Disease diagnosis by detection of shed normal tissue antigens
AssigneeOrtho Diagnostic Systems Inc.
InventorsRussell E. Thompson, Robert H. Rubin, Nina T. Rubin, Teresa H. Chan
Life of this patent
Estimating the term…
Abstract
Methods are provided for the detection of proximal convoluted tubule causing diseases or kidney harmful drug monitoring by detecting the presence of shed normal proximal tubule associated antigens in a body fluid such as urine. The preferred embodiment employs an ELISA sandwich format wherein one monoclonal antibody specific for a first epitopic site on said antigen is immobilized on a solid phase and a second antibody, specific for a second epitopic site on said antigen is directly or indirectly labeled.
Claims55
A method for diagnosing disease or other conditions affecting the proximal tubules of the human kidney resulting in the release of normal proximal tubule associated antigens into a body fluid comprising the steps of:
- (a) providing a solid phase surface having immobilized thereon a first antibody produced by cell line deposited as ATCC HB8540 or ATCC HB8428 and specific for a first epitopic site on said antigen;
- (b) providing a second antibody from the other of said deposited cell lines, said second antibody having associated therewith a detectable entity and specific for a second epitopic site on said antigen;
- (c) contacting said first and second antibodies with said body fluid sample suspected of containing the proximal tubule associated antigen to be detected under conditions suitable for immunological reactions whereby said antigen reacts with said first and second antibodies to form a sandwich complex;
- (d) detecting the entity associated with said sandwich complex whereby the presence of said antigen may be determined.
A method for detecting conditions resulting in the shedding of normal human kidney associated antigens into a body fluid comprising the steps of:
- (a) providing a first antibody produced by the cell lines deposited in ATCC HB8540 or ATCC HB8428 and specific for a first epitopic site on said antigen, said first antibody having associated therewith either the acceptor or donor molecules of a fluorescent energy transfer pair;
- (b) providing a second antibody from the other of said ATCC cell lines, said second antibody having associated therewith the other of said acceptor-donor molecules and specific for a second epitopic site on said antigen;
- (c) contacting said first and second antibodies with said body fluid sample suspected of containing the antigens to be detected under conditions suitable for immunological reactions whereby said antigen reacts with said first and second antibodies;
- (d) illuminating said acceptor and donor molecules at a frequency selected to substantially excite said donor molecules but not said acceptor molecules;
- and
- (e) detecting light emitted by said acceptor molecules or said donor molecules and relating same to the presence or absence of said antigen to be detected.
A method for detecting the presence of normal proximal convoluted tubule tissue associated antigen in urine comprising the steps of reacting said urine with either one or both antibodies produced by cell lines ATCC HB8540 or ATCC HB8428 and detecting label associated with said reacted antibodies.
A method for detecting the presence of normal human kidney associated antigens in urine comprising competitively reacting said antigen with an antibody produced by cell line ATCC HB8540 specific for said sample antigen and reagent antigen having substantially similar reactivity with said antibody as said sample antigen, said reagent antigen having associated therewith a detectable label;
- and
- detecting label associated with said antigen which has reacted with said antibody or with said antigen which has not reacted with said antibody for determining the presence of said antigen in said sample.
A method for detecting the presence of normal human kidney associated antigens in urine comprising competitively reacting said antigen with an antibody produced by cell line ATCC HB8428 specific for said sample antigen and reagent antigen having substantially similar reactivity with said antibody as said sample antigen, said reagent antigen having associated therewith a detectable label;
- and
- detecting label associated with said antigen which has reacted with said antibody or with said antigen which has not reacted with said antibody for determining the presence of said antigen in said sample.
Dependencies are inferred from the claim text.