Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximate 34 kDa. 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). PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in 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 condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 4 to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer. 3 Patients with PSA values between 4-10ng/ml should undergo further analysis of the prostate by biopsy.

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). The PSA Qualitative Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of 4ng/ml.

 

【DIRECTIONS FOR USE】

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.1. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum, Plasma or Venipuncture Whole Blood specimens:

· Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) or 2 drops of venipuncture whole blood (approximately 80 ul) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

· To use a capillary tube: Fill the capillary tube and transfer approximately 80 ul of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul and start the timer. See illustration below.

3. Wait for the colored line(s) to appear*. Read result at 5 minutes. Do not interpret the result after 10 minutes.

*Note: if migration is not observed in the result window after 30 seconds, add one or two extra drops of buffer. It is suggested not to use the buffer, beyond 30 days after opening the vial.