A rapid test for the semi-quantitative detection of Prostate Specific Antigen (PSA) in whole blood, serum or plasma. For professional in vitro diagnostic use only. .
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 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 3 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 3-10ng/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).4 The PSA 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 3ng/ml and a reference value of 10ng/m
Materials Provided
