Abstract: A method of producing a microfluidic device having at least one flow path may include providing a base substrate with a first surface and a top substrate with a second surface, hydrophilically treating at least one of the first and the second surfaces to provide a surface layer with a higher surface tension than the surface tension prior to the hydrophilic treatment, partly or totally removing the surface layer with a higher surface tension in a selected pattern of the hydrophilically treated first and/or second surfaces, to thereby provide the selected pattern with a lower surface tension than prior to the partly or totally removal of the surface layer with a higher surface tension in said selected pattern of the hydrophilic treated first and/or second surfaces, and joining said base substrate and top substrate to each other to provide a flow path between said first and second surfaces.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: 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.

Abstract: 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.

Abstract: A device for determining an assay result may include a test strip, a light source system, a light detection system, and a processor.

Abstract: Patients can be segregated into groups expected to have differential responses to drug treatment based on test results. Patient sub-populations expected to benefit from a particular treatment can thus be identified and directed to that treatment. Similarly, sub-populations expected to suffer a greater risk of side effects from a particular treatment can be identified and steered to other, safer treatments. A patient under treatment can be monitored for safety.

Abstract: A solid-phase test device and a method for the detection of sialidase activity in a fluid sample. The test device includes a solid support provided with a pre-deposited dry form of a sialidase detecting composition. The sialidase detecting composition includes a sialidase substrate and a color-developing reagent. When the sialidase substrate is exposed to sialidase it yields an intermediate compound which reacts with the color-developing reagent to form a detectable color change.

Abstract: A diagnostic device for performing a diagnostic blood test of a subject comprising a thimble-like element adapted to be engaged with the subject's finger, a puncturing unit for producing a blood sample from the subject's finger, and an at least one test element in flow communication with said blood sample.

Abstract: Damage to tissue, such as ischemic damage, can cause the release of mitochondrial markers. The released markers can be detected in a sample taken from a subject, indicating that the subject has suffered damage.

Abstract: Disclosed is an assay device for the determination of analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilising a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilising a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: An assay device includes a first reagent including a magnetic particle and a second reagent including detectable component. The first and second reagent can each independently bind to an analyte in a sample. Applying a magnetic field can selectively concentrate the detectable component in a detection zone, where a detectable change ca be measured and related to the amount of analyte in the sample.

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: The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.

Abstract: A hybrid device (10) that combines a microfluidic component and a porous components (15) is provided. The microfluidic component includes a sample addition zone (1), a resuspension chamber (13), a mixing chamber (17), and a transfer structure (16), which facilitates fluid flow by capillary action.

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract: Disclosed is a device for collecting a fluid specimen. The device comprises a container that can receive a fluid specimen; a plunger movably positioned within the container, wherein the plunger can move from an initial position at an upper region of the container to a secondary position below the first position; a fluid segregation chamber that can receive a portion of the fluid specimen from the container, wherein any fluid in the segregation chamber is segregated from the fluid specimen in the container; a fluid flow lumen that provides a passageway for at least a portion of the fluid specimen to flow into the fluid segregation chamber, wherein a first end of the passageway has a first opening that opens into the fluid segregation chamber and a second end of the passageway has a second opening that can receive at least a portion of the fluid specimen; and a seal member that covers the first opening or the second opening to prevent fluid from flowing therethrough.