Alere Scarborough, Inc.

Binax, Inc.

Alere Switzerland Gmbh

Norman James Moore

Vladimir Andrei Koulchin

Elena Valentin Molokova

Mary K Konstantin

Roger N Piasio

Phillip I Tarr

Alan H Davis

Myron Whipkey

Mary Kathleen Fent

Erin Hayes

Vincent Anthony Sy

Steven Muszynski

Dorothy Joanis

Kristin Gordon

The present invention involves extracting frombacteria, particularlybacteria, an essentially protein-free O-polysaccharide or carbohydrate antigen, coupling this antigen to an activated chromatographic column through a protein space molecule which is first conjugated to the antigen, utilizing the column thus prepared for the affinity purification of raw polyvalent antibodies to the samebacterium from which the O-polysaccharide or carbohydrate antigen was separated&#x2014;thereby obtaining antigen-specific antibodies which are useful for the rapid detection of the correspondingbacterium or its antibody in human bodily fluids such as urine, sputum, blood and the like or in environmental samples suspected of harboring thebacterium.

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Disclosed is a cell wall C-polysaccharide antigen ofwhich contains not more than 10% by weight of protein, and preferably less which has been purified with 0.1N Na OH prior to deproteinizing. Also disclosed are polyvalent antibodies raised againstwhich have been affinity purified by passing them over a chromatographic affinity matrix to which is coupled the purified and at least partially deproteinized antigen to render them antigen-specific.

Provided are methods and devices for detecting methicillin-resistant

The present invention involves extracting frombacteria, particularlybacteria, an essentially protein-free O-polysaccharide or carbohydrate antigen, coupling this antigen to an activated chromatographic column through a protein spacer molecule which is first conjugated to the antigen, utilizing the column thus prepared for the affinity purification of raw polyvalent antibodies to the samebacterium from which the O-polysaccharide or carbohydrate antigen was separated&#x2014;thereby obtaining antigen-specific antibodies which are useful for the rapid detection of the correspondingbacterium or its antibody in human bodily fluids such as urine, sputum, blood and the like or in environmental samples suspected of harboring thebacterium.

A process is disclosed for obtaining a C-polysaccharide cell wall antigen containing not more than about 10% protein from bacteria. The antigen thus obtained is conjugated to a spacer molecule, and the free end of the latter is then conjugated to a chromatographic affinity column. The column is then utilized to purify raw antibodies to bacteria, thereby producing antigen-specific antibodies. A portion of such antibodies is conjugated to a labeling agent which displays a visible color change upon reaction of the antibodies with their antigenic binding partner and embedded in a first zone of an immunochromatographic assay device. Another portion of such antibodies is bound to the reaction zone of the device which has a view window. When a liquid sample, such as patient urine, cerebrospinal fluid or blood is applied to the first zone, the conjugate of antibodies and labeling agent and the sample move along a flow strip of bibulous material to the reaction zone wherein, if the sample contains or its cell wall antigen, a sandwich is formed among the labeled conjugate, the antigen and the bound antibodies and a color change is observed. The immunochromatographic assay thus performed is completed within about 15 minutes. This assay affords a basis for rapid and reliable diagnosis of various pathogenic states caused by including pneumonia, bronchitis, otitis media, sinusitis, meningitis, and secondary disease states that commonly occur when primary pneumonic infection caused by this bacterium persists undiminished over a time period of 3-5 days.

Process and materials for the rapid detection of streptococcus pneumoniae employing purified antigen-specific antibodies

A method for determining and diagnosing inflammatory enteric disease using an immunochromatographic test device having a multiplicity of test zones. The method tests for the presence of at least one enteric pathogen and at least one of certain inflammatory enteric disease markers. The enteric pathogens tested for can be any number of enteric pathogens such as the pathogens O157, Campylobacter, Salmonella, Listeria, Shigella, and Yersinia. The inflammatory enteric disease markers tested for are fecal lactoferrin, a bacteria marker, a virus marker, and a protozoa marker. Positive results for any one of the pathogens indicates that pathogen as the cause of the inflammatory enteric disease. Positive results for fecal lactoferrin indicate an inflammatory condition of the intestines. Positive results for the bacteria, virus, protozoa markers indicate respectively a bacterial, viral, or protozoan cause of infection as the cause of the disease. Liquid fecal sample is mixed with a mixture containing antibodies to the pathogens and the markers. These antibodies are conjugated to a label. Each test zone on the test device has immovably fixed upon it a complementary antibody that binds specifically with one of the labeled antibodies in the mixture. Positive results appear as a stripe across the corresponding test zone.

Method for detecting enteric disease

In qualitative or quantitative assays which employ a test device comprising a test strip pretreated for detection of a specified target analyte dissolved in a liquid medium, the presence of solid, semisolid and/or colloidal materials in the liquid medium may interfere with the assay results. The present invention involves collecting the sample from a flowing or quiescent pool of liquid also containing solid, semisolid or colloidal material with a swab comprised of a handle and a mass of fibrous material or foamed, open cell material which, when immersed in and thoroughly wetted by the liquid, entraps solid, semisolid and/or colloidal material and delivers only the liquid to the sample receiving zone of the test strip.

Growing community of inventors

North Berwick, ME, United States of America

Norman James Moore