The U.S. Food and Drug Administration said Thursday it would provide human blood samples infected with Zika, West Nile or dengue viruses for those that develop infection-detecting products.
The FDA stated that the additional measure would help diagnostic developers to “assess whether their tests can contribute to distinguishing recent Zika virus infection from infection with West Nile or dengue viruses.”
The FDA will provide the blood samples to developers of serological tests. These tests identify proteins (antibodies) produced by the body’s immune system when it detects harmful organisms such as Zika virus in the blood.
“Serological tests are especially important (but) development of these types of tests have been particularly challenging because antibodies produced by the body to fight Zika virus are difficult to differentiate from antibodies produced to fight related viruses, such as dengue and West Nile viruses,” the FDA said in a statement.
Using the same serological panel to evaluate a myriad of testing devices from different companies approved under the FDA’s Emergency Use Authorization (EUA) will help experts compare the different virus tests, the state agency said.
“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to assess better how well their tests perform. This is part of our efforts 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,” FDA Commissioner Scott Gottlieb said.
Diagnostic developers will now be able to use these blood samples to see if their tests can distinguish the Zika virus from the West Nile or dengue viruses.
The Blood Systems Research Institute provided the samples from Zika virus-infected individuals that the FDA used to prepare the panel, the federal agency said.
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