Other

Binax, Inc.

Alere Scarborough, Inc.

Quantix Systems, L.p.

Alere Switzerland Gmbh

Smithkline Diagnostics, Inc.

Roger N Piasio

Nathan Turner

Alan H Davis

Howard Milne Chandler

Donald J Lennon

Norman James Moore

William J Palin

Myron Whipkey

Erik R Piasio

Erin Hayes

Bruce C Reinemann

Steven Muszynski

Madeline Wareing

Leslie Latt

Dorothy Joanis

Kristin Gordon

Karen Prouty

Methods for performing dry chemistry, lateral flow-reconstituted chromatographic enzyme-driven assays are described. A combination of components necessary to elicit a specific enzyme reaction are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final 'read zone' wherein the color developed is read against predetermined color standards for the desired reaction. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays.

Methods for performing dry chemistry, lateral flow-reconstituted chromatographic enzyme-driven assays

Provided are methods and devices for detecting methicillin-resistant

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A lateral flow chromatographic assay format for the performance of rapid enzyme-driven assays is described. A combination of components necessary to elicit a specific enzyme reaction, which are either absent from the intended sample or insufficiently present therein to permit completion of the desired reaction, are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final 'read zone' wherein the color developed is read against predetermined color standards for the desired reaction. Pretreatment pads for the sample, as needed, (e.g. a lysing pad for lysing red blood cells in whole blood) are placed in front of the sample pad in the flow path as appropriate. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays.

Method of assaying glucose-6-phosphate dehydrogenase on a chromatographic test strip

Provided are methods comprising the use of non-sugar organic compatible solutes for protection and preservation of the activity of biologically active molecules and conjugate labels. The methods are particularly adaptable for use in conjunction with immunoassays, such as for example, immunochromatographic test assays and may be incorporated into any test methodology wherein a dry test strip is used as a carrier for depositing, mobilizeable and/or immobilized biologically active molecules and/or conjugate labels.

Organic non-sugar compounds for protection of biologically active molecules and conjugate labels and methods of use thereof

The present invention relates to modifying rapid immunochromatographic ('ICT') tests for the detection of characteristic carbohydrate antigens of bacteria that are known to be causative of otitis media and respiratory diseases in children under the age of approximately 12 years. The test modifications involve either (1) reducing the total amount of antibodies to the carbohydrate antigen employed in each test, (2) adding at least one fixed 'scrub' line located just prior to the capture line in the sample flow path to the prepared ICT test strip to &#x201c;scrub&#x201d; out an identical amount of target antigen from all bodily fluid test samples obtained from both colonized but otherwise healthy children and diseased children, or (3) combinations of (1) and (2).

Modification of bioassays for detection of antigens characteristic of bacteria that are causative of ear and respiratory infections to eliminate false positive results caused by nasopharyngeal colonization of children

A lateral flow chromatographic assay format for the performance of rapid enzyme-driven assays is described. A combination of components necessary to elicit a specific enzyme reaction, which are either absent from the intended sample or insufficiently present therein to permit completion of the desired reaction, are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final 'read zone' wherein the color developed is read against predetermined color standards for the desired reaction. Pretreatment pads for the sample, as needed, (e.g. a lysing pad for lysing red blood cells in whole blood) are placed in front of the sample pad in the flow path as appropriate. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays. Specific assays for glucose-6-phosphate dehydrogenase ('G-6PD'), total serum cholesterol, &#x3b2;-lactamase activity and peroxidase activity are disclosed.

Dry chemistry, lateral flow-reconstituted chromatographic enzyme-driven assays

Superparamagnetic ('SPM') subunits of 1&#x2013;30 nm average mean diameter (e.g. ferro fluid) subparticles are treated with a magnetically noninterfering substance capable of coating and covering them (e.g, BSA) and they spontaneously form agglomerates of about 100 nm to about 450 nm or higher average mean diameter and are then used to form complexes with target biological ligands such as viruses, contained in large volumes of liquid. The complexes are subjected to the gradient intensity of a strong magnetic field, and excess liquid is removed, where upon an immunochromatographic assay is conducted to determine the identity and/or amount of target ligand present, in which operation SPM particles that bonded to the ligand function as tags for ligand detection.

Process for (A) separating biological/ligands from dilute solutions and (B) conducting an immunochromatographic assay thereof employing superparamagnetic particles throughout

Process for (A) separating biological/ligands from dilute solutions and (B) conducting an immunochromatographic assay thereof employing superparamagnetic particles throughtout

An assay device for detection or determination of an analyte in a sample uses either removably attachable components or hinged panels to provide greater flexibility and reduce manufacturing and storage costs. In one embodiment of the device, the device comprises: (1) a first opposable component including:(a) a first panel; (b) a second panel mounted on the first panel generally parallel to the first panel with space between the first and second panel, the second panel having an opening forming a first receptacle for a sample collection device; and (c) a second receptacle for a test strip formed by the first panel and the second panel; and (2) a second opposable component hingedly attached to the first opposable component. In this device, the first and second opposable components can be brought into operable contact so that fluid is expressed from the sample collection device and applied to the test strip for detection or determination of an analyte by a test performed on the test strip. Other embodiments of devices are included, as well as test kits and method of use of the devices.

Detachable-element assay device

A chromatographic assay device for use with immunoassays allows rapid and convenient assays of analytes of biological interest, and permits extractions to be carried out in situ, avoiding the use of separate extraction vessels. The device has a wide dynamic range and avoids interference from particulates or colored components. In one form, the device comprises: (1) a first opposable component comprising a sample preparation zone adapted to receive a sample to be assayed; and (2) a second opposable component comprising a chromatographic medium. The first and second opposable components can be brought into opposition so as to cause the sample preparation zone to apply the sample to be tested to the chromatographic medium. Preferably, the analyte is detected with a visually detectable label. Other variations of the device vary the arrangement of components to provide optimal chromatography for a variety of analytes, as well as to permit bidirectional chromatography; still other variations are suitable for competitive immunoassays. The devices can be incorporated in test kits, and assay methods, both sandwich and competitive, using the devices are also disclosed.

Immunochromatographic assay device

The invention pertains to an immunoassay method for determining the presence of volatile organic compounds in aqueous, soil and air samples by simultaneously collecting and testing a sample volume suspected to contain such organic compounds. As a major problem in the assay of such materials is their rapid evaporation, the present immunoassay is specifically designed to eliminate or minimize the evaporation of the volatile organic analyte during sample handling as well as during the assay process itself. The immunoassay method is based on an assay vessel which has a lower portion, in which the immunoassay actually takes place, and an inert upper portion, which can hold a sufficiently large volume of sample to prevent or minimize evaporation of the organic compound from the smaller volume in the lower portion. The assay is performed by: (1) coating the vessel's lower portion with an antibody specific for the organic analyte; (2) adding the sample to the vessel, wherein the volume of the sample added is between about two to about thirty times the volume of the vessel's lower portion; (3) adding a conjugate between a detectable label and an organic compound for which the antibody is specific; (4) allowing the organic analyte and the added conjugate to compete for binding to the immobilized antibody; and (5) detecting the binding of the detectable label to the immobilized antibody. In another embodiment of the immunoassay, the lower portion of the vessel has inserted therein a solid phase device whose surface is coated with an immobilized antibody specific for the organic analyte.

Quantitative immunoassay for volatile organic compounds

Antibodies are raised against immunogens which include an aromatic ring moiety, preferably the compound 6-aminohexyl-p-tolylacetamide, which immunologically cross-react with small aliphatic organic compounds. These antibodies are useful in immunoassay methods for detecting a class of very small organic molecules such as 1,1-dihaloethylene and 1,1,2-trihaloethylene, whether alone or as a functional group on another molecule. Such antibodies and methods provide important tools for detecting significant environmental pollutants.

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Cumberland Foreside, ME, United States of America

Roger N Piasio