Back to results
US 12,510,543 B2Granted
Prostate antigen standards and uses thereof
AssigneeOPKO Diagnostics, LLC
InventorsVincent Linder, Christina Higgins, Kim Pettersson
Life of this patent
Estimating the term…
Abstract
Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.
Claims14
A method of measuring the level of iPSA in a sample, the method comprising:
- contacting iPSA present in the sample with a capture antibody specific for iPSA and nicked PSA under conditions in which the capture antibody binds at least to iPSA, thereby producing a capture-antibody-iPSA complex;
- combining the capture-antibody-iPSA complex with a tracer in a buffer having a pH in a range of 6.5 to less than 7.5 such that the tracer binds to the capture-antibody-iPSA complex;
- and
- detecting the tracer bound to the capture-antibody-iPSA complex;
- wherein the tracer comprises a 4D4 antibody.
2 more elements
A method for quantifying levels of a prostate antigen, the method comprising:
- performing an immunoassay to measure a level of a prostate antigen in a sample, wherein the prostate antigen comprises intact prostate specific antigen (iPSA), wherein the immunoassay comprises:
- contacting iPSA present in the sample with a capture antibody specific for iPSA and nicked PSA under conditions in which the capture antibody binds at least to iPSA, thereby producing a capture-antibody-iPSA complex;
- combining the capture-antibody-iPSA complex with a tracer in a buffer having a pH in a range of 6.5 to less than 7.5 such that the tracer binds to the capture-antibody-iPSA complex;
- and
- detecting the tracer bound to the capture-antibody-iPSA complex;
- wherein the tracer comprises a 4D4 antibody;
- performing the same immunoassay to measure the level of the prostate antigen in each titer in a set of prostate antigen standards, wherein the set of prostate antigen standards comprises at least two titers containing known levels of the prostate antigen, wherein each intermediate titer of the prostate antigen is equidistant from the titer above and below it on a logarithmic scale, wherein the quantity of the smallest non-zero titer of the set is below the limit of quantification of the immunoassay, and wherein the level of the prostate antigen in the largest titer in the set is between i) a blood level of the prostate antigen in the upper quartile of a target population of male subjects and ii) a level of the prostate antigen that is 100-fold higher than the blood level in the upper quartile of the target population of male subjects;
- and
- determining the level of the prostate antigen in the sample based on the measured levels of the prostate antigen in the set of prostate antigen standards.
6 more elements
Dependencies are inferred from the claim text.