Roche Diagnostics Elecsys PlGF

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Roche Diagnostics Asia Pacific Pte Ltd

Class:

Class C IVD

Manufactured by:

Roche Diagnostics GmbH

Therapeutic area:

Immunology

Therapeutic indications:

Immunoassay for the in vitro quantitative determination of placental growth factor (PlGF) in human serum. The 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 cobas e immunoassay analyzers.

Product summary:

Models: Elecsys PlGF - 05144671190, PlGF CalSet - 05144701190, PreciControl Multimarker - 05341787190, Elecsys PlGF - 07027648190

Authorization date:

2011-02-28