This artcile has been updated following a correction issued by Diagnostic Hybrids on Sep. 2.
NEW YORK (GenomeWeb News) – Diagnostic Hybrids on Wednesday issued a correction to an earlier statement and said that the US Food and Drug Administration has not cleared any additional claims or new intended uses for its respiratory virus test kit.
The Athens, Ohio-based firm said that its D3 Ultra DFA Respiratory Virus Identification Kit is the only monoclonal antibody-based screening kit commercially available that can detect and identify influenza A virus, as well as influenza B virus, respiratory syncytial virus, adenovirus, and parainfluenza virus types 1, 2, and 3.
Diagnostic Hybrids said that although the kit has shown that it could detect the 2009 influenza A (H1N1)v virus in two culture isolates, "the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1)v virus have not been established. The D3 Ultra kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes," the firm added in a statement.
Diagnostic Hybrids' announcement comes one week after Prodesse said that FDA had cleared additional claims for its ProFlu+ assay, which says that it correctly identifies as Influenza A positive specimens containing novel 2009 H1N1 influenza virus.