris

Rosie L Habeshaw

Brian Jeffrey Birch

Miles Hugh Eddowes

Edward Baginski

Catherine Lovell

Fiona McNae

Paul Hc Mundill

A test kit for determining the presence of one or more analytes in a fluid sample, including an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, where precisely located engagement of the assay device with the reading device causes a 'lock-and-key' interaction between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means including at least one fixed projecting portion and at least one displaceable projecting portion, and a contact portion of the assay device casing includes a recess shaped to accommodate the fixed projecting portion of the switch actuating means but not the displaceable projecting portion.

Test kits and devices

A fertility determining system employing hormone level measuring apparatus on selected days in a menstrual cycle to determine the levels of analytes, i.e., estrone-3-glucuronide ('E3G') and luteinizing hormone ('LH'), in early morning urine. The fertility/infertility signalling algorithm relies upon data characterizing the user earlier in that menstrual cycle, and also upon her analyte pattern in past recent cycles. At a point in a menstrual cycle which is user-dependent, the early morning E3G urine level is compared against the lower E3G level earlier in the cycle. The beginning of the fertile period is signalled when a sufficient E3G increase occurs. The end of the fertile period (and, correspondingly, the reestablishment of a period requiring no contraception) is signalled a period after the LH surge. In the absence of an LH surge in any subject, the end of the fertile phase is signalled a period of time following the peak of the E3G urinary metabolite of estradiol.

Fertility computing system and method

A method of 'reading' the result of an assay effected by concentrating a detectable material in a comparatively small zone of a carrier in the form of a strip, sheet or layer through the thickness of which electromagnetic radiation such as visible light is transmissible, wherein at least a portion of one face or the carrier is exposed to incident electromagnetic radiation which is substantially uniform across the entire portion, the portion including the small zone, and electromagnetic radiation emerging from the opposite face of the carrier is measured to determine the assay result. Preferably the radiation is diffuse light.

Reading devices and assay devices for use therewith

A method for determining the time of maximum fertility in the mammalian ovulation cycle, for the purpose of assisting conception, wherein testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from an individual human subject to detect an elevated concentration of first analyte, such as luteinising hormone (LH) indicative of the event of ovulation, and additionally testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from the individual subject to detect an elevated concentration of a second analyte, such as estradiol or a metabolite thereof, especially estradiol-3-glucuronide (E3G), to provide advance warning of ovulation.

Test methods, devices and test kits

A test kit for determining qualitatively or quantitatively the presence of one or more analytes in a fluid sample, comprising an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, wherein precisely located engagement of the assay device with the reading device causes a 'lock-and-key' interaction, ie. a unique 3-dimensional interaction, between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means comprising at least one fixed projecting portion and at least one displaceable projecting portion, and a contact portion of the assay device casing comprises a recess shaped to accommodate the fixed projecting portion of the switch actuating means but not the displaceable projecting portion thereof, the contact portion also comprising an interface portion that contacts and displaces the displaceable portion of the switch actuating means when the fixed projecting portion is accommodated within the recess.

Fertility computing method

A method of monitoring the status of a current ovulation cycle of an individual human female subject, involving testing of the body fluid concentration of an analyte of significance in relation to the status of the ovulation cycle, such as urinary E3G, during at least part of the pre-ovulation phase of the current ovulation cycle of the individual subject, and identification from the results of such testing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that has been adapted to the individual human subject on the basis of analyte concentration test data obtained from the individual human subject during one or more previous ovulation cycles.

Monitoring method

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 &ldquo;daily&rdquo; tests required per month can be minimized.

Monitoring methods and devices for use therein

A method of providing warning of the onset of the fertile phase of the human ovulation cycle, involving measurement in absolute or relative terms of the body fluid concentration of an analyte such as estradiol or a metabolite thereof wherein if in the current cycle a concentration measurement conducted at about the termination of menses reveals a body fluid concentration that is typical of that found in the body fluid of an average human female subject about 3 days prior to the time of ovulation during a 28-day cycle, the current cycle is immediately declared to be in its fertile phase. Where the a analyte is E3G, the E3G concentration measurement is conducted on at least one or numerical days 4 to 7 of the current cycle, counting from the onset of menses, and the fertile phase is declared immediately if the E3G measurement reveals a concentration equal to or greater than a threshold concentration chosen in the range of about 25 to about 35 ng/ml.

Ovulation cycle monitoring methods

A method of monitoring the status of a current ovulation cycle of an individual human female subject, involving testing of the body fluid concentration of an analyte of significance in relation to the status of the ovulation cycle, such as urinary E3G, during at least part of the pre-ovulation phase of the current ovulation cycle of the individual subject, and identification from the results of such testing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that has been adapted to the individual human subject on the basis of analyte concentration test data obtained from the individual human subject during one or more previous ovulation cycles. Preferably testing for said analyte concentration during the current ovulation cycle is commenced a plurality of days (preferably at least 5) following the onset of menses but at least 2 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject.

An assay result reader, for use in conjunction with an assay device comprising a porous liquid-permeable carrier in the form of a strip or sheet through the thickness of which electromagnetic radiation is transmissible, the carrier including a detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in the detection zone, detection of the detectable material being effected by determining the extent to which electromagnetic radiation transmitted through the thickness of said carrier is attenuated by the presence of the detectable material bound in the detection zone.

A testing device for qualitatively or quantitatively sensing an electrochemical or analogous reaction at the surface of a test strip (46), the current flowing or charge accumulated at the test strip being processed by electronics (50) to generate a current signal suitable for activating a display (52) typically in the form of a thermochromic layer.

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Northampton, United Kingdom

Michael Catt