FDA Assembles Plasma Sample Panel for Zika Test Developers

Troy Brown, RN

Disclosures

August 17, 2017

The US Food and Drug Administration (FDA) has assembled a panel of human plasma samples to help regulators and public health professionals evaluate serological tests for Zika virus infection.

"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 an FDA news release announcing the panel. "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. 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."

Two blood tests are primarily used for diagnosis of viral infections such as Zika: nucleic acid tests that detect the presence of a virus's RNA, and serological tests that detect a 'patient's antibodies against the infectious agent.

Serological tests are particularly important, as a virus's genetic material is detectable for only a short time. However, development of serological tests for Zika infection has been complicated because it is hard to differentiate antibodies against Zika virus from antibodies against related viruses such as dengue and West Nile.

The FDA's sample panel includes plasma samples from anonymous persons infected with Zika, West Nile, or dengue. "Although the panel is not for research purposes, diagnostic developers can use these samples to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue viruses," the FDA explains in the news release. "Using the same serological panel to evaluate different devices available under Emergency Use Authorization (EUA) will help public health professionals compare the performance of different Zika virus tests."

Developers who have communicated with the FDA through the pre-EUA process and have tests that are in the final stages of validation will have access to the panel.

The FDA has thus far granted EUAs to three serological tests intended to detect recent Zika virus infection (in chronological order): Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM assay. Other developers who would like to request a panel should contact the FDA.

 

The FDA prepared the panel using samples from Zika virus-infected persons supplied by Blood Systems Research Institute from a study supported by Contract No. HHSN268201100001I from the National Heart, Lung, and Blood Institute, National Institutes of Health. The FDA obtained the samples from individuals infected with dengue and West Nile separately.

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