System information

For cobas e 411 analyzer: test number 311

For cobas e 601 and cobas e 602 analyzers:

Intended use

Immunoassay for the in vitro quantitative determination of α1‑fetoprotein in human serum and plasma. This assay is intended for the use as:

▪ An aid in the diagnosis of hepatocellular carcinoma (HCC).

▪ An aid in the management of patients with non‑seminomatous germ cell tumors.

▪ One component in combination with other parameters to evaluate the risk of trisomy 21 (Down syndrome).Further testing is required for diagnosis of chromosomal aberrations.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.