Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening.

Abstract: High throughput personal genomic testing has created a need for robust quality control mechanisms to track sample identity, reagent integrity, and other factors with significant influence on assay performance. A method of massively parallel sequencing using an accompanying barcoded molecular standard enables one to track nucleic acid analytes to identify them by project, lot, batch, or patient. The molecular standard contains sequences present in the analyte, allowing it to be processed simultaneously without any other additional reagents. Within the molecular standard, a calibrator sequence permits assessment of fidelity of sequence determination. Additional sequences in the molecular standard may be used to manipulate the molecular standard separate from the analyte. The molecular standard can be used to benchmark sequencing platforms and assess error rates.

Abstract: High throughput personal genomic testing has created a need for robust quality control mechanisms to track sample identity, reagent integrity, and other factors with significant influence on assay performance. A method of massively parallel sequencing using an accompanying barcoded molecular standard enables one to track nucleic acid analytes to identify them by project, lot, batch, or patient. The molecular standard contains sequences present in the analyte, allowing it to be processed simultaneously without any other additional reagents. Within the molecular standard, a calibrator sequence permits assessment of fidelity of sequence determination. Additional sequences in the molecular standard may be used to manipulate the molecular standard separate from the analyte. The molecular standard can be used to benchmark sequencing platforms and assess error rates.

Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening. A first portion of the partially lysed sample can be mounted on a slide and observed for atypical cells and cytologic abnormalities. A second portion of the partially lysed sample can be screened for genetic markers known to correlate with a risk of cervical cancer. Surprisingly the presence of beads in the mixture from the partial lysing process does not interfere with slide processing or cellular analysis. The method is particularly useful for cervical screening, where a combination of cytology and genetic screening present a more complete picture of cervical health.

Abstract: High throughput personal genomic testing has created a need for robust quality control mechanisms to track sample identity, reagent integrity, and other factors with significant influence on assay performance. A method of massively parallel sequencing using an accompanying barcoded molecular standard enables one to track nucleic acid analytes to identify them by project, lot, batch, or patient. The molecular standard contains sequences present in the analyte, allowing it to be processed simultaneously without any other additional reagents. Within the molecular standard, a calibrator sequence permits assessment of fidelity of sequence determination. Additional sequences in the molecular standard may be used to manipulate the molecular standard separate from the analyte. The molecular standard can be used to benchmark sequencing platforms and assess error rates.

Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening. A first portion of the partially lysed sample can be mounted on a slide and observed for atypical cells and cytologic abnormalities. A second portion of the partially lysed sample can be screened for genetic markers known to correlate with a risk of cervical cancer. The method is particularly useful for cervical screening, where a combination of cytology and genetic screening present a more complete picture of cervical health. The disclosed method streamlines the diagnostic process for protocols that require both types of assays, without compromising screening accuracy.

Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening. A first portion of the partially lysed sample can be mounted on a slide and observed for atypical cells and cytologic abnormalities. A second portion of the partially lysed sample can be screened for genetic markers known to correlate with a risk of cervical cancer. The method is particularly useful for cervical screening, where a combination of cytology and genetic screening present a more complete picture of cervical health. The disclosed method streamlines the diagnostic process for protocols that require both types of assays, without compromising screening accuracy.

Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening. A first portion of the partially lysed sample can be mounted on a slide and observed for atypical cells and cytologic abnormalities. A second portion of the partially lysed sample can be screened for genetic markers known to correlate with a risk of cervical cancer. The method is particularly useful for cervical screening, where a combination of cytology and genetic screening present a more complete picture of cervical health. The disclosed method streamlines the diagnostic process for protocols that require both types of assays, without compromising screening accuracy.

Abstract: Systems and methods are directed to computer-assisted navigation of images of a cytological specimen, including the acts of analyzing a first image of the cytological specimen to identify a plurality of objects of interest within the cytological specimen, displaying a plurality of images each comprising one of the plurality of identified objects of interest within the cytological specimen and including a second image of at least one object of interest, and displaying, responsive to receiving a user selection of the second image of the at least one object of interest, a field of view of the at least one object of interest and neighboring objects of interest, wherein the second image of the at least one object of interest has a first magnification, and wherein the field of view of the at least one object of interest is displayed at a second magnification different than the first magnification.

Abstract: Systems and methods of use to facilitate classification of cytological specimens are discussed. The system acquires or imports image data of a cytological specimen. The imported image data may include, or the system may otherwise perform an image analysis to identify one or more objects of interest in a respective specimen image dataset, including feature attributes for the identified objects. The system analyzes the feature attributes by predetermined criteria and/or optionally with user inputted criteria. The system includes an analysis tool that assists the user in identifying cytologically abnormal objects, if present in a particular specimen, by manipulating and viewing images of objects selected as a function of feature attributes. More generally, the analysis tool aides the user to find, extract, and display abnormal objects from within a large dataset of images and facilitates navigation through large amounts of image data and enables the efficient classification of the entire specimen.

Abstract: The invention provides a device, system and method for sample collection wherein a sample can be separated into multiple portions of sample at the site of collection. The separation of portions of sample occurs by separating parts of the specimen collection device. Each of the separable parts contacting a portion of sample can be deposited into separate vessels. The device reduces the risk of sample contamination, because the separable parts can be separated by the action of a release mechanism that allows a user to separate the parts without touching or otherwise contacting the sample collecting region. The release mechanism may be trigger-activated to expel a separable part of the device.

Abstract: The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening. A first portion of the partially lysed sample can be mounted on a slide and observed for atypical cells and cytologic abnormalities. A second portion of the partially lysed sample can be screened for genetic markers known to correlate with a risk of cervical cancer. Surprisingly the presence of beads in the mixture from the partial lysing process does not interfere with slide processing or cellular analysis. The method is particularly useful for cervical screening, where a combination of cytology and genetic screening present a more complete picture of cervical health.

Abstract: A computer-assisted method of classifying cytological samples, includes using a processor to analyze images of cytological samples and identify cytological objects of interest within the sample images, wherein the processor (i) displays images of identified cytological objects of interest from the sample images to a reviewer, (ii) accesses a database of images of previously classified cytological objects, and (iii) displays to the reviewer, interspersed with the displayed images of the identified objects of interest from the sample images, one or more images obtained from the database of images of previously-classified objects.

Abstract: Systems and methods of use to facilitate classification of cytological specimens are discussed. The system acquires or imports image data of a cytological specimen. The imported image data may include, or the system may otherwise perform an image analysis to identify one or more objects of interest in a respective specimen image dataset, including feature attributes for the identified objects. The system analyzes the feature attributes by predetermined criteria and/or optionally with user inputted criteria. The system includes an analysis tool that assists the user in identifying cytologically abnormal objects, if present in a particular specimen, by manipulating and viewing images of objects selected as a function of feature attributes. More generally, the analysis tool aides the user to find, extract, and display abnormal objects from within a large dataset of images and facilitates navigation through large amounts of image data and enables the efficient classification of the entire specimen.

Abstract: A cap configured for use with a specimen container includes a cap body having a top surface defining an opening therethrough, a torque pattern disposed on the top surface of the cap body, and a pierceable and self-resealing membrane disposed across the opening, where, when the membrane is intact or resealed, the membrane forms a fluid-tight seal across the opening.

Abstract: Methods and systems for collecting cells on a filter disposed in a specimen fluid containing suspended cells of a biological specimen. A short vacuum pulse is applied across a filter to sip specimen fluid. A percentage or portion of the filter surface area covered by cells is determined is representative of or correlates to the density of cells in the specimen fluid. A maximum vacuum amplitude and/or duration are determined utilizing the determined filter coverage. A longer, continuous vacuum or slurp is applied across the filter to collect cells on the filter while limiting the amplitude and/or duration of the slurp based at least in part upon the determined maximum vacuum amplitude and/or duration.

Abstract: An apparatus for processing a specimen from a fluid sample includes a first set of one or more microfluidic channels configured to deliver the sample fluid to a filter disposed on an inflatable bladder configured to transfer the specimen from the filter to a slide. The apparatus is configured to collect an approximate monolayer of particles and includes a second set of one or more microfluidic channels configured to remove fluid flowing through the filter disposed on the inflatable bladder. The apparatus also includes a pressure source, a sample container connected to the pressure source and the first set of one or more microfluidic channels, a fluid flow gauge configured to measure a fluid flow rate through the filter, and a stain source connected to the first set of one or more microfluidic channels.

Abstract: A handheld apparatus for preparing a specimen slide includes a handle, a filter holder assembly coupled to and extending from the handle; and a slide holder assembly coupled to and extending from the handle spaced apart from the filter holder assembly, wherein the slide holder assembly comprises a plurality of positioning members movably coupled to one another, and a slide holder movably coupled to one of the positioning members to allow a slide mounted on the slide holder to make rolling contact with an outward facing surface of a filter mounted on the filter holder assembly.

Abstract: A computer-assisted method of classifying cytological samples, includes using a processor to analyze images of cytological samples and identify cytological objects of interest within the sample images, wherein the processor (i) displays images of identified cytological objects of interest from the sample images to a reviewer, (ii) accesses a database of images of previously classified cytological objects, and (iii) displays to the reviewer, interspersed with the displayed images of the identified objects of interest from the sample images, one or more images obtained from the database of images of previously-classified objects.

Abstract: A handheld apparatus for preparing a specimen slide includes a handle, a filter holder assembly coupled to and extending from the handle; and a slide holder assembly coupled to and extending from the handle spaced apart from the filter holder assembly, wherein the slide holder assembly comprises a plurality of positioning members movably coupled to one another, and a slide holder movably coupled to one of the positioning members to allow a slide mounted on the slide holder to make rolling contact with an outward facing surface of a filter mounted on the filter holder assembly.