Cytyc Corporation

Roche Diagnostics Hematology, Inc.

Constitution Medical, Inc.

Daniel C Lapen

David J Zahniser

Eric Yeaton

Dennis P Poole

Brian James McKeen

Mark J Licari

Gail E Radcliffe

Louise Isenstein

Norman Soule

Kerri Horton

Charles A Festel

Stephen Conroy

Katherine K Mui

Anne A Hurley

Peter Albany

Kimberly Lindfield

Noorul Rahman

Petrus S Oud

Trudee Klautky

Peter S Oud

Kerri Licari

Somthouk Lim

Eric D Yeaton

Brian J Mckeen

Stephen Edward Conroy

The apparatus disclosed herein features a substrate arm and gripper, a platform having a top surface located opposite the substrate when the substrate arm is in a specimen processing position and featuring at least one fluid port located on a surface of the platform facing the substrate and at least one vacuum port located on the surface of the platform facing the substrate, and during operation, the apparatus is configured to (a) dispense a first quantity of fluid from the at least one fluid port to fill a separation between the substrate and the platform, (b) dispense an additional quantity of fluid from the at least one fluid port into the separation to displace a portion of the first quantity of fluid, and (c) remove the portion of the first quantity of fluid from the separation through the at least one vacuum port.

Automated systems and methods for preparing biological specimens for examination

The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.

Fixative and staining solutions

The systems and methods disclosed herein permit automated preparation of biological specimens for examination. The disclosed systems and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a biological specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation cycles for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining biological specimens.

The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The formulations can include a cytological fixative solution including Azure B, a surfactant, methanol, and ethylene glycol. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.

Kits and methods for qualifying automated biological screening system. At least one biological specimen having a plurality of marked target zones (MTZs) exhibiting an attribute is provided. The biological specimen(s) is processed through the automated biological screening system to determine locations of biological objects suspected of exhibiting the attribute. The locations of the MTZs can be compared to the locations of the suspicious biological objects in order to determine a number of matches. The automated biological screening system can then be qualified based on the number of matches, and optionally based on statistical information related to the biological specimen. The statistical information can be acquired by processing the biological specimen through a qualified automated biological screening system over a number of runs.

Method of generating and using biological qualification slides to qualify biological screening devices

An automated method for classifying a cytological sample is provided. The method comprises interrogating the sample with one or more wavelengths of light to obtain a result, and then attaching one or more designators to the sample based on whether the result meets a given criterion. The method allows for rapid feedback on the characteristics of the sample, permitting automated designation of the sample as positive for a given characteristic, and allowing for immediate remedial actions if the sample fails to meet the criterion.

Automated cytological sample classification

A method for treating a biological sample with a Papanicolaou staining process is provided. The method comprises incorporating a detergent treatment into the staining process at any of various steps. The method has been found to advantageously reduce the number of artifacts produced during Papanicolaou staining. Also provided is a sample stained by such a process.

Papanicolau staining process

Instruments and processes according to the invention provide for the preparation of a fluid sample that has a substantially known concentration of a select particulate matter. In one aspect, the invention is understood as laboratory instruments for sample preparation. These instruments can include a filter that is submersible within a fluid suspension of particulate matter. To collect particulate matter from the fluid suspension, the instruments can cause a fluid flow that pulls fluid across the filter to trap particulate matter against one surface of the filter. The instruments can then remove the filter from the fluid suspension and dispose the filter above a collection vessel such that the side of the filter that is carrying particulate matter is positioned above the opening of the collection vessel. The laboratory instruments can then send a collection fluid through the filter in a direction opposite to the original fluid flow, thereby washing the particulate matter off the filter and into the collection vessel. The laboratory instruments according to the invention can provide samples having a known concentration by passing a known volume of collection fluid through the filter, thereby trapping the collected particulate matter within a known volume of collection fluid.

Methods for collecting fluid samples having select concentrations of particles

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.

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Lancaster, MA, United States of America

Daniel C Lapen