What is it about?

[-2]proPSA is a form of free PSA (fPSA) that can improve the detection of prostate cancer. Its utility has been studied through the following indices, that also require PSA and fPSA to be quantified: the prostate health index (PHI) and the percentage of [-2]proPSA (%[-2]proPSA). Beckman Coulter is the manufacturer that provides the automated [-2]proPSA assay and has also developed the PHI. Hence, both derivatives of [-2]proPSA – %[-2]proPSA and PHI – have been performed in clinical practice exclusively with PSA and fPSA also from Beckman Coulter. This exclusively Beckman Coulter solution has been, in our opinion, an obstacle to a broader implementation of this tests in most of the large clinical laboratories. We evaluated the clinical performance of the %[-2]proPSA and of the PHI using two common assays for PSA and fPSA: Abbott Architect and Roche cobas; we compared it with the performance of the original Beckman Coulter indices, performed using the Hybritech calibration. We arrived to the conclusion that, with the appropriate cutoff adjustments, both [-2]proPSA derivatives maintain their diagnostic performance (diagnostic sensitivity, specificity, predictive values and number of spared biopsies) when calculated with PSA and fPSA by these two other manufacturers. We hope that this study can contribute to a broader implementation of these diagnostic indices in clinical laboratories worldwide.

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Why is it important?

PHI helps better diagnosing prostate cancer, specially clinically significant prostate cancer, while reducing the number of unnecessary biopsies. This study shows a way to facilitate the implementation of this test in clinical laboratories, by using different manufacturers for PSA. We show that the clinical performance of PHI is maintained, even when it is calculated with PSA from manufacturers that are different from the one used in the originally developed index.


We hope that this study helps to broaden the implementation of this new serum based test for prostate cancer diagnosis, in clinical laboratories worldwide.

Manuel Garrido
Department of Clinical Pathology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal

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This page is a summary of: The prostate health index and the percentage of [-2]proPSA maintain their diagnostic performance when calculated with total and free PSA from different manufacturers, Clinical Chemistry and Laboratory Medicine (CCLM), July 2021, De Gruyter,
DOI: 10.1515/cclm-2021-0554.
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