REF:

C5207 (Strip)

C5208 (Cassette)

INTENDED PURPOSE:

NOVAtest® Prostate Specific Antigen Semi-quantitative Test is an immunoassay that uses double-antibody sandwich method for semi-quantitative detection of prostate specific antigen (PSA) in human serum, plasma and whole blood specimens. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Prostate cancer is the most common cancer in men worldwide, with an estimated 1,600,000 cases and 366,000 deaths annually. The incidence of prostate cancer increases with age and accounts for a growing number of newly diagnosed patients.

Prostate-specific antigen (PSA) is the most widely used biomarker for prostate cancer in all the main phases of prostate cancer detection. Clinical trials give a PSA cut-off concentration of 3ng/mL as a significant marker for prostate cancer which is confirmed by biopsy test. Hence, PSA-density might inform biopsy decisions, and spare some men from the morbidity associated with a prostate biopsy and diagnosis of low-grade prostate cancer.