Inverness Medical Switzerland Gmbh

Unilever Patent Holdings B.v.

Conopco, Inc.

Unipath Limited

Michael Evans Prior

Keith May

Ian Richards

Paul James Davis

Michael Catt

Stewart Wilson

Carole R Cunningham

Zhi G Zhang

Paul Henry Mundill

Paul H C Mundill

David Alan Percival

Paul Hc Mundill

Ian Jobling

An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilized in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reacts on in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.

Assays

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

An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.

An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilized in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.

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

An analytical test device useful for example in pregnancy testing, comprises a hollow casing () constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier () which communicates indirectly with the exterior of the casing via a bibulous sample receiving member () which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture () in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.

Fertility computing method

An analytical test device useful for example in pregnancy testing, comprises a hollow casing ( ) constructed of moisture-impervious solid material, such as; plastics materials, containing a dry porous carrier ( ) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member ( ) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture ( ) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.

Capillary immunoassay and device therefor comprising mobilizable particulate labelled reagents

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

Analytical test device for imuno assays and methods of using same

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.

An analytical test device useful for example in pregnancy testing, comprises a hollow casing (,) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (,) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (,) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilized on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture (,) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.

An analytical test device useful for example in pregnancy testing, comprises a hollow casing (,) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (,) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (,) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture (,) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.

A process of manufacturing test strips of the type comprising a length of porous carrier material capable of acting as a liquid flow path for a sample liquid and having at least zone downstream from a first end of the strip which zone contains an immobilized specific binding agent to act as a capture means during an assay to reveal the presence of an analyte in applied sample liquid, and in which process the specific binding agent is deposited onto a sheet of the porous carrier material which is then blocked and subdivided into a plurality of individual identical test strips, wherein blocking of the porous carrier material is achieved by applying a solution of blocking agent to the sheet upstream from the zone in an amount sufficient to ensure that the solution permeates downstream to beyond the zone. Preferably there is a plurality of zones of immobilized agent arranged in series on the strip, and wherein blocking is achieved by applying a solution of blocking agent to the sheet upstream from the first of the plurality of zones in an amount sufficient to ensure that the solution permeats downstream to beyond the last of the plurality of zones.

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Rushden, United Kingdom

Michael Evans Prior