System information

For cobas e 411 analyzer: test number 2120 For cobas e 601 and cobas e 602 analyzers: Application Code Number 499

Intended use

This assay, a quantitative in vitro diagnostic test for total (free + complexed) prostate‑specific antigen (tPSA) in human serum and plasma, is indicated for the measurement of total PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The test is further indicated for serial measurement of tPSA to aid in the management of cancer patients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.