Abstract: 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.

Abstract: A reagent useful in immunoassays, comprising a direct particulate level co-sensitised with a specific binding agent having specificity for an analyte or analyte analogue and with a non-specific protein which can participate in a control reaction with another specific binding agent which does not bind to the first specific binding agent nor participate in the formation of a complex by means of which detection of the analyte or analyte analogue is accomplished. Preferably the first specific binding agent is an antibody raised in a first species and the non-specific protein is an immunoglobulin from another species. Optionally, the reagent additionally comprises a second population of the direct particulate label sensitised solely with the non-specific protein.

Abstract: 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.

Abstract: A micro flow system is provided for separating particles, comprising a microfabricated member having a flow channel (5) defined therein for guiding a flow of a fluid containing the particles through the flow channel, first inlet means (2) positioned at one end of the flow channel for entering the fluid into the flow channel, first outlet means (7) positioned at the other end of the flow channel for discharging the fluid from the flow channel, the flow of the fluid containing the particles being controlled in such a way that one particle at the time passes a cross section of the flow channel, the member being positioned in a field that is substantially perpendicular to a longitudinal axis of the flow channel so that particles residing in the flow channel and being susceptible to the field across the flow channel are deflected in the direction of the field.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) 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 mea

Abstract: With a method of establishing an enveloped flow in a channel, in the channel an envelopment area (3) with a channel section (6, 7) is configured to which a stub with an outlet is connected, where the stub, which can be configured as a polyhedron, is arranged substantially at right-angles to the envelopment area and with the plane of the outlet substantially at right-angles to the channel section. An inlet channel (9, 11) and an outlet channel (8, 10) are connected to the envelopment area. By providing a narrowing-down in the cross-section of the channel in immediate extension of the envelopment area (3), a hydrodynamic focussing of the sample fluid is achieved when a fluid, such as a sample fluid, is introduced into the stub, and a carrier fluid is introduced into the inlet channel. The advantage of the invention is that since it is necessary only to have two fluid inlets, a relatively simple structure can be established, which can be built up in a monolithic manner, e.g. by injection molding.

Abstract: A device, system and method for photometric detection of coagulation in whole blood. The present invention is easy to implement and operate. Furthermore, the present invention has the advantage of being considered to fulfill the desired standard of using photometry for measuring blood coagulation. Also, a photometric coagulation test device for whole blood specimens according to the present invention provides medical accuracy to the home user and, at the same time, is simple to construct. The present invention is also useful for detecting and determining blood agglutination, for example as the results of a serological reaction with an antibody.

Abstract: Disclosed is an assay device comprising liquid transport means adapted to take up a liquid sample and conduct the liquid to an analyte detection region operable to provide a test signal indicative of the presence and/or amount of an analyte in the liquid sample; the assay device further comprising a sample presence signal generation means, which is not generated by means of an immunoreaction. This sample presence signal generation means can comprise a coloured portion, which is overlaid by a material (e.g. nitrocellulose) that is opaque, when dry, and translucent or transparent, when wet, to allow the coloured portion to become visible to the user. In another embodiment the signal generation means comprises a colour changing material which under-goes a change in its visible properties upon wetting (eg. pH indication). A third embodiment uses a mobilisable detectable which, when wetted by the sample, is carried along resulting in a streaked line parallel with the flow direction.

Abstract: A microfluidic separation system for separating fluid sample medium from cells provided in a sample, for example, a sample of bodily fluid which is to be subjected to further analysis. The system may include a microfluidic structure and a cell aggregation agent. The microfluidic structure may include one or more microfluidic channels operable to separate aggregated cells from fluid sample medium by size exclusion.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) 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 mea

Abstract: 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.

Abstract: 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.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as; plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) 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 me