Patent ID: 11921115
Assignee: OPKO DIAGNOSTICS, LLC
Field: Measurement (Instruments)
Classification: CPC G  C | IPC C  G

Claim 8:
9. A prostate antigen detection kit for quantifying levels of the prostate antigen, wherein the prostate antigen is intact prostate specific antigen (iPSA), the kit comprising:
a set of prostate antigen standards for quantifying levels of the prostate antigen in a sample using an immunoassay, wherein each prostate antigen standard is present in a container as a solution, 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 largest titer of 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 75-fold higher than the blood level in the upper quartile of the target population of male subjects;
a tracer antibody comprising a 4D4 antibody;
a buffer having a pH of 6.5 to 7.0; and
instructions for quantifying levels of the prostate antigen.