Abstract: Instances of the present technology may include a method for operating a hematology analyzer. The method may include passing a control material through a hematology analyzer. The control material may include a first cell population and a second cell population. The method may also include determining a first cell population volume measurement and a second cell population volume measurement. A first value of a first cell population distribution width and a second value of a second cell population distribution width may be calculated. The method may include comparing the first value to a first reference range. The method may also include comparing the second value to a second reference range. Furthermore, the method may include classifying an operational status of the hematology analyzer based on the comparison of the first value to the first reference range and based on the comparison of the second value to the second reference range.

Abstract: Described are devices for and methods of modulating a fluid sample. The devices (10, 40, 60, 80, 100, 130, 160, 220) include at least one sample-modulating component (20, 76, 78, 90, 110, 112, 116, 150, 152, 154, 162, 164, 182, 184, 186, 222, and 230) and, in some embodiments, two or more sample-modulating components.

Abstract: Disclosed herein are finished products, methods, compositions and kits for derivatizing plastic (e.g., “polymer”) surfaces in a manner that renders the surfaces appropriate for various downstream applications. For example, flow cells incorporating modified plastic surfaces provide greatly enhanced stability for retention of attached chemical species such as polypeptides and nucleic acids.

Abstract: The instant disclosure provides methods of extracting stain-independent features from digital images of histologically stained cells. Stain-independent features provide consistent assessment of cell morphology in the presence of staining variation and across different stains or stain formulations. Improved consistency in cell morphology assessments finds use in automated cell classification and other image processing applications. Also included are systems for practicing the described methods. The instant disclosure also provides computer readable media storing instructions that, when executed by a computing device, cause the computing device and/or components of a described system to perform steps of a method involving of extraction of stain-independent features from digital images.

Abstract: The invention generally relates to a sample dispenser including an internal standard and methods of use thereof. In certain embodiments, the invention provides a fluid dispenser that includes a fluid chamber. A portion of an inner wall of the chamber includes an internal standard. The chamber is configured such that fluid introduced to the chamber must interact with the portion of the chamber wall that includes the internal standard prior to flowing through an outlet of the chamber. The dispenser additionally includes a member coupled to the chamber such that it can control movement of fluid within the chamber.

Abstract: Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.

Abstract: A phantom for medical imaging instrumentation, the phantom including a first hydrogel matrix, said matrix containing additives for simulating the optical and acoustic properties of a living organ or tissue. In the phantom, the additives include Indian ink or haemoglobin, silica powder and titanium dioxide powder. The phantom may contain a tumor simulator in solid or liquid form. It may also comprise several hydrogel matrices, each matrix including additives in different concentrations depending on the organ or tissue simulated. A method of producing the phantom includes one or more freeze-thaw cycles for optimizing the characteristics of the phantom.

Abstract: Disclosed are compositions and methods for the labeling of two or more targets with different labels. Specifically, disclosed are compositions for biotin and the protection of biotin within multilabel assays which employ the biotin-biotin binding protein binding relationship for each distinct label in relation to targets such as nucleic acids, polypeptides, antibodies or cells. These multilabel assays are enabled through the use of biotin with desthiobiotin, orthogonal protecting schemes for biotin, or a combination of the approaches.

Abstract: The present invention provides dual labeled protein standards useful for the simultaneous determination of the molecular weight of a subject protein as well as the relative mass (i.e., amount) of the subject protein present in an electrophoresis lane. The invention is also directed to methods suitable for the preparation of such dual labeled protein standards and to methods of using such dual labeled proteins to simultaneously determine the molecular weight and the relative amount of a subject protein. Further embodiments are directed to the use dual labeled protein standards to make a more accurate determination of the amount of a protein present in an electrophoresis lane. Yet further embodiments are directed to kits containing the presently described dual protein standards. Dual labeled protein standards made and used in accordance with the embodiments set forth herein may be used to simultaneously determine the molecular weight and the relative amount of a subject protein in real time.

Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: A dye binding method for protein analysis is disclosed. The method includes the steps of preparing an initial reference dye solution of unknown concentration from an initial reference dye concentrate and creating an electronic signal based upon the absorbance of the initial reference dye solution. Thereafter, an electronic signal is created based upon the absorbance of a dye filtrate solution prepared from the initial reference dye solution and an initial protein sample. The absorbance signals from the reference dye solution and the dye filtrate solution are sent to a processor that compares the respective absorbances and calculates the protein content of the protein sample based upon the difference between the absorbances.

Abstract: An object of the present invention is to provide a control material which can be preferably employed in detection of 1,5-anhydro-D-glucitol and glycoalbumin, which are employed as excellent indices for diabetes. The present inventor has found that mannitol which is added to serum or plasma used as control material stabilizes 1,5-anhydro-D-glucitol and glycoalbumin present in the serum or plasma for a long period of time, and that the object can be attained through provision of (1) an agent for stabilizing control material, the agent being composed of mannitol and (2) control material containing mannitol and 1,5-anhydro-D-glucitol.

Abstract: In alternative embodiments, the invention provides nucleic acid sequences that are genetic polymorphic variations of the human TMEM216 gene, and TMEM216 polypeptide encoded by these variant alleles. In alternative embodiments, the invention provides methods of determining or predicting a predisposition to, or the presence of, a ciliopathy (or any genetic disorder of a cellular cilia or cilia anchoring structure, basal body or ciliary function) in an individual, such as a Joubert Syndrome (JS), a Joubert Syndrome Related Disorder (JSRD) or a Meckel Syndrome (MKS). In alternative embodiments, the invention provides compositions and methods for the identification of genetic polymorphic variations in the human TMEM216 gene, and methods of using the identified genetic polymorphisms and the proteins they encode, e.g., to screen for compounds that can modulate the human TMEM216 gene product, and possibly treat JS, JSRD or MKS.

Abstract: The invention pertains generally to novel compositions and methods for constructing chemically sensitive ion channels. The compositions and methods include, for example, novel gramicidin A derivatives and their use in constructing novel ion channels for use as biosensors.

Abstract: Hemoglobin in a sample solution is quickly and reliably denatured; at the same time, quick and accurate measurement of hemoglobin and a hemoglobin derivative is realized. In a method for measuring hemoglobin and a hemoglobin derivative, and a reagent composition, a measurement kit, an analysis device, and an analysis system used in the method, a sample solution containing a blood component is treated with a nonionic surfactant, an oxidizing agent, and a metal salt to denature hemoglobin in the sample solution to measure the hemoglobin, and thereafter the amount of a hemoglobin derivative in the sample is measured by an immunological method using an antibody specifically binding to a denatured site of the denatured hemoglobin derivative.

Abstract: The present invention provides, as a novel diagnosis marker for type 1 diabetes mellitus, a type 1 diabetes mellitus diagnostic composition comprising alanyl-tRNA synthetase, glycyl-tRNA synthetase, asparaginyl-tRNA synthetase, or tryptophanyl-tRNA synthetase, a diagnostic kit comprising the same, and a diagnostic method using the same. The composition, the kit, and the method, according to the present invention, may be used for early diagnosis and confirmed diagnosis of type 1 diabetes mellitus because type 1 diabetes mellitus can be easily diagnosed from a patient sample.

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 provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample.

Abstract: A method for identifying a biological analyte that is affected by a stressor is disclosed in which two substantially identical biological samples are provided, with a first sample being a control sample and a second sample being an experimental sample. The control sample is grown with a nutrient having an isotope of a first atom, whereas the experimental sample is grown with a nutrient having a second isotope of the first atom. The experimental sample is grown with a stressing agent and regimen. The samples are admixed, and the formed composite is mass spectroscopically assayed for analyte peaks. The ratio of first isotope to second isotope is determined for the peaks, as is a sample median isotopic ratio. The ratio for assayed analyte peaks is compared with the median ratio. An analyte whose isotopic ratio significantly deviates from the median ratio is an analyte affected by the stressing agent.

Abstract: The present invention provides an auto-developing and regularly-weighted protein molecular weight marker kit, comprising: (a) a plurality of recombinant proteins having formula (I), (B)m-A-(C)n??(I), wherein A is a polypeptide of SEQ ID NO: 1, B and C are independently any mutually identical or different polypeptides with the value of molecular weight being a multiple of 5, and m and n is independently 0 or any integer larger than 0; and (b) one or more solvents for stabilizing the recombinant proteins. The present invention also provides a method for preparing the auto-developing and regularly-weighted protein molecular weight marker kit.

Abstract: A method of removing abnormal data in a blood component analysis system using spectroscopy to estimate a concentration of a blood component by analyzing a photo-plethysmographic (PPG) signal obtained by radiating light of first and second wavelengths reacting to the blood component on a subject and detecting light corresponding to the first and second wavelengths output from the subject, includes collecting the PPG signal corresponding to the first and second wavelengths for a predetermined unit period of time, calculating “n” parameters, with respect to “n” pulse data included in the collected PPG signal, where n is a positive integer, calculating an average of the “n” parameters, and comparing a ratio of a number of parameters whose deviation from the average is greater than a predetermined standard deviation to the “n” parameters with a predetermined removal reference value to determine whether the “n” pulse data is valid.

Abstract: Methods are provided herein for determining antioxidant activity of a test sample in intact cells. The method includes determining the antioxidant capacity of a test sample in intact red blood cells, wherein the test sample is added to intact red blood cells and oxidative damage is measured by alteration of fluorescence intensity of an oxidation-sensitive fluorescent indicator dye.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: The invention concerns an internal standard used to quantitative analysis of the risk of humoral (i.e. vascular) transplant rejection. The internal standard consists of a stable composition of the C4d complement bound to a carrier consisting of erythrocytes or microparticles. The invention also concerns a method for analyzing in vitro the risk of humoral organ transplant rejection, which consists in determining the amount of component of C4d component fixed on the erythrocytes contained in a blood sample from a patient.

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 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: Methods of evaluating molecular isomers of branched-chain amino acids are featured. The methods can include: derivatizing one or more molecular isomers of branched-chain amino acids in a sample comprising a branched-chain amino acid labeled with one or more heavy atoms as a first standard; adding, to the sample, after derivatization, a nonderivatized or derivatized branched chain amino acid that is labeled with one or more heavy atoms, as a second standard; evaluating the sample using tandem mass spectrometry; and detecting peaks indicative of derivatized and nonderivatized forms of one or more branched-chain amino acids in the sample.

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: At least one embodiment of a stabilizing system includes a stabilizing agent present in an amount or concentration sufficient to completely or substantially prevent or reduce degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: The present invention provides dual labeled protein standards useful for the simultaneous determination of the molecular weight of a subject protein as well as the relative mass (i.e., amount) of the subject protein present in an electrophoresis lane. The invention is also directed to methods suitable for the preparation of such dual labeled protein standards and to methods of using such dual labeled proteins to simultaneously determine the molecular weight and the relative amount of a subject protein. Further embodiments are directed to the use dual labeled protein standards to make a more accurate determination of the amount of a protein present in an electrophoresis lane. Yet further embodiments are directed to kits containing the presently described dual protein standards. Dual labeled protein standards made and used in accordance with the embodiments set forth herein may be used to simultaneously determine the molecular weight and the relative amount of a subject protein in real time.

Abstract: The present invention relates to the field of the distinction between bacterial meningitis and viral meningitis. It relates in particular to an in vitro method for detecting the presence of bacterial meningitis, which comprises determining the concentration of procalcitonin present in a test blood sample and of proteins present in a test cerebrospinal fluid sample, and comparing the concentrations thus determined to the concentration of procalcitonin and of proteins present in a reference sample or to a reference value. It also relates to a kit comprising means for detecting procalcitonin and proteins in the cerebrospinal fluid, and to the use thereof for the production of a diagnostic tool for bacterial meningitis.

Abstract: The invention involves obtaining signatures of species (including chemical, biological, or biochemical molecules) and/or signatures of interactions between species and using them to characterize species, characterize interactions, and/or identify species that could be useful in a variety of settings. Signatures can be obtained using aqueous multi-phase partitioning and can be used to predict molecular interactions for applications such as drug discovery. A plurality of aqueous multi-phase partitioning arrangements can define an overall system providing an information-intensive signature, maximizing precision and sensitivity.

Abstract: The present invention provides a simple method for the stabilization of a peptide in a biological sample and a reagent for the stabilization, a simple method for the preservation of a biological sample comprising a peptide and a reagent for the preservation, and a method for the accurate measurement of a peptide in a biological sample and a reagent for the measurement. Addition of a saccharide to a biological sample enables the stabilization of a peptide in the biological sample, the preservation of the biological sample comprising a peptide in a stable condition and the accurate measurement of a peptide in the biological sample. As the present invention can stabilize a peptide in a biological sample collected in the clinical examination, the peptide as a marker in the biological sample can be measured accurately in the clinical examination.

Abstract: A method for identifying a biological analyte that is affected by a stressor is disclosed in which two substantially identical biological samples are provided, with a first sample being a control sample and a second sample being an experimental sample. The control sample is grown with a nutrient having an isotope of a first atom, whereas the experimental sample is grown with a nutrient having a second isotope of the first atom. The experimental sample is grown with a stressing agent and regimen. The samples are admixed, and the formed composite is mass spectroscopically assayed for analyte peaks. The ratio of first isotope to second isotope is determined for the peaks, as is a sample median isotopic ratio. The ratio for assayed analyte peaks is compared with the median ratio. An analyte whose isotopic ratio significantly deviates from the median ratio is an analyte affected by the stressing agent.

Abstract: The present invention relates to compositions and methods for identifying and quantifying platelet proteins that relate to various bodily states. The present invention further provides methods and compositions for determining whether an individual is using alcohol or other licit or illicit drugs at levels hazardous or harmful to their health. The invention also provides methods for identifying individuals who would benefit from or who may be harmed by specific medications or therapies.

Abstract: The present invention provides multicolor reagent formulations containing in a single container both fluorescently labeled detection reagents and single-color compensation control reagents, wherein the compensation control reagents consist of reagent-capture particles bound to a fluorescently labeled detection reagent included in the multicolor reagent formulation. The multicolor reagent formulations of the present invention simplify manufacture and commercial distribution of multicolor reagent kits.

Abstract: Disclosed herein are compositions and methods comprising two or more proteins in which at least one of the proteins has been altered to reduce their mutual recognition and binding. Such compositions are useful as reference, calibrators or controls in methods and assays for determining the amount of one or more of the proteins that may be present in a sample of interest or in confirming the presence of one or more of the proteins in the sample. More particularly, it relates to compositions and methods comprising altered placental growth factor-1 (PlGF-1) and soluble fms-like tyrosine kinase (sFlt-1) and methods for determining the amount or confirming the presence of sFlt-1 and/or PlGF-1 in a sample of interest.

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: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: An object of the present invention is to provide a control material which can be preferably employed in detection of 1,5-anhydro-D-glucitol and glycoalbumin, which are employed as excellent indices for diabetes. The present inventor has found that mannitol which is added to serum or plasma used as control material stabilizes 1,5-anhydro-D-glucitol and glycoalbumin present in the serum or plasma for a long period of time, and that the object can be attained through provision of (1) an agent for stabilizing control material, the agent being composed of mannitol and (2) control material containing mannitol and 1,5-anhydro-D-glucitol.

Abstract: The invention is in the field of coagulation diagnosis and relates to a liquid, buffer-based D-dimer composition, which additionally contains fibrinogen and which is suitable as a standard material for control or calibration purposes for D-dimer test procedures.

Abstract: Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter's user. Methods for use of the solutions are also provided.

Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: A method for extracting proteins from heterogeneous fluids by precipitation using microfluidics. The method uses an automated protocol for precipitation of proteins onto surfaces, rinsing the precipitates to remove impurities, and resolubilization in buffer for further analysis. The method is compatible with proteins representing a range of different physicochemical properties, as well as with complex mixtures such as fetal bovine serum and cell lysate. In all cases, the quantitative performance (measured using a fluorescent assay for % recovery) was comparable to that of conventional techniques, which are manual and require more time.

Abstract: The invention provides compositions, kits, and methods for calibrating a mass spectrometer using two or more recombinant proteins and one or more energy-absorbing molecules. The recombinant proteins of the invention display high purities, making them suitable for use in mass spectrometry.

Abstract: The present invention concerns a method for determining an allergic response by determining the extent of degranulation of human IgE sensitized cells upon activation by allergens in food products.

Abstract: The invention involves obtaining signatures of species (including chemical, biological, or biochemical molecules) and/or signatures of interactions between species and using them to characterize species, characterize interactions, and/or identify species that could be useful in a variety of settings. Signatures can be obtained using aqueous multi-phase partitioning and can be used to predict molecular interactions for applications such as drug discovery. A plurality of aqueous multi-phase partitioning arrangements can define an overall system providing an information-intensive signature, maximizing precision and sensitivity.

Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: A corrected reporter ion intensity is calculated in tandem mass spectrometry based quantitation using isobaric labels. An analyte in each of two or more samples of a mixture of samples is labeled with a different isobaric label. The analyte is eluted from the mixture of samples and intensities of the eluting analyte are measured. An analyte intensity is selected at each of at least two times from the measured intensities. Tandem mass spectrometry is performed on the eluting analyte at each of the at least two times. A plurality of reporter ion intensities is produced. A system of linear equations is created expressing each reporter ion intensity of the plurality of reporter ion intensities as a sum of a background noise intensity and the product of a fragmentation efficiency and an analyte intensity. A corrected reporter ion intensity is calculated from a solution of the system of linear equations.

Abstract: Methods, compositions, and kits for labeling tetracysteine-tagged proteins with biarsenical fluorophores with increased specificity, including compositions, methods and kits particularly adapted for labeling of tetracysteine-tagged proteins to be resolved within an electrophoresis gel.