FDA clears Quidel molecular RSV + hMPV assay

13 March 2013 (Last Updated March 13th, 2013 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

The assay, which is the company's third molecular PCR product, distinguishes between RSV and hMPV viruses that cause respiratory infections with very similar symptoms in children.

Quidel chief scientific officer Dr Timothy Stenzel said RSV and hMPV infections can also mimic flu-like illness and can cause ambiguity in assigning a course of treatment.

"The assay distinguishes between RSV and hMPV viruses that cause respiratory infections with very similar symptoms in children."

"For these reasons, a duplex test such as the RSV + hMPV assay can prove to be very valuable," Stenzel said.

Quidel's molecular product line includes PCR reagent kits, which provide various features including simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result as well as other benefits that favorably affect diagnostic test outcomes.

Quidel president and chief executive officer Douglas Bryant said; "We intend to broaden our menu of molecular assays over the next several quarters, and in doing so, will provide our customers with a number of easy to use infectious disease tests that can be run on their existing thermocyclers."

The RSV + hMPV assay shares a common extraction protocol with other Quidel molecular assays.

Prior to its launch in Europe in March 2012, the assay had also received CE mark approval.