Large disparities in prostate-specific antigen (PSA) results from different assays have been observed in the College of American Pathologists (CAP) Ligand Assay Survey, with interassay results varying severalfold. Survey specimens are predominately composed of free PSA and do not reflect the composition of typical patient specimens.
To characterize a pilot material developed for CAP in which pooled sera samples were spiked with purified PSA and alpha(1)-antichymotrypsin-bound PSA at targeted concentrations and to compare it to CAP survey and reference materials.
CAP survey, reference, and pilot materials were analyzed using 10 total PSA and 7 free PSA assays. These assays included Food and Drug Administration-approved assays and assays for research use only.
Variability among the 10 total PSA methods was greatest for the 1997 ligand survey material (CV range, 56%-65%) followed by the pilot material (CV range, 10%-29%) and the reference material (CV range, 6%-13%). In contrast, interassay variability for the 7 free PSA methods was similar for the 3 preparations, with the exception of one specimen close to the limit of detection of the assays. As determined with the Hybritech Tandem-R method, the ligand survey specimens were essentially composed of all free PSA, whereas the reference and pilot materials were composed of approximately 10% and 35% free PSA, respectively.
The newly formulated pilot material prepared using a human base that contained defined concentrations of free PSA and alpha(1)-antichymotrypsin-bound PSA more closely resembled patient specimens and minimized differences among methods compared with the semen-supplemented original survey material.