The invention relates to an in vitro quantative cell-based assay that uses a primary mouse cell model system permissive to viral vector infection and a quantitative high content image-based system for determining potency of a transgene-expressing viral vector drug product for lot disposition.

Methods for the detection and diagnosis of endometriosis are disclosed herein. More specifically, sensitive single-cell expression analysis methods to detect specific gene expression patterns in cell populations obtained from endometrial cells are provided.

The present disclosure relates to, inter alia, devices, systems, and methods for use in the magnetic separation of biological entities from fluid samples. This device includes a magnetic separation chamber configured to receive a fluid sample for magnetic separation, where the magnetic separation chamber includes at least two magnets mounted on the surface or in the wall of the magnetic separation chamber. The device also includes a force provider configured to move the magnetic separation chamber in a side-to-side motion to mix and/or magnetize the fluid sample. In one embodiment, the magnetic separation chamber is in a form of a sleeve and comprises a substantially central channel for loading a vessel containing the fluid sample therein. The systems and methods of the present disclosure involve the use of this device to separate biological entities from fluid samples.

This disclosure provides a method for determining male fertility status, and its relationship to the probability of generating a pregnancy as calculated using a regression model. The method comprises determining G.sub.M1 localization patterns following induced sperm capacitation, identifying the percentage of various patterns, particularly the ratio of [(AA+APM)/total number of G.sub.M1 localization patterns] and determining if the percentage of certain GMI localization patterns in response to induced capacitation is altered. Based on the change in the percentage of localization patterns of certain patterns in response to induced capacitation, alone or in combination with other sperm attributes, male fertility status can be identified.

Myeloid derived suppressor cells (MDSCs) are a heterogeneous group of immature myeloid cells with the ability to mediate immunosuppression in cancer. Disclosed herein are methods of identifying MDSCs, methods of isolating MDSCs, and methods of treating patients.

A marker of fetal trophoblast cells, an identification method, a detection kit and the use thereof. The identification method comprises performing dyeing treatment on a sample containing fetal trophoblast cells with a fluorescence-labeled HK2 antibody substance, and then performing fluorescence detection, wherein HK2 positive cells are target cells. The kit comprises a fluorescence-labeled HK2 antibody substance and a cell nucleus dye. The above-mentioned technical solution can sensitively and reliably detect fetal trophoblast cells in the cervical mucus or blood samples of pregnant women in the first trimester, and especially can be used for prenatal diagnosis in early pregnancy.

Methods for single cell analysis by determining the presence and/or amount of one or more target molecules in a plurality of cells may include: (i) immobilizing said plurality of cells on a solid substrate, wherein the cells are immobilized in form of a monolayer; (ii) determining the position of the individual immobilized cells on the solid substrate; (iii) measuring the auto-fluorescence of the individual immobilized cells: (iv) contacting the immobilized cells with a first detection reagent comprising (a) a moiety that specifically recognizes and binds a first target molecule and (b) a fluorescent label under conditions that allow binding of the detection reagent to the first target molecule; (v) measuring the fluorescence of the fluorescent label of the detection reagent bound to the first target molecule for the individual immobilized cells; (vi) determining the presence and/or amount of the first target molecule in the individual immobilized cells by comparing the fluorescence measured in step(v) with the fluorescence measured in step (iii) on a cell-by-cell basis.

The present invention includes a method of macrophage phenotype profiling for the assessment, determination, and stratification of risk of development of fibrosis and/or cirrhosis within the liver, and treatment thereof, comprising the steps of: (a) obtaining a liver biopsy sample from a subject; (b) using fluorescently labeled antibodies to analyze the sample, by laboratory assay, for marker identification and expression comparison of one or more macrophage profiling markers relative to the level of expression of a macrophage profiling marker in at least one control or standard sample, and (c) using spectral analysis to correlate the fluorescent signal generated by the macrophage profiling marker/antibody complex to the risk of developing fibrosis and/or cirrhosis, and treating with anti-viral agents or changes in diet, weight loss, or reduction of fat consumption.

EphA2 T-cell epitope are provided herein. The epitopes include peptides corresponding to specific fragments of human EphA2 protein containing one or more T-cell epitopes, and conservative derivatives thereof. The EphA2 T-cell epitopes are useful in an assay, such as an ELISPOT assay, that may be used to determine and/or quantify a patient's immune responsiveness to EphA2. The epitopes also are useful in methods of modulating a patient's immune reactivity to EphA2, which has substantial utility as a treatment for cancers that overexpress EphA2, such as renal cell carcinoma (RCC). The EphA2 epitopes also can be used to vaccinate a patient against EphA2, by in vivo or ex vivo methods.

A method of selecting retinal pigmented epithelial (RPE) cells from a mixed population of cells is disclosed. The method comprises: (a) analyzing the cells of the mixed population of cells for at least one of the following parameters: (i) cells which autofluorescence above a predetermined threshold; (ii) cells which express CD81 above a predetermined threshold; and (iii) cells which scatter light perpendicular to a laser beam above a predetermined threshold; and (b) selecting cells which are positive for at least one of the parameters, thereby sorting RPE cells from a mixed population of cells.