The present invention provides a method and device for conducting a rapid in vitro enzyme immunoassay test for the direct and qualitative detection of two or more viral antigens from specimens of symptomatic patients. The method for immunoassay of viral antigens is performed on a membrane. Non-immunological capture of viral antigens takes place by absorption onto the membrane. Captured antigen binds to a detection reagent that includes a label conjugated to a specific antibody. The test is a differentiated test such that two or more viral antigens may be distinguished from each other in a single test. The invention also includes a kit for performing an assay in accordance with the method of the present invention, wherein the kit comprises the device of the present invention.
Assay Of Blood Or Other Biologic Samples For Target Analytes
Robert A. Levine - Guilford CT Stephen C. Wardlaw - Old Saybrook CT Rodolfo R. Rodriguez - Owings Mills MD Adrien P. Malick - Granite MD Alvydas J. Ozinskas - Dayton MD
Assignee:
Becton Dickinson and Co. - Franklin Lakes NJ
International Classification:
G01N 33543 G01N 33558
US Classification:
435 724
Abstract:
A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample. Upon centrifugation, the complexes will settle out in different areas in the tube according to the respective density of the body or bodies; and the degree of label emission of the complex layers can enable qualitative and/or quantitative analyses of the sample to be made. Unbound labeled binding materials will be separated from the complexed layers by the washing action of ascending or descending components of the sample during the centrifugation step.
Assay Of Blood Or Other Biologic Samples For Target Analytes
Robert A. Levine - Guilford CT Stephen C. Wardlaw - Old Saybrook CT Leon W. M. M. Terstappen - Palo Alto CA Kristen L. Manion - Benecia CA Rodolfo R. Rodriguez - Owings Mills MD Adrien P. Malick - Granite MD Subhash Dhanesar - Owings Mills MD Stephen J. Lovell - Baltimore MD Alvydas J. Ozinskas - Dayton MD
Assignee:
Becton Dickinson and Co. - Franklin Lakes NJ
International Classification:
G01N 33543 G01N 33546
US Classification:
435 724
Abstract:
A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample. Upon centrifugation, the complexes will settle out in different areas in the tube according to the respective density of the body or bodies; and the degree of label emission of the complex layers can enable qualitative and/or quantitative analyses of the sample to be made. Unbound labeled binding materials will be separated from the complexed layers by the washing action of ascending or descending components of the sample during the centrifugation step.
Assay Of Blood Or Other Biologic Samples For Target Analytes
Robert A. Levine - Guilford CT Stephen C. Wardlaw - Old Saybrook CT Leon W. M. M. Terstappen - Palo Alto CA Kristen L. Manion - Benecia CA Rodolfo R. Rodriguez - Owings Mills MD Adrien P. Malick - Granite MD Subhash Dhanesar - Owings Mills MD Stephen J. Lovell - Baltimore MD Alvydas J. Ozinskas - Dayton MD
Assignee:
Becton Dickinson and Co. - Franklin Lakes NJ
International Classification:
G01N 33543 G01N 33558
US Classification:
435 724
Abstract:
A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample. Upon centrifugation, the complexes will settle out in different areas in the tube according to the respective density of the body or bodies; and the degree of label emission of the complex layers can enable qualitative and/or quantitative analyses of the sample to be made. Unbound labeled binding materials will be separated from the complexed layers by the washing action of ascending or descending components of the sample during the centrifugation step.
Joseph R. Lakowicz - Columbia MD Badri P. Maliwal - Baltimore MD Richard Thompson - Baltimore MD Alvydas Ozinskas - Dayton MD
International Classification:
G01N 33533
US Classification:
436537
Abstract:
A fluorometric luminescence immunoassay method includes forming a sample by exposing a first immune reaction reactant to a second immune reaction reactant capable of reacting with the first reactant, one of the first and second immune reaction reactants being labelled with a photoluminescent energy transfer donor and the other being labelled with a photoluminescent energy transfer acceptor complementary to the photoluminescent donor. At least the photoluminescent donor has the property of photoluminescence, and the photoluminescent donor and acceptor are chosen so that when the first immune reaction reactant reacts with the second immune reaction reactant, the donor and the acceptor are capable of interacting to produce a detectable luminescence lifetime change. The sample is excited with radiation, and the resulting emission is detected. The apparent luminescent lifetime is then calculated to determine the presence of a reaction product of the first and second immune reaction reactants.