System information

For cobas e 411 analyzer: test number 290 For cobas e 601 and cobas e 602 analyzers: Application Code Number 211

Intended use

Immunoassay for the in vitro quantitative determination of pregnancy-associated plasma protein A in human serum. This assay is intended for the use as one component in combination with other parameters to evaluate the risk of trisomy 21 (Down syndrome) during the first trimester of pregnancy. Further testing is required for diagnosis of chromosomal aberrations. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.