System information

For cobas e 411 analyzer: test number 1810

For cobas e 601 and cobas e 602 analyzers: Application Code Number 134

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 cobas e immunoassay analyzers.