System information

For cobas e 411 analyzer: test number 1590

For cobas e 601 and cobas e 602 analyzers: Application Code Number 472

Intended use

Immunoassay for the in vitro quantitative determination of anti‑Müllerian hormone (AMH) in human serum and plasma. The determination of AMH is used for the assessment of the ovarian reserve and the prediction of response to controlled ovarian stimulation (COS) in conjunction with other clinical and laboratory findings. In addition, the determination of AMH (in pmol/L) in combination with body weight is used for the establishment of the individual daily dose of the human recombinant follicle-stimulating hormone (rFSH) follitropin delta of Ferring (in accordance with the current prescribing information of the Ferring follitropin delta) in controlled ovarian stimulation for the development of multiple follicles in women undergoing an assisted reproductive technology program. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.