FDA Gives Arbor Vita’s Avian Flu Test the Go-Ahead
Device detects NS1 protein from throat and nose swabs in 40 minutes.
FDA approved Arbor Vita’s (AVC) AVantage™ A/H5N1 Flu Test. This is a noninvasive rapid diagnostic for this subtype of the avian influenza A virus through the detection of nonstructural protein 1 (NS1) from throat swabs or nose swabs collected.
The device can detect the presence of the virus in less than 40 minutes, without complicated sample preparation, according to AVC. The FDA points out that other sanctioned tests take three to four hours to produce results in the detection of this influenza A virus subtype.
In clinical studies, the test correctly identified the absence of infection in more than 700 specimens, FDA reports. Additionally, it correctly detected the presence of influenza A/H5N1 virus subtype in 24 cultured specimens from infected patients.
The U.S. Navy was an integral partner in evaluating this flu test for FDA clearance, the firm adds. The Naval Health Research Center in San Diego provided testing on both archival and prospective clinical specimens to ensure the specificity of the test, while Navy Medical Research Unit-3 provided access to avian influenza isolates for development and testing.