| 1. The Free PSA assay is intended to be used in conjunction with the Total PSA assay in men aged 50 years or older with total PSA between 4 and 10 ng/mL and DRE non-suspicious of cancer, to determine the % Free PSA value. |
| 2. Studies have shown that, in general, men with prostate cancer have lower levels of "free" PSA when compared to men without prostate cancer. |
| 3. Elevated PSA concentrations can only suggest the presence of prostate cancer until biopsy is performed. PSA concentrations can also be elevated in benign prostatic hyperplasia or inflammatory conditions of the prostate. PSA is generally not elevated in healthy men or men with non-prostatic carcinoma. |
| 4. The Abbott Architet chemiluminescent immunoassay is used. |
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| Source: |
| 1. Catalone WJ et al. Use of the Percentage of Free Prostate-Specific Antigen to Enhance Differentiation of Prostate Cancer from Benign Prostatic Disease. JAMA; 1998; 279:1542-1547. |
| 2. Abbott Diagnostics. Architect Free PSA package insert 77-4134R3 June 2007. |