Abstract: The present invention relates to devices and methods for the detection of occult blood in a test sample. These devices and methods can detect the presence of one or more of the following components of occult blood: hemoglobin, transferrin, hemoglobin-haptoglobin complex, and albumin. Methods for the detection of occult blood in a test sample include the following steps: exposing said test sample to two or more of the following antibodies: anti-hemoglobin antibodies, anti-hemoglobin-haptoglobin-complex antibodies, anti-transferrin antibodies, and anti-albumin antibodies or one or more of the following antibodies: anti-hemoglobin-haptoglobin-complex antibodies, anti-transferrin antibodies, and anti-albumin antibodies; determining the level of reactions between the antibodies and their corresponding components of occult blood that may be in the test sample; and deciding on the presence of occult blood.

Abstract: A self-contained system for testing for the presence of occult blood in a specimen has been provided. The system includes a housing holding a test element and a container for releasing a developing medium onto the test element. The housing includes a base portion encasing both the container and the test element, and a cover. The system further includes specimen openings and results openings having different configurations, one from the other, which provides enhanced visualization of test results. The system also includes structure, such as channels, effective to control a rate of flow of developing medium to the specimen openings.

Abstract: Methods and compositions are provided for the diagnosis and treatment of iron misregulation diseases, including HFE polypeptides, agonists, and antagonists, and transferrin receptor agonists and antagonists.

Abstract: The invention provides a kit for a glycated haemoglobin assay, said kit comprising: a porous membrane capable of retaining precipitated haemoglobin; a first reagent comprising zinc ions in aqueous basic solution or comprising a water soluble zinc compound; a second reagent comprising a chromophore-boronic acid conjugate; and optionally, an aqueous washing reagent; wherein at least one of the first and second reagents further comprises a surfactant capable of lysing erythrocytes, and wherein said second reagent if liquid is acidic.

Abstract: The invention provides improved sample preparation techniques as will as improved methods of analysis of samples. The techniques include a method of preparing a sample of MALDI-TOF analysis comprising applying a material having a liquid component to a carrier, removing at least a portion of the liquid component, and applying a MALDI matrix over the material to be analysed. In other embodiments, the sample preparation techniques include digestion of peptides prior to analysis by MALDI-TOF, which may be done in the presence of a surfactant, and sandwiching a sample for analysis between layers of MALDI matrix on a sample carrier.

Abstract: New diagnostic indexes and the method of use for detection of iron deficiency have been disclosed. These include a logistic function of mean cell hemoglobin (MCH) and mean cell volume (MCV), and a logistic function of mean cell hemoglobin concentration (MCHC) and MCH.

Abstract: A method of producing low hemoglobin concentration cell percentage (LHCC %) and the method of use for detection of iron deficiency have been disclosed. LHCC % is a sigmoid function of mean cell hemoglobin concentration (MCHC), which correlates linearly with hypochromic red cell percentage.

Abstract: Disclosed are cellular hemoglobin A1c (Hb A1c) normal and abnormal (high) controls for use in detecting Hb A1c levels. The present invention also relates to methods for generating cellular Hb A1c controls using red blood cells and methods for using the cellular controls. The present invention encompasses several methods for the preparation of Hb A1c cellular controls including: (1) a boronate method where the glycation occurs non-specifically; (2) a stabilized diabetic blood method where the glycation occurs specifically on Hb A1c, and (3) the glycation of normal blood method that is achieved by controlling conditions such that glycation occurs predominantly on Hb A1c. These methods produce cellular Hb A1c controls with desirable stability and that can be detected on a variety of instruments.

Abstract: An assembled hematin is formed by depositing hematin on an electrically charged substrate in one or more layers alternating with one or more layers of polyelectrolyte, preferably a cationic polymer. In a method for polymerizing an aromatic monomer, the assembled hematin is contacted with the monomer and a template, preferably an anionic polymer. In a method for polymerizing aniline, the aniline, sulfonated multi walled carbon nano tubes, PEG hematin and a reaction initiator are dispersed in water.

Abstract: The present invention relates to assay methods for the determination of cobalamin or vitamin B12 in a body fluid and in particular to assay methods for the metabolically active pool of cobalamin, comprising contacting a cell free sample of a body fluid with an immobilised or immobilizable specific binding ligand for TC II or holo TC II, separating a ligand bound fraction from a non-ligand bound fraction and measuring the holo-TC II or TC-II bound cobalamin content therein.

Abstract: An assembled hematin is formed by depositing hematin on an electrically charged substrate in one or more layers alternating with one or more layers of polyelectrolyte, preferably a cationic polymer. In a method for polymerizing an aromatic monomer, the assembled hematin is contacted with the monomer and a template, preferably an anionic polymer. In a method for polymerizing aniline, the aniline, sulfonated multi walled carbon nano tubes, PEG hematin and a reaction initiator are dispersed in water.

Abstract: A quantitative fecal examination apparatus includes a fecal collector removably mounted on a container base, having the fecal collector provided with a suction portion for sucking a fecal specimen into the collector and then the fecal specimen is disposed into the container base for examination test or for sucking the fecal specimen for further laboratory test including microscopic inspection, and having a quantitative design in the examination apparatus for collecting the fecal sample in a pre-set quantity for more precise examination.

Abstract: One aspect of the invention provides a device that non-invasively determines the concentration of a substance in a target. The device includes a first electrode, a measuring circuit, and a data processor. In one embodiment of the device, the first electrode can be electrically insulated from the target, e.g., a cover layer of insulating material covers the first electrode.

Abstract: The invention is directed to devices and methods that allow for simultaneous multiple biochip analysis. The method of analyzing the plurality of biochips includes inserting a first biochp into a first station of an analysis device, inserting a second biochip into a second station of the analysis device, wherein each of the first and second biochips include a substrate, the substrates including an array of detection electrodes, each electrode including a different capture binding ligand, a different target analyte, and a label, and a plurality of electrical contracts, detecting current as an indication of the presence of the labels on the first biochip, and detecting current as an indication of the presence of the labels on the first second biochip. The devices and method may be used with multiple cartridges comprising biochips comprising arrays, such as nucleic acid arrays, and allow for high throughput analysis of samples.

Abstract: An apparatus is provided for hematology testing, which has a sensing unit defining a counting orifice for the flow of a blood sample through the counting orifice to analyze the blood sample, and a pump unit having three syringes. A first syringe is coupled in fluid communication with the sensing unit on the inlet side of the counting orifice for injecting a stream of blood sample through the counting orifice. A second syringe is coupled in fluid communication with the sensing chamber on the inlet side of the counting orifice for simultaneously injecting a sheath of fluid surrounding the sample stream on the inlet side of the counting orifice. And a third syringe is coupled to the sensing chamber on the outlet side of the counting orifice for aspirating a sheath of fluid from the sensing chamber surrounding the sample stream on the outlet side of the counting orifice.

Abstract: Improved methods and apparatus that make more accurate and reduces risk of filling reaction chambers of cartridge cells with blood samples to conduct blood coagulation tests of the type employing the plunger technique are disclosed. A cartridge holder is provided that secures a test cartridge in a fixed upright position and deflects the plunger flag of each cartridge cell to enable manual insertion of a blood dispenser deeply into the reaction chamber to fill the reaction chamber and avoid contamination of surfaces of the cartridge outside the reaction chamber. Preferably, the cartridge holder provides illumination of the reaction chamber during filling, so that the user can judge when the reaction chamber is properly filled with blood dispensed from the blood dispenser. The cartridge holder may incorporate image magnification to facilitate viewing of the reaction chamber as it is filled.

Abstract: Systems and methods for determining the concentration of hemoglobin derivatives in bodily fluids include devices for measuring and comparing the absorption of electromagnetic radiation by cellular and cell-free hemoglobin at two or more wavelengths in the Soret region. Systems and methods for determining erythrocyte membrane fragility include devices for measuring the concentration of at least one cell-free hemoglobin derivative, and using the absorption properties of cellular and cell-free hemoglobin derivatives in the Soret region.

Abstract: Methods for testing a fecal sample for the presence of hemoglobin, comprising performing a chemical fecal occult blood test on the sample and then performing an immunochemical fecal occult blood test on a portion of the sample exposed to the chemical reagents used in the chemical fecal occult blood test.

Abstract: A biological sample collection and test kit and a method of using the kit are disclosed in the application. The kit includes a swab, having a sample collection portion, a cover for covering the sample collection portion of the swab for hygienic purpose. Also disclosed is a package for the swab and the cover.

Abstract: New diagnostic indexes and the method of use for detection of iron deficiency have been disclosed. These include a logistic function of mean cell hemoglobin (MCH) and mean cell volume (MCV), and a logistic function of mean cell hemoglobin concentration (MCHC) and MCH.

Abstract: A method of producing low hemoglobin concentration cell percentage (LHCC %) and the method of use for detection of iron deficiency have been disclosed. LHCC % is a sigmoid function of mean cell hemoglobin concentration (MCHC), which correlates linearly with hypochromic red cell percentage.

Abstract: A cyanide-free lytic reagent composition and method of use for measuring the total hemoglobin concentration and white blood cells in a blood sample are disclosed. The lytic reagent composition includes a quaternary ammonium surfactant to lyse red blood cells and release hemoglobin and a ligand to form a stable chromogen with the hemoglobin. The lytic reagent composition has a pH in a range of 3 to 10. The lytic reagent composition can also include a second quaternary ammonium surfactant. The ligand can be malic acid, malonic acid, ethylene diamine, N,N-diethylethylene diamine, N,N?-diethylethylene diamine, diethylene triamine, tetraethylene pentamine, 1,6-hexanediamine, 1,3-pentanediamine, 2-methylpentamethylenediamine, 1,2-diaminocyclohexane, 4-aminoacetophenone, bis-hexamethylenetriamine, pyridazine, or 3,6-dihyroxypyridazine.

Abstract: A method of measuring an analyte in a sample with excellent sensitivity using a redox reaction is provided. In this method, a reducing substance or an oxidizing substance derived from the analyte is measured in the presence of a tetrazolium compound and sodium azide using the redox reaction, and an amount of the analyte is determined from the amount of the reducing substance or oxidizing substance thus measured. The tetrazolium compound and the sodium azide are present at a ratio in a range from 20:3 to 20:12. Preferably, a solution containing the tetrazolium compound and the sodium azide is aged and then added to the sample.

Abstract: Methods and kits useful in the detection of occult blood in biological samples and specimens, for example to screen for colorectal cancer or detect blood in samples ex vivo, e.g., at a crime scene. Also provided are methods useful in diagnosing whether a subject is predisposed to, or suffers from, an occult-blood related disorder; and methods for direct micro-mapping of the distribution of occluded vessels associated with cerebral vascular injury.

Abstract: An apparatus is provided for testing fluid samples includes a sensor, which can be light source, directed to a flow cell and a photo sensor for detecting a light beam reflected from the flow cell. The photo sensor monitors the fluid in the flow cell by sensing the reflected light beam from the flow cell, thereby monitoring the test.

Abstract: Nitrosylhemoglobin can be produced by introducing gaseous NO into an aqueous solution of hemoglobin. It has been demonstrated that nitrosylhemoglobin in aqueous solution can be converted to SNO-hemoglobin upon introduction of oxygen to the solution, as is postulated to occur in the lungs. Nitrosylhemoglobin can be used in methods to produce the physiological effects of NO, for example, to reduce vasoconstriction and to inhibit platelet aggregation.

Abstract: A method is disclosed whereby the concentration of a blood substitute, such as cross-linked hemoglobin, in a serum or plasma specimen is rapidly and accurately identified and quantified. The method further takes the measured concentration of the blood substitute and uses it to correct for its effect, if any, on a measured analyte concentration, e.g., serum/plasma total protein. Further, the method allows for the determination of the concentration of true hemoglobin in the presence of blood substitutes. The method is carried out in respect of samples contained in a primary or secondary labelled tube, or a pipette tip used to dispense serum or plasma in a blood analyzer.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

Abstract: The present invention is drawn to a hematology control made from particles a particle having a biopolymer attached to a surface of the particle. The particle simulates a component of a blood sample, such as a reticulocyte or nucleated red blood cell component of a blood cell sample in a flow cytometer or hematology analysis instrument. The present invention is further drawn to methods of making and using the hematology control.

Abstract: An apparatus is provided for testing fluid samples includes a sensor, which can be light source, directed to a flow cell and a photo sensor for detecting a light beam reflected from the flow cell. The photo sensor monitors the fluid in the flow cell by sensing the reflected light beam from the flow cell, thereby monitoring the test process. The apparatus may have additional light source so that the photo sensor may monitor the test process by detecting the absorption light beam or fluorescent light beam from the flow cell at different phases of the test process.

Abstract: An apparatus is provided for testing fluid samples includes a sensor, which can be light source, directed to a flow cell and a photo sensor for detecting a light beam reflected from the flow cell. The photo sensor monitors the fluid in the flow cell by sensing the reflected light beam from the flow cell, thereby monitoring the test.

Abstract: A self-contained system for testing for the presence of occult blood in a specimen has been provided with features enhancing its ease of use. The system includes a housing holding a test matrix and a container for releasing a developing medium onto the test matrix. The housing includes a base portion encasing both the container and the test matrix, and a moveable cover for selectively covering and uncovering the base. The cover is provided with a tab which can be manipulated with a finger of one hand, and the base is provided with tabs which can be grasped easily with one or two other fingers of the same hand, thus allowing the cover to be easily opened and closed with one hand. Other ease-of-use features include an applicator with a tip configured for optimized retrieval and even spreading of the specimen on the test matrix, and indicia imprinted at various positions on the housing designating both the location and order in which the different steps of the testing procedure are to be performed.

Abstract: A method of monitoring calibration of a spectrophotometric apparatus that includes one or more than one calibration algorithm for one or more than one analyte, involves measuring absorbance of a quality control material with the apparatus to obtain a measurement, calculating one or more than one value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectrum having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and the spectral segment includes a principal calibration wavelength for the one or more than one analyte. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus having at least one primary calibration algorithm is also disclosed.

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 method of monitoring calibration of a spectrophotometric apparatus having one or more than one calibration algorithm for one or more than one analyte. This method involves measuring an absorbance of a quality control material to obtain a measurement, calculating one or more than one concentration value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one concentration value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectra having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength therebetween. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus containing one or more than one primary calibration algorithm is also provided.

Abstract: The present invention provides an isolated archael and bacterial heme binding protein which reversibly binds oxygen with a low affinity. The heme binding protein may be utilized as a blood substitute. The invention also provides a method for controlled storage of oxygen by contacting a bacterial heme binding protein with oxygen allowing the protein to bind and store oxygen. The also provides methods to sense gaseous ligands using the heme binding protein. In other embodiments, the invention provides chimeric proteins having a heme-binding domain of an isolated heme binding archael bacterial protein and a heterologous signaling domain.

Abstract: Methods, devices and kits for facilitating medical diagnostic assays and reducing the time required for taking of such assays. The methods comprise initiating a reaction, obtaining at least three measurements, at three different time points, of a value or level of an observable associated with the reaction, and estimating an end point value for the observable from the measurements.

Abstract: Methods are described for detecting and quantifying occult blood in a biological sample using laser desorption mass spectrometry (LD MS). Biological samples that can be analyzed using various embodiments of the present invention include stool (fecal occult blood, FOB), and any bodily fluid including urine, cerebrospinal fluid and other bodily fluids. If the heme or heme metabolite is bound to protein, the sample is treated with acid before analysis to release the porphyrin. Some of the methods use LD MS with a time of flight analyzer (TOF) to detect and measure unbound heme, other hemoglobin metabolites and other molecules that have a porphyrin-based structure, e.g., bilirubin, biliverdin, protoporphyrin IX, and Zinc protoporphyrin in the biological sample. In other methods, matrix-assisted laser desorption/ionization mass spectrometry (MALDI MS) is used to detect and quantify the individual ?- and ?-polypeptide chains of hemoglobin.

Abstract: The present invention provides a microfluidic device for synthesizing an array of compounds and methods for using the same. In particular, the microfluidic device of the present invention comprises a solid support base, an elastomeric layer attached to the solid support, and a plurality of flow channels located within the interface between the solid support and the elastomeric layer. In addition, the solid support comprises a functional group for forming a bond with a reactive reagent. In some embodiments, the microfluidic device further comprises a second plurality of flow channels that intersect the first plurality of flow channels. A plurality of control channels are also present in the microfluidic devices of the present invention. The control channels can be actuated to regulate flow of fluids within the flow channel(s).

Abstract: A method is provided for determining the level of an analyte in the blood of an individual based on determination of the level of the same analyte in non-blood sample (e.g. urine, saliva and hair) obtained from the individual. The non-blood sample contains red blood cells and the volume of the blood in the sample together with the amount of the analyte in the sample are the basis for calculating the level of the analyte in the individual's blood. Kits for carrying out the above method are also provided.

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: Novel bipyridyl-osmium complex conjugates and their use in electrochemical assays are described. The redox reversible-osmium complexes can be prepared to exhibit unique reversible redox potentials and can thus be used in combination with other electroactive redox reversible species having redox potentials differing by at least 50 millivolts in electrochemical assays designed for use of multiple electroactive species in the same cell and in the same sample without interference between the two or more redox coupled conjugate systems.

Abstract: The invention concerns a reagent for determination of leucocytes and measurement of haemoglobin in a sample of blood. This reagent comprises a buffer system that is suited to adjust selectively the pH of the reagent to an acidic value, at least one detergent of cationic type, a nitrogenous compound and, optionally, at least one inorganic salt. This reagent can be used in haematological analyses in human medicine and also permits the identification of a leucocytic subpopulation, in particular the basophil polymorphonuclear leucocytes.

Abstract: An assembled hematin is formed by depositing hematin on an electrically charged substrate in one or more layers alternating with one or more layers of polyelectrolyte, preferably a cationic polymer. In a method for polymerizing an aromatic monomer, the assembled hematin is contacted with the monomer and a template, preferably an anionic polymer. In a method for polymerizing aniline, the aniline, sulfonated multi walled carbon nano tubes, PEG hematin and a reaction initiator are dispersed in water.

Abstract: The invention concerns a method for quantitative or qualitative determination of an analyte or its interaction or reaction kinetics in a system with at least two different phases, comprising the step of taking at least one measurement signal from at least one of the phases, whereby the different phases are present in parallel when taking the signal and whereby each measurement signal is attributed to one of at least two phases. In addition, the invention concerns a sample carrier, in particular for use in the method constituting the invention with one or more wells. The sample carrier is characterized by the fact that at least a portion of the sample carrier at least in the range of one or more wells is coated with fluorescence-quenching material.

Abstract: A method of determining the percentage of glycated hemoglobin in a blood sample is disclosed wherein at least one of the assay steps is performed electrochemically. The method includes determining the total amount of hemoglobin in a sample by electrochemically measuring, in an oxygen electroreduction reaction at a cathode, the amount of oxygen in the sample. Because the amount of oxygen dissolved in the sample is known, the total hemoglobin is determined by subtracting the amount of free oxygen from the total oxygen measured, recognizing the fast equilibrium Hb+O2?HbO2. This can be followed by determining the amount of glycated hemoglobin in the sample. The cathode reaction is accomplished by contacting the sample with an enzyme, the enzyme being a copper-containing enzyme having four copper ions per active unit. The family of these enzymes includes, for example, laccases and bilirubin oxidases.

Abstract: A selective complex of a lipoprotein with hemoglobin or a hemoglobin analogue; a method of assaying hemoglobin or a hemoglobin analogue in a sample, comprising reacting the sample with a lipoprotein which is capable of selectively forming a complex with hemoglobin or a hemoglobin analogue; and a kit for assaying hemoglobin or a hemoglobin analogue, comprising a lipoprotein which is capable of selectively forming a complex with hemoglobin or a hemoglobin analogue.

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: 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: An improved reagent system for preparation of cells for flow cytometry having a physiologically compatible salt solution composition including a lysing agent, an agent for minimizing white blood cell lysis, and optionally a preservative.