Abstract: The invention concerns a method for the immunological determination of an analyte on a chromatographic test strip containing one or several absorbent matrices on a carrier material which are in liquid-transferring contact with one another wherein the matrices form an application zone at one end and a suction zone at the other end of the carrier material, a conjugate zone in the application zone or adjoining the application zone which contains a visually detectable, particle-labelled analyte binding partner, a chromatographic zone adjoining the conjugate zone and a capture zone between the chromatographic zone and suction zone wherein the capture zone contains solid phase-bound binding partners for the analyte or for an unlabelled analyte-specific binding partner by applying the analyte solution to the application zone and measuring the bound label in the capture zone as a measure of the analyte characterized in that a fluorescent dye is applied to the application zone or to a matrix between the application zo

Abstract: An immunity testing device formed of a thin sheet of material folded to three portions, and the two end portions; named “front cover”0 and “back cover”; fold back to different sides of the center part; named base seat; to provide protection on both sides of the base seat. Two absorbent sheets bridged with a test paper are fixed on the side of base seat that's facing the front cover. A hole is present at the position of the first absorbent sheet on base seat for specimen application. The front cover is disposed with observation cover plates at the position corresponding to the test paper and/or water-absorbing sheets for observation of test result as well as for preventing pollution before, and after use. The test paper is pre-embedded with antibodies/antigens to capture the corresponding antigens/antibodies in the test specimen as in Immunity method. The used testing device can be burned down to ensure environmental protection.

Abstract: The invention provides an improved test cell for detecting the presence of an analyte in a liquid sample. The device has an elongate casing defining a liquid sample inlet, a reservoir volume, a test volume, and a window through the casing at the test volume. Disposed within the cell is a sample absorbent, a novel biphasic substrate and a reservoir, together capable of transporting an aqueous solution within the casing along a flow path extending from the sample inlet through the test volume and into the reservoir volume. The invention further comprises a method for detecting the presence of an analyte in a liquid sample using the device and a biphasic chromatographic material for carrying out the method.

Abstract: Self-testing for a disease or physiological condition is achieved by having the individual being tested obtain a sample of physiological fluid, e.g., blood, urine, sputum or saliva, from him or herself. The sample is introduced into an assay system which produces a coded pattern indicative of the presence or a different coded pattern indicative of the absence of the disease or physiological condition. The individual then transmits the coded pattern to a remote location, for example by making a telephone call to an interpretation center, and receives from the remote location an interpretation of the coded pattern together with any counseling which may be appropriate in view of the interpretation of the coded pattern. The coded patterns are selected such that the individual may not interpret the test results without consulting the interpretation center.

Abstract: Assay devices, kits, and methods for detection of one or more analytes in a sample are provided. The assay device features the controlled release of reagents and hence is particularly suitable for binding assays such as immunoassays. The assay device achieves greater sensitivity than conventional rapid test assays, leading to stronger visual signals than those produced by conventional devices, easier interpretation of results, and reduced occurrence of indeterminate results. The device can be used for detecting analyte in a variety of biological samples without the need for conventional sample filtration techniques, and thus is suitable for use by untrained personnel without specialized equipment. In addition, the device can be used to simultaneously analyze a number of analytes using a single sample.

Abstract: A method is disclosed for producing a soluble conjugate vaccine, and preferably protein/polysaccharide conjugates. In this process, the polysaccharide is reacted with a reagent so as to provide a functional group on the polysaccharide molecule. Once the functional group is in place, the polysaccharide is reacted with a homobifunctional or heterobifunctional vinylsulfone to produce a vinylsulfone derivatized polysaccharide. Thereafter, the vinylsulfone derivatized polysaccharide is reacted with a protein to produce the conjugate. If desired, the protein may be derivatized with a functional group prior to the conjugation reaction step. In an alternative embodiment, the protein may be functionalized with a reactive group and then derivatized with the vinylsulfone group to produce a vinylsulfone derivatized protein. This protein may then be reacted with a polysaccharide to produce the conjugate. Optionally, the polysaccharide may be functionalized with a reactive group prior to the conjugation reaction.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

Abstract: Microporous solid phase materials that are suitable for lateral flow and other assays for detecting the presence of analytes in test samples, that are stable under variations in humidity and, even after storage for extended periods of time, can form stable covalent bonds with molecules containing a free primary or secondary amine group or sulfhydryl group are described. The invention further concerns chemically derivatized solid phase materials, and conjugates comprising such materials. Examples of lateral flow devices for the quantitative or semi-quantitative determination of an analyte in a biological sample are described.

Abstract: Disclosed is an improvement to a dry assay device for determining the concentration of a first analyte in a sample of body fluid and a second analyte in the same sample of body fluid. The device involves the use of a strip of an absorbent material through which the sample of body fluid flows and wherein the first analyte is determined calorimetrically in a first region of the strip and the second analyte is determined by an immunoassay which takes place in a second region of the strip located downstream from the first region. The improvement involves placing the strip in a hollow casing having a top and a bottom and which is so constructed that when the top and bottom of the casing are mated there is formed a U shaped, body fluid impervious barrier around the first region of the strip to prevent the sample of body fluid from flowing in any direction other than in the direction of the second region of the strip.

Abstract: The present invention encompasses a capture membrane comprising a porous filter membrane having a hapten bound directly or indirectly to the membrane wherein complexes formed by specific binding having an anti-hapten bound to a binding member of the specifically binding complex are removed from a solution by the hapten as the solution passes through the membrane. In the preferred embodiment biotin is the hapten and avidin or streptavidin is the anti-hapten.

Abstract: The present invention involves an optical assay device and method of use for the detection of an analyte of interest in a sample that conveniently allows control of the flow characteristics of the sample through the device without significant user intervention. The optical assay device includes a base having an absorbent material, and a member having an optically active test stack that is rotatably coupled to the base for rotation between a lowered position and a raised position. In the lowered position, the optically active test stack contacts the absorbent material for drawing the sample through the surface. In the raised position, the optically active test stack does not contact the absorbent material.

Abstract: The present invention provides a method and a composition for detecting the levels of a plurality of biomolecular probes in a sample. In particular, the invention relates to a hybridization composition for detecting the presence or levels of different polynucleotide sequences in a sample.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the. sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test results determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and an insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: The present invention provides a viscometric method of detecting the presence or absence of an analyte in a solution. The method utilizes a dispersion of a conjugate and a receptor. The conjugate functions as an analog of the analyte, and the receptor can interact with both the analyte and the conjugate to change the viscosity of the dispersion. The test solution is introduced into an aliquot of the dispersion. Equivalent spots of the dispersion and the aliquot containing the analyte within the dispersion are then placed on a substrate such that the spots can spread upon the substrate. The presence of analyte in the test solution is detected by noting a change in the viscosity of the dispersion through a comparison of the spots. To facilitate the method, the invention provides a test kit comprising a conjugate comprising an analog of the analyte, a receptor binding the analog and the analyte, and a substrate upon which spots of liquid can spread.

Abstract: A hand held, self-contained, automatic, low power and rapid sensor platform for detecting and quantifying a plurality of analytes. A sample solution potentially containing an unknown amount of an analyte is passed through an affinity column which contains antibodies to which the analyte binds thereby extracting the analyte. The affinity column is then rinsed to remove any other chemicals that may fluoresce. The rinsed affinity column is then eluted with a known volume of elution fluid causing the analyte to release from the antibody and dissolve in the fluid (eluant). The eluant is then placed in the quartz cuvette of a fluorometer. The analyte suspended in the eluant fluoresces at a waveband which is different than that of the light source that excites it. The amount of fluorescence is measured and the level of analyte determined.

Abstract: A magnetic focusing immunosensor for the detection of pathogens comprising a laser, an exciting fiber and a collecting fiber, a fiber optic magnetic probe in communication with the collecting and exciting fibers and means for detecting, collecting and measuring fluorescent signals in communication with the collecting fiber. The probe and the collecting and exciting fibers are configured to focus paramagnetic microspheres attached to antigen/antibody/optically labeled complexes in a predetermined pattern in the field of view of the collecting fiber while blocking background interference.

Abstract: Immobilization of SH group-containing compounds on a solvent-insoluble support is carried out in the presence of an antioxidant to prevent oxidation of SH groups to S—S bonds. This improves immobilization efficiency and suppresses deterioration of inherent characteristics of the SH group-containing compound. Antioxidants include sodium pyrosulfite (sodium disulfite), sodium sulfite, sodium hydrogensulfite, sodium hydrosulfite and L-ascorbic acid. SH group-containing compounds include cysteine, peptides or proteins containing cysteine and thiol compounds such as ethanethiol, aminoethanethiol, benzylthiol and thiophenol. Preferably, the SH group-containing compound has a molecular weight not more than 3×104. The support may be activated by a functional group such as glycidyl, imidocarbonato, tosyl, tresyl, carboxyl, amino, azido or hydroxyl. The support can be inorganic such as glass beads or organic such as a synthetic polymer or a polysaccharide.

Abstract: The invention describes the particles comprising an energy donor as a first component and a fluorescent dye as a second component positioned in said particles at an energy exchanging distance from one another, wherein the two components have a Stokes shift of greater than or equal to 50 nm, said particle having bound on its surface, a protein, polypeptide, nucleic acid, nucleotide or protein containing ligand analogue are disclosed and claimed. In addition, novel fluorescent dyes are described which exhibit intramolecular energy transfer for use to label various molecules, proteins, polypeptides, nucleotides and nucleic acids or to incorporate into particles.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: A device that provides for both the collection of saliva and detection of at least one analyte therein, e.g., a drug, is provided. This device provides for rapid analysis of saliva samples, while also providing a convenient assay method that does not require the addition of extraneous reagents, or other materials. Thereby, this device can be used by non-laboratory personnel without risk of user introduced errors.

Abstract: A test device for detecting or determining an analyte in a test solution includes an absorbent material having separate contact, competitive binding, and measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The competitive binding portion has a binding material for the analyte non-diffusively bound thereto. The measurement portion has a receptor for the analyte and marker-encapsulating liposomes non-diffusively bound thereto. In a method for using the test device, a solution containing the analyte and the analyte-liposome conjugate is allowed to traverse the absorbent material from the contact portion through the competitive binding portion and on through the measurement portion of the absorbent material. The amount of marker in the measurement portion of the absorbent material, following traversal by the test solution, is then determined as a measure of the analyte in the sample.

Abstract: A method of determining the concentration of IgG antibodies in the biological fluids of mammals. The assay may be performed in a lateral flow cassette or dipstick format where dehydrated immobilized reagents are spaced along a membrane. A sample of a mammalian biological fluid is exposed first to an IgG complexing agent to yield a conjugate. The conjugate then moves along the membrane and is exposed to a standard mammalian IgG applied to the membrane at a test position. Binding of the IgG is indicated by a color change at the test position on the membrane. A control reagent of dehydrated anti-IgG complexing agent may be applied to the membrane at the control position spaced downstream from the test position. Interaction of the IgG complexing agent with the anti-IgG complexing agent forms a visible line at the control position on the membrane.

Abstract: The invention relates to water-soluble polymeric thiosulfates, to a method for their preparation by polymer-analogous addition of tetrathionate to unsaturated polymers and to their application in surface coating.

Abstract: A method for isolating an active catalyst from a library of compounds that are potential catalysts is disclosed. The method involves providing a library which comprises a plurality of discrete solid supports, each solid support having a different organic compound bound thereto; and providing a reaction solution in a reaction vessel, the reaction solution containing the reactant or reactants necessary for a chemical reaction to occur in the presence of a catalyst for that reaction. The library and the reaction solution are then combined in the reaction vessel, and then one of the discrete solid supports is detected that is characterized by a temperature change in said solution greater than the temperature change of a plurality of other of said discrete solid supports in said solution. The detected solid support carries an active catalyst for the chemical reaction. Continuous flow apparatus for carrying out the method is also disclosed.

Abstract: A method for determining whether a subject has had a stroke and, if so, the type of stroke which includes analyzing the subject's body fluid for at least four selected markers of stroke, namely, myelin basic protein, S100 protein, neuronal specific enolase and a brain endothelial membrane protein such as thrombomodulin or a similar molecule. The data obtained from the analyses provide information as to the type of stroke, the onset of occurrence and the extent of brain damage and allow a physician to determine quickly the type of treatment required by the subject.

Abstract: The present invention provides a method and a device that utilizes capillarity-mediated, chromatographic transport, for the qualitative or semi-quantitative analysis of selected analytes in liquid samples. The device utilizes an applicator/collection device for collecting and administering the sample to the flow path such that reagent(s) flow through the applicator/collection device, washing the sample into the reaction pathway. The device farther utilizes an air gap between the initial location of the reagent and the reaction pathway to funnel the reagent efficiently through the sample so as to collect all or substantially all of the sample and make it available for the reaction(s).

Abstract: The subject invention relates to a rapid, field-portable, modular, versatile and highly reliable assay device for substances, particularly drugs of abuse, which provides a positive signal in the presence of a specific substance for which the device has been specifically adapted to test. The subject invention also concerns methods for making and using the assay device. The device is easily and reliably manufactured by laminating a series of manufactured layers to each other to form an upper card assembly and a lower card assembly. The upper card assembly is bonded to the upper side of a layer which has an immobilized reagent specific for a test substance bound thereto, and the lower card assembly is bonded to the lower side of the layer having the immobilized reagent. The device can be manufactured and distributed in a unitary, ready-to-use form.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention also provides a system and method of screening test chemicals in fluorescent assays using photon reducing agents. The present invention also provides compositions, pharmaceutical compositions, and kits for practicing these methods.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention further provides a method of determining bound and free analyte in a sample using at least one photon reducing agent. The present invention also provides a method of screening test chemicals in fluorescent assays using photon reducing agents.

Abstract: Disclosed is a method for the immobilization of an analyte such as deoxypyridinium (DPD) onto a solid support. The method involves binding an antigen-amino acid-deoxypyridinium complex to the support via an anti-antigen binding partner located in a capture zone of the solid support. Preferably, the support is nitrocellulose and the antigen has the fluorescein structure.

Abstract: Invented is a method of preparing combinatorial libraries and combinatorial libraries prepared thereby. Also invented is a method for identifying compounds having desired characteristics from a combinatorial library or a set of combinatorial libraries by the use of flow cytometry. Also invented is a method for encoding combinatorial libraries using fluorophore labeled beads.

Abstract: The present invention provides monoclonal antibodies specific for kringle 5 of apo(a) and hybridomas secreting such antibodies. The invention also relates to assay methods for directly measuring concentrations of lipoprotein(a) [Lp(a)] in a plasma sample. In one embodiment, the method involves the specific capture of Lp(a) from a plasma sample with a monoclonal antibody developed against kringle 5 of apo(a), which is non-cross-reactive with plasminogen and kringle 4 of apo(a). The quantity of the Lp(a) present in the sample is then measured by detecting the amount of Lp(a)-anti-kringle 5 complex that has formed in the reaction. Alternatively, the Lp(a) may be captured non-specifically and then detected with the monoclonal antibody specific for kringle 5 of apo(a). The invention also provides competitive assays using the above-mentioned kringle 5 specific monoclonal antibodies.

Abstract: The present invention relates to a measuring device which comprises electrodes fabricated on porous membrane substrate in which the sample migrates chromatographically; and the method of quantifying material in the sample by using the device. The sample material for measuring can be quantified by the measuring device of this invention, which is consists pretreatment bands in the lower part of porous membrane substrate and electrodes in the upper prt of pretreatment bands, by the procedure as foolows: The sample material for measuring is chromatographically migrated in the porous membrane substrate by applying the sample on the lower part of the porous membrane substrate; and then the changes of electric signal by the material at the electrode are measured to quantify the material.

Abstract: Novel activated peptides and conjugates thereof, useful in diagnostic assays and therapeutics, and processes for the preparation thereof are disclosed.

Abstract: The present invention provides novel cyclosporine C (CsC) derivatives having improved protein conjugatibility and hydrolytic stability. The present invention further provides a CsC derivative conjugated to a carrier, e.g., a solid support. Preferably, the solid support is a latex or magnetic particle.

Abstract: Boron complexes of certain bis-heterocyclic compounds are provided. The complexes resemble monomethine cyanines and are useful for imparting fluorescent properties to materials by covalent and noncovalent association. The compounds have the following general formula: wherein the dotted lines Z1 and Z2 represent the atoms necessary to complete a structure selected from the group consisting of one ring, two fused rings, and three fused rings, each said ring having five or six atoms, and each said ring comprising carbon atoms and, optionally, no more than two atoms selected from oxygen, nitrogen and sulfur, and R1 through R5 represent various atoms or groups and M is Cl or F.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention further provides a method of determining bound and free analyte in a sample using at least one photon reducing agent. The present invention also provides a method of screening test chemicals in fluorescent assays using photon reducing agents.

Abstract: This invention relates to a lateral flow immunochromatographic assay device with an increased range of sensitivity without an increase in the clearance time or the occurrence of false positive results. The indicator reagent for the analyte is located in both a separate labeling reagent region and a discrete zone of the analyte detection region.

Abstract: The antitope of an antibody is masked with a masking agent, followed by immobilization on a support. The masking agent is then eluted to produce an improved immunosorbent, which is capable of binding more than double the amount of an antigen than existing immunosorbents having the same antibody bound at the same density. Preferably, the masking agent is an antigen or other compound having an epitope for which the antitope of the bound antibody has an avidity. In a preferred embodiment, greater than 30% of the bound antibodies maintain the same vicinity as when unbound for specific antigen or hapten molecules. Preferably, the support is formed of any conventional immunosorbent support material which allows the bound and unbound antibody to maintain an avidity for the same compounds or antigens.

Abstract: The present invention relates to the field of immunoassays for metal ions. The invention presents: chelators, chelates, antibodies specific for the chelates, tracers comprising chelates conjugated to detectable labels, and immunoassays utilizing the foregoing.

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.

Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by (1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen; (2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and (3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears on both of the immunoassay plots.

Abstract: A compound having a polysaccharide binding domain such as contained by a cellulose and essentially lacking in polysaccharidase activity is purified from other ingredients in a mixture using an affinity partition system. A mixture containing the compound is contacted with a system containing as a first phase an aqueous solution of oligosaccharide polymer such as cellulose and as a second phase a solution of a polymer such as a poly(ethylene glycol)-poly(propylene glycol) copolymer. The compound petitions into the first phase and binds to the oligosaccharide polymer, preferably with a Ka of 103 to 107, to form a complex. The complex is collected, and the compound is dissociated from the oligosaccharide polymer. The compound may be formed of a non-peptide chemical moiety or a peptide moiety linked to a polypeptide having the polysaccharide binding domain.

Abstract: Methods for measuring the amount of an analyte in a membrane, by applying to the membrane a clearing agent, are disclosed. The clearing agent can be an agent that has approximately the same refractive index as the membrane; alternatively, the clearing agent can be a dissolving agent, that dissolves the membrane. The analyte can be labelled to facilitate detection. Representative labels include fluorescent labels and detectable particles.

Abstract: Devices for conducting an assay are disclosed which utilize shrink wrap as a casing material. The use of shrink wrap casings enables the preliminary fluid filtering step and the chemical detection step to be combined, provides improved control over the flow of fluids into and through the assay device and reduces the time, material, effort, expense and risk of contamination involved in conducting assays.

Abstract: The invention provides a method for measuring the amount of analyte in a sample of biological fluid using a simple low sample volume reagent test strip with a built in metering system. The test strip may include a microtitration zone to prevent oversampling and an integrated capillary to prevent problems associated with short sampling and act as means of absorbing the fluid sample. The test strip comprises a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip. The test strip is used in single use applications such as the determination of the concentration of glucose in blood.

Abstract: A test device for detecting or quantifying determining an analyte in a test solution includes an absorbent material having contact, liposome lysing and electrochemical measurement portions. The contact portion is positioned for contact with and uptake of the test solution. The liposome lysing portion is segregated from the contact portion and has a liposome lysing agent bound thereto. The liposome lysing portion is further either positioned between the contact portion and the electrochemical measurement portion, or partially or completely coincides with the electrochemical measurement portion. The electrochemical measurement portion comprises a first conductor comprising a plurality of fingers disposed on the absorbent material, and a second conductor similarly comprising a plurality of fingers disposed on the absorbent material, where the fingers of the first and second conductors are interdigitated to form an array.