Abstract: Novel biofunctionalized quantum dots include a mercaptoalkanoic acid linked to the surface of a nanocrystalline core and a bio-functional group linked to the surface. Biofunctionalized quantum dots are made by a novel synthesis method. Biofunctionalized quantum dots can be used in imaging or therapy applications.

Abstract: The present invention relates generally to glutathione derivatized beads which are adapted for use in conjunction with glutathione-S-transferase fusion proteins (generally, GST fusion proteins, which contain a fluorescent label such as fluorescent green protein) for use in flow cytometry. The present invention also relates to methods for detecting and/or quantifying interactions between a GST fusion protein and their binding partners, in particular, labeled binding partners such as fluorescently labeled binding partners. By creating glutathione beads with an appropriate high or increased site density, disadvantages often associated with low affinity systems and quick off-rates in solution may be resolved to provide a workable system and method. Methods of identifying potential agonists, antagonists and regulator compounds of proteins fused to GST from libraries of compounds represents another aspect of the present invention.

Abstract: Arrays of microparticle populations, each population labeled with a single fluorescent dye, are provided for use in multiplex assays. The populations form a virtual multidimensional array wherein each microparticle is identified by fluorescence intensity in two different fluorescence detection channels. The arrays are useful in a variety of assays, including multiplex, multi-analyte assays for the simultaneous detection of two or more analytes by, for example, flow cytometry, and a labeling reagents in, for example, microscopy. The use of singly-dyed microparticles to form multidimensional arrays greatly simplifies the creation of multiplex assays.

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: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

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: Microplates containing spherical “microsphere” fluorescence standards are disclosed. The microplates can be prepared using several methods including airbrushing, application with an inkjet printer, or controlled evaporation. Spherical bead standards containing two or more regions stained with dyes of different fluorescence lifetimes, and methods for their preparation are also disclosed. The microplates can be used as calibration standards for fluorescence and confocal microscopes, and as calibration tools for microscope-based high content screening (“HCS”) instruments.

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: The invention relates to a device for detecting one or several analytes in a sample, characterized in that it comprises one or more reaction chambers and/or one or more reagent application channels, and one or more capillary systems and one or more negative vessels. The invention also relates to a method for detecting one or more analytes in a sample fluid by visualization of agglutination, characterized in that a) the sample fluid is brought into contact with a reagent, b) the reaction mixture is exposed to the effects of gravitation or magnetism, wherein the reaction mixture is strained through the capillary system of the inventive device with a negative vessel connected to the inventive device, and c) the reaction between the analyte and the reagent is determined. The invention also relates to one such method wherein the reaction mixture is brought into contact with another reagent during step b).

Abstract: A container having a flexible wall receives a continuous flow of a biological fluid that includes a target antigen and emits a continuous flow of the biological fluid at least partially depleted from the target antigen. The container further comprises a compartment with magnetic beads coupled to an affinity marker that binds the target antigen, and the target antigen is separated from the biological fluid using a magnetic force and an automatic mechanical force, wherein at least one of the magnetic force and automatic mechanical force is transmitted through the flexible wall.

Abstract: Methods and apparatus for analyzing bioprocess fluids are provided. A plurality of particles coated with a plurality of capture agents having an affinity for one or more biological markers is combined with bioprocess fluid to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to a sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.

Abstract: A method for measuring an analyte in a whole blood sample comprising the steps of (1) bringing the whole blood sample into contact with a first substance which is carried on an insoluble carrier and specifically binds to the analyte to be measured and a second substance which is labeled with an alkaline phosphatase and specifically binds to the analyte to be measured, and (2) measuring a resulting complex on the basis of an enzyme reaction of the alkaline phosphatase, the measuring step (2) being carried out in the presence of an inhibitor of endogenous alkaline phosphatases, is disclosed.

Abstract: The present invention relates to sensitive SE(R)RS based methods for detecting analytes such as explosives and drugs, which may be present in a sample at extremely low levels. The methods may be generally carried out in situ employing novel chemistry which is compatible with flow-cell technology and with time-scales and concentrations required for rapid and informative screening of large numbers of samples. The present invention also relates to novel compounds e.g. synthons and apparatus for use with the methods disclosed.

Abstract: An object of the present invention is to provide a method utilizing a carrier for measuring hyaluronic acid wherein deposition of carrier is less, a storage stability is good and an accuracy in measurement has same high degree as that performed by the conventional reagents, and a reagent kit for the same. Also, the present invention relates to “a method for measuring hyaluronic acid, comprising forming a hyaluronic acid/HABP complex by contacting hyaluronic acid in a sample with HABP, reacting said complex with an anti-HABP antibody-supported carrier, measuring optical change by agglutination product generated by said reaction and calculating the quantity of hyaluronic acid from the measured value” and “a reagent kit for the measurement of hyaluronic acid comprising a reagent comprising a hyaluronic acid binding protein and a reagent comprising an anti-hyaluronic acid binding protein antibody-supported carrier”.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover even rare cell types in high yield.

Abstract: The invention relates to a method of assessing the risk of suffering from atherosclerosis in an individual comprising removing anti-lipoprotein immune complexes from a sample from the individual, measuring the level of cholesterol/lipoprotein associated with said anti-lipoprotein immune complexes, and determining thereby the risk of atherosclerosis in the individual.

Abstract: Methods, compositions and kits are disclosed. The compositions are light emitting and comprise a polymeric matrix having dissolved therein a photoactive compound. The composition has the characteristic that, after activation of the photoactive compound, the rate of decrease in the intensity of light emission at any time during a 20-fold decrease in the intensity is proportional to the intensity of the light emission. In one embodiment the polymeric matrix is comprised of particles of about 20 nm to about 100 ?m in diameter to which is bound a specific binding pair member. The particles generally comprise a polymeric matrix having dissolved therein about 1 to about 20% by weight of a dopant. The compositions may be used in methods for determining an analyte. A combination is provided comprising (1) a medium suspected of containing the analyte, (2) and the aforementioned composition. The photoactive substance is activated and the effect of the activating on the optical properties of the combination is detected.

Abstract: Compositions suitable for use as signal generation components of an immunoassay, and methods for their use. According to one aspect of the invention, the composition includes a carrier having a coating of an aminodextran and a metal chelate incorporated therein. The metal chelate is present in the amount of at least 0.065 ?Mole per gram of carrier, and the aminodextran coating density averaging at least about 45 ?g per milligram of carrier. In another aspect of the invention, carrier is dyed with a complex having the formula: M(L1)x(L2)y, wherein M is a metal selected from the group consisting of europium, terbium, dysprosium, samarium, osmium and ruthenium; L1 is a ligand selected from the group consisting of DPP, TOPO, TPPO; L2 comprises a ligand having the formula wherein R is one or more substituents, each substituent comprising an electron donating group; n=2-10; x=1-2; and y=2-4.

Abstract: The use of probe arrays in which probes of various biological substances such as DNA are immobilized on the surface of a solid is becoming established as an effective means for high-speed screening. Different kinds of probes, such as DNA, are immobilized on the surface of a multiple number of independently treatable fine particles, such as beads, instead of the surface of a single solid, and the resulting beads are aligned in a capillary or a cell in a designated order. The size of the area where one probe is immobilized is reduced. The bead probe array is characterized in that such small beads are aligned one by one in a designated manner using a sheet with holes, and one or a multiple number of beads are held in the holes and then transferred to a probe array holder such as a capillary.

Abstract: Fetal blood multi-lineage progenitor cells that are capable of a wide spectrum of transdifferentiation are described.

Abstract: A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a chromatographic zone on which is disposed a plurality of microporous particles. The chromatographic zone can effectively reduce the “hook effect” in a simple, efficient, and relatively inexpensive manner. In particular, the plurality of microporous particles allows larger-sized analyte/probe complexes to reach the detection zone before the uncomplexed analyte. Because the uncomplexed analyte is substantially inhibited from competing with the complexes for the binding sites at the detection zone, the incidence of “false negatives” may be limited, even at relatively high analyte concentrations.

Abstract: Methods and compositions comprising immunoassays for the detection of antigens and antibodies in a sample are described. In particular, the present invention provides assays that are useful for the rapid and simultaneous detection of multiple different antigens and antibodies. In preferred embodiments, the assays include fluorescent labels of multiple wavelengths or intensities, which are used to label the antigens and antibodies directly and to label beads coated with molecules specific for the antigen or antibody. The detection of a fluorescence shift indicates the presence or identity of the antigen or antibody in the sample.

Abstract: The present invention discloses a nano-cluster that includes a plurality of nano-particles, wherein the nano-particles can disperse in response to an environmental cue. Also disclosed is a method of preventing, treating, or diagnosing a disease or condition in a subject comprising administering a therapeutically effective amount of a composition comprising nano-clusters of the present invention.

Abstract: A system for the rapid characterization of analytes in saliva. In one embodiment, a system for detecting analytes includes a light source, a sensor array, and a detector. The sensor array is formed from a supporting member, in which a plurality of cavities may be formed. A series of chemically sensitive particles, in one embodiment, are positioned within the cavities. The particles may produce a signal when a receptor, coupled to the particle, interacts with the cardiovascular risk factor analyte and the particle-analyte complex is visualized using a visualization reagent. Using pattern recognition techniques, the analytes within a multi-analyte fluid may be characterized. In an embodiment, each cavity of the plurality of cavities is designed to capture and contain a specific size particle. Flexible projections may be positioned over each of the cavities to provide retention of the particles in the cavities.

Abstract: This invention provides methods of using ion-detecting microspheres containing an ionphore and a chromoionphore in clinical laboratory instrumentation such as flow cytometry for sample analysis. In one embodiment, the microspheres are contacted with a flowing stream of a sample under conditions that allow the ion-selective ionophores to complex with the ions in the sample, and to cause deprotonation of the chromoionophore. The complexes are then exposed to an excitation wavelength light source suitable for exciting the deprotonated chromoionophore to emit a fluorescence signal pattern. Detection of the fluorescence signal pattern emitted by the deprotonated chromoionophore in microspheres containing the complexes allows for determination of the presence of the target ions in the sample. In one embodiment, lead ion-detecting microspheres are provided that can detect nanomolar levels of lead ions with response times on the order of minutes.

Abstract: Methods for detecting analytes in a sample are provided. A plurality of particles, each of which is coated with a capture agent having an affinity for the analyte, is combined with the sample to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to the sensor surface, and a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.

Abstract: This invention pertains to a surface ligand; preparation of the ligand; colloidal nanoparticle, such as quantum dot bearing one or more of the ligand; and a bioconjugate characterized by a nanoparticle bearing one or more of the ligand conjugated to a biomolecule. The ligand is characterized by the presence of a first module containing atoms that can attach to an inorganic surface; a second module that imparts water-solubility to the ligand and to the inorganic surface that may be attached to the ligand; and a third module that contains a functional group that can, directly or indirectly, conjugate to a biomolecule. Order of the modules can be different and other modules and groups can be on the ligand. Preparation of the ligand includes the steps of reacting a compound having atoms that can attach to an inorganic surface with a water-solubilizing compound that imparts the property of water-solubility to the ligand and the inorganic surface to which it may be attached and purification thereof.

Abstract: The present invention provides a method of analyzing the specific interaction between a molecule to be analyzed and a molecule that specifically interacts with the former molecule on a solid phase using a molecule-immobilized solid phase support mixture prepared by binding the subject molecule to the solid phase support without specifying the binding position on the molecule side, particularly a method wherein the immobilization is conducted via a spacer introduced to the molecule without specifying the binding position on the molecule side, which method makes it possible to identify and select only a molecule that exhibits a specific interaction with a molecule to be analyzed, without an investigation of structure-activity correlation, which has conventionally been essential, and hence enables an analysis of the interaction between these molecules.

Abstract: Removal of abundant proteins from a sample enhances detection and resolution of less abundant proteins in the sample such as in two-dimensional gel electrophoresis. The removal is accomplished by immunosubtraction of several high abundance, interfering or contaminating proteins simultaneously.

Abstract: Methods for detecting viruses are provided. A plurality of particles, each of which is coated with a capture agent having an affinity for the virus, is combined with the sample to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.

Abstract: It is an object of the present invention to provide magnetic substance-encapsulated particles which have uniform magnetism, high dispersion stability and a narrow particle size distribution, a method of producing the same, particles for immunoassay formed by using the magnetic substance-encapsulated particles and a method of immunoassay in which the magnetic substance-encapsulated particles or the particles for immunoassay are used. The present invention relates to a magnetic substance-encapsulated particle, which comprises an organic polymer material and a magnetic substance having an average particle size of 1 to 30 nm, the magnetic substance being contained within a particle in a state of being dispersed.

Abstract: Methods for detecting bacteria are provided. A plurality of particles, each of which is coated with a capture agent having an affinity for the bacteria, is combined with the sample to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.

Abstract: Fetal blood multi-lineage progenitor cells that are capable of a wide spectrum of transdifferentiation are described.

Abstract: Analyzers and methods of analysis are described for performing blood cell counting and immunoassay on a whole blood specimen in one measurement section. An assay sample is prepared by blending carrier particles sensitized with an antibody or an antigen against a substance to be immunoassayed and a fluorescent dye for staining blood cells with the whole blood specimen. Optical information is detected from a particle in the assay sample, and the blood cells are differentiated and counted based on the detected optical information. A rate of agglutination of the carrier particles is obtained based on the detected optical information, thereby enabling detection of the substance to be immunoassayed.

Abstract: Methods for detecting estradiol and metabolites thereof in a sample are provided. A plurality of particles, each of which is coated with a capture agent having an affinity for estradiol, is combined with the sample to form a plurality of estradiol-particle complexes. The system also includes a transport arrangement for transporting the sample and/or particles to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of estradiol-particle complexes that are bound to the sensor surface.

Abstract: Methods for therapeutic drug monitoring are provided. A plurality of particles, each of which is coated with a capture agent capable of binding a therapeutic drug of choice is combined with the sample to form a plurality of therapeutic drug-particle complexes. The system also includes a transport arrangement for transporting the sample and/or particles to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of therapeutic drug-particle complexes that are bound to the sensor surface.

Abstract: This invention relates to the field of biological assays where cells can be classified and enumerated using flow cytometry optical instrumentation. The invention combines information from multi-angle, light scatter from the cell itself and multi-angle light scatter from small, optically resonant particles that are selectively bound to surface molecules on the cell to carry out classification and enumeration. This light scatter method enables an instrumentation system that is simple to use, inexpensive to build, and mechanically robust; making it suitable for use in remote clinical environments.

Abstract: Using two types of antibodies, i.e., a first antibody having a higher affinity for a target substance than for a competitive substance and a second antibody having a higher affinity for the competitive substance than for the target substance, a specimen is treated with these two antibodies. Then, the competitive substance in the specimen first binds to the second antibody and thus the ratio of the target substance to the competitive substance in the specimen is enlarged. As a result, the target substance becomes liable to bind to the first antibody and, in its turn, the reactivity of the target substance is elevated compared with the case of using the first antibody alone. Thus, the target substance in the specimen can be accurately assayed while avoiding the effects of the competitive substance contained in the specimen.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: Disclosed are ionic gel-coated beads (including Hydrogel™-coated beads), which are capable of adsorbing, or absorbing, proteins and other biomolecules onto or into the gel coating. The gel-coated beads with absorbed or adsorbed biomolecules are suitable for use in an assays, purification or other purposes. The beads have a core made from any of a number of materials, including latex, coated with the gel shell. The biomolecules can be retained within the gel, following adsorption, by covalent attachment, or, by selection of conditions of ambient pH and/or ionic strength such that they are retained without further reaction. Therefore, adsorbed proteins would retain the ability to bind to their respective ligands.

Abstract: An infrared fluorescent particle comprising a functional group or a substance that is capable of binding to an analyte, wherein fluorescence at infrared wavelength is emitted from the particle upon exposure of the particle to excitation light at infrared wavelength. The infrared fluorescent particle of the present invention is capable of binding to the analyte. Due to a high penetration of the fluorescence and the excitation light into biological substances, the infrared fluorescent particle of the present invention can reduce an influence of luminescence, light absorption or light scattering which is occurred due to the analyte and the surrounding substances.

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: 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 method for performing an immunoassay is described. The method is particularly useful for detecting extracellular polysaccharide (EPS) and/or lipopolysaccharide (LPS) producing microorganisms. The method is particularly useful for detecting microorganisms which produce extracellular polysaccharides (EPS) also known as exocellular polysaccharides, capsule, and/or lipopolysaccharides (LPS). In a preferred method for detecting microorganisms which produce EPS, LPS, or both, the EPS and/or LPS is extracted from a sample with cetyltrimethylammonium bromide (CTAB) to produce molecular aggregates which are then preferentially bound to colored polystyrene latex particles over other components in the sample, and the bound EPS and/or LPS detected using a lateral flow immunoassay apparatus which has immobilized thereon antibodies specific for the EPS and/or LPS. The method can also be used to detect particular viruses, for example viruses of the potyviridae or tobamoviridae group.

Abstract: The present invention is to provide a simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, comprising the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, comprising (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: Heterogeneous assays for different analytes in a single biological sample are performed simultaneously in a multiplexed assay that combines flow cytometry with the use of magnetic particles as the solid phase and yields an individual result for each analyte. The particles are distinguishable from each other by characteristics that permit them to be differentiated into groups, each group carrying an assay reagent bonded to the particle surface that is distinct from the assay reagents of particles in other groups. The magnetic particles facilitate separation of the solid and liquid phases, permitting the assays to be performed by automated equipment. Assays are also disclosed for the simultaneous detection of antibodies of different classes and a common antigen specificity or of a common class and different antigen specificities.

Abstract: The present invention relates to a method of transporting an analyte present in a sample, to a method of concentrating an analyte present in a sample, and to a device for implementing these methods. In the method of transporting an analyte present in a sample of the present invention, a solution A in which the analyte is attached to magnetic particles is prepared from the sample; the solution A is introduced into a first container connected via a bottleneck to a second container; and the analyte attached to the magnetic particles is moved, by means of a magnetic system, from the first container to the second container via the bottleneck, the second container being filled with all or part of the solution A and/or with another solution.

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 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.