Abstract: The present disclosure relates generally to methods and systems for detecting, characterizing biomarker expression and morphological analysis in cell samples. The methods allow for the use of automated platforms to stain cells for molecular biomarkers and Romanowsky-type staining for cell morphology analysis. Cells that are prepared according to the disclosed methods can also be used in the diagnosis of certain conditions.

Abstract: The disclosure features calibration fluids that include a plurality of beads, such as cellulose, silica, poly(methyl-methacrylate) (PMMA), melamine, cross-linked agarose, polyvinylacetate (PVA), and/or polystyrene beads, where the beads are sized and colored to represent at least one type of blood cell; and a carrier fluid, that can include a polymer or polymerizing matrix, e.g., a water-soluble resin, e.g., an acrylic or polyurethane water-soluble resin or a starch or a cellulose, serum, and/or one or more or sugars. The disclosure also features methods of using the calibration fluids to calibrate automated sample preparation systems, such as automated hematology analyzer systems, e.g., image-based hematology analyzer systems.

Abstract: This disclosure relates generally to the use of automated platforms in the preparation of biomarker-stained cellular samples for microscopic analysis and use of such stained cells in the diagnosis of certain conditions. Disclosed herein is a method of affinity staining a Romanowsky-type stained sample on automated advanced staining systems, wherein the automated advanced stainer destains the sample prior to contact with a biomarker-specific reagent. Also disclosed herein are methods of processing body fluid samples for morphological and biomarker analysis by depositing cells of the sample in a thin layer onto one or more solid supports, staining at least one such solid support with a Romanowsky-type stain and staining at least one such solid support for one or more biomarkers useful for categorizing one or more cells of the sample.

Abstract: Components, e.g., background, cytoplasm, nucleus and nucleolus, of a biological specimen are identified using multi-wavelength analysis. Specimen components, such as nucleoli, are selected, and a determination is made whether cells having nucleoli are cancer cells or regular repair cells based on one or more physical characteristics of the identified component. The physical characteristics can be one or more of a shape, size, texture and gray value.

Abstract: Components, e.g., background, cytoplasm, nucleus and nucleolus, of a biological specimen are identified using multi-wavelength analysis. Specimen components, such as nucleoli, are selected, and a determination is made whether cells having nucleoli are cancer cells or regular repair cells based on one or more physical characteristics of the identified component. The physical characteristics can be one or more of a shape, size, texture and gray value.

Abstract: Systems and methods for positioning a sample applicator relative to a substrate include: (a) obtaining an image of the sample applicator in proximity to the substrate, where the image includes a direct image region corresponding to the sample applicator and a first reflected image region corresponding to an image of the sample applicator reflected from a surface of the substrate; (b) determining a position of an edge of the sample applicator in the direct image region; (c) determining a position of a reflected edge of the sample applicator in the first reflected image region; (d) determining a distance between the edge of the sample applicator and the reflected edge of the sample applicator; and (e) determining the position of the sample applicator relative to the substrate based on the distance between the edges.

Abstract: Methods, systems, and computer software for screening and assisting in screening biological specimens. Images of a biological specimen are obtained, and image data is generated from the images. Objects of interest (OOI) are identified from the image data. The OOIs are assigned to each of a plurality of fields of interest (FOIs), at least partially based on the assignment of OOIs to other FOIs. For example, OOIs that have not previously been assigned to other FOIs can be assigned to a selected FOI. In this manner, the OOIs can be grouped within the FOIs to maximize the number of OOIs included within FOIs, or alternatively, to minimize the number of FOIs required to include all of the OOIs. Once assignment of the OOIs is complete, a field of view (FOV) can be scanned relative to each FOI in order to present the OOIs to a technician, such as a cytotechnologist.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: An apparatus and method for verifying the location of an area of interest within a sample are disclosed. An imaging system includes an optical system and a stage movable relative to the optical system. A computer server is in communication with the imaging system and with a review station. The imaging system is capable of spatially locating a datum mark on the sample and determining a spatial offset value of the mark relative to a nominal position thereof. The coordinate systems of a respective one of the imaging system and the review station can be standardized. The method includes locating a datum mark on the sample, and identifying an area of interest within the sample. The method further includes determining the location of the area of interest relative to the mark. The method further includes locating again the datum, and checking that a dimensional error in locating the datum mark is less than a tolerance value to verify location of the area of interest.

Abstract: Methods, systems, and computer software for screening and assisting in screening biological specimens. Images of a biological specimen are obtained, and image data is generated from the images. Objects of interest (OOI) are identified from the image data. The OOIs are assigned to each of a plurality of fields of interest (FOIs), at least partially based on the assignment of OOIs to other FOIs. For example, OOIs that have not previously been assigned to other FOIs can be assigned to a selected FOI. In this manner, the OOIs can be grouped within the FOIs to maximize the number of OOIs included within FOIs, or alternatively, to minimize the number of FOIs required to include all of the OOIs. Once assignment of the OOIs is complete, a field of view (FOV) can be scanned relative to each FOI in order to present the OOIs to a technician, such as a cytotechnologist.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating and imaging a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating and imaging a cytological sample. The analysis can be automated or manual.

Abstract: The present invention relates to the analysis of cytological material. Specifically, the invention relates to stains and methods of producing the stains, methods of staining cells for cytological or histological analysis to contrast the nuclear portion of the cell from the cytoplasmic portion, and systems and methods for illuminating a cytological sample. The analysis can be automated or manual.

Abstract: Cellular analysis in accordance with the invention involves staining cellular material with a thionin stain to distinguish the nuclear portion from the cytoplasm, counterstaining, illuminating the thionin-stained cellular material with energy in the infrared spectrum, and imaging the stained cellular material. The analysis can be automated or manual.

Abstract: Disclosed is a monolayering device comprising a cell sensor arrangement for receiving a liquid suspension of cells and for controlling the number of cells passing through to an application vessel, a filter tape having the application vessel positioned thereabove at a first station, a vacuum source for sucking the liquid of the liquid suspension from the application vessel through the tape, a tape moving arrangement for moving the portion of the tape having the cells deposited thereon from the first station to a second station whereat a slide is positioned, and a sponge having a fixative therein mounted on a block for biasing the tape against the slide so that the cells will adhere to the slide.