Abstract: The present invention provides, among other things, devices, methods and applications of collecting, preserving, transporting, and analyzing tiny body fluids which have targeted biomarkers.

Abstract: The present invention provides methods and compositions, e.g., kits, for assaying a vitamin D moiety in a sample, comprising or using, inter alia, a buffer that is capable of dissociating a vitamin D moiety from its binding protein and/or a buffer of acidic pH, and at least two antibodies, e.g., at least two monoclonal antibodies, that are separately conjugated to particles, e.g., latex particles, wherein at least one of said antibodies (or the first antibody) has a specific binding affinity towards the vitamin D moiety, and at least another said antibody (or the second antibody) has a specific binding affinity towards the complex formed between the first antibody and the vitamin D moiety, if present in said sample. In some embodiments, the optical change due to the agglutination reaction between the antibodies and the vitamin D moiety is measured for determination of the amount of vitamin D content in the samples. Kits and reaction mixtures for assaying a vitamin D moiety in a sample are also provided.

Abstract: The invention relates to a carrier with a binding surface at which target components that comprise label particles, for example magnetic particles, can collect and optionally bind to specific capture elements. An input light beam (L1) is transmitted into the carrier and totally internally reflected at the binding surface. The amount of light in the output light beam (L2) and optionally also of fluorescence light emitted by target components at the binding surface is then detected by a light detector. Evanescent light generated during the total internal reflection is affected (absorbed, scattered) by target components and/or label particles at the binding surface and will therefore be missing in the output light beam (L2). This can be used to determine the amount of target components at the binding surface from the amount of light in the output light beam (L2, L2a, L2b).

Abstract: A method for the in vitro detection of cartilage tissue and/or for the in vitro determination of the purity of cartilage tissue includes: a) treating a tissue sample with a protease and b) testing the protease-treated tissue sample for the presence of protease-resistant fragments of type II collagen and/or type I collagen. Methods can be carried out for preparing a cartilage cell culture, and for preparing a cartilage cell-loaded implant. Protease-resistant fragments of type II collagen and/or type I collagen can be used for the in vitro detection of cartilage tissue and/or for the in vitro determination of the purity of cartilage tissue. A kit can be used for carrying out the methods.

Abstract: The invention provides a fusion ferritin protein wherein a ferritin heavy chain polypeptide is fused to a peptide, wherein the peptide is fused to the C-terminal end of the ferritin heavy chain; and the peptide includes at least a portion of a Mms6 protein sequence and at least one heterologous amino acid at its N-terminal end. The invention further provides methods of use of the ferritin fusion protein for Magnetic Resonance Imaging.

Abstract: The present invention is based on the ORF3 gene of Porcine Circovirus Type 2 (PCV2) and the identification of tis apoptotic role. This discovery has led to the development of an attenuated live vaccine against PCV2.

Abstract: The invention provides methods for isolating cells, particularly antibody-secreting cells that have a high likelihood of secreting antibodies specific for a desired antigen for the purpose of making monoclonal antibodies.

Abstract: Disclosed is a method for measuring thrombin generation in a whole blood sample. The whole blood sample may be applied forthwith, without prior processing. The blood cells and blood plasma in the whole blood sample are separated by (lateral) flow migration. Also disclosed is an assembly of a sample support and a device dedicated to measure thrombin generation in a whole blood sample. Advantageously, the sample support comprises a separator medium allowing separation of whole blood into blood cells and blood plasma by means of (lateral) flow migration.

Abstract: The invention relates to medicine, in particular to a method for carrying out a preliminary instant diagnosis of oncologic diseases. The method involves sampling a patient's blood, mixing the sample with a reagent and recording reaction results. A supernatant liquid, which is produced by cultivating the finite cell line of a porcine embryo kidney culture in anaerobic conditions, is used as a reagent. The presence of oncologic disease is determined according to a positive reaction of erythrocytes and a negative or positive reaction of a citrated blood with the reagent. The inventive method makes it possible to make a preliminary conclusion about the presence of oncologic disease within a short time.

Abstract: The present invention relates to novel methods for detecting at least one member of a known binding pair in a sample, including a cell, where one member of the pair (termed the “receptor”) is expressed by a bacteriophage, which phage is then used to detect the presence of the other member of the pair (termed the “ligand” or “target”). Rather than detecting the binding of at least one phage using antibody-based technology, the present invention relates to detecting the nucleic acid associated with the phages. In one aspect, the invention relates to identifying at least one antigen-bearing moiety (e.g., a red blood cell antigen) of interest present on a cell, e.g., a red blood cell, using antibody-displaying bacteriophages, using antiglobulin reagent-displaying bacteriophages and detecting at least one nucleic acid associated with the phage.

Abstract: The present invention relates to novel methods for detecting a member of a known binding pair in a sample, including a cell, where one member of the pair (termed the “receptor”) is expressed by a bacteriophage, which phage is then used to detect the presence of the other member of the pair (termed the “ligand” or “target”). Rather than detecting the binding of the phage using antibody-based technology, the present invention relates to detecting the nucleic acid associated with the phage. In one aspect, the invention relates to identifying an antigen-bearing moiety (e.g., a red blood cell antigen) of interest present on a cell, e.g., a red blood cell, using antibody-displaying bacteriophage, as well as detecting anti-red blood cell auto- or alloantibodies and/or complement in a sample, using antiglobulin reagent-displaying bacteriophage and detecting a nucleic acid associated with the phage.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies of an individual, comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes, erythrocyte membrane fragments or blood group antigens.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies, said antigenic molecules carried by the erythrocytes consisting of antigenic molecules carried not only by the erythrocytes, but also by at least one other cell population, other than the blood group antigen molecules, said method comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes or erythrocyte membrane fragment.

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: 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 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: Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay for determining a concentration of an analyte in a whole blood sample suspected of containing the analyte. The method comprises determining by means of the assay a concentration of the analyte utilizing a hemolyzed portion of the blood sample to obtain concentration value 1 and determining by means of the assay a concentration of the analyte utilizing a non-hemolyzed portion of the blood sample and multiplying the concentration times a hematocrit factor to obtain concentration value 2. A ratio of concentration value 1 divided by concentration value 2 is determined and is compared to a predetermined ratio of known reliability. If the ratio is less than the predetermined ratio, a false result is indicated.

Abstract: Provided is a microfluidic control chip, which includes a filter section having a filter to which anti-immunoglobulin antibodies, which are bound to endogenous antibodies in blood to thereby remove the endogenous antibodies, are immobilized, a first reaction section to which detection antibodies immobilized to fluorescent nano-particles are adsorbed, the detection antibodies being bound to proteins to be detected in blood which is introduced from the filter section with the endogenous antibodies removed therefrom, and a second reaction and detection section including capture antibodies immobilized thereto, binding the capture antibodies to the proteins, which are bound to the detection antibodies introduced from the first reaction section, and detecting a concentration of the proteins based on an intensity of fluorescent light. Thus, the microfluidic control chip can minimize interference of an immune response to maximize the immune response.

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: 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: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: The present invention comprises the use of sickle cells or sickle cell precursors loaded with a therapeutic agent that localizes in tumors and induces a tumoricidal response.

Abstract: The present invention relates to isolated canine animal plasma, a method for isolating canine animal plasma, plasma obtained form an immunised or hyperimmunised canine animal and treating a canine animal with the isolated canine animal plasma. The method includes the step of selecting a canine animal having a blood group compatible with a recipient canine animal having an unmatched blood group, namely, selecting a canine animal for a blood group that does not cause plasma transfusion reaction and/or haemolysis. In one form, the method includes the step of immunising or hyperimmunising a canine animal plasma donor with one or more antigens of a canine animal pathogen. The pathogen is preferably a bacteria or virus.

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: Methods, compositions and kits are disclosed. The compositions are light emitting and comprise a polymeric matrix having dissolved therein a photoactive compound. The composition has the characteristic that, after activation of the photoactive compound, the rate of decrease in the intensity of light emission at any time during a 20-fold decrease in the intensity is proportional to the intensity of the light emission. In one embodiment the polymeric matrix is comprised of particles of about 20 nm to about 100 ?m in diameter to which is bound a specific binding pair member. The particles generally comprise a polymeric matrix having dissolved therein about 1 to about 20% by weight of a dopant. The compositions may be used in methods for determining an analyte. A combination is provided comprising (1) a medium suspected of containing the analyte, (2) and the aforementioned composition. The photoactive substance is activated and the effect of the activating on the optical properties of the combination is detected.

Abstract: The invention includes Rh(D) binding proteins, including antibodies, and DNA encoding such proteins. Methods of generating such proteins and DNAs are also included.

Abstract: The invention provides for a process for preparing a sensitivity control for blood group determination including dissolving an amount of an antigen in water to give an antigen solution of known concentration, contacting the antigen solution with cells to allow insertion of antigen molecules into the cell membranes of the cells to give transformed cells or contacting the antigen solution with cells that have been modified by the insertion of a linker molecule into the membranes of the cells to allow attachment of antigen molecules to the linker molecules to give transformed cells, washing the transformed cells to give a transformed cell solution, and determining the concentration of the transformed cell solution to enable the solution to be used as a sensitivity control for blood group determination.

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: Methods and apparatus for analyzing nonoperational data acquired from optical discs, and in particular, trackable optical discs having concurrently readable nonoperational structures are provided. Analysis can involve identifying patterns in the data that reproducibly distinguish underlying structures, or identifying patterns in the data that report physical properties of the nonoperational structures. When an optical disc has a plurality of physically nonidentical concurrently readable nonoperational structures, analysis can involve identifying patterns in the data that distinguish among the physically nonidentical nonoperational structures. Also, relative physical locations of nonoperational structures on the disc can be calculated. A system for remotely analyzing data in order to expedite complex data analysis and reporting the results thereof is also provided.

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: This invention relates to the field of biological assays where cells can be classified and enumerated using flow cytometry optical instrumentation. The invention combines information from multi-angle, light scatter from the cell itself and multi-angle light scatter from small, optically resonant particles that are selectively bound to surface molecules on the cell to carry out classification and enumeration. This light scatter method enables an instrumentation system that is simple to use, inexpensive to build, and mechanically robust; making it suitable for use in remote clinical environments.

Abstract: A method for identifying or monitoring SLE in an individual is provided. The method includes quantitating complement component C4d on the surfaces of platelets and comparing the amounts of C4d to reference levels of C4d on platelets of individuals without SLE and/or on platelets of the individual obtained at a different time. Kits for use in the above-described methods are provided along with computer readable media tangibly embodying executable instructions to perform the methods.

Abstract: The invention is related to methods of diagnosing inflammatory diseases or conditions by determining levels of components of the complement pathway on the surface of white blood cells.

Abstract: Systems and methods allowing for the automatic control and scheduling of a staining apparatus for biological samples on slides present within the apparatus. In some embodiments, the actions of a robot coupled to the staining apparatus, which performs some of the staining tasks on the individual slides in accordance with their respective protocols, may be prioritized and scheduled. In some embodiments, the scheduling may result in increasing or maximizing the throughput of slides. In some embodiments, robot scheduling ensures that the individual slides are processed substantially within the tolerances specified by their respective protocols. In some embodiments, the robot scheduler may respond to spontaneous user actions and adaptively schedule or re-schedule robot actions.

Abstract: The present invention relates to novel nucleic acid molecules encoding a Rhesus D antigen contributing to the weak D phenotype which are characterized by one or a combination of missense mutations or by a gene conversion involving exons 6 to 9 of the RHD and RHCE genes. The present invention further relates to vectors comprising the nucleic acid molecules of the invention, to hosts transformed with said vectors, to proteins encoded by said nucleic acid molecules and to methods of producing such polypeptides. The fact that missense mutations and the conversion referred to above can be directly correlated to the weak D phenotype has a significant impact on the routine testing of blood samples. For example, oligonucleotides and antibodies can now be designed that generally allow the detection of weak D phenotypes in a sample. Such oligonucleotides, antibodies as well as a variety of diagnostic methods all fall within the scope of the present invention.

Abstract: A diagnostic assay device that directs an applied sample to the analytical membrane of a directed flow device. The device has a sample receiving port defined by layers of built-up material on one end of the test strip. The port contains the sample and specifically directs it to the membrane in a controlled fashion. Additional features include configuration of the housing in a general C-shape with the test strip spanning the opening of the C-shape to allow access by a reader device. A preferred method employs superparamagnetic particles to label the target analytes for detection and measurement by means of an electromagnetic reader device.

Abstract: In the present invention, a reagent capable of immunospecific reaction with the analyte of interest is conjugated to a photocatalytic microparticle. After the immunospecific binding has occurred, the assay amplification is performed by exposing photocatalytic particles to actinic UV light in presence of an oxidizable compound. Photocatalytic particles are catalyzing multiple occurrences of oxidation of oxidizable compound under UV light irradiation resulting in detectable changes such as color change. This provides for amplification of each single act of immunospecific binding and is followed by colormetric detection. Thus a high sensitivity quantitative or qualitative immunoassay can be realized.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution layered above particulate layers. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: Methods for diagnosing and monitoring systemic lupus erythematosus (SLE) or scleroderma by determining, in a blood sample from the individual being diagnosed or monitored, complement component C4d deposited on surfaces of red blood cells in the sample, and optionally also determining complement receptor CR1 deposited on the red blood cell surfaces. For diagnosis this is compared with the quantity of C4d (and optionally CR1) present on red blood cells of normal individuals. For monitoring it is compared with a value in a sample or samples previously obtained from the individual patient. The comparison may be made with individual values for C4d and CR1 and/or with a ratio of the two found in normal individuals.

Abstract: A method and apparatus for controlling the processing of a liquid sample, e.g., a blood sample, based on a measurement related to the sample's ability to coat a surface against which the sample is brought into contact while being routinely transported. Preferably, the sample is advanced through a tube, and the amount of sample residue remaining within the tube is measured and correlated to coating process subsequently carried out on the sample, e.g., a process for producing blood-smears on a microscope slide. In a preferred embodiment, the amount of sample residue in a blood-transport tube is used to control the motion profile (i.e., acceleration and velocity) of a drop-spreading member used to spread a blood drop on a microscope slide in an automated slide-making instrument.

Abstract: According to the present invention, there is provided a delivery vehicle including sickle red blood cells carrying a moiety. The moiety can be any type of diagnostic or therapeutic agent. The present invention further provides for a method of diagnosing systemic hypoxia, acidosis, or hypertonicity by administering sickle red blood cells to a patient and detecting the location of the sickle red blood cells. Additionally, the present invention provides for a method of therapeutic treatment of systemic hypoxia, acidosis, or hypertonicity by administering sickle red blood cells to a patient. Further, the present invention provides for a delivery vehicle that specifically localizes or concentrates at systemic hypoxia, acidosis, or hypertonicity areas. The delivery vehicle is used in diagnosing and therapeutically treating these areas of hypoxia, acidosis, or hypertonicity also. The present invention further provides for a method of making the delivery vehicle described herein.

Abstract: The present invention pertains to the field of medicine and may be used for producing a specific antiserum as well as for carrying out immunological diagnoses of malignant tumours. This method for producing an antiserum involves sampling an embryo at the foetal stage from animals of a same genetic type so as to obtain a cell suspension. After immunization, this method involves sampling spleen cells from the animal, separating lymphocytes and immunizing the animal of the same genetic line using the lymphocyte suspension. An antiserum is then obtained and cells originating from healthy organs of the same animals are added to the antiserum. The mixture is finally decanted and the liquid located above the sediments is filtered. In order to carry out a diagnosis, the filtrate is added to the subject's blood and the results are obtained by immuno-fluorescence, by blood tests or using other methods of immunological diagnosis.

Abstract: A method is provided for determining the level of an analyte in the blood of an individual based on determination of the level of the same analyte in non-blood sample (e.g. urine, saliva and hair) obtained from the individual. The non-blood sample contains red blood cells and the volume of the blood in the sample together with the amount of the analyte in the sample are the basis for calculating the level of the analyte in the individual's blood. Kits for carrying out the above method are also provided.

Abstract: Methods, compositions and kits are disclosed. The compositions are light emitting and comprise a polymeric matrix having dissolved therein a photoactive compound. The composition has the characteristic that, after activation of the photoactive compound, the rate of decrease in the intensity of light emission at any time during a 20-fold decrease in the intensity is proportional to the intensity of the light emission. In one embodiment the polymeric matrix is comprised of particles of about 20 nm to about 100 ?m in diameter to which is bound a specific binding pair member. The particles generally comprise a polymeric matrix having dissolved therein about 1 to about 20% by weight of a dopant. The compositions may be used in methods for determining an analyte. A combination is provided comprising (1) a medium suspected of containing the analyte, (2) and the aforementioned composition. The photoactive substance is activated and the effect of the activating on the optical properties of the combination is detected.

Abstract: Simultaneous forward and reverse blood group testing is described using both a visual detection system and a fluorescent based labeling and detection system. Forward and reverse tests could be performed separately, but A and B agglutinates can be detected and discriminated simultaneously.

Abstract: Disclosed are novel protein and peptide compositions comprising soluble and bound forms of immunologically-active blood group antigens including mammalian Rh antigens. In preferred embodiments methods for the isolation and purification of serologically-active human Rh antigens such as D, c, C, E, and e are disclosed. Also disclosed are methods for the adsorption of immunologically-active Rh antigens to solid supports. Diagnostic kits, methods, and devices for the detection of Rh antibodies in clinical and non-clinical samples are also disclosed. Devices, compositions and methods for the isolation, purification and quantitation of anti-Rh antibodies from solution are also provided.

Abstract: A method for conveniently detecting binding between the von Willebrand factor and glycoprotein Ib and a means to be used therein. The von Willebrand factor fixed in a reactor immobilized in a reaction vessel in the presence of bottrocetin is bound to a chimeric protein constructed by fusing the carboxyl terminal of a partial protein containing the von Willebrand factor-binding site of glycoprotein Ib with the amino terminal of the Fc region of an immunoglobulin molecule. Then the Fc region of the above immunoglobulin molecule is detected to thereby detect the binding between the von Willebrand factor and the glycoprotein Ib or inhibition of this binding.

Abstract: The present invention recognizes that separation of components of a sample facilitate, and are often necessary for, sample analysis. Dielectrophoretic separation provides an efficient, reliable, nondisruptive, and automatable method for the separation of moieties in a sample based on their dielectric properties. The present invention provides compositions and methods for enhancing the dielectrophoretic separation of one or more moieties in a sample. A first aspect of the present invention is a solution that when mixed with a sample, modifies at least one dielectric property of one or more components of the sample and has a conductivity such that one or more moieties of the sample can be separated using dielectrophoresis. Such solutions can be used in the analysis of samples on chips, and can be used in methods that use binding partners, including microparticles that can be translocated by dielectrophoretic forces, traveling-wave dielectrophoretic forces or magnetic forces.