FDA provides plasma samples to promote serologic testing for Zika

Scott Gottlieb

To assist the regulatory assessment of serological tests for Zika virus, the FDA has provided manufacturers with a panel of human plasma samples, according to a release issued by the organization.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” FDA Commissioner Scott Gottlieb, MD, said in the release.

“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform,” Gottlieb continued. “This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”

All plasma samples were collected from anonymous donors infected with Zika, West Nile or dengue viruses. These samples are not for research purposes but rather for diagnostic developers to assess whether their serologic tests can differentiate between the various viruses.

According to the release, an emphasis is to be placed on serologic testing measures as opposed to RNA testing because the window for detecting recent infection and the virus’ genetic material is observable. The organization notes that results from these tests have been increasingly difficult to analyze because Zika virus antibodies are very similar to those in related infections such as dengue or West Nile virus.

The panel is available to all developers who have had prior interaction with the FDA and who have a product in the final stages of validation. – by Katherine Bortz

Resources: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572197.htm