Abstract: A fluid handling apparatus 10 has a plurality of fluid handling subassemblies 16 arrayed on a plate body 12. Each of the fluid handling subassemblies includes: an injecting section 26 for injecting a fluid; a fluidized section 28 for allowing the fluid to continuously flow downwards; a fluid housing chamber 30 for receiving the fluid from the fluidized section; a wall portion 20 formed between the fluid housing chamber and the fluidized section; slits 20b for allowing the fluid to enter the fluid housing chamber; and a surface-area increasing means 22 for increasing the area of a contact surface with the fluid in the fluidized section. The slits extend from a lower end positioned in the vicinity of the lower end of the fluidized section, to an upper end higher than the upper end of the fluidized section, for allowing the injecting section and fluidized section to be communicated with the fluid housing chamber.

Abstract: The present invention relates to a system for measuring the biological activity of chemoattractants comprising at least two units separated by a semipermeable carrier wherein biologically active carbohydrate structures, preferably glycosaminoglycan (GAG) structures, are immobilized on the surface of said carrier. According to the invention, this system can be used for fast and economic measurement of the degree of cell mobility and chemotactic activity.

Abstract: A rapid immunochromatographic assay system is provided for measuring the amount of glycated albumin in a blood sample relative to the total level of albumin in the sample. The assay system is comprised of a disposable cassette that contains the test strips and testing reagents, and a measurement device that automatically reads, calculates and displays the test results over a period of time. The test cassette contains two test strips that are used to measure glycated albumin and total albumin respectively. The strips are contiguous beneath the single sample application well so that the same sample is tested simultaneously by both test strips. Part of the sample will migrate thru the glycated albumin test strip where it will react with the glycated albumin test reagents to yield a glycated albumin result, while part of the sample will migrate thru the total albumin test strip where it will react with the total albumin test reagents to yield a total albumin result.

Abstract: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods comprise sandwich assays, and utilize an internal calibration reaction that closely mimics the reaction of test particles by the use of a two-step reaction.

Abstract: Disclosed herein are materials and methods for the efficient and universal fabrication of microcantilevers terminated with living cells. Methods disclosed describe the passive attachment of cells to microcantilevers that represent cells in suspension comprising living cells attached thereto via association with a hydrophobic layer. Also, disclosed are efficient methods for seeding single and multiple cells to cantilevers that represent isolated adherent cells and tissue constructs of tunable confluency.

Abstract: The invention relates to a method for improving the heat stability of glucose dehydrogenase (GDH). The invention provides a method for preparing a glucose sensor with soluble flavin-bound GDH by providing a composition comprising soluble flavin-bound GDH at an acidic pH and heat drying the composition onto a glucose sensor.

Abstract: The present invention provides a method for the detection of an enzyme E1 in a liquid sample comprising the steps of: a) providing a complex (Sa-Sb-M), wherein (Sa-Sb) is a substrate S of E1 cleavable into Sa and Sb by E1, and M is a marker linked to Sb, b) incubating the sample with the complex under conditions enabling the cleavage of S into Sa and Sb by E1, c) separating non-cleaved complex (Sa-Sb-M) from the sample, and d) measuring M in the sample. Furthermore, the present invention further provides kits and devices for the detection of an enzyme E1.

Abstract: A system and method for recognition of images may include the use of alignment markers. The image recognized may be a pattern from an array, a character, a number, a shape, and/or irregular shapes. The pattern may be formed by elements in an array such as an identification marking and/or a sensor array. More particularly, the system and method relate to discriminating between images by accounting for the orientation of the image. The size and/or location of alignment markers may provide information about the orientation of an image. Information about the orientation of an image may reduce false recognitions. The system and method of image recognition may be used with identification markings, biosensors, micro-fluidic arrays, and/or optical character recognition systems.

Abstract: The present invention relates to devices, methods, and kits used to determine the source of an aliquot of a biological fluid, including the presence of additives in the biological sample.

Abstract: A method and kit for detecting Trichomonas vaginalis infection in a human subject are disclosed. In the method, a body-fluid sample such as a vaginal-swab sample or urine is obtained from the subject and contacted with an antibody specific against a Trichomonas adhesin peptide, forming an antibody-adhesin peptide complex if the subject is infected with Trichomonas. The presence or absence of the complex establishes, with a reliability of at least 80%, in the case of a vaginal swab sample, and with a reliability of at least 40% in the case of a urine sample, the presence or absence, respectively, of Trichomonas infection in the subject. A preferred test kit employs a dry-strip, sandwich assay, format.

Abstract: A method of rapid detection of influenza viruses and/or virus particles comprising a hemagglutinin and a neuraminidase component, said method comprising the steps of: a) binding the viruses and/or virus particles to a support containing at least one type of carbohydrate receptor selected from the group consisting of natural or synthetic oligosaccharide, which is conjugated to, or situated in composition with glycoproteins like glycophorin, a1-acid glycoprotein, a2-macroglobulin, ovomucoid, and combinations thereof which carbohydrate receptor binds to the hemagglutinin component of the viruses and/or virus particles; b) reacting the neuraminidase component of the bound viruses and/or virus particles with its labelled enzyme substrate, causing the generation of a detectable signal; and c) detecting the signal generated in step b).

Abstract: Embodiments of the invention provide methods, monoclonal antibodies, polyclonal antibodies, assays, and kits for detecting HPV infection and HPV related cancer diagnosis, including infection by various HPV genotypes, early and/or late stage HPV-associated or HPV-specific cancers. Various specific or pan monoclonal antibodies recognizing specific epitope for specific HPV protein or HPV type, or common epitope for various HPV proteins or HPV types are obtained. The invention also provides one or more solid surface to coat the testing cell lysate. Also, the anti-HPV antibody can be coated on the solid surface of the invention to capture HPV proteins and detect HPV infection.

Abstract: The invention is related to different embodiments of a kit for the simultaneous qualitative and/or quantitative determination of a multitude of analytes comprising a sensor platform comprising an optical thin-film waveguide with a layer (a) transparent at least at an excitation wavelength on a layer (b) with lower refractive index than layer (a), also transparent at least at said excitation wavelength, and at least one grating structure (c) modulated in said layer (a), for the incoupling of said excitation light into layer (a), at least one array of biological or biochemical or synthetic recognition elements immobilized in discrete measurement areas (d) directly or by means of an adhesion-promoting layer on layer (a), for specific recognition and/or binding of said analytes and/or for specific interaction with said analytes, means for laterally resolved referencing of the excitation light intensity available in the measurement areas, and optionally means for the calibration of one or more luminescences gen

Abstract: Temporary tattoos to be applied to the skin of a wearer for the detection of an analyte are generally disclosed. The temporary tattoo can be applied to the skin via a temporary tattoo decal. The temporary tattoo can indicate the presence of an analyte by displaying a certain spectral response (e.g., color change) in the presence of a targeted analyte. This change in color can indicate to the wearer and/or caregiver the presence of the targeted analyte in real-time.

Abstract: A rapid diagnostic test system includes a lateral-flow strip for performing a binding assay. The lateral-flow strip contains a binding agent having a deposition density that varies periodically along at least a portion of the lateral-flow strip. The test system further includes an imaging system that is used to capture an image of the portion of the lateral-flow strip.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A method and apparatus for treating a biological sample with a liquid reagent, comprising first and second substrates having facing surfaces defining a space therebetween in which the biological sample may be treated with the liquid reagent, wherein the first substrate comprises a relatively rigid fluid impermeable element while the second substrate comprises a relatively flexible liquid impermeable element.

Abstract: Malarial parasite Plasmodium falciparum is responsible for the most severe form of malaria in humans, causing about 2 million deaths every year. Lack of effective vaccines and emergence of drug-resistant strains necessitate the need of novel drug targets to treat the disease. The present invention describes a novel assay method of identifying candidate compounds as anti-malarials based on the property of binding to plasmodial parasite 90 kDa heat shock protein.

Abstract: An optical assay apparatus having an optical filter, an optical sensor with a light ray redirection portion and an assay sensing portion, and a filter to block certain wavelengths of excitation light rays and to pass certain wavelengths of signal recovery light rays from the optical sensor. A method for performing an assay that includes providing at least one assay station, moving the optical sensor into position over a respective fluid in at least one assay station, immersing the assay sensing portion in the respective fluid, and removing the assay sensing portion from the respective fluid.

Abstract: A test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid is provided, as well as methods for making and using the test strip. This test strip is commercially usable, for example, in a diagnostic device at a point of care for detection of analytes in whole blood.

Abstract: A reaction of a sample mixture liquid is detected accurately, by allowing a solid reagent to be dissolved and reacted in a liquid sample quickly and accurately. A disc main body, and at least one sample mixing unit provided at the disc main body are provided, and the sample mixing unit is provided with: a liquid sample reserve unit; a reagent chamber capable of disposing a plurality of the solid reagents; and a measurement chamber to which a sample mixture liquid containing a liquid sample and a solid reagent mixed in the reagent chamber is supplied. The reagent chamber has a form which allows a plurality of the solid reagents to be disposed in the direction substantially parallel to the radial direction of the disc in which centrifugal force is generated, or in the direction substantially perpendicular to the radial direction of the disc.

Abstract: A method and apparatus for thin film fluid processing of biological samples without rinsing between treatments is provided. An apparatus having a treatment zone for treating a biological sample with a liquid reagent, comprising first and second substrates having facing surfaces defining a space therebetween in which the biological sample may be treated with the liquid reagent, wherein the first substrate comprises a relatively fluid impermeable element while the second substrate comprises a relatively flexible gas permeable element.

Abstract: The present invention provides a protease detection material having, on a support, at least a layer containing a dye precursor and a layer which contains a protease substrate and is disposed on the same side of the support as the layer containing the dye precursor and farther from the support than the layer containing the dye precursor, wherein the layer containing the protease substrate further contains a development center-forming substance. Further, a set of protease detection materials and a method for measuring protease using the above-described protease detection material are provided. A protease detection material, a set of protease detection materials, and a method of measuring protease which allow protease activity to be measured promptly with high sensitivity, and that allow, at the same time, morphological observation of tissues and cells on a thin film to be performed easily.

Abstract: The present invention provides an apparatus for measuring activity signals of a biological sample comprising: a measurement chamber (A) storing a target liquid containing a biological sample; a porous insulating substrate (5) provided with a measurement electrode (1) on at least one side; and a conveying device (8) which conveys the target liquid stored in the measurement chamber (A) and passes the target liquid through the porous insulating substrate (5) from the measurement electrode (1) side, wherein the conveying device (8) is operated to trap the biological sample contained in the target liquid onto the measurement electrode (1), so that the activity signals of the biological sample are measured through the measurement electrode (1). According to the apparatus, activity signals emitted from the biological sample can be detected easily, rapidly and accurately.

Abstract: Conductimetric assay devices that have both low end and high end sensitivity are described. The geometric shape and/or arrangement of the capture zones make it possible for the assay devices to have both low end and high end sensitivity. Also described is a conductimetric assay device having a pre-capture zone to capture unbound analyte. The assay device overcomes the problem of flooding by the analyte.

Abstract: A biosensor is provided with a development layer for developing an inspection target solution, that has a reagent immobilization part where an antibody for a measurement target in the inspection target solution is immobilized and a reagent holding part which marks in a dry state and holds an antibody which can be eluted by development of the inspection target solution in parts of the development layer. The biosensor measures a bonding amount of the marker reagent bonded to the reagent immobilization part, thereby qualitatively or quantitatively measuring components to be measured in the inspection target solution, and is further provided with a space forming material that forms a cavity part, which is a space into which the inspection target solution flows, between the development layer for developing the inspection target solution and the space forming material.

Abstract: Methods and compositions are provided for detecting biomolecular interactions. The use of labels is not required and the methods can be performed in a high-throughput manner. The invention also provides optical devices useful as narrow band filters.

Abstract: A novel hydrogel copolymer, a substrate coated with the copolymer, a method of producing a microarray using the copolymer, and a microarray produced by the method are provided. The use of the hydrogel copolymer makes efficient removal of protein and high integration of nucleic acid and protein on a substrate for a microarray possible.

Abstract: An indicator device for determining the efficacy of an antimicrobial treatment process. The indicator device includes an active agent encapsulated in an encapsulation component. The encapsulation components preferably takes the form of an electrospun nanofiber including a polymer.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A multi-layered device for detecting the presence or absence of an analyte within a test sample is described. The device includes a sensing layer and a control layer. The sensing layer is configured to support a reaction so as to exhibit a signal indicative of the presence or absence of the analyte in the test sample. The control layer is in fluid communication with and vertically adjacent to the sensing layer and includes a reagent capable of inhibiting the reaction and/or other unwanted side reactions at the sensing layer after a certain period of time by diffusive movement of the reagent from the control layer to the sensing layer.

Abstract: A diagnostic assay device that directs an applied sample to the analytical membrane of a directed flow device. The device has a sample receiving port defined by layers of built-up material on one end of the test strip. The port contains the sample and specifically directs it to the membrane in a controlled fashion. Additional features include configuration of the housing in a general C-shape with the test strip spanning the opening of the C-shape to allow access by a reader device. A preferred method employs superparamagnetic particles to label the target analytes for detection and measurement by means of an electromagnetic reader device.

Abstract: The present invention relates to novel methods for the diagnosis of Helicobacter pylori infection. Specifically, the present invention relates to novel non-invasive methods for the detection of the presence or absence of a Helicobacter pylori antigen or a metabolite produced by the bacterium in a biological sample with a biosensor-based measurement. The present invention also related to the use of a biosensor containing specific antibodies against H. pylori or antigen-binding fragments thereof immobilized thereto together with biomolecule-repellent polymers preventing the non-specific binding. The invention also relates to test kits useful in the methods.

Abstract: A BUN (blood urea nitrogen) sensor containing immobilized carbonic anhydrase and immobilized urease for the in vitro detection of urea nitrogen in blood and biological samples with improved performance and precision characteristics.

Abstract: A high-throughput, anchorage-independent assay is described, which screens compounds for inhibition of cancer cell growth. The assay utilizes a three-dimensional matrix or semi-solid media transfected with the subject compound, and enables live colony growth determination and imaging.

Abstract: A biosensor, a method of making a biosensor, and a method of using a biosensor are described. A biosensor includes a transducer and a peptide encoding the most probable binding domain of an olfactory receptor protein. In embodiments, the transducer is a piezoelectric crystal. The method of making a biosensor includes modeling the three dimensional structure of an olfactory receptor protein; identifying the most probable binding domain of an olfactory receptor protein using a protein docking program; synthesizing a peptide encoding the most probable binding domains or a part thereof; and attaching the peptide to a transducer.

Abstract: The invention provides devices and methods for rapid quantification of microorganisms and cells. In one embodiment, the devices comprise a container having an upper compartment and a lower compartment, wherein the upper compartment is connected to a passage through which a fluid sample can flow and enter the upper compartment, and wherein the lower compartment is connected to a passage through which a fluid sample can flow and exit the lower compartment; a mounting structure upon which a filter can be positioned; a filter, wherein the filter separates the upper compartment from the lower compartment, wherein the filter comprises a chromogen; a first template covering the filter, wherein the first template comprises a predetermined number of holes through which a liquid sample can flow through to discrete locations on the filter; and an absorbent pad under the filter and in contact with the filter.

Abstract: The present invention is directed to a growth medium support plate including an essential planar body part extending therefrom. The growth medium support plate also includes a stem member for connecting a cap to the support plate. The stem member is connected to the body part so as to have a position co-planar with the body part and a position inclined to the plane of the body part. The support plate includes at least one fixed projection extending from and co-planar with said body part adjacently to the stem member and the stem member having in the position coplanar with the body part a releasable connection to the at least one fixed projection.

Abstract: In the serum, PSP94 occurs as a free form or is associated with a carrier protein. PSP94 in its bound form has been quantified in the blood of prostate cancer patients and these measurements have shown utility as evaluation or prognosis of prostate cancer. Diagnostic assays, methods, and kits for detecting a free form of PSP94, and reagents such as antibodies able to bind to a free form of PSP94 are disclosed herein.

Abstract: Methods are disclosed for producing a bioweapon-sensitive fibrous-network product, wherein the subject products exhibit a color change in response to exposure to a biological agent (or portion thereof) as used in a biological weapon. Also disclosed are fibrous-network products that contain units of biopolymeric material that impart a color change to the products in response to exposure to a biological agent (or portion thereof) as used in a biological weapon.

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: Apparatus and methods consistent with certain principles related to the present invention include a first channel, where a fluid flows through the first channel, where the first channel comprises an upstream region, a tagging region downstream of the upstream region, where at least one analyte is tagged when the fluid flows through the tagging region, a capture region downstream of the tagging region, where at least one tagged analyte is captured when the fluid flows through the capture region. A second channel communicating the upstream region of the first channel with the first channel intermediate the tagging region and capture regions, where a portion of the fluid flows through the second channel and subsequently flows into the capture region of the first channel, and where the fluid flowing through the tagging region flows into the capture region before the portion of the fluid flowing through the second channel flows into the capture region of the first channel.

Abstract: Solutions exhibiting little or no evaporative loss at elevated temperatures, i.e., in excess of 100° C., are employed in place of conventional aqueous-based antigen retrieval solutions.

Abstract: An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Abstract: In one aspect, an assay test strip includes a test label that specifically binds a target analyte and a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label. In another aspect, an assay test strip includes a test label that specifically binds a target analyte and at least one non-specific-binding label that is free of any specific binding affinity for the target analyte. Systems and methods of reading assay test strips also are described.

Abstract: In a method for analysis biomolecules (3) attached to a solid surface of a substrate (1) are used for detecting the presence of analytes (4) in a sample by binding of the analytes to the biomolecules. The biomolecules (3) are attached directly to the surface of the substrate together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent nonspecific binding of analytes (4) and other biomolecules. The invention relates also to a biosensor where biomolecules (3) are attached directly to the substrate (1) together with biomolecule-repellent molecules (5), which cover the surface between the biomolecules (3) to prevent non-specific binding of analytes (4) and other biomolecules. The biomolecules (5) can be self-assembled hydrophilic polymers. One example of using the invention is immunological analysis using surface plasmon resonance (SPR).

Abstract: A substrate includes: a base material; and chelators which are three dimensionally covalently bound to the base material at a density of 7.8×1015/mm3 or greater and 4.5×1017/mm3 or less, or two dimensionally covalently bound to the base material at a planar density of 2.0×1011/mm2 or greater and 1.0×1013/mm2 or less. Metal ions are coordinately bound to the chelators, and a bioactive substance having histidine tags are coordinately bound to the metal ions. A blocking agent having ligand sets are coordinately bound to the metal ions to which the bioactive substance is not coordinately bound.

Abstract: The present invention concerns an immunological test for determining NT-proBNP comprising at least two antibodies to NT-proBNP, wherein at least one of the antibodies to NT-proBNP is a monoclonal antibody. One of these antibodies is directed at least against parts of the epitope of NT-proBNP comprising the amino acids 38 to 50. In addition, one of these antibodies is directed at least against parts of the epitope of NT-proBNP comprising the amino acids 1 to 37 or 43 to 76. The epitope recognized by the antibodies can slightly overlap.

Abstract: A filtration based biological specimen collection and transfer device is provided. The filtration and transfer device comprises a tubular body with two axial ends, an annular flange disposed at one of the axial ends, and a biological specimen filter affixed to the outer surface of the annular flange. Preferably, the annular flange has disposed on its outer surface an annular ridge having a uniform height and forming a planar rim upon which the filter sits. Optionally, the annular flange comprises two mounting portions and the filter is bonded to each of those mounting portions. A method of collecting microscopic biological particles carried in a fluid is provided using the filtration and transfer device and a method of manufacturing the filtration and transfer device are also provided. A filtration based biological specimen collection and transfer system using the filtration and transfer device and a kit for use with filtration based biological specimen collection and transfer systems are also provided.