System information

For cobas e 411 analyzer: test number 830 For cobas e 601 and cobas e 602 analyzers: Application Code Number 096

Intended use

Immunoassay for the in vitro quantitative determination of soluble fms‑like tyrosine kinase‑1 (sFlt‑1) in human serum. The Elecsys sFlt‑1 assay is used in combination with the Elecsys PlGF 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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.