Abstract: It is an object of the present invention to provide an immunoassay method which is capable of simultaneous quantification of a plurality of test substances under a same analysis condition, through adjustment of the measurement sensitivity/range by simply varying the size of particles for use as labels, without changing the spectra of these particles.

Abstract: Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator's contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Abstract: Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator's contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

Abstract: Embodiments of the present invention relate to devices and methods for detecting cellular products using detection particles having product-specific detection reagents and having a characteristic spectral feature. In particular, devices and methods are provided for measuring secreted cellular products including cytokines. Detection substrates, include microwells having product-specific capture reagents thereon or comprising hydrophobic membranes are described having greater capability to detect products from individual cells in a mixture of heterogeneous cells. With the use of multiple detection particles, multiple cellular products can be detected in a single well. Additionally, using the inherent spectral properties of detection particles, no enzymatic reactions are needed to visualize a secreted product, thereby increasing the sensitivity, reproducibility and ease of use.

Abstract: Novel conjugates and immunogens derived from risperidone and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of risperidone and paliperidone in biological fluids.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay for determining a concentration of an analyte in a whole blood sample suspected of containing the analyte. The method comprises determining by means of the assay a concentration of the analyte utilizing a hemolyzed portion of the blood sample to obtain concentration value 1 and determining by means of the assay a concentration of the analyte utilizing a non-hemolyzed portion of the blood sample and multiplying the concentration times a hematocrit factor to obtain concentration value 2. A ratio of concentration value 1 divided by concentration value 2 is determined and is compared to a predetermined ratio of known reliability. If the ratio is less than the predetermined ratio, a false result is indicated.

Abstract: This invention relates to apparatus for carrying out continuous or batch centrifugation solid-liquid separation processes in which the solid-liquid mixture is subjected to magnetic field gradients and centrifugation.

Abstract: Novel conjugates of doxorubicin and novel doxorubicin immunogens derived from the 13 and 14 positions of doxorubicin and antibodies generated by these doxorubicin linked immunogens all of which are useful in immunoassays for the quantification and monitoring of doxorubicin in biological fluids.

Abstract: A method and apparatus for the manipulation of colloidal particulates and biomolecules at the interface between an insulating electrode such as silicon oxide and an electrolyte solution. Light-controlled electrokinetic assembly of particles near surfaces relics on the combination of three functional elements: the AC electric field-induced assembly of planar aggregates; the patterning of the electrolyte/silicon oxide/silicon interface to exert spatial control over the assembly process; and the real-time control of the assembly process via external illumination. The present invention provides a set of fundamental operations enabling interactive control over the creation and placement of planar arrays of several types of particles and biomolecules and the manipulation of array shape and size. The present invention enables sample preparation and handling for diagnostic assays and biochemical analysis in an array format, and the functional integration of these operations.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

Abstract: A microsphere-based analytic chemistry system is disclosed in which self-encoding microspheres having distinct characteristic optical response signatures to specific target analytes may be mixed together while the ability is retained to identify the sensor type and location of each sensor in a random dispersion of large numbers of such sensors in a sensor array using an optically interrogatable encoding scheme. An optical fiber bundle sensor is also disclosed in which individual microsphere sensors are disposed in microwells at a distal end of the fiber bundle and are optically coupled to discrete fibers or groups of fibers within the bundle. The identities of the individual sensors in the array are self-encoded by exposing the array to a reference analyte while illuminating the array with excitation light energy.

Abstract: A gel microdrop composition is provided. In certain embodiments, the gel microdrop composition contains a polymer matrix, an effector particle that releases an effector molecule into the polymer matrix, a first reporter particle that emits a first optically detectable signal and a second reporter particle that emits a second optically detectable signal that is distinguishable from the first optically detectable signal, where the effector particle and said first and second reporter particles are encapsulated by the polymer matrix. Methods of screening that employ the gel microdrop composition and methods of making the gel microdrop composition are also disclosed.

Abstract: An ultra sensitive method for detection of biomolecules includes the step of providing a plurality of bioreceptor functionalized nanoparticle probes. The nanoparticles can include metal, semiconductor, radioactive isotope or fluorescent dye molecules. A sample solution suspected of including the target is contacted with the probes, wherein if present, the target binds to the bioreceptor. After such binding a separating step follows. In the separating step, probes having the target bound thereto are separated from probes not having the target bound thereto. In one embodiment probes having the target bound thereto are then decomposed to generate ions, or broken into discrete radioactive isotopes or fluorescent dye molecules to form a solution including a large plurality of metal ions, radioactive isotopes or dye molecules.

Abstract: Provided are an agglutination-inhibition assay and a reagent for agglutination-inhibition assay, which can be used for measuring a ligand in a sample at high sensitivity in a wide range from the low-concentration range to the high-concentration range and have good reproducibility of measurement. Specifically, provided are an agglutination-inhibition assay and a reagent for agglutination-inhibition assay, in which used are an insoluble carrier particle carrying a ligand, a specific receptor in the free-form and an insoluble carrier particle carrying a specific receptor which binds to a different site on the ligand than the receptor in the free-form.

Abstract: This invention relates to a continuous or batch centrifugation solid-liquid separation process comprising simultaneously subjecting the solid-liquid mixture to localized magnetic field gradients and the centrifugation and to improved centrifugation solid-liquid separation processes wherein the improvement comprises simultaneously subjecting the solid-liquid mixture to a homogeneous magnetic field, a magnetic field gradient or both prior to and/or during the centrifugation.

Abstract: A method and kit for assaying a cell sample for the presence of at least a threshold number of cells of a given type are disclosed. The kit includes an assay device having a sample chamber for receiving the cell sample and an elongate collection chamber containing a selected-density and/or viscosity medium and having along its length, a plurality of cell-collection regions, and particles which are capable of specific attachment to cells of the selected cell type, and which are effective, when attached to the cells, to increase the density or magnetic susceptibility of the cells. In operation, particle-bound cells and particles in the cell sample are drawn through the elongate collection chamber under the influence of a gravitational or selected centrifugal or magnetic-field force until the particle-bound cells and particles completely fill successive cell-collection regions in the collection chamber.

Abstract: Ultrasound-assisted particle agglutination assay methods and apparatuses are described based on first providing a standing wave ultrasound field at a resonance frequency of a test liquid in a resonator cell containing microparticles covered with a binding agent with high affinity to an analyte sought to be detected by the assay test. Formation of the specifically-bound and nonspecifically-bound aggregates of these microparticles is then followed by effective stirring of the liquid with swept-frequency sonication causing disintegration of nonspecifically-bound aggregates and leaving specifically-bound aggregates in place for further detection and measurement. The methods and devices of the invention allow significant improvement in the sensitivity and specificity of agglutination tests and are advantageously applicable to detecting various proteins, DNA, RNA and other biologically active substances. Specific examples are provided.

Abstract: The invention is directed to methods of screening for HLA antibodies comprising detecting antibodies specific for native HLA antigens and denatured HLA antigens. The invention also provides for method of predicting whether a transplant recipient has an increased risk for rejecting the transplanted organ.

Abstract: The present invention provides an active assay method for detecting a biological analyte. According to the method, a probe molecule is immobilized on a surface. An analyte is then placed in fluidic connection with the probe molecule on the surface. A force is then applied to the analyte to move it toward the surface to facilitate contact and possibly binding of the analyte to the probe. Optionally, another force can be applied or the force can be reversed, to remove unbound or weakly bound analyte from the surface. Analyte that remains bound to the surface is then detected. The detection can include rolling or sliding beads over an analyte and/or probe on a substrate, and detecting bound beads. The present invention furthermore, provides devices, such as electrophoresis apparatuses and biochip assemblies, for carrying out the methods of the invention.

Abstract: Device and method for detecting the presence of known or unknown toxic agents in a fluid sample. Targets in the sample are bound to releasable receptors immobilized in a reaction region of a micro- or nano-fluidic device. The receptors are selected based on their affinity for classes of known toxic agents. The receptors are freed and the bound and unbound receptors separated based on differential electrokinetic mobilities while they travel to a detection device.

Abstract: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: The enumeration of cells in fluids by flow cytometry is widely used across many disciplines such as assessment of leukocyte subsets in different bodily fluids or of bacterial contamination in environmental samples, food products and bodily fluids. For many applications the cost, size and complexity of the instruments prevents wider use, for example, CD4 analysis in HIV monitoring in resource-poor countries. The novel device, methods and algorithms disclosed herein largely overcome these limitations. Briefly, all cells in a biological sample are fluorescently labeled, but only the target cells are also magnetically labeled. The labeled sample, in a chamber or cuvet, is placed between two wedge-shaped magnets to selectively move the magnetically labeled cells to the observation surface of the cuvet. An LED illuminates the cells and a CCD camera captures the images of the fluorescent light emitted by the target cells.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: New applications for the use of distinguishable particulate labels available in a variety of hues and sized in the submicron range are described. These applications include profiling of cellular components, obtaining secretion patterns, identifying a multiplicity of components in chromatographic or electrophoretic techniques and identification of desired immunoglobulin secreting cells.

Abstract: Assays, such as immunoassays, and related articles are disclosed.

Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: Disclosed is number coding of pairs (“doublets”) or small sets (“multiplets”) of solid phase carriers which provides distinguishable subtypes of a given type of such carriers, where each carrier type is distinguishable on the basis of a different code. Such number coding is useful for augmenting a coding system, such as a color code, and thereby effectively multiplying the number of “colors” (distinguishable sub-types). It can be applied, for example, to determine whether a sample is homozygous or heterozygous at a number of different sites for one of two different alleles, where the same color code is applied for each of the two alleles, and the alleles with the same color code are distinguished by knowing how many carriers are associated with molecules which detect each different allele.

Abstract: A method to determine specificity of ligand binding includes comparing a solid phase carrier first extract obtained by pre-treating a sample with a ligand-immobilized solid phase carrier and a solid phase carrier second extract obtained by treating the pretreated sample again with a ligand-immobilized solid phase carrier in terms of the proteins contained therein, and identifying a protein whose content is remarkably decreased in the second extract compared to the first extract, in order to solve 1) the problem of the solubility of subject ligand, 2) the problem of the non-specific protein-denaturing effect of the subject ligand added, and the like, in antagonism experiments in target search using an affinity resin.

Abstract: The present invention provides methods, diagnostic assays, and diagnostic kits based on said methods, to determine levels of immunosuppressive complexes containing immunosuppressive drugs tacrolimus, sirolimus and cyclosporine A separately and in combination, formed in the blood of a drug-treated patient or in a patient candidate to immunosuppressive drug therapy. These methods, assays and kits are especially useful when using automated systems.

Abstract: A negative isolation method for separately isolating preparations of Th1 and Th2 helper lymphocytes from peripheral blood mononuclear cells involving the use of novel combinations of monoclonal antibodies to separately sequester specific Th1 and Th2 lymphocytes and contaminating leukocytes and erythrocytes, adding a magnetic colloid to the cells, and using a magnetic column for fractionation of Th1 and Th2 cells. Imbalances in the relative numbers of Th1 and Th2 lymphocytes can be used in the diagnosis and prognosis of human diseases.

Abstract: A chromatographic specific binding assay strip device, comprising: a non-permeable platform strip; a permeable membrane testing strip positioned on top of said non-permeable platform strip, with the testing strip comprising at least one capture reagent site containing a capture reagent for at least one specific analyte, a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip, a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip; a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad positioned on said supporting strip, said conjugate pad comprising a semi-permeable membrane containing a colorant conjugate.

Abstract: An object of the present invention is to provide latex particles with high production reproducibility, by which a sufficiently high value of signal ?S (=value of signal?value of noise) can be realized in immunodiagnosis.

Abstract: Elevated number of Circulating Endothelial Cells (CEC) have been implicated in disease conditions associated with the formation or destruction of blood vessels such as acute coronary syndrome, thrombocytopenic purpura, sickle cell disease, sepsis, lupus, nephrotic syndromes, rejection of organ transplants, surgical trauma and cancer. This invention provides a method for assessing the levels of CEC which vary between different studies using a sensitive enrichment, imaging, and enumberation analysis. CD146 is one of the most specific endothelium-associated cell-surface antigens which can be used in image cytometry. CEC analysis provides an essential tool in prognostic/diagnostic evaluation in the clinic.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: The present invention is related to compositions useful for the measurement of free or unbound analyte concentrations in a fluid. The present invention includes the use of capture ligands and stabilizing agents to improve the accuracy of analyte concentration assays. Methods and tools for using the present invention are also disclosed.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

Abstract: A sensitive, multicomponent diagnostic test for infection with T. cruzi, the causative agent of Chagas disease, including methods of making and methods of use. Also provided is a method for screening T. cruzi polypeptides to identify antigenic polypeptides for inclusion as components of the diagnostic test, as well as compositions containing antigenic T. cruzi polypeptides.

Abstract: The present invention provides a measurement reagent that is capable of suppressing nonspecific aggregation even when the amount of antibody to be carried is increased, and is capable of measuring in a wide measurement concentration range with high measurement sensitivity; an immunoturbidimetric assay using the same; and a method of producing thereof. A method of producing an insoluble carrier particle of the present invention is a method of producing an insoluble carrier particle carrying an antibody or an antigen on a particle surface thereof. The method includes a sensitization reaction processes in which the antibody or the antigen is brought into contact with the insoluble carrier particle in the presence of an amino acid with a charged polar side chain in a sensitization reaction solution. The insoluble carrier particles obtained by the producing method of the present invention show favorable dispersibility because nonspecific aggregation is suppressed. As can be seen from Examples 1-1 to 1-4 in FIG.

Abstract: Nanotubes and nanotube array structures comprise (a) a nanotube having an inner wall portion; and (b) a bilayer coating formed on the inner wall portions, with the bilayer coating comprised of surfactants. A secondary compound such as a protein, peptide or nucleic acid may be associated with the bilayer coating. The structures are useful for, among other things, affinity purification, catalysis, and as biochips.

Abstract: The present invention relates to immobilized procainamide analogs, as well as to a method of making immobilized procainamide analogs. These immobilized analogs are prepared by activating the carboxyl group on a substituted p-benzoic acid derivative toward nucleophilic attack; reacting the activated benzoic acid derivative with a polyamine to produce the benzoic acid derivative of Formula 3: and binding the benzoic acid derivative of Formula 3 to a latex polymer having functional groups that react with aliphatic amino groups. A method of conducting an immunoassay using the immobilized procainamide analog Formula 3 is described, comprising the steps of preparing a solution comprising said immobilized procainamide analog; adding a sample suspected of containing procainamide to said solution; adding an anti-procainamide antibody to said solution and observing the rate of increase in solution turbidity following antibody addition.

Abstract: Improved single-container, two-phase optical assays for analytes are provided which are faster and require less steps than conventional two phase optical assays. The assays of the invention involve first mixing and incubating an assay mixture including a buffer, solid particles (e.g., agarose beads), an analyte-containing sample, and an affinity agent operable to bind analyte(s) to the solid particles, followed by separation of the mixture into a particle-rich phase and a substantially particle-free phase. In one aspect, the settling step is gravity-induced and is instrumentally monitored to determine when substantially full separation has occurred. Thereafter, the respective phases may be photometrically measured to obtain qualitative and/or quantitative information about the analyte(s). It has been found that measurements taken with only one sensor set before and after settling of the particle-rich fraction give scientifically valid results as a two phase optical assay.

Abstract: The present invention provides methods of quantifying the amount or concentration of one or more peptides and/or proteins in one or more samples using differentially isotopically-labeled peptides and/or proteins. The invention also provides methods of identifying one or more peptides and/or proteins in one or more samples.

Abstract: This invention involves the nano-structured support used for separation or/and analysis, especially the chip substrate, ELISA plate substrate, planar chromatography strip and chromatography gel. Besides, it involves the functionalized nano-structured support of high sensibility for separation or/and analysis, especially the analysis-chip, ELISA plate, planar chromatography reagent strip and chromatography gel. In addition, this invention also involves the nano-structured marking system for analysis. Moreover, it concerns the test kit; especially the chip kit, ELISA kit, and planar chromatography kit. What's more, this invention involves the preparing methods and the applications of all those mentioned above, especially the chip analysis, analyses with ELISA plate, planar chromatography strip and chromatography separation.

Abstract: A fluorescent labeling reagent of the present invention includes an inorganic fluorescent particle and a material (A) having a material (B) of biological origin adsorbed or bound thereto. The inorganic fluorescent particle is integrated with the material (A) so as to form the reagent of the present invention. The inorganic fluorescent particle used in the present invention is capable of emitting light with a wavelength of 650 nm to 1600 nm in the infrared region or the near-infrared region which can be detected by means of Si—CCD or InGaAs—PD and can penetrate an H2O rich sample when excited by light with a wavelength of 650 nm or longer which has the shortest transparent wavelength of AlInGaP-LD including oxygen adsorption type hemoglobin used for DVDs etc.

Abstract: Compositions and methods for binding to assay substrata in a stable and protective manner, thereby enhancing assay performance, are provided. The compositions comprise lyotropic materials (for example, lyotropic liquid and/or liquid crystalline materials) and may contain macromolecular standards, markers or capture compounds. The compositions are capable of binding to assay substrata such as that of chips that are employed for MALDI and SELDI mass spectroscopy analyses and plates that are used for ELISA type assays.

Abstract: An adsorbent for whole blood in the form of essentially spherical non-aggregated particles. The adsorbent comprises a porous carrier material having an average pore size of ?1.5 ?m, whereby a maximum of 50% of the pore volume may be in pores having a pore size of >1.5 ?m, whereby the outer surfaces of the porous carrier material have at least one surface modification M1 so that the outer surface essentially does not interact with blood cells, and the inner surfaces of the porous carrier material, e.g., the surfaces of the pores of the porous carrier material, have at least one surface modification M2 which interacts with substances present in blood.

Abstract: Disclosed are photoluminescent particles. The particles include a core nano-sized particle of carbon and a passivation agent bound to the surface of the nanoparticle. The passivation agent can be, for instance, a polymeric material. The passivation agent can also be derivatized for particular applications. For example, the photoluminescent carbon nanoparticles can be derivatized to recognize and bind to a target material, for instance a biologically active material, a pollutant, or a surface receptor on a tissue or cell surface, such as in a tagging or staining protocol.

Abstract: The present invention relates to multi-polymer-coated magnetic nanoclusters, aqueous magnetic fluids comprising same, and methods of their use in separation procedures. The multi-polymer-coated magnetic nanoclusters comprise a super paramagnetic core, with a first polymer attached thereto, which does not render the first polymer-super paramagnetic particle complex colloidally stable, and a second polymer attached thereto, which stabilizes the complex of multi-polymer-coated magnetic nanoparticles. Methods of use comprise methods of separation, including separation of expressed protein from cells and viruses expressing the same.