System information

For cobas e 411 analyzer: test number 820 For cobas e 601 and cobas e 602 analyzers: Application Code Number 083

Intended use

Immunoassay for the in vitro quantitative determination of placental growth factor (PlGF) in human serum. The Elecsys PlGF assay is used in combination with the Elecsys sFlt‑1 assay to determine the sFlt‑1/PlGF ratio. The sFlt‑1/PlGF ratio is intended for use as an aid in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical information. In addition the sFlt‑1/PlGF ratio is intended for use as an aid in short-term prediction of preeclampsia (rule-out and rule-in) in pregnant women with suspicion of preeclampsia in conjunction with other diagnostic and clinical information. This assay is intended for the use as one component, in combination with other parameters, to evaluate the risk of early-onset preeclampsia during the first trimester of pregnancy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.