FDA clears Diagnostic Hybrids' rapid respiratory virus test
This article was originally published in Clinica
Executive Summary
Diagnostic Hybrids' test for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) has received 510(k) clearance from the US FDA. The D3 FastPoint L-DFA RSV/MPV identification kit identifies the viruses, which are the most common causes of lower respiratory infection in young children, within 25 minutes. It is the only FDA-cleared product that can detect both RSV and hMPV antigens simultaneously, the Athens, Ohio company claimed, adding that other rapid, point-of-care tests do not generally identify MPV. Like the firm's two other D3 FastPoint respiratory virus tests, the diagnostic uses monoclonal antibodies to detect the viruses in nasopharyngeal swabs, aspirates and washes.