System information

For cobas e 411 analyzer: test number 2140 For cobas e 601 and cobas e 602 analyzers: Application Code Number 751

Intended use

Immunoassay for the in vitro quantitative determination of free prostate‑specific antigen in human serum and plasma. This assay is indicated for measurement of fPSA in conjunction with the Elecsys total PSA assay to develop a ratio (% fPSA) of fPSA to tPSA. This ratio is useful when used in conjunction with the Elecsys total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and an Elecsys total PSA value in the range 4 ng/mL to 10 ng/mL. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.