Abstract: Aqueous calibration or quality control reagents that include urea are disclosed; the reagents may further include at least one amino acid-containing composition to provide pH stability thereto. Methods of production and use thereof are also disclosed.

Abstract: This disclosure describes single-use test cartridges, cell analyzer apparatus, and methods for automatically performing microscopic cell analysis tasks, such as counting and analyzing blood cells in biological samples. A small measured quantity of a biological sample, such as whole blood, is placed in a mixing bowl on the disposable test cartridge after being inserted into the cell analyzer. The analayzer also deposits a known amount of diluent/stain in the mixing bowl and mixes it with the blood. The analyzer takes a measured amount of the mixture and dispenses in a sample cup on the cartridge in fluid communication with an imaging chamber. The geometry of the imaging chamber is chosen to maintain the uniformity of the mixture, and to prevent cells from crowding or clumping as it is transferred into the imaging chamber by the analyzer. Images of all of the cellular components within the imaging chamber are counted and analyzed to obtain a complete blood count.

Abstract: The invention relates to a method for compensation for different sensitivities at different wavelengths in a spectrometric measuring system, including steps of calibrating the measuring system in a wavelength range with respect to one or more known reference standards, creating a wavelength-dependent compensation algorithm for linearization, and adjusting the measuring system using the compensation algorithm. The invention further discloses a corresponding measuring system.

Abstract: In the examples set forth herein, nucleic acid extraction materials are capable of selectively extracting cell free nucleic acids, including cell free DNA, directly from whole blood samples or plasma. Also included are methods of making and using the nucleic acid extraction materials. One example of a nucleic acid extraction material includes a substrate. This example of the nucleic acid extraction material also includes a polycation bonded to at least a portion of a surface of the substrate. In this example, the polycation consists of a polymer of a quaternized monomer selected from the group consisting of a quaternized 1-vinylimidazole monomer and a quaternized dimethylaminoethyl methacrylate monomer, or a copolymer of a neutral monomer and the quaternized monomer.

Abstract: Methods are provided for end users of diagnostic measurement procedures to prepare quality controls having desired analyte recoveries, estimate recoveries of quality controls already prepared, and compare estimated and measured recoveries. To prepare a quality control containing a particular analyte, a desired recovery of a measurement procedure for the analyte can be scaled by a correlation factor to obtain a target nominal concentration of the analyte in the quality control. Alternatively, the nominal concentration of an analyte in a quality control can be scaled by a correlation factor to obtain a predicted recovery of a measurement procedure for the analyte. The correlation factors can be based on recovery data previously obtained using the measurement procedure and optionally one or more reference procedures, and can be calculated using regression analysis of these data.

Abstract: Embodiments of systems and methods for automated sample handling are disclosed. In an example, a system for automated sample handling includes reaction wells, a magnet, a magnetic manipulator, and a punch. The reaction wells are configured to each hold a reagent and collectively move horizontally. A first reaction well holds magnetic beads, and a second reaction well is partitioned by a seal. The magnet is configured to move vertically and capture the magnetic beads on a bottom surface of the first reaction well when moving to an upper position beneath the first reaction well. The magnetic manipulator is configured to manipulate the magnetic beads and includes a magnetic rod configured to move vertically to be above or in the first reaction well and a sheath below the magnetic rod and configured to move vertically and receive the magnetic rod. The punch is configured to move vertically and break the seal of the second reaction well when moving to a lower position in the second reaction well.

Abstract: A diagnostic kit for viscoelastic analysis of a sample includes a pipette tip containing constituent (A) and a measurement cup containing constituent (B), wherein the constituents (A) and (B) are adapted to form a diagnostic composition upon combination, wherein the diagnostic composition includes an activator of coagulation and a calcium salt. A method of performing a viscoelastic analysis on a sample using such a diagnostic kit is also disclosed.

Abstract: The disclosure herein includes methods for producing an anatomical model, which method may include: providing a mold assembly, which mold assembly may include: a first mold portion having an outer surface and an inner surface; and a second mold portion having an outer surface and an inner surface; disposing a lining material on either a portion of the inner surface of the first mold portion or a portion of the inner surface of the second mold portion, or both; forming a first cavity between the inner surface of the first mold portion and the inner surface of the second mold portion; positioning a portion of an insert in the first cavity; introducing a first material into the first cavity; removing a portion of the insert to expose a second cavity inside the mold assembly; and introducing a second material into the second cavity.

Abstract: The automatic analysis device 100 is provided with: a specimen dispensing mechanism 101 that dispenses subject blood plasma and/or normal blood plasma to be added to correct the coagulation time of the subject blood plasma, into a plurality of specimen containers 103; reaction containers 104 that contain the subject blood plasma and/or the normal blood plasma; a reagent dispensing mechanism 106 that dispenses a reagent into the reaction containers 104; and a detecting unit 113 which applies light from a light source 115 to the subject blood plasma and/or the normal blood plasma to which the reagent is added in the reaction containers 104, and which measures the coagulation time on the basis of the obtained scattered light and/or transmitted light.

Abstract: There is provided a serum- or plasma-separating composition less likely to cause separation between a liquid organic compound and a thixotropy imparting component and capable of maintaining a homogeneous blended state for a prolonged period. The serum- or plasma-separating composition comprises a liquid organic compound, a thixotropy imparting component, and a thermoplastic elastomer.

Abstract: Mass spectrometry (MS) active, fluorescent rapid tagging reagent is provided having three substituent groups: (a) a tertiary amino group or other MS active atom; (b) a highly fluorescent moiety; and (c) a reactive group that can react with an amine. The reactive group provides rapid tagging of desired bio-molecules. The fluorescent moiety provides the fluorescent signal. The tertiary amino group provides the MS signal.

Abstract: Certain embodiments of a sensor cartridge element include a sensor module, an electrode arrangement installed on the sensor module, and a delivery arrangement securely coupled to the sensor module. The sensor module includes an analysis cell and a skin piercing member. The electrode arrangement generates an electrical signal when exposed to a fluid sample collected in the analysis cell. The delivery arrangement includes a drug reservoir, a piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber. Metering electronics and an actuator can manage collection of fluid samples and/or dispensing of drug doses.

Abstract: A method reconstructing optical properties of a medium uses a reconstruction system having a radiation source illuminating a medium and a detector receiving a signal emitted by the medium. This method includes establishing, for a source-detector pair, a first distribution of a signal received by the detector for a reference medium, the received signal emitted by the reference medium subsequent to the illumination of the medium by the source, determining, for the source-detector pair, a first modeling function of a light scattering signal between the source and the detector in the reference medium, establishing, for the source-detector pair, a second distribution of a signal received by the detector for the medium, the received signal being emitted by the medium to be characterized subsequent to illumination of said medium by the source, and computing a signal corrected as a function of the first modeling function and of the second distribution.

Abstract: An optically heterogeneous phantom structure for use in optical imaging techniques. The phantom structure includes an external shape simulating an object to be subjected to an optical imaging technique, the external shape defining an external surface that encloses an internal volume of the external shape; and an optically heterogeneous material filling the internal volume and having heterogeneous optical properties for simulating at least one optical parameter of at least one region within the object. A method of producing the optically heterogeneous phantom structure. The method includes selectively depositing precursors of a first material and a second material by 3D printing so that the precursor of the second material is surrounded by the precursor of the first material within a predetermined internal region of the precursor of the first material, and forming the phantom structure. Variations of the method include additives to the materials.

Abstract: Aqueous calibration or quality control reagents that include urea are disclosed; the reagents may further include at least one amino acid-containing composition to provide pH stability thereto. Methods of production and use thereof are also disclosed.

Abstract: A method for the risk detection, early diagnosis, prognosis, and monitoring of Parkinson's disease in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with Parkinson's disease, or an earlier sample from the individual of interest.

Abstract: The invention is directed to a swipe with at least one ionization reagent associated with the swipe for detecting target analytes and methods of detecting the target analyte molecules that can indicate the presence of, for example, explosives, narcotics, chemical warfare agents, biological warfare agents, or toxins. The swipe can be used to transfer molecules from a surface to the swipe for further analysis. In particular, the swipes can include an ionization reagent that is preferably a low volatility compound and capable of forming ionization reagent-analyte complexes with target analytes. The swipe can also include multiple ionization reagents with different volatilities such that they are released sequentially during a thermal ramp-up. Alternatively, the swipe can have multiple ionization reagents associated with spatially separated portions of the swipe such that they can be releasable sequentially to detect multiple target analytes.

Abstract: A novel reagent for clarification of an emulsion containing a salt and first and second surfactants is used in a method of clarifying emulsions which may contain inorganic, organic or biological particles to be measured. The reagent may be proved as kit of parts for in situ preparation thereof.

Abstract: A measurement standard suitable for measuring amounts of certain elements in pharmaceutical excipients is described. A reference standard is dissolved in a solvent, for example acetone, and mixed with a pharmaceutical excipient such as cellulose, lactose or calcium carbonate. The solvent is then evaporated to provide a dry standard.

Abstract: The present invention relates to methods of inducing an immune response to cytomegalovirus (CMV) using a genetically modified CMV that is conditionally replication defective. The methods of the invention can be used to treat and/or prevent primary CMV infection, infection due to reactivation of a latent CMV and a super-infection of a different strain of CMV that had been previously encountered. The present invention also relates to a replication defective CMV which has been recombinantly altered to allow for external control of viral replication. Compositions comprising the replication defective CMV are also encompassed by the present invention.

Abstract: A method for the risk detection, early diagnosis, prognosis, and monitoring of Alzheimer's disease in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with Alzheimer's disease, or an earlier sample from the individual of interest.

Abstract: A method of treating a patient who has extravasation of blood from an intravascular compartment to an extravascular compartment. An agent is administered to the patient which mitigates a harmful effect of break-down products of blood at an extravascular site, resulting in the patient having reduced morbidity and mortality. The morbidity and mortality of the patient is further reduced by concomitant administration of a suspension of submicron protein spheres having a molecular weight of ranging from 780 billion Daltons to less than 0.8 billion Daltons.

Abstract: Embodiments of the invention include methods and compositions for producing proficiency testing standards for noninvasive prenatal genetic diagnostics and for the detection and monitoring of cancer. The compositions can include a plurality of different nucleosomal DNA fragments derived from either primary cells or cell lines. The amount of the different nucleosomal DNA fragments can be varied so as to simulate naturally occurring cell free DNA samples obtained from the blood of the pregnant woman or naturally occurring cell free DNA samples obtained from the blood of cancer patients.

Abstract: The invention relates to methods of isolating white blood cells (WBCs) from a sample, e.g., whole blood, using magnetic particles that specifically bind to WBCs and a series of specific steps and conditions. The methods can include one or more of decreasing the viscosity of the sample prior to WBC isolation, agitating the sample at specified frequencies, and/or using a sample container arranged such that all of the sample is placed in close proximity (e.g., within 5, 2, 1, or 0.5 mm) to the source of the magnetic field. The new methods provide for isolation of WBC preparations with high yield, purity, and viability. The methods are designed for compatibility with automation protocols for rapid processing of multiple samples.

Abstract: This invention relates to a correction liquid for a liquid membrane type ion-selective electrode that makes it possible to measure a ratio between a sodium ion concentration and a potassium ion concentration in urine by correcting for an influence from an ionic strength of the urine. The correction liquid comprises a sodium ion-sensitive part that selectively reacts with the sodium ion and a potassium ion-sensitive part that selectively reacts with the potassium ion, and measures a ratio between a sodium ion concentration and a potassium ion concentration in urine, and comprises the sodium ion, the potassium ion, and an electrolytic ionic strength modifier.

Abstract: The present invention relates to reagents for separating proteins from detergent, reagents for detecting proteins in the presence of a detergent, and methods of using the same. The separating reagents contain a cyclic oligomer such as cyclodextrin and a cellulose derivative such as 2-hydroxyethyl cellulose. When used in combination with standard protein-complexing dyes, the reagents allow detection of proteins in electrophoresis gels at nanogram levels.

Abstract: A method and system for testing the functional capability of an analytical instrument uses first and second blind samples. Each blind sample is a test substance with an amount of a parameter to be tested that is unknown to the user. Each blind sample is provided with an identification means with a unique identification. When the blind samples are tested by the user in the instrument being tested, the measurement values obtained and the unique identifications read are compared against predetermined values that are accessible to a test program configured as software on the analytical instrument. By comparison of the measurement values and the predetermined values, the functional capability of the analytical instrument is determined and the result is transmitted to an output unit of the analytical instrument.

Abstract: In one embodiment, a product includes a plurality of particles, each particle including: a carrier that includes a non-toxic material; and at least one DNA barcode coupled to the carrier, where the particles each have a diameter in a range from about 1 nanometer to about 100 microns.

Abstract: The present disclosure relates to a staining methodology employing a particle contrast agent composition capable of rapidly staining cells in a single step. The particle contrast agent composition can be comprised of a combination of one or more particle contrast agents, one or more permeabilizing agents, and one or more fixing agents. The particle contrast agent composition can include Crystal Violet, New Methylene Blue, Saponin, and Gluteraldehyde.

Abstract: Described are methods and systems to apply a plurality of test voltages to the test strip and measure a current transient output resulting from an electrochemical reaction in a test chamber of the test strip so that an estimated interferent value can be determined so that such interferent value can be used to correct the current transients at specific time points for more accurate glucose concentration determination.

Abstract: Techniques are disclosed relating to analysis and reduction of crosstalk between signals. These techniques may be applicable in many fields, such as single-tube PCR or DNA melt analysis, PCR or melt data from neighboring wells of a multi-well plate, capillary electrophoresis data (e.g., DNA sequencing), gas chromatography, multispectral imaging, dual-color fluorescence correlation spectrometry, electrical crosstalk, etc. According to one embodiment, crosstalk between fluorescence signals from different species may be determined based on a correlation between the time derivatives of the fluorescence signals from the fluorescent species.

Abstract: A liquid mixture used to test and validate test devices for inspecting objects or persons is provided. The mixture containing glycerol and consisting of a mixture of glycerol, ethanoic acid and water.

Abstract: A system and related method for determining the volume of a sample solution delivered by a liquid delivery device. The system includes devices for adding and removing diluent, the sample solution under analysis and a mixture of the two in a cell having a substantially constant cross sectional area and a known horizontal optical path length. The system includes one or more spectrophotometers to measure horizontally and vertically absorbance associated with two distinct chromophores. A first chromophore of unknown concentration is in the diluent and a second chromophore of known concentration is in the sample solution. The method determines absorbance horizontally and vertically of the first chromophore prior to adding the sample solution and then determining absorbance of the first chromophore horizontally and vertically and the second chromophore horizontally after mixing the diluent and sample solution together. That information is used to determine the volume of the sample solution added to the cell.

Abstract: Embodiments of the invention include methods and compositions for producing proficiency testing standards for noninvasive prenatal genetic diagnostics and for the detection and monitoring of cancer. The compositions can comprise a plurality of different nucleosomal DNA fragments derived from either primary cells or cell lines. The amount of the different nucleosomal DNA fragments can be varied so as to simulate naturally occurring cell free DNA samples obtained from the blood of the pregnant woman or naturally occurring cell free DNA samples obtained from the blood of cancer patients.

Abstract: A homologous series of neutrally charged compounds having at least one functional group bearing a positive charge and at least one functional group bearing a negative charge are advantageous retention index standards for liquid chromatography, especially for liquid chromatography-mass spectrometry (LC-MS) methods, more especially for LC-MS methods employing electrospray (ESI) or atmospheric pressure chemical ionization (APCI) ionization systems.

Abstract: Colloidal formulation for staining proteins and methods of their use are provided.

Abstract: Provided are synthetic dendrimer calibrants for mass spectrometry. The calibrants are distinguished by their relative ease and rapidity of synthesis, comparatively low cost, long shelf life, high purity, and amenability to batch synthesis as mixtures. The latter characteristic enables parallel preparation of higher molecular weight compounds displaying useful distributions of discrete molecular weights, thereby providing multi-point mass spectrometry calibration standards. Methods of making, tuning and using said calibrants are provided.

Abstract: A biological reaction apparatus for receiving at least one substrate having a sample located in a sample region, and a separate cover, such that a reaction chamber is formed between the cover and substrate over the sample region. The apparatus includes a substrate locator for locating the substrate; a cover locator for locating and moving the cover with respect to the substrate; a fluid dispenser for dispensing fluid into the reaction chamber; and a draining mechanism which includes a wick.

Abstract: A simulant that includes a carrier and DNA encapsulated in the carrier. Also a method of making a simulant including the steps of providing a carrier and encapsulating DNA in the carrier to produce the simulant.

Abstract: The present invention refers to a method of processing a biological fluid which comprises cellular components by a freezing/thawing treatment. The method is particularly useful for preparing biological samples for analyte detection.

Abstract: The present invention concerns a reagent composition for releasing vitamin D compounds bound to vitamin D-binding protein, a method for the detection of a 25-hydroxyvitamin D compound in which the 25-hydroxyvitamin D compound is released from vitamin D-binding protein using this reagent and the mixture obtained in this manner is analyzed, the use of the reagent to release vitamin D compounds as well as a kit for detecting 25-hydroxyvitamin D which contains the reagent for releasing vitamin D compounds in addition to the usual immunological reagents.

Abstract: A method of flowing a fluid with a tracer in a microfluidic channel of an assay device and detecting the tracer for determining the channel location or condition of the channel.

Abstract: Disclosed herein is a method for identifying the compounds contributing to a pungent odor from an air conditioner, a method for artificially reproducing the pungent odor, and preparing a corresponding pungent odor composition. Through the analysis method of the present invention, the compounds contributing to the pungent odor from an air conditioner may be identified and quantified. The pungent odor may be reproduced from a combination of the compounds identified by the analysis method of the present invention. The reproduced pungent odor may provide significant data required for development of an apparatus and a method for removing specific odors.

Abstract: A biosensor has an underfill detection system that determines whether a sample of a biological fluid is large enough for an analysis of one or more analytes. The underfill detection system applies an excitation signal to the sample, which generates an output signal in response to the excitation signal. The underfill detection system switches the amplitude of the excitation signal. The transition of the excitation signal to a different amplitude changes the output signal when the sample is not large enough for an accurate and/or precise analysis. The underfill detection system measures and compares the output signal with one or more underfill thresholds to determine whether an underfill condition exists.

Abstract: A biosensor calibration method configured to measure a concentration of a specific substance contained in sample liquid to be measured, including: a first step configured to acquire a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor; a second step configured to acquire a second output value that is output by the biosensor when second calibration liquid having a different concentration from that of the first calibration liquid is continuously brought into contact with the biosensor after the first step and determine time for replacement of the biosensor on the basis of the first output value and the second output value.

Abstract: A method that identifies the compounds contributing to a fish-like odor from an air conditioner and artificially reproduces the fish-like odor, and prepares a corresponding fish-like odor composition. Through the analysis method of the present invention, the compounds contributing to the fish-like odor from an air conditioner are identified and quantified. The fish-like odor is reproduced from a combination of the compounds identified by the analysis method of the present invention. The reproduced fish-like odor provides significant data required for development of an apparatus and a method for removing specific odor.

Abstract: A method that identifies the compounds contributing to a sweet odor from an air conditioner, reproduces the sweet odor, and prepares a corresponding sweet odor composition. Through the analysis method of the present invention, the compounds contributing to the sweet odor from an air conditioner are identified and quantified. The sweet odor is reproduced from a combination of the compounds identified by the analysis method of the present invention. The reproduced sweet odor provides significant data required for development of an apparatus and a method for removing specific odor.

Abstract: A method is provided that identifies the compounds contributing to a malodor from an air conditioner, reproduces the malodor, and prepares a corresponding malodor composition. Through the analysis method of the present invention, the compounds contributing to the malodor from an air conditioner are identified and quantified. The malodor is reproduced from a combination of the compounds identified by the analysis method of the present invention. The reproduced malodor provides significant data required for development of an apparatus and a method for removing specific odor.

Abstract: The present invention provides multi-parameter analysis methods for determining the presence or absence of pre-cancerous or cancerous cells in a cervical sample and for screening cervical abnormality in a cervical sample. The invention also provides an apparatus and automated methods for screening cervical abnormality in a sample. The invention further provides a sampling device and a sample collection assembly for collecting cell samples, including cervical samples.

Abstract: A method for calibrating an imager of a reagent analyzer, comprises positioning a dry reagent pad at a first read position in a field of view of the imager, the first read position illuminated by an illumination source with a first intensity, detecting a reference optical signal by the imager, indicative of a first reflectance value of the dry reagent pad at the first read position, positioning the dry reagent pad at a second read position, the second read position illuminated with a second intensity different from the first intensity, detecting a first optical signal by the imager, indicative of a second reflectance value of the dry reagent pad at the second read position, and calculating, by a processor, a calibration factor for the dry reagent pad at the second read position based on a difference between the reference optical signal and the first optical signal.