Becton Dickinson and Company Limited

James D Mansour

Thomas H Schulte

Burton H Sage

John L Haynes

Vernon R Neece

The present invention relates to a flow-through device that has a quality control procedure for a binder used in the test area of an assay device to bind an analyte from a test sample. The invention provides for a method for determining the presence of an analyte in a fluid sample, said method employing an assay test kit including an assay device having a porous membrane having an upper surface and a lower surface, a test area on the upper surface of said membrane, a binder for the analyte attached to said test area; a delivery device comprising a well for receiving the sample, said well having an opening at a lower end thereof, wherein said sample is capable of being delivered through the well to a portion of the test area on the upper surface of said porous membrane of the assay device; a vessel containing a tracer having a tag, wherein said tracer is for application to said portion of the test area whereby the tag of said tracer is detected in said portion of the test area when the analyte is present in the fluid sample; and a vessel containing an analyte positive control sample comprising said analyte which is applied to the test area and said tracer is applied to the test area whereby the tag of said tracer is detected in said test area thus confirming that said analyte is specifically bound by said binder in the test area.

Quality control procedure for membrane flow-through diagnostic assay

Apparatus having an antimicrobial surface includes a medical device and a plurality of metals, at least one of which is in contact with a surface of the device and in contact with a different metal. The invention includes a method to use the apparatus to treat a living body wherein the antimicrobial surface of the apparatus is contacted with a body electrolyte thereby inhibiting growth of microorganisms in the body consequent to the use of the apparatus.

Antimicrobial surfaces and inhibition of microorganism growth thereby

A method for rapid detection of microorganisms in a body fluid sample includes detecting the microorganisms after treatment of the sample with a lysing agent in order to dissolve sample components other than microorganisms, and staining with a fluorescent dye. The lysing agent may be part of a composition which includes a culture medium thereby providing simultaneous lysis and growth before staining. Detection is preferably accomplished by reliance on the fluorescence emitted by the dye having been properly excited by light energy. A composition suitable for use in the above-described method includes a growth medium and a lysing agent.

Composition and method for rapid detection of microorganisms in clinical

A method to determine the Gram sign of microorganisms includes staining the microorganisms with a plurality of fluorescent dyes, applying excitation energy to the stained microorganisms, and observing the color of the fluorescence emission of the stained microorganisms. Gram-positive and Gram-negative microorganisms stain different colors, and assignment of the Gram sign may be made on the basis of the color of the stained microorganisms.

Fluorescent gram stain

A method for the assessment of bacteriuria and pyuria includes the simultaneous detection and quantitation of microorganisms, leukocytes and squamous epithelial cells in a urine specimen. The three cell types are stained with a fluorescent dye, and the urine specimen is analyzed directly, preferably by a single flow microfluorometry protocol.

Detection and quantitation of microorganisms, leukocytes and squamous

A method for detection of intracellular bacteria in a blood sample by staining with ethidium bromide and observing microscopically using fluorescence is provided. The bacteria stain rapidly and selectively and are detectable in complex mixtures. The bacteria may be in whole blood or may optionally be partially isolated or purified before staining.

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Raleigh, NC, United States of America

James D Mansour