REF:

C5201 (Strip)

C5202 (Cassette)

INTENDED PURPOSE:

NOVAtest® Prostate Specific Antigen Test is an immunoassay that uses double-antibody sandwich method for qualitative detection of prostate specific antigen (PSA) in human serum and plasma specimens. It’s used as an aid in the diagnosis of prostate cancer. 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.