Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: A diagnostic test kit for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The diagnostic kit utilizes reactive complexes to facilitate the detection of the enzyme or enzyme inhibitor. The reactive complexes include a substrate joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter and magnetic substance. In one embodiment, for example, a peptide, protein, or glycoprotein substrate is joined to a reporter (e.g., dyed latex particle) and magnetic particle. In this embodiment, the substrate provides a cleavage target for a proteolytic enzyme. Specifically, upon contacting the reactive complexes, the proteolytic enzyme cleaves the substrate and releases the reporter and/or magnetic particle. The signal exhibited by the released reporters may then be used to indicate the presence or quantity of an enzyme or enzyme inhibitor within the test sample.

Abstract: A method for detecting a substance, comprising developing a developing liquid through a test region up to a reference region, and a detection device for use therein, wherein the reference region comprises a metal compound other than an alkali metal salt, and the developing liquid that reaches the reference region contains a label that can be accumulated in the reference region. The label is preferably a colored particle, and is preferably bound to an antibody or an antigen.

Abstract: Bioelectronic devices for the detection of estrogen include a collection of eukaryotic cells which harbor a recombinant lux gene from a high temperature microorganism wherein the gene is operably linked with a heterologous promoter gene. A detectable light-emitting lux gene product is expressed in the presence of the estrogen and detected by the device.

Abstract: A simple easy to manufacture analytical device capable of performing membrane based immunoassays on batch of samples within 3 to 10 minutes wherein the method permits focused application of samples, costly labeled immunoassay and signal amplification reagents, said device includes an antibody-immobilized micro porous membrane, breadth corner layer of which is directly attached to a semi-rigid liquid-impervious body with water insoluble adhesive; absorbent body is provided separately and is not attached to analytical device during manufacture, absorbent body is wetted and is placed proximal to the lower surface of the membrane thereby forming networks of capillary channels with the absorbent body; flow of samples or reagents is always kept downwards and focused without application of any force to the absorbent body and the use of disposable adsorbent body permits stepwise addition of signal amplification reagents for ultra sensitive detection of diagnostically important molecules by visual examination of the m

Abstract: Optical bio-discs for biochemical analysis, bio-disc analysis systems and biochemical analysis methods are described herein. In one embodiment, the bio-disc includes a sample analysis circuit that includes a separation membrane for separating an investigational feature of a sample. The bio-disc also includes a conjugate release pad, and an analysis membrane containing analysis zones that may be analyzed for the presence of analytes. An analysis method includes providing a sample to a separation membrane in a bio-disc, separating an investigational feature from the sample using a separation membrane, mixing reagents that include signal elements for detecting an analyte with the investigational feature so as to form a reagent-investigational feature mixture and capturing an analyte with a signal element bound thereto in an analysis zone on an analysis membrane.

Abstract: A test device (20) for detecting human blood includes a strip (22) having an introduction station (24), a test station (26), and a control station (28) disposed in spaced apart relationship. The test sample introduction station (24) has labeled antihuman Hb antibodies, the test station (26) has immobilized antihuman Hb antibodies, and the control station has immobilized polyclonal antibodies. A test sample (500) is deposited at the introduction station (24). If human hemoglobin is present in the test sample (500), a colored line will appear at the test station (26) and at the control station (28). If no human hemoglobin is present in the test sample (500), a colored line will only appear at the control station (28).

Abstract: An assay device and method are provided which allow the determination of the presence or absence of at least one analyte in a test sample, while providing specific identification of the test subject. The assay device includes a reaction medium having at least one reaction zone and at least one control zone, which is capable of providing a pattern suitable for identifying the test subject. The pattern suitable for identifying the test subject is preferably a fingerprint. In a preferred embodiment of the invention, the reaction zone and the control zone include at least one member of a ligand/receptor pair.

Abstract: This invention provides a novel Cryptosporidium parvum protein disulfide isomerase polypeptide, and nucleic acids that encode this polypeptide. The invention also provides methods, reagents, and kits that are useful for diagnosing infection by Cryptosporidium parvum. The methods are based on the discovery of binding agents, including recombinant polyclonal antibodies, that bind to the protein disulfide isomerase polypeptide of C. parvum.

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

Abstract: 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: The release by trichomonads of a hydrolase that hydrolyzes a narrowly defined class of substrates at a low pH without interference from hydrolases that are unrelated to trichomoniasis is the basis for a selective diagnostic assay for trichomoniasis that measures hydrolysis of any of these substrates by vaginal fluid at a low pH. Selective assays for trichomoniasis are also obtained by removing particulate matter from a sample of vaginal fluid to extract a fraction devoid of particles greater than a selected size, and where desired, combining the extracted fraction with any of certain specified hydrolase inhibitors, then testing the fraction for enzymatic hydrolase activity. These qualities of trichomoniasis are the basis for a series of diagnostic tests and test devices that produce results that are detectable by visual and other means with a high degree of accuracy.

Abstract: Superparamagnetic (“SPM”) subunits of 1–30 nm average mean diameter (e.g. ferro fluid) subparticles are treated with a magnetically noninterfering substance capable of coating and covering them (e.g, BSA) and they spontaneously form agglomerates of about 100 nm to about 450 nm or higher average mean diameter and are then used to form complexes with target biological ligands such as viruses, contained in large volumes of liquid. The complexes are subjected to the gradient intensity of a strong magnetic field, and excess liquid is removed, where upon an immunochromatographic assay is conducted to determine the identity and/or amount of target ligand present, in which operation SPM particles that bonded to the ligand function as tags for ligand detection.

Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.

Abstract: The invention concerns an analytical test element for the determination of an analyte in a liquid containing an inert carrier, a detection element and a channel capable of capillary liquid transport which has a sample application opening at one end and a vent opening at the other end of the channel capable of capillary liquid transport, wherein the channel capable of capillary liquid transport is formed at least partially by the carrier and the detection element and extends in the direction of capillary transport from the sample application opening at least to the edge of the detection test element that is nearest to the vent opening and wherein a notch is located in one of the surfaces forming the channel capable of capillary liquid transport at the edge of the test element forming the sample application opening so that one side of the edge of the test element forming the sample application opening is at least partially discontinuous and the surface opposite to the notch is exposed.

Abstract: The invention suggests a method of producing an array for the detection of components from a biological sample, wherein the detection molecules are immobilized on one or more supports, said support(s) is/are embedded and subjected to curing, the support is separated into sections, and the sections are applied on another support.

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

Abstract: A self contained diagnostic test device is provided for use in the collection and detection of a biological specimen or the like. The device comprises a tubular swab and reagent dispensing cap component for receiving specimens. The reagent dispensing cap component includes barrel, reagent chamber, and results window subcomponents, and delivers one or more selected reagents to a specimen testing chamber for contacting the collected specimen, upon the rotation of the reagent chamber component.

Abstract: A method to determine the presence or absence of Streptococcus Group A antigen in a sample, comprising the following steps: extracting the antigen from the sample in an assay chamber with two or less extraction reagents, wherein the two reagents may be added to the assay chamber in no particular sequence; introducing a lateral flow immunochromatographic assay device into the extraction reagents containing the extracted antigen without further addition of reagents or manipulation of the sample; forming an antigen-indicator labeling reagent complex; and determining the presence or absence of the antigen in the sample by the presence or absence of a signal formed by the binding of the antigen-indicator labeling reagent complex to an indicator capture reagent specific for said antigen-indicator labeling reagent complex.

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: Means of conveniently examining nephropathy; and a method of assaying substance(s) in association with nephropathy (for example, podocalyxin and/or nephrin) in the urine to be used in the above means. The above assay method can be provided by releasing proteins in association with nephropathy, which exist on the surface of podocytes, from the cell surface and thus assaying the substances existing on the cell surface and/or free substances contained in the urine.

Abstract: The present invention relates to a structure comprising a biological membrane and a porous or perforated substrate, a biological membrane, a substrate, a high throughput screen, methods for production of the structure membrane and substrate, and a method for screening a large number of test compounds in a short period. More particularly it relates to a structure comprising a biological membrane adhered to a porous or perforated substrate, a biological membrane capable of adhering with high resistance seals to a substrate such as perforated glass and the ability to form sheets having predominantly an ion channel or transporter of interest, a high throughput screen for determining the effect of test compounds on ion channel or transporter activity, methods for manufacture of the structure, membrane and substrate, and a method for monitoring ion channel or transporter activity in a membrane.

Abstract: A device for analyzing immunoassays with a liquid assay medium includes a vessel for holding the assay medium. The vessel has a base comprised of a solid body having a first side wall and a top surface forming a boundary surface of the solid body. First reaction agents are dissolved in the assay medium in the vessel and are labeled with a luminophore or different luminophores and second reaction agents are bonded to the boundary surface within a boundary layer of the assay medium. A transmitter for emitting light rays is arranged so that the light rays are coupled into the base of the vessel via the first side wall and conducted at the total reflection angle to the boundary surface so that luminophore-labeled first reaction agents that are bonded to the second reaction agents are optically excited by at least some of the light rays and emit fluorescent and/or phosphorescent rays. A receiver is positioned for quantitatively detecting the fluorescent rays and/or phosphorescent rays.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: A self-contained biological indicator for evaluating the effectiveness of a sterilizer utilizing an anti-microbial gas or liquid fluid. The indicator is comprised of a tubular casing having open ends and defining an interior chamber. A source of viable microorganisms is disposed within the chamber. A frangible ampoule containing a culture medium capable of promoting growth of the microorganism and a detector means capable of reaction with the metabolites of the microorganism to produce a visual indication is disposed within the chamber. The ampule is operable by pressure applied to an external surface thereof to permit the microorganism and the medium to come into contact with each other. A cap assembly is mounted to each end of the tubular casing. Each cap assembly includes a telescoping element movable from a first position defining an opening communicating with the chamber and a second position crushing the ampoule and forming a gas/fluid impermeable seal around the chamber.

Abstract: A lateral flow method for the determination of an analyte in a sample utilizes biospecific affinity reactions. The method comprises forming a complex comprising Reactant I - - - Analyte? - - - Reactant* wherein Reactant* and Reactant I exhibit biospecific affinity to the analyte, Reactant* is analytically detectable, and Analyte? is the analyte or an analyte-related reactant, determining a detectable signal from Reactant* in the complex (sample value), and obtaining the amount of analyte in a sample by comparing the sample value with one or more calibrator values, each of which corresponds to a standard amount of analyte. Before determination of the calibrator value, either calibrator or a binder for the calibrator has been bound to a matrix and is released at the determination of calibrator value.

Abstract: Disc assay devices and methods for the detection and enumeration of microorganisms are disclosed. The devices and methods include a plurality of discs attached to a substrate and a reflector on one surface of each of the discs to reflect electromagnetic energy of selected wavelengths after the energy has passed through the disc. The reflector may be useful to improve the accuracy of detection and/or enumeration of target microorganisms on the assay devices. A system for detecting and/or enumerating target microorganisms on disc assay devices is also provided.

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 further 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: Disclosed is a device and methods for the rapid chemiluminescence assay of surfaces to detect the presence of microbial contamination. The device and methods are suitable for use by untrained personnel under the relatively harsh and variable conditions found in the field, for example in fast food restaurants and other food preparation areas. The chemiluminescence reaction that is the source of the analytical signal in the disclosed assay device and method is preferably based on a luciferase/luciferin system.

Abstract: Multifunctional, polyionic copolymers with molecular architectures and properties optimized for specific applications are synthesized on/or applied to substrate surfaces for analytical and sensing purposes. The coatings are particularly useful for suppression of non-specific interaction, adsorption or attachment of molecular or ionic components present in an analyte solution. Chemical, biochemical or biological groups that are able to recognize, interact with and bind specifically to target molecules in the material containing the analyte to be detected can be coupled to, integrated into, or absorbed to the multifunctional copolymers. These multifunctional copolymer coatings are compatible with a variety of different established methods to detect, sense and quantify the target molecule in an analyte.

Abstract: Disclosed is a device and methods for the rapid chemiluminescence assay of surfaces to detect the presence of microbial contamination. The device and methods are suitable for use by untrained personnel under the relatively harsh and variable conditions found in the field, for example in fast food restaurants and other food preparation areas. The chemiluminescence reaction that is the source of the analytical signal in the disclosed assay device and method is preferably based on a luciferase/luciferin system.

Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: The present invention relates to articles of manufacture inclusive of or in combination with a biological assay material, formed from a material capable of detecting and identifying the presence of one or more particular toxic substances, wherein said toxic substances may comprise a multiplicity of biological materials.

Abstract: A sample solution treating instrument is provided for facilitating rapid and simplified adjustment of the condition of a sample solution proper for analysis with a biosensor before supplying the solution to the biosensor. The sample solution treating instrument includes, for example, a catalyst or an adsorbent which can remove any interfering substance in order to adjust the sample solution for measurement with a biosensor.

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

Abstract: 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 colorimetrically 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 relates to bioassay materials useful for the detection of toxic substances and, more particularly, to packaging materials for food and other products, along with methods for their manufacture and use. The invention provides a unique composite material capable of detecting and identifying multiple biological materials within a single package. The biological material identification system is designed for incorporation into existing types of flexible packaging material such as polyvinylchloride or polyolefin films, and its introduction into the existing packaging infrastructure will require little or no change to present systems or procedures.

Abstract: This invention discloses a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques. In one embodiment of the invention, a test sample obtained from bodily fluids reacts with a gold labeled antigen. The resulting complex travels across the membrane, and along the lateral flow strip. Red colored lines formed in specific locations along the test strip indicate the presence of class specific antibodies in the test specimen. In another embodiment of the invention, the lateral flow assay serves as an immunochromatographic screening test for the detection of allergen-specific IgE antibodies in human serum. Test sample reacts with gold labeled anti-IgE antibody. The resulting complex travels across the membrane where immobilized allergens capture the allergen specific IgE complex.

Abstract: A device for conducting a chemical reaction comprises a body having at least first and second channels formed therein. A reaction vessel extends from the body. The reaction vessel has a reaction chamber, an inlet port connected to the reaction chamber via an inlet channel, and an outlet port connected to the reaction chamber via an outlet channel. The inlet port of the vessel is connected to the first channel in the body, and the outlet port of the vessel is connected to the second channel in the body.

Abstract: A lateral flow immunoassay device includes a membrane strip for enabling capillary migration of a sample therealong with a labeled reagent disposed on the membrane. The label reagent is formulated for suspension in the sample migrating therepast. A captive reagent is immobilized on the strip on a path of sample migration and the captive reagent is formulated to bind to the labeled reagent to form a visible colored site on the strip. An element is provided for changing the strip to a color which enhances visual perception of the colored site.

Abstract: A test device and a kit for conducting an assay for the determination of an analyte in a sample comprises (i) a housing (1,2), and within said housing, (ii) a flow matrix (6) allowing liquid to be transported by capillary action and having at least one zone with immobilized capturing agent capable of directly or indirectly binding to the analyte, (iii) a liquid container (13) for sample liquid, and (iv) at least one liquid container for liquid other than sample liquid. The device further comprises (v) separation means (5) between the flow matrix (6) and the liquid containers (13), wherein said separation means (5) are mounted in movable relationship with the liquid containers to in a first position prevent liquid contact of the flow matrix (6) with the liquid containers (13), and in a second position permit liquid receiving contact of the flow matrix (6) with the liquid containers (13).

Abstract: A method and apparatus for screening an array of test compounds for bioactivity by contacting an array of test compounds with a detector layer capable of detecting bioactivity, and detecting a detector layer response. The detector layer is comprised of physiologically viable cells. The method and apparatus allow a large number of test compounds to be simultaneously assayed in parallel without the need for complex fluidic devices.

Abstract: A mold indicator having a piece of leather, a covering over at least a first portion of the piece of leather, at least a second portion of the piece of leather not covered by the covering exposable to an environment around the mold indicator. The mold indicator including the piece of leather is untanned. The mold indicator including the covering is a layer includes anti-mold agent.

Abstract: A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Abstract: A device and method allow for detecting the presence of microorganisms in clinical and non-clinical specimens. The device, a sensor, provides an environment to culture microbial organism colonies from a fluid sample, and a means to facilitate microbial detection and quantification, either manually or with an instrument. The sensor has a microorganism immobilization matrix layer and a sensor layer. Detected microbial colonies are immediately available for further testing. The sensor provides an area for accepting a fluid sample, a mechanism to immobilize the fluid sample on an interior surface of the plate, nutrients to facilitate growth of microorganisms in the sample, and a sensor for allowing the detection and/or enumeration of microorganism colonies within the sample.

Abstract: A process challenge device and method of using the same is presented for testing the efficiency of various sterilization procedures on objects to be sterilized. The device is assembled from two tapered end portions having opposite open ends and an open pathway extending therethrough. A central chamber in the open pathway receives a Biological Indicator for testing the efficiency of the sterilization process. The device is ideal for testing a sterilization process on elongated objects such as tubing, at any point along their length. The coupling structures on the end portions provide the device with single-use security.

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 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: A catcher, having an immunological epitope, is fixed to a detection zone of a spreading layer. A marker, capable of easy detection, has an inmmunological epitope. The marker and bispecific antibodies are soluble so that they can move on the spreading layer. The bispecific antibodies include a first bispecific antibody, having specificity for the detectable material in the fluid sample and the marker, and a second bispecific antibody, having specificity for the detectable material in the fluid sample and the catcher. Pore sizes and particle diameters are set so that the reaction product in which the marking elements and the particles are bonded are caught at a catching section. The concentration of the marking elements and the particles are increased to improve detection sensitivity. The result is an inexpensive and simple detection apparatus being highly-sensitive for the immunological detection of a detectable material, without wasting valuable antibodies.

Abstract: A process for detecting an analyte which process comprises (a) contacting a sample suspected of containing said analyte with a containment means comprising a barrier which separates signal generating reagents from said sample, in the presence of an element which interacts specifically with said analyte, under conditions whereby interaction between the analyte and the said element results in activation of the signal generating reagents within the containment means on the side of the barrier opposite to the sample, and (b) detecting any signal generated and retained within the containment means from the sample side of the barrier. The process of the invention provides for sensitive detection of very small numbers of analyte materials using measurement techniques which include counting methods such as flow cytometry.