Abstract: A method of making a fluid sample collection card includes providing a support layer, forming an upper layer with a card stock, the upper layer including a sample window and a viewing window, supporting an absorbent layer with the support layer, and positioning the upper layer on the absorbent layer, wherein the upper layer is configured such that as a fluid is being absorbed by the first absorbent layer portion, presence of a portion of the fluid within the second absorbent layer portion indicates that a first volume of the fluid absorbed by the absorbent layer is a minimum necessary volume of the fluid sufficient to perform at least one test on at least one component in the fluid.

Abstract: A method for determining the concentration of chlorine dioxide in a chlorine dioxide solution having the following steps: (1) isolating two samples, Sample 1 and Sample 2, from the chlorine dioxide solution; (2) stripping the chlorine dioxide from Sample 1; (3) completely converting the chlorine dioxide in Sample 2 to other chlorine species; (4) transporting the chlorine dioxide samples either within the facility or outside the facility to a testing site; (5) separately determining the concentration of the chlorine containing species in each of Samples 1 and 2; and (6) calculating the concentration of chlorine dioxide in said chlorine dioxide solution based upon the information obtained in step (5).

Abstract: An interface is provided for storing microfluidic samples in a nanoliter sample chip. A fluid access structure provides a fluid access region to a selected subset of sample wells from an array of sample wells. A fluid introduction mechanism introduces a sample fluid to the fluid access region so that the sample wells in the selected subset are populated with the sample fluid without the unselected sample wells being populated with the sample fluid.

Abstract: The present invention provides methods for preventing clumping of cells in microfluidic devices by addition of diazolidinyl urea (DU). DU can be added to samples at the time of collection or can be added to samples post-collection. DU can also be pre-added to sample collection devices.

Abstract: A transportation system for transporting a biological material container between a sterile field and a nonsterile field and substantially maintaining sterility of the biological material container includes a housing assembly that removably houses the biological material container. The system also includes a port defined by the housing assembly, and the port provides communication into the biological material container from outside the housing assembly. The housing assembly includes a first member that covers a first portion of the biological material container such that a second portion of the biological material container extends from the first member. The housing assembly also includes a second member that covers the second portion of the biological material container. The second member is removably coupled to the first member to expose the second portion of the biological material container. A keying member that keys the transportation system in a centrifuge is also disclosed.

Abstract: The invention relates to a cell fixative that can be used in the preparation of slides for investigation by microscopy techniques. In particular the present invention provides a cell fixative that contains a light curable mounting medium.

Abstract: Devices, systems, and methods for the collection of biological samples. In at least one exemplary embodiment, a device comprises a collection medium having top and bottom surfaces and a predetermined size and shape, the top surface comprising a position marker and at least one binding site operable to bind a biological sample, a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium. The protective facing being sized and shaped to define a first void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, and a second void positioned to expose the position marker for alignment of the collection medium.

Abstract: Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with a solid support such as, for example, a particle. The support includes a chemiluminescent composition that includes a metal chelate. The present inventors observed that, when such support such as, e.g., particles, were employed in assays for the determination of an analyte, stability of signal output by the chemiluminescent composition associated with the particle was unacceptably reduced as compared to particles including other chemiluminescent compositions. In accordance with embodiments of the present invention, the stability of signal output from such particles is enhanced by including in a medium that contains the particles a sufficient amount of one or more stabilizing agents, which may be a chelating agent and/or a metal chelate such as, for example, the metal chelate that is associated with the particle.

Abstract: A synthetic urine solution is described. The synthetic urine solution is a shelf stable, food grade composition formed of water having a pH between 3 and 10. A thickening agent is dissolved within the water to form a solution having a specific gravity between 1.025 g/cm3 and 1.225 g/cm3. To provide a realistic appearance and odor, a coloring agent and urea are dissolved within the solution. Finally, to provide a shelf stable product, a preservative is also dissolved within the solution.

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: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties.

Abstract: A device for separating and drying a fluid sample in one embodiment includes an upper layer including a sample window and a viewing window extending therethrough, the viewing window spaced apart from the sample window, an absorbent layer, having a width and a length, positioned beneath the upper layer and extending beneath the sample window and the viewing window, and a non-absorbent layer positioned beneath the absorbent layer, the non-absorbent layer having a width and a length greater than the width and the length of the absorbent layer.

Abstract: A suitable container for plasma lyophilization has been designed for lyophilization (lyo-bag), storage, reconstitution and administering of blood products. A rigid support frame for use with a lyo-bag with sidewalls was designed as an external removable supportive system, which provides the necessary stability for the flexible container during lyophilization. A removable bottom wall support sheet was designed for use with any flexible container for lyophilization.

Abstract: The present invention relates to a processing method for long-term stabilization of biological red blood cell volume. The red blood cells can be further used in reference materials and calibrators of a hematology analyzer. The method of the present invention comprises contacting the sample with a solution comprising a membrane-fixation reagent and an aldehyde for a processing period to terminate or slow down the red blood cell metabolism. It is provided by experiments that such process enables the volume of the red blood cells to be stable in a period over 120 days.

Abstract: A fluorogenic lifting strip containing titanium dioxide has been successful in the lifting and enhancement of impressions and bloody impressions from nonporous, semi porous and porous surfaces. The lifting strip is best when activated with an alcohol such as ethanol or methanol. When the lifting strip has dried after application it can easily be removed from the surface lifting the impression onto a contrasting white background. The lifting trip can be subsequently visualized with an ALS or Laser to fluoresce the lifted impression with optimal contrast for visualization and examination. This method is safe, easy, and effective on several surfaces of contrasting colors.

Abstract: Systems and methods for determining cardiac conditions. According to at least one embodiment of a stabilizing system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for cardiovascular disease in a body fluid comprising the diagnostic marker and a detection agent capable of detecting the diagnostic marker.

Abstract: Described are methods of visualizing biological samples using histological staining and invisible light (e.g., infrared or near-infrared) fluorescence.

Abstract: A collection container and a method for collecting a biological sample, particularly whole blood, includes at least one stabilizing agent in an amount effective to stabilize and inhibit protein degradation and/or fragmentation. The stabilizing agent is able to stabilize proteases in the biological sample, particularly at the point of collection, by inhibiting protein degradation and/or fragmentation in the sample when the sample is stored. The stabilizing agent includes one or more protease inhibitors.

Abstract: The invention relates to a method of using high-mass matrix assisted laser desorption-ionization (MALDI) mass spectrometry for the quantitative analysis of the amount of aggregation (dimers, trimers or multimers) of antibodies or other therapeutic proteins in purified pharmaceutical samples or complex biological matrices, as well as to the use of this method for characterization of antibodies, drug development and quality control of therapeutic proteins, including automated high throughput applications.

Abstract: The invention relates to novel nucleic acids encoding a mammalian PCADM-1 gene, and proteins encoded thereby, whose expression is increased in certain diseases, disorders, or conditions, including, but not limited to, prostate cancer. The invention further relates to methods of detecting and treating prostate cancer, comprising modulating or detecting PCADM-1 expression and/or production and activity of PCADM-1 polypeptide. Further, the invention relates to novel assays for the identification of DNA-binding proteins and the double-stranded oligonucleotide sequences that specifically bind with them. Finally, the invention relates to DNAZYMs or DNA enzymes which specifically bind PCADM-1 mRNA to inhibit PCADM-1 gene expression and thereby destroy tumor cells and tumor tissue.

Abstract: Systems, including apparatus and methods, for microfluidic processing and/or analysis of samples. The systems include a microfluidic device having a substrate and a thin-film layer formed on the substrate. The thin-film layer may be included in electronics formed on the substrate. The electronics may provide electronic devices configured to sense or modify a property of the sample. The thin-film layer defines an opening for routing movement of fluid and/or sample within the device.

Abstract: A sample collection system includes a vial and a collection stick. The collection stick includes an elongated handle portion and an absorbent head portion detachably connected to the handle portion. The absorbent head portion is configured to absorb and retain the fluid sample therein prior to insertion of the collection stick within the vial. During the sample collection process, the collection stick is inserted into the vial to express the fluid sample from the absorbent head portion into the vial. The absorbent head portion is retained within the vial in a generally compressed state with the handle portion being detached and removed from the vial.

Abstract: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties.

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: A procedure for analyzing a fluid residual product, consisting of a rinsing solution and product loss, from a process for cleaning objects that are part of a manufacturing process. The procedure is characterized in that it includes the steps of measuring the flow of residual product at repeated occasions at a physical location in the cleaning process, measuring a magnitude corresponding to the contents of product loss in the cleaning system at the same repeated occasions at the same location in the cleaning process, determining based on this information the amount of product loss that flows past during a time period (T0?t1), and reporting this information related to the final product or raw materials of the manufacturing process. The invention also concerns a system for the execution of the process.

Abstract: Disclosed are methods for detecting antibody in a sample, where the antibody targets an antigen expressed by red blood cells or red blood cell ghosts. Rather than detecting the binding events between a particular antigen antibody pair (as in traditional agglutination based assays) the methods herein allow for multiplexed detection of clinically important allo-immune antibodies to blood group antigens. Specifically the method involves generating fluorescently encoded red blood cells or red blood cell ghosts with known antigen presentation and using them to detect the presence of antibody in serum/plasma with a fluorescent sandwich type immunoassay. The assay results can be read using flow cytometric or fluorescent microscope based imaging techniques.

Abstract: The present invention provides a reagent for measuring clotting time including a nonionic surfactant, a nickel ion and a tissue factor. A method for stabilizing a tissue factor, and use of a nonionic surfactant and a nickel salt for stabilizing a tissue factor are also disclosed.

Abstract: A liquid applicator for applying a liquid sample to a liquid receiving surface is disclosed. The liquid applicator comprises a bibulous line to hold a first predetermined volume of liquid for application to a liquid receiving surface. A second predetermined volume less than or equal to the first predetermined volume is applied to the liquid receiving surface in a substantially uniform and consistent pattern. Systems and methods for using embodiments of the liquid applicators are also disclosed.

Abstract: An apparatus for drying microtitration filter tray cavities and filters configured therein using a flow of gas, the cavities each comprising an upper and a lower aperture and the microtitration filter tray being mounted on a chamber designed for the vacuum filtration of microtitration filter trays in a manner that a vacuum can be applied to the lower apertures of the cavities receiving the filters, and includes a heat exchanger which can be mounted on and later removed from the microtitration filter tray and can be heated and comprises at least one inlet aperture and at least one outlet aperture between which a flow of gas may move through the heat exchanger, the heat exchanger being designed to heat the gas flow and to guide it onto the upper cavity apertures, the gas flow being generated by a vacuum pump communicating with the vacuum chamber.

Abstract: A fluid sample collection system includes a vial, a plunger and a fluid sample collection device having an absorbent for absorbing and retaining a fluid sample therein. The plunger includes an elongated handle portion and a plunger head portion detachably connected to the handle portion. The plunger also includes a splash guard supported on the handle portion. During the sample collection process, the saturated absorbent from the sample collection device is placed into the vial and the plunger is then advanced toward a closed end of the vial to express the fluid sample from the absorbent. The plunger head portion is retained within the vial with the absorbent in a generally compressed state and the handle portion is detached and removed from the vial.

Abstract: A fluid sample collection system includes a vial, a plunger and a fluid sample collection device having an absorbent for absorbing and retaining a fluid sample therein. The plunger includes an elongated handle portion and a plunger head portion detachably connected to the handle portion. The plunger also includes a splash guard supported on the handle portion. During the sample collection process, the saturated absorbent from the sample collection device is placed into the vial and the plunger is then advanced toward a closed end of the vial to express the fluid sample from the absorbent. The plunger head portion is retained within the vial with the absorbent in a generally compressed state and the handle portion is detached and removed from the vial.

Abstract: A liquid reagent in which a methylene blue compound color former is stably stored in a liquid state; and a method of stabilizing a methylene blue compound color former in a liquid state. A methylene blue compound color former is stabilized by causing it to coexist with either a quaternary ammonium compound having a C12 or higher hydrocarbon chain or a salt thereof in a liquid medium. Examples of the methylene blue compound color former include 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino) phenothiazine.

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 method of testing a compound for its capability of quenching singlet excited state energy from a photon-excited photoactive compound, thereby photostabilizing said photoactive compound, comprising mixing: (1) a composition comprising a photoactive compound in a solvent and determining the degree of fluorescence of said composition (1) by exposing the composition (1) to UV radiation in an amount sufficient for the photoactive compound to reach an electronic singlet excited state, and (2) a mixture comprising said photoactive compound with a test compound in a solvent, and determining the degree of fluorescence of said mixture (2) by exposing the mixture to UV radiation to the same degree as composition (1), and comparing the degree of fluorescence of composition (1) with mixture (2).

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: The invention relates to novel nucleic acids encoding a mammalian PCADM-1 gene, and proteins encoded thereby, whose expression is increased in certain diseases, disorders, or conditions, including, but not limited to, prostate cancer. The invention further relates to methods of detecting and treating prostate cancer, comprising modulating or detecting PCADM-1 expression and/or production and activity of PCADM-1 polypeptide. Further, the invention relates to novel assays for the identification of DNA-binding proteins and the double-stranded oligonucleotide sequences that specifically bind with them. Finally, the invention relates to DNAZYMs or DNA enzymes which specifically bind PCADM-1 mRNA to inhibit PCADM-1 gene expression and thereby destroy tumor cells and tumor tissue.

Abstract: The present invention relates to specimens for use in microanalysis processes. One aspect of the invention is directed toward using a mold to form specimens for a microanalysis process (e.g., including an atom probe and/or transmission electron microscope processes). Other aspects of the invention are directed towards embedding specimen material (e.g., including nanoparticles) in an embedment material to produce a specimen suitable for use in a microanalysis process. Still other aspects include combining specimen material with an embedment material to enhance a microanalysis process. Yet other embodiments of the invention are directed toward combining a specimen material with multiple embedment materials to produce specimens suitable for a microanalysis process. Further aspects of the invention are directed toward analyzing at least a portion of a specimen produced by one or more of the processes discussed above.

Abstract: A specimen holder (10) is proposed in order to create a capability for preparing, in a cutting device, in particular a microtome or ultramicrotome, a specimen that is to examined in an AFM. The specimen holder (10) is embodied in several parts. It comprises an insert (12) in which the specimen is secured. Also provided is a receiving ring (14) in which the insert (12) can be received. The insert together with the receiving ring (14) is mounted, in particular thread-joined, on a base element (16). As a result of the mounting of the receiving ring (14) on the base element (16), the insert together with the specimen is fixed in its position.

Abstract: An automated machine for handling and embedding tissue samples contained on microtome sectionable supports. The machine includes an input member configured to hold a plurality of the microtome sectionable supports prior to a tissue embedding operation. An output member is configured to hold a plurality of the microtome sectionable supports after the tissue embedding operation. A cooling unit is configured to hold at least one of the microtome sectionable supports during the tissue embedding operation. A motorized carrier assembly is mounted for movement and configured to hold at least one of the microtome sectionable supports. The carrier assembly moves the support from the input member to the cooling unit and, finally, to the output member. A dispensing device dispenses an embedding material onto the microtome sectionable support and at least one tissue sample carried by the microtome sectionable support during the embedding operation.

Abstract: A system and method operative in accordance with the present disclosure facilitate storage and retrieval of individual or discrete samples of biological, non-biological, and chemical material stored on dry media. Sample material may be disposed upon or within a porous or solid (i.e., non-porous) sample storage medium and subsequently archived in, and retrieved from, storage elements such as multi-well plates, for example, using robotic devices or other automated apparatus. The disclosed system and method enable ejection of sample material from a sealed storage element into a specific well of a multi-well daughter plate, or into a specific cuvette, test tube, or similar container. In some embodiments, a sample carrier comprising a storage medium may be punched or ejected through a first seal of the storage element with an apparatus or implement such as a disposable piercing tip, for instance, inserted through a second seal of the storage element.

Abstract: The invention concerns a device for isolating, on a reactive surface, an analyte from a liquid sample containing the analyte.

Abstract: A method of manufacture and device for a dual-gate CMOS structure. The structure includes a first plate in an insulating layer and a second plate above the insulating layer electrically corresponding to the first plate. An isolation structure is between the first plate and the second plate.

Abstract: The present invention relates to a method of stabilizing and/or isolating nucleic acids, wherein a biological sample containing nucleic acids is contacted with a cationic compound. The invention also relates to said cationic compound per se and to the use of said cationic compound in stabilizing and/or isolating nucleic acids. Furthermore, the invention relates to pharmaceutical compositions, diagnostic compositions, and to compositions used in research, which include cationic compounds or a complex being formed upon contact of said cationic compound with a nucleic acid.

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: The present invention describes semi- and fully-automated methods and reagents therefor for the assay and analysis of body fluid samples, particularly non-blood samples. The methods and reagents are especially useful for the assay and analysis of cerebrospinal fluid (CSF) samples. The reagent compositions sphere and fix all cells in the sample in suspension. Reported results can include red blood cell (RBC) and white blood cell (WBC) counts, WBC differential values, cell-by-cell volumes and dry-mass concentrations.

Abstract: A collection container and a method for collecting a biological sample, particularly whole blood, includes at least one stabilizing agent in an amount effective to stabilize and inhibit protein degradation and/or fragmentation. The stabilizing agent is able to stabilize proteases in the biological sample, particularly at the point of collection, by inhibiting protein degradation and/or fragmentation in the sample when the sample is stored. The stabilizing agent includes one or more protease inhibitors.

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: Disclosed are methods for detecting antibody in a sample, where the antibody targets an antigen expressed by red blood cells or red blood cell ghosts. Rather than detecting the binding events between a particular antigen antibody pair (as in traditional agglutination based assays) the methods herein allow for multiplexed detection of clinically important allo-immune antibodies to blood group antigens. Specifically the method involves generating fluorescently encoded red blood cells or red blood cell ghosts with known antigen presentation and using them to detect the presence of antibody in serum/plasma with a fluorescent sandwich type immunoassay. The assay results can be read using flow cytometric or fluorescent microscope based imaging techniques.

Abstract: The present invention relates to a vessel for withdrawing blood, the vessel containing a solution which comprises a guanidinium salt, a buffer substance, a reducing agent, and/or a detergent as components. The vessel is particularly suited for withdrawing blood which is to be analyzed with respect to nucleic acids.