Prostate antigen standards and uses thereof
AssigneeOPKO Diagnostics, LLC
InventorsVincent Linder, Christina Higgins
Life of this patent
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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.
Claims25
A method for quantifying levels of a prostate antigen, the method comprising:
- performing an immunoassay to detect presence of a prostate antigen in a sample;
- and
- quantifying levels of the prostate antigen detected in the sample in relation to a minimal set of informative prostate antigen standards detected using the same immunoassay.
8-9. (canceled)
(canceled)
19-24. (canceled)
A prostate antigen detection kit for quantifying levels of a prostate antigen, the kit comprising a minimal set of informative prostate antigen standards for quantifying levels of a prostate antigen in a sample using an immunoassay, wherein each prostate antigen standard is present in a container as a solution.
27-39. (canceled)
A method for preparing prostate antigen standards for quantifying levels of a prostate antigen in a sample, the method comprising:
- (i) obtaining an antigen associated with prostate cancer;
- (ii) preparing a stock solution of the antigen in a suitable buffer, wherein the stock solution is at a titer between i) the blood prostate antigen concentration of the upper quartile of a target population of subjects and ii) 75-fold higher than that blood prostate antigen concentration;
- and
- (iii) preparing a minimal set of prostate antigen standards by serial dilution of the stock solution, such that each intermediate titer of prostate antigen standard is equidistant from the titer above and below it on a logarithmic scale.
41-53. (canceled)
Dependencies are inferred from the claim text.