Abstract: Methods and compositions for quantitative immunoassays are provided, in which ligand-conjugated probes are used to label samples and ligand-surfaced microspheres are used as quantitative reference standards. Certain embodiments provide a method of quantitative flow cytometry where ligands are oligonucleotides, and a sample comprising one or more cells is contacted with a hybridized antibody::fluorophore labeled targeting construct to label the cells, and the labeled cells are analyzed. In some embodiments, a population of quantitative labeled oligospheres labeled with the same fluorescent label as the cells is analyzed using the flow cytometer and used to create a quantitative standard curve of cytometer intensity versus molecules fluorescent label per oligosphere event. A standard curve trendline is established and used to determine the molecules of fluorescent label per cellular event for the antigen-positive cell populations.

Abstract: A diagnostic kit for evaluating stress hormones, and methods of use and manufacture thereof.

Abstract: Subpopulations of spore-like cells expressing specific cell surface and gene expression markers are provided. In one embodiment, the cells express at least one cell surface or gene expression marker selected from the group consisting of Oct4, nanog, Zfp296, cripto, Gdf3, UtF1, Ecat1, Esg1, Sox2, Pax6, nestin, SCA-1, CD29, CD34, CD90, B1 integrin, cKit, SP-C, CC10, SF1, DAX1, and SCG10. Also provided are methods for purifying a subpopulation of spore-like cells of interest from a population of spore-like cells, and methods for inducing differentiation of the isolated spore-like cells into cells of endodermal, mesodermal or ectodermal origin. The spore-like cells can be used to generate cells originating from all three germ layers and can be used to treat a patient who has a deficiency of functional cells in any of a wide variety of tissues, including the retina, intestine, bladder, kidney, liver, lung, nervous system, or endocrine system.

Abstract: The present invention provides a method for analyzing simultaneously multiple human antigen-specific cell populations of a sample, the sample comprising B cells and antigen-specific cells, the method comprising a) separation of B cells from said sample, b) dividing the B cells into n sub-samples, c) differentially labeling the B cells of said sub-samples, wherein at least n-1sub-samples are labeled, d) pulsing of the B cells of each sub-sample with single or multiple peptides, e) pooling of the labeled and peptide-pulsed B cells with cells of said sample comprising said antigen-specific cells, f) co-cultivation of the cells of step e), g) flow cytometry analysis of the B cells with regard to their cell number and CD83 expression, thereby determining the potency of said antigen-specific cells in said sample.

Abstract: The present invention, relates to the use of TFF3 in the diagnosis and detection of Barrett's Oesophagus using non-invasive, non-endoscopic methods.

Abstract: A method and kit for determining antibody sensitivity and quality of a clone cell stain. The method comprises: obtaining a solid-phase carrier, cells and an antibody; adsorbing the antibody on the solid-phase carrier; incubating the cells and the antibody; preserving cells bound with the antibody; and dyeing and counting the cells bound with the antibody, so as to determine the antibody sensitivity or the quality of the clone cell stain based on the cell count. The kit comprises components used in the method.

Abstract: Methods of assessing the immunomodulatory potential of a multipotent stromal cell (MSC) population are provided. Aspects of the methods include evaluating the amount of CD54/IL-6 associated with an MSC in a sample of the MSC population to obtain a CD54/IL-6 result and providing an assessment of the immunomodulatory potential of the MSC population based on the obtained CD54/IL-6 result. Also provided are systems and kits that find use in practicing the subject methods.

Abstract: The disclosure relates to an apparatus for segregating particles on the basis of their ability to flow through a stepped passageway. At least some of the particles are unable to pass through a narrower passageway bounded by a segregating step, resulting in segregation of the particles. The breadth of the leading edge of at least one step of the apparatus is significantly greater than the overall width of the passageway in which the step occurs, permitting high and rapid sample throughput. The apparatus and methods described herein can be used to segregate particles of a wide variety of types. By way of example, they can be used to segregate circulating tumor cells from a human blood sample.

Abstract: The present invention provides a microporous membrane for detecting at least one target analyte in a sample. The membrane includes an array that comprises at least one capture element and the at least one control element printed on the membrane surface, the at least one capture element corresponding to and being able to bind a target analyte, the plurality of control elements, when present including: i) at least one fiduciary marker, ii) at least one negative control to monitor background signal, iii) at least one negative control to monitor assay specificity, iv) at least one positive colorimetric control, v) at least one positive control to monitor assay performance or any combination thereof.

Abstract: The present disclosure is directed to a kit for the detection of an analyte of interest in a sample comprising, in one or more vials, containers, or compartments, a. a surface comprising (i) a capture reagent for the analyte, said capture reagent bound to the surface, and (ii) an anchoring reagent bound to an anchoring oligonucleotide sequence, said anchoring reagent bound to the surface, b. a first detection reagent for the analyte that is linked to a first nucleic acid probe, wherein the first nucleic acid probe comprises an extended sequence that is complementary to the anchoring oligonucleotide sequence and c. a second detection reagent for the analyte that is linked to a second nucleic acid probe.

Abstract: The invention utilizes the techniques and instruments which are typically used in flow cytometry (FC) as a tool for analyzing adsorbed materials. Thus the invention provides a method for analyzing a component which is adsorbed to an insoluble metal salt, comprising steps of: (i) labelling the adsorbed component with a binding reagent; and (ii) analyzing the labelled adsorbed component by flow cytometry.

Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Abstract: The present invention relates to a differential diagnostic method using flow cytometry, performed by means of differential fluorescent marking of biological agents, such as cells and pathogens of interest, with fluorescent substances. The diagnostic method generally consists in performing fluorescent marking of biological agents with gradual concentrations of fluorescent substances, and in analyzing the reactivity profile of IgG1 to the biological agents. The present invention further relates to a diagnostic kit.

Abstract: The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: A method or system detects abnormalities in a biological sample cells. The method or system performs at least the following steps, or is capable to carry out at least the following steps, respectively: a) acquiring an image of the sample by digital image acquisition, b) optionally, carrying out digital image processing, c) selecting a field of view, d) determining, by digital image processing, whether or not, in the field of view, cell aggregates exist, and e1) selecting a new field of view and carrying on with step c) if, in step d), it turns out that, in the field of view, the determination of cell aggregates is negative, or e2) carrying out further process steps if in step d), it turns out that, in the field of view, the determination of cell aggregates is affirmative.

Abstract: This document provides methods and materials related to determining whether or not a pregnant mammal (e.g., a pregnant human) has preeclampsia. For example, methods and materials related to the use of urinary podocytes to determine whether or not a pregnant human has preeclampsia are provided.

Abstract: A particle detector apparatus for optically ascertaining a number of particles arranged on a surface of, for example, a particle filter. The particle detector apparatus includes a light source, an optical focusing device, a spatially resolving light detector and an evaluation device. The light source emits source light onto the surface. The optical focusing device focuses image light that is emitted from the surface in response to the source light onto the spatially resolving light detector. The spatially resolving light detector includes light sensors that measure brightness values based on the image light, such that the light detector produces image data based on the brightness values delivered by the light sensors. The evaluation device then ascertains the number of particles based on the image data.

Abstract: The disclosure provides evidence that the abundance of this particular “oncogenic HSP90” species, which is not dictated by HSP90 expression alone, predicts for sensitivity to HSP90 inhibition therapy, and thus is a biomarker for HSP90 therapy. The disclosure also provides evidence that identifying and measuring the abundance of this oncogenic HSP90 species in tumors predicts of response to HSP90 therapy. “Oncogenic HSP90” is defined herein as the HSP90 fraction that represents a cell stress specific form of chaperone complex, that is expanded and constitutively maintained in the tumor cell context, and that may execute functions necessary to maintain the malignant phenotype. Such roles are not only to regulate the folding of overexpressed (i.e. HER2), mutated (i.e. mB-Raf) or chimeric proteins (i.e. Bcr-Abl), but also to facilitate scaffolding and complex formation of molecules involved in aberrantly activated signaling complexes (i.e. STATS, BCL6).

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.