System information

For cobas e 411 analyzer: test number 761 For cobas e 601 and cobas e 602 analyzers: Application Code Number 148

Intended use

Immunoassay for the in vitro quantitative determination of the sum of human chorionic gonadotropin (hCG) plus the hCG β‑subunit in human serum and plasma. This assay is intended for use as an aid in: ▪ Early detection and monitoring of pregnancy. The test is also intended for the use as 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. ▪ Oncology, to serve the management of patients with trophoblastic diseases. This assay is useful in the detection and monitoring of hCG‑producing tumor cells of either ovarian, placental or testicular origin. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.