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. 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.
The PSA Qualitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of PSA in whole blood, serum or plasma. The membrane is pre-coated with PSA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PSA antibodies on the membrane and generate a colored line. To serve as a procedural control, a colored line will always appear in the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.
- Test cassettes
- Package insert
Materials Required But Not Provided
- Specimen collection containers
- Lancets (for fingerstick whole blood only)
- Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)