Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximately 34 kDa.1 PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1–Antichymotrypsin (PSA‐ACT) and PSA complexed with α2–macroglobulin (PSA‐MG).2 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.

POSITIVE RESULT: A colored band appears in the control band region (C) and another colored band appears in the T band region.

NEGATIVE RESULT: One colored band appears in the control band region (C). No band appears in the test band region (T).

INVALID RESULT:Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

Sensitivity and Specificity

The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) has been tested with a leading commercial PSA EIA test using clinical specimens.

Relative Sensitivity: 98.7% (97%‐100%)*
Relative Specificity: 98.5% (97.1%‐99.9%)*
Accuracy: 98.6% (97.5%‐99.7%)* *95% Confidence Interval