Abstract: The invention provides an accurate, economical, automatable, high throughput method for the determination of the concentration of glycosaminoglycan anticoagulants, including low molecular weight heparin (LMWH) anticoagulants, in aqueous solutions. A method for cleaning a unit of manufacturing equipment used in the preparation of a LMWH to obtain an acceptable residual concentration of LMWH is further provided.

Abstract: A system and method for providing 20% ethanol solutions meeting bioburden and endotoxin specifications, which provides the 20% ethanol solution in a ready-to-use form which may be dispensed directly from the container in which the solution is shipped, and which may be used in connection with storage, reuse and/or rejuvination of Protein A.

Abstract: The invention relates to the detection of fusion proteins. Described are a set of at least a first and a second molecular probe, each probe provided with a dye wherein the dyes together allow energy transfer, at least one probe provided with a reactive group allowing juxtaposing at least the first and second probes wherein the reactive group allows modulation of juxtaposing the probes such that there is an increased likelihood of energy transfer between the dyes. A method is provided which permits detecting the presence of a fusion protein in a cell at the single cell level.

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 method for manufacturing chip stack packages may include: providing at least two wafers, each wafer having a plurality of chips, and scribe lanes formed between and separating adjacent chips; forming a plurality of via holes in peripheral portions of the scribe lanes; forming connection vias by filling the via holes; establishing electrical connections between the chip pads and corresponding connection vias; removing material from the back sides of the wafers to form thinned wafers; separating the thinned wafers into individual chips by removing a central portion of each scribe lane; attaching a first plurality of individual chips to a test wafer; attaching a second plurality of individual chips to the first plurality of individual chips to form a plurality of chip stack structures; encapsulating the plurality of chip stack structures; and separating the plurality of chip stack structures to form individual chip stack packages.

Abstract: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: A process for the detection of antibodies in a test sample by preparing a suspension of erythrocytes with a test serum or plasma by mixing a test serum or plasma with erythrocytes; incubating the suspension of erythrocytes at a temperature of from 37° C. to 45° C. to bind any antibodies in the test serum or plasma to the surface of said erythrocytes; combining the suspension of erythrocytes with an amount of a solution of a macromolecule which is effective to agglutinate the erythrocytes; packing the resultant red cell agglutinates by centrifuging the suspension of erythrocytes; and, determining the presence of anti-erythrocyte antibodies by observing if antibody-dependent erythrocyte agglutination has occurred.

Abstract: Elevated number of Circulating Endothelial Cells (CEC) have been implicated in disease conditions associated with the formation or destruction of blood vessels such as acute coronary syndrome, thrombocytopenic purpura, sickle cell disease, sepsis, lupus, nephrotic syndromes, rejection of organ transplants, surgical trauma and cancer. This invention provides a method for assessing the levels of CEC which vary between different studies using a sensitive enrichment, imaging, and enumberation analysis. CD146 is one of the most specific endothelium-associated cell-surface antigens which can be used in image cytometry. CEC analysis provides an essential tool in prognostic/diagnostic evaluation in the clinic.

Abstract: Provided are methods comprising the use of non-sugar organic compatible solutes for protection and preservation of the activity of biologically active molecules and conjugate labels. The methods are particularly adaptable for use in conjunction with immunoassays, such as for example, immunochromatographic test assays and may be incorporated into any test methodology wherein a dry test strip is used as a carrier for depositing, mobilizeable and/or immobilized biologically active molecules and/or conjugate labels.

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: During the investigation of the mechanism that cellular water in woody plants growing in cold districts keeps liquid state at low temperature, the inventors have studied to identify the causative substances. As the results, the present inventors identified supercooling promoting agents in woody plants. The supercooling ability of identified flavonoid glycoside and synthesized flavonoid glycoside with similar structure was tested. It was found that the supercooling promoting agent comprising these flavonoid glycosides enables to stably supercool bulk water at low temperature for long-term. The aqueous solution containing the supercooling promoting agent of the present invention is useful to store biological materials at low temperature.

Abstract: A sheath liquid for a particle analyzer used to analyze particles contained in a sample is described. The sheath liquid includes water and a refractive-index adjustment agent with glycerols and/or sulfate. A method for producing the sheath liquid and a method for analyzing particles using the sheath liquid are also described.

Abstract: This invention is directed to a method for preparation of a biological sample for measurement of protein epitopes that allows for the preservation of intracellular protein epitopes and detection of signal transduction pathways based on the ability to capture transient activation states of the epitopes. The method provided by the invention allows for the rapid fixation of biological samples containing red blood cells, to ensure that epitopes of signal transduction molecules and other intracellular protein epitopes are preserved in the active state. The method of the invention further allows for lysis of red blood cells, thereby making it a useful method for cytometric analysis of biological samples, including, for example, whole blood, bone marrow aspirates, peritoneal fluids, and other red blood cell containing samples. The invention also provides a method to recover or “unmask” epitopes on intracellular antigens that have been made inaccessible by the cross linking fixative necessary to fix the sample.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A method of stabilizing a hem protein which is effective against the denaturation and degradation of a hem protein typified by hemoglobin and a storage solution therefor. A method of stabilizing a hem protein and a storage solution therefor characterized in that an iminocarboxylic acid or its salt is made to coexist in a sample containing the hem protein, wherein the above-described iminocarboxylic acid is a compound represented by the following general formula (1) wherein R represents a hydrogen atom or a hydroxyl group; and X's represent each a hydrogen atom, an alkali metal or an ammonium group.

Abstract: The present invention relates to compositions for improving assay accuracy for plasma samples by decreasing or eliminating false results due to platelet interference. The compositions of the present invention comprise compositions that include a platelet interference reducing agent in an amount effective to decrease the platelet interference activity in the plasma sample, particularly platelet-rich plasma sample, to be analyzed. The most preferred platelet interference reducing agent of the present invention is 1-(1,3-Bis(hydroxymethyl-2,5-dioxoimidazolidin-4-iyl)-1,3-bis(hydroxymethyl) urea, also called “Diazolidinyl urea” or “DZU”.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: The present invention relates to a method for arresting, protecting and/or preserving an organ which includes administering effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) local anaesthetic to a subject in need thereof. The present invention also relates to a method for arresting, protecting and/or preserving an organ which comprises adding a composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic to the organ. The present invention further provides a pharmaceutical or veterinary composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: A calibration gas generation method and apparatus for generating a selectively humidified calibration gas to a measurement probe includes a delivery conduit having a conduit inlet adapted to receive a carrier gas stream and a conduit outlet for delivering a calibration gas stream. The apparatus is provided with a first injection unit having a first intake in fluid communication with a first reservoir and a first outlet in fluid communication with the delivery conduit, the first reservoir being adapted to hold a first analyte in liquid form, and a second injection unit having a second intake in fluid communication with a second reservoir and a second outlet in fluid communication with the delivery conduit, the second reservoir being adapted to hold a humidificant in liquid form.

Abstract: The present invention relates generally to high-throughput assay methods that determine the proliferative status of hematopoietic stem and progenitor cells. The present invention further relates to high-throughput assays for screening compounds that modulate the growth of hematopoietic stem and progenitor cells and for identifying subpopulations thereof that are suitable for transplantation. The assay of the present invention is particularly useful for quality control and monitoring of the growth potential in the stem cell transplant setting and would provide improved control over the reconstitution phase of transplanted cells.

Abstract: The present invention relates generally to high-throughput assay methods that determine the proliferative status of hematopoietic stem and progenitor cells. The present invention further relates to high-throughput assays for screening compounds that modulate the growth of hematopoietic stem and progenitor cells and for identifying subpopulations thereof that are suitable for transplantation. The assay of the present invention is particularly useful for quality control and monitoring of the growth potential in the stem cell transplant setting and would provide improved control over the reconstitution phase of transplanted cells.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: The present invention is directed to compositions and methods for improving a chemiluminescent signal. In particular, a reaction buffer with an alkaline pH range of about 9 to 10 provides a maximal chemiluminescent intensity and longevity of luminol that is catalyzed by superoxide anions. The addition of carbonate to the reaction buffer provides an optimal signal to background ratio and stability of a chemiluminescent signal from luminol catalyzed by superoxide anions. The method includes preparing a buffer with an alkaline pH, combining the buffer with a working reagent to produce and detect a chemiluminescent signal. The working reagent includes luminol, a coumaric acid and a peroxide. The composition includes a buffer having a pH from about 9 to about 10, a stock reagent comprising luminol, a coumaric acid, a peroxide, and a second buffer having a pH of about 8.5.

Abstract: Disclosed is a single population of simulated leukocyte granules prepared from mammalian whole white blood cells, which is useful in calibrators for a hematology analyzer, a calibrator which includes the single population of simulated leukocyte granules. Disclosed is also a method of preparing the single population of simulated leukocyte granules. The method of preparing single population of simulated leukocyte granules includes the actions of: obtaining mammalian whole white blood cells; treating the mammalian whole white blood cells with a hemolytic agent and a leukocyte treating liquid which includes an isotonic saline solution. The isotonic saline solution may include a fixative, an oxidizer, and a carbohydrate compound; fixing the treated mammalian whole white blood cells with a fixative; and suspending the fixed cells in a preservation medium for long-term preservation of fixed cells.

Abstract: A method of staining bacteria comprises: working a polymethine dye on a sample in the presence of a substance capable of reducing nitrite ions to stain bacteria in the sample. A method of detecting bacteria comprises the following steps of: (1) working a polymethine dye on a sample by a method as described above to stain bacteria in the sample, (2) introducing the thus treated sample into a detecting part of a flow cytometer and irradiating cells of the stained bacteria one by one with light to measure scattered light and fluorescent light emitted from each of the cells; and (3) discriminating the bacteria from other components in accordance with an intensity of a scattered light signal and an intensity of a fluorescent light signal or a pulse width reflecting the length of particles to count the bacteria.

Abstract: The invention relates to a reagent and a process for the identification and counting of biological cells in a sample. This reagent comprises a cell lysing agent selected from at least one detergent in a concentration capable of specifically lysing a given type of cells in the sample, and a stain capable of marking the intracellular nucleic acids of the remaining unlysed cells. Application in particular for the identification and counting of cells using an automated analysis system based on flow cytometry.

Abstract: Methods, systems and reagents are provided for preserving nucleic acids in a bodily fluid, such as urine, blood, blood serum, and amniotic fluid. The preservative includes an amount of at least one chelator enhancing component selected from the group consisting of lithium chloride, guanidine, sodium salicylate, sodium perchlorate, guanidine thiocyanate, and sodium thiocyanate in the range of from about 0.1M to about 2M and an amount of least one buffer component selected from the group consisting of Tris and HEPES.

Abstract: Compositions and methods are disclosed for automated storing, tracking, retrieving and analyzing biological samples, including dry storage at ambient temperatures of nucleic acids, proteins (including enzymes), and cells using a dissolvable dry storage matrix that permits recovery of biologically active materials. RFID-tagged biological sample storage devices featuring dissolvable or dissociable matrices are described for use as supports of biological samples, which matrices can be dried and subsequently rehydrated for sample recovery. Also disclosed are computer-implemented systems and methods for managing sample data.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A control and a cellular fraction for use therein and methods for making the same, including a first cellular component including a plurality of a first group of processed animal red blood cells other than human blood cells; a second cellular component including a plurality of a second group of processed animal red blood cells other than human blood cells; a third cellular component including a plurality of a third group of processed animal red blood cells other than human blood cells; wherein one or more of the first second and third cellular components include a nucleus; and the control simulates erythroblasts of a human blood sample on an automated blood analyzer that analyzes blood cells using impedance, optical measurements or both.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover rare cell types in high yield.

Abstract: The present invention provides methods for collecting, storing or transporting liquid suspension of biological specimens containing analytes of interest in a dry state. The dried biological specimens containing analytes of interest are reconstituted and released for subsequent analysis by compressing or centrifuging the matrix. Also provided are method of using kits for collecting, storing, transporting and recovering biological specimens containing analytes of interest.

Abstract: The present invention provides a method for preparing a five-part differential white blood cell control and a white blood cell control prepared thereby. The white blood cell control obtained by the method of the present invention perfectly retains the light scattering properties of every type of white blood cells and has much higher stability than that of real white blood cells, and therefore can be used for the quality control of five-part differential hematology analyzers based on the principle of multi-angle light scattering.

Abstract: The present invention is directed to compositions and methods for improving a chemiluminescent signal. In particular, a reaction buffer with an alkaline pH range of about 9 to 10 provides a maximal chemiluminescent intensity and longevity of luminol that is catalyzed by superoxide anions. The addition of carbonate to the reaction buffer provides an optimal signal to background ratio and stability of a chemiluminescent signal from luminol catalyzed by superoxide anions. The method includes preparing a buffer with an alkaline pH, combining the buffer with a working reagent to produce and detect a chemiluminescent signal. The working reagent includes luminol, a coumaric acid and a peroxide. The composition includes a buffer having a pH from about 9 to about 10, a stock reagent comprising luminol, a coumaric acid, a peroxide, and a second buffer having a pH of about 8.5.

Abstract: A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.

Abstract: An apparatus includes semiconductor processing equipment. A particle detecting integrated circuit is positioned in a vacuum environment, the particle detecting integrated circuit containing a device having a pair of conductive lines exposed to the vacuum environment. The pair of conductive lines is spaced at a critical pitch corresponding to diameters of particles of interest. A computer system is linked to the particle detecting integrated circuit to detect a change in an electrical property of the conductive lines when a particle becomes lodged between or on the lines.

Abstract: An immunodiagnostic test card includes a flat planar member and at least one dilution chamber that is supported by the flat planar member. The at least one dilution chamber can be disposed adjacent chambers used for testing a patient sample that are provided on the immunodiagnostic test card or can be provided separately.

Abstract: The present invention relates to the qualitative and quantitative validation of marker indices, especially for medical diagnosis and particularly for the determination of the growth fraction in a sample with antibodies against the Ki-67 protein. Diagnostic kit for the quantification of a cell fraction labeled by a marker for in vitro diagnosis, characterized in that a pseudo-tissue is used for the intra- and inter-assay standardization of the marker index.

Abstract: Provided herein are reagents for use in an automated environment for cell conditioning of biological samples wherein the cells or tissues are predisposed for access by reagent molecules for histochemical and cytochemical staining procedures. The reagents include, but are not limited to, components optimized to facilitate molecular access to cells and cell constituents within the biological sample. Also provided herein are reagents for use in an automated environment for removing or etching embedding media by exposing a biological sample to be stained in histochemical or cytochemical procedures without the dependence on organic solvents. The reagents include, but are not limited to, components optimized to facilitate removal or etching of the embedding media from the biological sample.

Abstract: Erythrocytes from a vertebrate animal other than a human that have been size reduced and treated with a fixing agent by conventional methods to resemble human platelets are further treated to achieve a size distribution that is detected in a consistent manner by different methodologies of blood cell counting. The further treatment includes heating to a denaturing temperature followed by a second treatment with a fixing agent. The resulting cells are useful as controls for calibrating and checking the accuracy of automated blood cell counting equipment.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: Compositions, reagents, kits, systems, system components, and methods for performing assays. More particularly, the invention relates to the use of novel combinations of reagents to provide improved assay performance.

Abstract: The invention provides an accurate, economical, automatable, high throughput method for the determination of the concentration of glycosaminoglycan anticoagulants, including low molecular weight heparin (LMWH) anticoagulants, in aqueous solutions. A method for cleaning a unit of manufacturing equipment used in the preparation of a LMWH to obtain an acceptable residual concentration of LMWH is further provided.

Abstract: The invention relates to measuring of the adhesion of platelets ex vivo. In this method, monodisperse polymer particles are added to blood, and the number of platelets in the blood are measured before and after shaking of the sample. The level of adhesion of the platelets is determined by comparing the number of platelets prior to shaking with the number of platelets after shaking. Methods of establishing an adhesion index and diagnosis of a patient are also provided.

Abstract: We disclose methods for measuring vitamin D metabolite in plasma or serum samples. The methods comprise a step of adding to the plasma or serum samples a non-competitive displacement agent comprising 8-anilino-1-naphthalenesulfonic acid ammonium salt, 3-(acetonylbenzyl)-4-hydroxycoumarin and a water miscible solvent. The non-competitive displacement agent separates vitamin D metabolite from binding proteins in the sample, such that the displaced vitamin D metabolite is available for capture and detection in subsequent binding assays. Thus, our invention finds use in methods of separating and detecting vitamin D metabolites otherwise tightly bound to plasma or serum binding proteins.

Abstract: A kit is provided for gathering biological specimens. The kit generally comprises a self-contained specimen gathering device including a protective housing and a preservation solution. Also provided is a method of gathering specimens and a holistic method of deterring crime using the kit.

Abstract: In one aspect, the invention provides methods for protein sample preparation for electrophoretic separation. The method comprises a step of providing a protein sample in solution, adding a chaotrope to the protein sample, adding a surfactant to the protein sample, wherein the final concentration of the surfactant in the solution is less than critical micelle concentration of the surfactant. In another aspect, the invention also provides methods of electrophoretic separation of protein samples that includes the protein sample preparation method as described herein. In yet another aspect, the invention provides a loading buffer solution composition for protein sample preparation that includes a surfactant in solution at a final concentration that is less than critical micelle concentration of the surfactant, and; a chaotrope.

Abstract: A lytic reagent composition and methods for differential analysis of leukocytes are disclosed. In embodiments, the analysis may utilize optical measurements in flow cytometry based hematology analyzers. The reagent system includes an anionic surfactant in a hypotonic solution, an inorganic buffer to maintain the pH in a range from about 6 to about 10, and optionally a leukocyte stabilizer. The reagent system is used to lyse red blood cells and stabilize the leukocytes to enable multi-part differentiation of leukocytes in a near physiologic pH environment on a flow cytometry based hematology analyzer using axial light loss, light scatter intensity, high-numerical aperture side scatter, and time-of-flight measurements.