Other

Dexall Biomedical Labs, Inc.

Thomas T Hubscher

Glen M Ford

Teri M Ruppenthal

Erik P Lillehoj

This disclosure teaches a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, haptens, and carbohydrates by lateral flow techniques. In one embodiment of the disclosure, a test sample is added to the test strip, which then migrates to the site of the immobilized allergens, thereby forming a first antibody IgE-allergen complex. A chase release buffer is added upstream to or from the site of the labeled anti-IgE antibodies, which is itself upstream from the sample site. The anti-IgE antibodies migrate downstream to the site of immobilized first complex, thereby forming a second complex indicating the presence of class specific IgE antibodies in the test specimen. In another embodiment of the disclosure, a liquid form of the labeled anti-IgE antibodies can be added to the test strip after the first complex has been formed.

Method for the visual detection of specific antibodies by the use of lateral flow assays

This invention discloses a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques. In one embodiment of the invention, a test sample obtained from bodily fluids reacts with a gold labeled antigen. The resulting complex travels across the membrane, and along the lateral flow strip. Red colored lines formed in specific locations along the test strip indicate the presence of class specific antibodies in the test specimen. In another embodiment of the invention, the lateral flow assay serves as an immunochromatographic screening test for the detection of allergen-specific IgE antibodies in human serum. Test sample reacts with gold labeled anti-IgE antibody. The resulting complex travels across the membrane where immobilized allergens capture the allergen specific IgE complex. Colored lines are formed int the test areas to indicate the presence of allergen-specific IgE antibodies.

Incorporation of selective binding substances in a solid phase assay device

An immunoassay of a liquid biological specimen for a specific analyte is conducted by forming a test sample by contacting the specimen with: (1) a binding substance of a ligand, antiligand or receptor capable of binding the analyte and (2) a detector substance of a colloidal gold or silver labeled ligand or antiligand to form a test sample. The test sample is applied by flowing onto a defined zone of an insoluble porous support film having a pore size impassable to a complex formed between the analyte, if present, with the binding substance and the detector substance, but passable to the binding substance and detector substance while remaining uncomplexed in the absence of the desired analyte. If the analyte is present in the test specimen, the detector substance binds with the analyte and the binding substance to form a visually inspectable complex on the surface of the porous support film. After application of the test sample to the porous support, the surface of the porous support is visually inspected for color to determine the presence and quantity or the absence of the analyte being assayed.

Non-captive substrate liquid phase immunoassay

This invention discloses a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques. In one embodiment of the invention, a test sample obtained from bodily fluids reacts with a gold labeled antigen. The resulting complex travels across the membrane, and along the lateral flow strip. Red colored lines formed in specific locations along the test strip indicate the presence of class specific antibodies in the test specimen. In another embodiment of the invention, the lateral flow assay serves as an immunochromatographic screening test for the detection of allergen-specific IgE antibodies in human serum. Test sample reacts with gold labeled anti-IgE antibody. The resulting complex travels across the membrane where immobilized allergens capture the allergen specific IgE complex. Colored lines are formed in the test areas to indicate the presence of allergen-specific IgE antibodies.

Method for the visual detection of specific antibodies in human serum by the use of lateral flow assays

Apparatus for performing determinations of immune reactants (e.g., antigens, antibodies) in bodily fluids includes multiple test units having respective elongated rods with transversely-expanded tips at their distal ends. The tips are each coated with respective immune reactants (e.g., allergens) which react in a known manner with respective allergen-specific or allergen-binding antibodies in human serum. The test units are color-coded to identify the allergen coatings and are supported at their proximal ends and positionally identified on a strip. By correlating the color code to a chart, the specific immune reactant (e.g., allergen) coating can be easily identified. The supporting strip for the test unit has through-holes which frictionally engage the proximal ends of the test unit rods with a spacing that permits all of the supported test units to be simultaneously inserted into an assembly of reaction containers arranged in a linear array. Additionally, the through-hole spacing in the strip permits alternate test units to be simultaneously placed in an array of test tubes that are transversely larger than the reaction containers and supported in a linear array in a test tube rack. The tip of each test unit may take the form of two frusto-conical sections joined by a short cylindrical section extending longitudinally between their larger ends. Alternatively, the frusto-conical sections may be multi-faceted to minimize scraping of the allergen coating from the tip during insertion and removal of the test units into the reaction containers/test tubes.

Methods for performing determinations of immune reactants in biological

A method and apparatus for performing determinations of immune reactants (e.g., antigens, antibodies) in bodily fluids utilize multiple test units having respective elongated rods with transversely-expanded polymer tips at their distal ends. The tip surfaces contain microgrooves and are coated with respective immune reactants (e.g., allergens) of the type which react in a known manner with respective allergen-specific or allergen-binding antibodies in human serum. The supporting strip for the test units has through-holes which frictionally or adhesively engage the proximal ends of the test unit rods with a spacing that permits all of the supported test units to be simultaneously inserted into a reaction vessel permitting simultaneous determination of reactants and degrees thereof against multiple immune reactants of varying kinds (i.e., allergens, antigens, antibodies) in a common sample of body fluid (i.e., serum, plasma, whole blood, etc.). The shallow microgrooves on the test tip permit rapid penetration of dye and rinsing of the test units. After incubation in the sample fluid, the test units are washed and then incubate in an enzyme-antibody conjugate. Upon additional rinsing the test units are permitted to incubate in a chromogenic substrate specific to the enzyme. The intensity of the resulting color (typically blue) on the tip is a measure of the amount of specific antibodies in the tested fluid sample.

Method and apparatus for performing determinations of immune rectants in

Apparatus for performing determinations of immune reactants (e.g., antigens, antibodies) in bodily fluids includes multiple test units having respective elongated rods with transversely-expanded tips at their distal ends. The tips are each coated with respective immune reactants (e.g., allergens of the type which react in a known manner with respective allergen-specific or allergen-binding antibodies in human serum. The test units are color-coded. By correlating the color code to a chart, the specific immune reactant (e.g., allergen) coating can be easily identified. The supporting strip for the test unit has through-holes which frictionally engage the proximal ends of the test unit rods with a spacing that permits all of the supported test units to be simultaneously inserted into an assembly of reaction containers arranged in a linear array. The through-hole spacing in the strip permits alternate test units to be simultaneously placed in an array of test tubes that are transversely larger than the reaction containers and supported in a linear array in a test tube rack. The tip of each test unit may take the form of two frusto-conical joined by a short cylindrical section extending longitudinally beween their larger ends. The frusto-conical sections may be multi-faceted to minimize scraping of the allergen coating from the tip during insertion and removal of the test units into the reaction containers/test tubes.

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Gaithersburg, MD, United States of America

Thomas T Hubscher