Prostate specific antigen test in serum | PSA521

INTENDED USE:

One-Step Prostate Specific Antigen (PSA) Test is a rapid and convenient immunochromatographic assay for the qualitative detection of human Prostate Specific Antigen in serum samples at or above the cutoff level of 4 ng/ml. It is intended for professional use as an aid in the diagnosis of prostate cancer. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the results of the tests.

SUMMARY AND EXPLANATION:

Prostate specific antigen (PSA) is a signal chain glycoprotein containing two hundred forty amino acid residues and four carbohydrate side chains. The complete gene encoding PSA has been sequenced and localized to chromosome 19. PSA functions as a kallikrein-like serine protease and is produced exclusively by the epithelial cells lining the acini and ducts of the prostate gland. It is secreted into the prostatic ducts and at ejaculation it serves to liquefy the seminal coagulum. Many studies confirm that PSA is the most useful and meaningful tumor marker known for prostate cancer. Quantitative PSA detection by enzyme linked immunosorbent assay (ELISA) indicates the range of normal human serum PSA concentration is between 0.1 and 2.6 ng/ml, and the half-life of serum PSA is between 2.2 and 3.2 days. One Step PSA test device is an antigen-capture immunochromatographic assay, detecting the presence of PSA in blood samples. Monoclonal antibodies specifically against PSA are 1) conjugated with colloidal gold and deposited on the conjugate pad and 2) immobilized on the Test Zone on the nitrocellulose membrane. When adequate volumes of the test sample is added the antibody conjugate is rehydrated and the PSA, if any in the samples, will interact with the colloidal gold conjugated antibodies. The antigen-antibody-colloidal gold complex will migrate towards the test window until the Test Zone (T) where they are captured by immobilized antibodies, forming a visible pink line (Test line), indicating a positive result. If PSA is absent in the sample, no pink line will appear in the Test Zone (T), indicating a negative result. To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone is an indication of an invalid result.