Abstract: A method for quantifying the quality degradation of individual stored red blood cell (RBC) units, thereby yielding information to improve decisions regarding their respective allocation, patient suitability, and use. The method comprises: a hemolysis step; an optical analysis step; and a computation step. The method is amenable to clinical implementation as well as indicative of any given unit's relative viability and thus prospective efficacy. This would provide clinicians with actual data on RBC quality when making decisions about which and how many units to use for transfusion of a given patient. Moreover, deploying this testing throughout the supply chain will improve distribution, planning, and inventory control decisions. A vital aspect of this testing method is the accumulation of copious output and other associated data and the mathematical analyses thereof to optimize algorithms by which to characterize each subsequent test output as meaningfully as possible.

Abstract: The present invention relates to methods of detecting hemoglobin in a test sample. These methods can be used to diagnose a subject suffering from a genetic disorder relating to hemoglobin metabolism, to determine the eligibility of a subject to be a blood donor, to determine the age of a stored blood sample or to identify a hemolyzed plasma sample. The present invention also relates to kits for use in the above described methods.

Abstract: A sample analyzer: measures a measurement sample including a sample and a reagent; creates a calibration curve based on first measurement data obtained by measuring a measurement standard sample including a standard sample and the reagent; provides calibration curve specifying information for specifying the calibration curve to the calibration curve; acquires an analysis result by processing second measurement data obtained by measuring the measurement sample based on the calibration curve; and stores the analysis result and the calibration curve specifying information provided to the calibration curve used in the process of the second measurement data in correspondence to each other.

Abstract: An apparatus and method for sealing a fluid sample collection device, comprising: loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop.

Abstract: Some embodiments of the invention provide a system comprising a meter and a disposable cartridge for analyzing a fluid sample typically blood that is drawn into the cartridge by capillary action, negative pressure, positive pressure, or a combination thereof. The cartridge has at least one flow path, and includes at least one optical chamber for spectroscopic measurement, and at least one biosensor for biosensor measurement. The meter has a sample slot for receiving the disposable cartridge. The cartridges have electrical output contacts, and the meter slot has electrical input contacts. When the output contacts mate with the input contacts, the optical chamber becomes positioned for spectroscopic measurement. The present invention can provide joint-diagnostic spectroscopic and biosensor measurements.

Abstract: A component measuring apparatus is provided with a case having a cylindrical case main body and a cover arranged to cover the base end opening section of the case main body; a chip mounting section for mounting a chip; a light measuring section for detecting a prescribed component; a printed board whereupon a control section having a function of controlling the operation of the light measuring section is arranged; a liquid crystal display device; a battery arranging section for arranging a battery provided on the cover; an O-ring arranged between the case main body and the light measuring section on the leading end section of the case main body; and an O-ring arranged between the case main body and the cover on the base end opening section of the case main body. Sealing of inside the case is ensured by the O-ring.

Abstract: A method of correction of particle interference to hemoglobin measurement of a blood sample on a hematology analyzer is provided. The method includes mixing an aliquot of a blood sample with a lytic reagent to lyse red blood cells and forming a sample mixture; measuring absorbance of the sample mixture at a predetermined wavelength of a hemoglobin chromogen formed in the sample mixture, and obtaining an apparent hemoglobin concentration of the blood sample using obtained absorbance; measuring concentration and size of cellular particles remaining in the sample mixture; removing contribution of the cellular particles to the apparent hemoglobin concentration using the concentration and the size of the cellular particles to obtain a corrected hemoglobin concentration of the blood sample; and reporting the corrected hemoglobin concentration of the blood sample.

Abstract: The present invention relates to an improved method, reagents and kit for the detection of fecal or urine occult blood. The reagents are either supplied as solutions in small vials or incorporated into a matrix that is treated, impregnated, or imprinted with the test reagents that are capable of undergoing a chromagenic reaction. The method elucidates false positives from dietary sources, oxidants in the toilet water supply and is specific for blood. A stabilized chromogenic solution is disclosed which contains phemolphthalin in a deoxygenated, basic solution. The chromagenic solution either in a liquid or matrix form is placed into the toilet water following urination or defecation. A few moments are allowed to occur for observation of the matrix turning from colorless to a hot-pink. A hot pink color is indicative of a false positive. If no color change occurs, an oxidizing solution is added to the toilet water.

Abstract: A calibration method that enables calibration easily in a short time in a measurement of hemoglobin A1c by use of a separation analysis is provided. In a measurement of a hemoglobin A1c amount by use of a separation analysis, a one-point calibration using a single calibration standard is performed to obtain calibration data to be used for correcting a measured value.

Abstract: The present invention is to present a sample analyzer which is automated even when measuring a small amount sample and is capable of improving a measurement precision. The sample analyzer S comprises a sample preparation section for preparing a measurement sample; a detector D3 for detecting an analyte contained in the measurement sample; and a controller 100 being configured to 1) control the sample preparation section so as to prepare a first measurement sample of a first dilution ratio, when measuring an ordinary amount sample; and 2) control the sample preparation section so as to prepare a second measurement sample of a second dilution ratio higher than the first dilution ratio, when measuring a small amount sample.

Abstract: The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.

Abstract: What is described is a single reference material and method of making useful for calibrating or qualifying instruments that are diagnostic spectroscopically for bilirubin, hemoglobin, and hemoglobin fractions, and, optionally, diagnostic for other blood analytes by sensor means.

Abstract: Methods of manufacturing test strips are disclosed. Embodiments include laminating a two piece covering layer over a substrate with a series of cavities, wherein the two pieces are separated by a gap, the gap forming a vent opening for the cavities. Other embodiments include covering the sample receiving chamber with a cover thinner than the cover covering the body of the test strip, the thicker body cover absorbing more force than the chamber cover to reduce the possibility of adhesives squeezing out from under the chamber cover. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.

Abstract: A method for analyzing hemoglobin in a sample by separation analysis while suppressing the denaturation of the hemoglobin includes separating hemoglobin in the presence of at least one of a sulfurous acid compound and a dithionous acid compound.

Abstract: The present disclosure provides a device for simultaneously detecting hemoglobin and glycohemoglobin in blood. The device includes a lateral flow assay strip, a laser-induced epifluorescence detection device, and an LED detection device. The present disclosure further provides a method for simultaneously quantifying hemoglobin and glycohemoglobin in blood by an immunological method using the same.

Abstract: An in-vitro non-invasive method for quantifying the lesions of the liver of the patient with metabolic steatosis addressing a diagnostic target, i.e. fibrosis, steatosis and/or steato-hepatitis (NASH) and measuring at least one marker selected from the group consisting of biomarkers and possibly clinical markers and possibly scores, the biomarkers being selected from the group consisting of glycemia, AST (aspartate aminotransferase), ALT (alanine aminotransferase), AST/ALT, AST.

Abstract: Stabilizers for colorants used for detection of enzymatic reactions, having a cyclodextrin and a catalase; reagents including stabilizers; and methods of use of such stabilizers and reagents.

Abstract: A sample analyzer and sample analyzing method perform following: a) mixing a sample with at least one of a first reagent and a second reagent, thereby preparing a measurement specimen; b) storing, in a memory, standard curve data corresponding to a reagent to be used in the step a) for preparing a measurement specimen; c) measuring the measurement specimen thereby obtaining measurement data; d) processing the measurement data based on the standard curve data, thereby obtaining an analysis result; and e) when the first, reagent and the second reagent are of the same type, determining a reagent to be used for the measuring between the first reagent and the second reagent, based on information regarding standard curve data stored in the memory.

Abstract: A mammalian disease detecting system used to provide a visual indication of a possible disease state includes particles made of a material that is substantially clear or transparent to permit the easy visual detection of blood in urine of a mammal. The system also includes additives to permit visually detection of possible disease states or infections in mammals, such additives being of the type that are not reactive with the particular material.

Abstract: A process, portable equipment and device for in vitro photometric determination of hemoglobin concentration in diluted blood. The present invention allows its use in field anemias prospection programs. The present invention has a light source (1) whose wavelength is between 500 and 550 nm, a cylindrical sample holder (3), whose diameter is between 8 and 20 mm, a photosensor (2) to perform the sample photometry and a microprocessor for automatically starting the light source, acquiring the signal obtained by the photosensor (2), performing the hemoglobin concentration calculations and displaying the results in a liquid crystal display. The device also has a sealed cylindrical bottle, which is simultaneously used as a package for the reagent and as an optical component in the process, allowing photometric reading through its walls.

Abstract: The present disclosure describes an apparatus and associated method for quantifying the quality degradation of individual stored red blood cell (RBC) units, thereby yielding information to improve decisions regarding their respective allocation, patient suitability, and use. This apparatus and the methods of its use are amenable to clinical implementation as well as indicative of any given unit's relative viability and thus prospective efficacy. This would provide clinicians with actual data on RBC quality when making decisions about which and how many units to use for transfusion of a given patient. Moreover, deploying this testing throughout the supply chain will improve distribution, planning, and inventory control decisions. A vital aspect of this testing system is the accumulation of copious output and other associated data and the mathematical analyses thereof to optimize algorithms by which to characterize each subsequent test output as meaningfully as possible.

Abstract: A method for detecting human or animal blood traces on a surface is described. The method is fundamentally based on the reaction of luminol and includes the preliminary operation of atomizing an inorganic powder suspension, such as titania, silica, alumina, hydroxyapatite, or the like, onto the surface to be investigated, after which a luminol composition is atomized thereon, which comprises a luminol compound, a peroxidic oxidising agent and an alkaline agent in an amount providing a pH within the range of 10 to 14. Furthermore, a kit for carrying out the detection method of the invention is described.

Abstract: The present invention relates to a method and an apparatus that measure the concentration of glycated hemoglobin by an optical technique. A wavelength in which the molecular extinction coefficient of oxyhemoglobin agrees or substantially agrees with the molecular extinction coefficient of deoxyhemoglobin is adopted as a measurement wavelength. Preferably, the measurement wavelength is set at from 417 to 421 nm. In the present invention, the concentration of glycated hemoglobin is measured by making use of column chromatography and of using a sample prepared from red blood cells in blood.

Abstract: A method of measuring HbA1c is provided that, even with a whole blood sample after storage, measurement accuracy substantially equal to a whole blood sample right after collection can be maintained. Whole blood is stored in a presence of a glycolytic inhibitor and protease is added to the stored whole blood sample to cleave hemoglobin in the whole blood sample. Then a glycated part of a hemoglobin fragment thereby obtained is treated with fructosyl amine oxidase. Thereafter, a glycation degree of HbA1c is determined by measuring a redox reaction between the glycated part and the fructosyl amine oxidase. Further, instead of storage of the whole blood in a presence of the glycolytic inhibitor, a strong electrolyte substance such as KCl, K2SO4, KNO, NaCl, Na2SO4, NaNO, MgCl2, MgSO4, Mg(NO)2, etc. is added to the whole blood after storage and a protease treatment is performed in a presence of the strong electrolyte substance.

Abstract: A method and apparatus to estimate the concentration of a non-fluorescent substance (e.g. haemoglobin) in a fluorescent assay by separately estimating the non time dependent alteration attributed to inherent filter effects from the time dependent alteration caused by the assay chemistry. Such a method obviates the requirement for a separate photometric or other measurement thereby simplifying the methodology and associated instrumentation.

Abstract: Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent.

Abstract: Method for the automatic analysis of a blood sample in which: an analysis solution containing the blood sample, a diluent, and at least one compound to lyze the erythrocytes; at least one compound to stabilize the haemoglobin in the form of a chromogenic complex, is formed in a single dilution and analysis tank, the haemoglobin level is measured in this analysis solution by spectrophotometry in the tank after the lysis of the erythrocytes; and an appropriate quantity of this analysis solution is taken from the tank on which a leucocytic differentiation is carried out by an optical elements characterized in that the analysis solution also contains at least one compound to protect the leucocytes, allowing the distinguishing of at least four main leucocyte sub-populations. A haematological analysis apparatus for the implementation of such a method is disclosed.

Abstract: A biological specimen collection card comprises a specimen retaining panel, a rear panel, and a cover panel. There is an opening in the specimen retaining panel for retaining an absorbent insert which is to be impregnated with a biological specimen. The absorbent insert is exposed on both sides of the specimen retaining panel when the absorbent insert is retained in the opening. The rear panel is angularly spaced apart from the specimen retaining panel when the collection card is in an open configuration to facilitate drying of the biological specimen. The cover panel is movable between a first position and a second position. The collection card is in the open configuration when the cover panel is in the first position, and the collection card is in a closed configuration when the cover panel is in the second position. The cover panel covers the absorbent insert when the absorbent insert is retained in the opening and the collection card is in the closed position.

Abstract: Disclosed is a method for diagnosing myocardial infarction in a subject who suffers from acute coronary syndrome and has a cardiac troponin level, which is detectable, but lower than the level that is considered as being indicative for a myocardial infarction. Also disclosed is a method for identifying a subject being susceptible to cardiac intervention, wherein the subject suffers from acute coronary syndrome and has a cardiac troponin level which is detectable, but lower than a level that is considered as being indicative for a myocardial infarction. These methods are based on the determination of myoglobin and, optionally, Heart-type fatty acid binding protein (H-FABP) in a sample of the subject and comparing the amount of myoglobin and, optionally, H-FABP to reference amounts. Also disclosed are kits or devices to carry out the methods.

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 presently disclosed subject matter provides methods of diagnosing retinal disorders in subjects by measuring hemoglobin and modified hemoglobin in the subjects. The presently disclosed subject matter further provides methods of treating retinal disorders in subjects by decreasing hypoxia in retinal tissue of the subjects through modulation of hemoglobin levels and activities in the retinal tissue.

Abstract: Methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).

Abstract: A method for determining the hematocrit of a blood sample is provided that includes the steps of: 1) depositing the sample into an analysis chamber operable to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the average optical density value of those i

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: The present invention describes examination devices, such as examination gloves, for detecting the presence of blood, and in particular hidden blood, in biological samples. Examination devices according to the present invention include, in certain embodiments, developer and indicator reagents in a single encapsulation, which offers numerous clinical and other benefits. Kits including devices according to the present invention in sterile packaging, and methods of making and using devices according to the present invention, are also described.

Abstract: The present invention provides a nanostructured substrate for SERS. A substrate of the invention comprises a surface featuring substantially monodisperse-sized metal nanoparticles disposed thereon. Preferably, the substrate surface provides for SERS and spectra therefrom. For example, a nanostructured substrate of the invention can be used to reproducibly and reliably detect or identify pathogens, molecules or combinations thereof. In one embodiment, a nanostructured substrate of the invention comprises a surface featuring metal nanoparticles substantially aggregated in clusters thereon. Exemplary metal nanoparticles disposed on the substrate surface can be silver, copper, gold or combinations thereof. Metal nanoparticles disposed on a substrate surface can also be substantially spheroidal comprising diameters in a range from about 40 to 120 nm.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase, and peroxidase. The invention provides kits for performing the methods of the invention.

Abstract: The present invention provides an apparatus and method for measuring the properties of blood using ultrasound. The present invention is particularly suitable for measuring HCT, HGB, MCV, RBC, MCHC, MCH or TPC of blood.

Abstract: A specimen sampling device having a first panel including multiple apertures (e.g., a first, second and third aperture) for receiving samples; a second panel having a removable tab at least partially aligned with the first, second and third apertures for receiving the samples, the removable tab accessible from an exterior of the device. A method of obtaining a fecal sample is also disclosed.

Abstract: The present invention relates to a method for diagnosing myocardial infarction in a subject who suffers from acute coronary syndrome and has a cardiac troponin level, which is detectable, but lower than the level that is considered as being indicative for a myocardial infarction. Moreover, the present invention relates to a method for identifying a subject being susceptible to cardiac intervention, wherein the subject suffers from acute coronary syndrome and has a cardiac troponin level which is detectable, but lower than a level that is considered as being indicative for a myocardial infarction. The methods of the present invention are based on the determination of myoglobin and, optionally, Heart-type fatty acid binding protein (H-FABP) in a sample of said subject and comparing the amount of myoglobin and, optionally, H-FABP to reference amounts. Also comprised by the present invention are kits or devices to carry out the methods of the present invention.

Abstract: A blood specimen dispenser is provided which dispenses a precise amount of collected blood from a blood specimen collector onto filter paper or the like for screening or evaluation.

Abstract: A device for biochemical processing and analysis of a measured sample volume of a sample is described. The device is characterised in that it consists of a sealed vessel (1) and that it comprises at least one thin pierceable membrane (2) through which a capillary tube (3) containing said measured sample volume of a sample can pass into said sealed vessel (1). Said sealed vessel (1) further contains at least one biochemically reactive substance (4) and a liquid (6). A method, wherein the device according to the invention is used for analysis, is also described.

Abstract: Assays in which samples of biological fluids are dispensed onto reagent-containing porous substrates are improved in the accuracy and repeatability by dispensing the biological fluids in two or more fractions thereof, separated by intervals in which the biological fluid is not dispensed. Reagents and other fluids may be dispensed during the intervals when the biological fluid is not dispensed. Alternatively, reagents and other fluids may be dispensed in a similar manner onto substrates already containing biological fluids.

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: A detection device and method for monitoring infestation by insects such as bed bugs is provided. A suitable device comprises a pair of plates separated by an internal spacing sized to permit entry into the detection device by one or more insects. Also disclosed is a method for readily detecting insects such as bed bugs in a multiple areas such as in multiple hotel rooms, areas where animals are housed, or the like.

Abstract: A fiber, an articles formed from a fiber and methods of making the fiber and associate article are disclosed. In one embodiment, the fiber comprises a synthetic polymer and a color-changing indicator. The color-changing indicator is dispersed throughout the synthetic polymer. The color-changing indicator reacts in the presence of a stimulus to produce a color change.

Abstract: The invention provides a method of detecting an S-nitrosothiol in a sample which includes treating the sample with a transition metal such as copper (I) and cysteine in the presence of a substance capable of blocking interactions between iron-containing compounds and NO and detecting the generated NO.

Abstract: The present invention relates to methods of detecting hemoglobin in a test sample. These methods can be used to diagnose a subject suffering from a genetic disorder relating to hemoglobin metabolism, to determine the eligibility of a subject to be a blood donor, to determine the age of a stored blood sample or to identify a hemolyzed plasma sample. The present invention also relates to kits for use in the above described methods.

Abstract: A linearity control system includes a series of linearity control compositions, each thereof includes white blood cell analogs and stabilized red blood cells in a suspension medium. The concentration of the white blood cell analogs in the series of control compositions increases from 0.2×103 to 800×103 analogs per microliter, and the concentration of the white blood cell analogs in at least one control composition is greater than 120×103 analogs per microliter. The stabilized red blood cells facilitate mono-dispersion of the white blood cell analogs in the suspension medium by gently mixing. The control compositions further include platelet analogs, or additionally include reticulocyte and/or nucleated red blood cell analogs. The linearity control system allows the verification of the reportable measurement range and linearity of the measurements of hematology analyzers for white blood cells, red blood cells and platelets in extended concentration ranges.

Abstract: An electrochemical method and a test strip for detecting hemoglobin in a specimen are provided. The method includes the steps of providing the specimen with a reagent including a buffer solution, a surfactant and an electron mediator, tetrathiafulvalene, modified by cyclodextrin; detecting electric current produced by reaction of the hemoglobin and the electron mediator in the specimen under a potentiostatic condition; and calculating a concentration of the hemoglobin in the specimen according to the detected electric current.