Beckman Coulter, Inc.

Smithkline Diagnostics, Inc.

Smithkline Corporation

Smithkline Beckman Corporation

Ronald J Schoengold

Wayne H Schrier

Joseph F Pagano

Corey L Jaseph

Franco Ruggeri

Josefina T Baker

Richard Sergei Matusewicz

John Warwick Silzel

David R Shockey

Myron C Rapkin

Pierre C Van Rysselberghe

A medical analysis system for reading and interpreting an occult blood test (OBT) device is provided. The instant system comprises an image sensor for capturing an image of the entire test area of the fecal occult blood test (FOBT) device and for converting the image into a digital data. The system further comprises a data processor conventionally coupled to the image sensor. The data processor compares the digital data with pre-determined threshold conditions of a positive FOBT by utilizing a spectrographic and morphologic image analysis algorithm and determines a presence of the occult blood in the sample. A hue angle analysis for data processing may be used. A method of performing FOBT on a sample is also provided.

Devices and methods for reading and interpreting guaiac-based occult blood tests

A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol. Other devices and methods for the separation of the liquid portion of blood from the cellular components of the blood are also disclosed.

Devices and methods for separating cellular components of blood from liquid portion of blood

Devices and methods for separating cellular components of blood from

A method and slide for collecting and testing fecal occult blood which permits multiple analyses of a single fecal sample. The slide contains a pocket-like member on a portion of the inside front cover of the slide. An absorbent insert is disposed in the pocket. When the cover is in a closed position the pocket overlies the fecal smear on the specimen viewing sheet and the insert can be removed from the pocket. This design permits an analysis to be done on the specimen receiving sheet of the slide together with a second confirmatory test on the insert.

Method and device for collecting and testing for fecal occult blood

A method and device for separating blood into fluid and cellular fractions for diagnostic tests. The whole blood is introduced to a carrier containing a layer of carbohydrate which results in the rapid separation of the fluid from the cellular fractions. In a preferred embodiment, the device is fabricated in a sandwich design containing layers of carbohydrate and reagent material between two layers of plastic.

Device and method for whole blood separation and analysis

A method and device for collecting and testing fecal occult blood which permits multiple analyses of a single fecal sample. The device is a combination of a sampler for collecting the fecal matter and a test slide. The fecal sampler comprises a pocket-like wipe pad for obtaining direct anal stool smears. An insert is disposed in the pocket of the wipe pad. The slide has a profiled opening similar to the design of the wipe pad. This opening acts as a receptacle for the pad when the fecal smear is transferred to the guaiac specimen receiving sheet of the slide. When the slide is closed the insert can be removed from the wipe pad. This design permits an analysis to be done on the specimen receiving sheet of the slide together with a second confirmatory test for human hemoglobin on portions of the insert. The fecal material on the insert is physically removed from the guaiac specimen receiving sheet.

A device for making a culture of micro-organisms has a container having an open end and means to seal the open end of the container. A second seal divides the container into a first compartment for a liquid culture medium remote from the open end of the container and a second compartment adjacent the open end of the container. A removable elongated member in the container has a portion extending through the second compartment and into said first compartment and removably engaging the second seal to seal liquid culture medium in the first compartment. A culture medium secured to a portion of said elongated member lies in the second compartment. Preferably the sides edges of the elongated member are tapered adjacent its inner end and a portion of the elongated member in the second compartment carries one or more solid culture mediums. Advantageously the second seal member is tapered to guide the elongated member through the center thereof.

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San Jose, CA, United States of America

Ronald J Schoengold