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PSA has been detected in various tissues of the male urogenital system but only prostate glandular cells and endothelial cells secrete it. The PSA level in the serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign conditions such as benign prostatic hyperplasia and prostatitis. A PSA level of 4 to 10 ng/mL is considered to be in the “gray‐zone” and above 10 ng/mL is highly indicative of cancer.3 Patients with PSA values between 4‐10 ng/mL should undergo further analysis of the prostate by biopsy. Authorities have begun to explore the possibility of using PSA levels lower than 4.0 ng/mL as the upper limit of normal for screening examinations. By lowering the PSA cutoff from 4 to 3 ng/mL, an increase in cancer detection by 13.2% can be achieved.4
The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH).5
The PSA Ultra Prostate Specific Antigen Rapid Test Strip (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold conjugate and anti‐PSA antibodies to selectively detect all three forms of PSA in whole blood, serum or plasma. The test has a cut‐off value of 4 ng/mL.