FDA Clearance for Au...
10th February 2014 Content supplied by: Meridian Bioscience
FDA Clearance for TRU FLU® to Add Avian H7N9 Influenza A Virus Claim
Meridian Bioscience’s TRU FLU® assay has received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU® is a rapid immunoassay that detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens.
New strains of Influenza viruses are continuously emerging to replace the more contemporary or common strains. The novel avian Influenza A strain H7N9 was first reported in China in March 2013. Since then, there have been 147 confirmed human cases of avian influenza A H7N9, with 47 deaths reported in China. It is important that rapid assays are able to detect novel strains as they emerge to enable physicians to deliver prophylaxis to and manage infected patients in a timely manner.
Meridian’s TRU FLU and TRU RSV® products provide closed systems that limit the exposure of laboratory personnel to infectious agents in test samples during incubation and disposal.
Date Published: 10th February 2014
FDA Clearance for Automated BD