IVD assay iAMP Covid-19 Detection Kit receives CE Mark
Fujirebio Europe has received the CE mark for the molecular IVD assay iAMP Covid-19 Detection Kit from its partner Atila Biosystems. The qualitative detection kit is based on real-time fluorescent reverse transcription isothermal amplification, eliminating the need for RNA extraction.
The detection kit was also granted Emergency Use Authorization by the US Food and Drug Administration on April 10.
The iAMP COVID-19 Detection Kit can be run on a Real-Time PCR PowerGene 9600 Plus or any other qPCR automate capable of measuring fluorescence in FAM/HEX channel in real-time.
The new iAMP COVID-19 molecular assay complements the existing panel of biomarkers available on the LUMIPULSE® G System for infection (PCT, Ferritin), inflammation (IL-6) and epithelial lung injury (KL-6) to predict disease severity in patients infected with SARS-CoV-2.
Products from Atila Biosystems are available through Fujirebio’s European affiliates and through a large portion of Fujirebio’s existing or new European distribution network.
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