The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.
The EUA makes the test, which detects Zika IgM antibodies in fingerstick samples, available for use in high and moderate complexity CLIA certified laboratories.
The test, which uses an immunochromatography format similar to a home pregnancy test, could enable quick, inexpensive testing for Zika and dengue infections.
The test, the fourth Zika serological assay available under EUA, qualitatively detects Zika virus IgM antibodies in human serum and plasma.
The University of Illinois team developed the technology with an eye at low-resource settings, including developing nations and rural communities.
Researchers were able to identify a specific protein signature for Zika, opening up the possibility that the signature could could be used to screen for exposure to Zika.
Developers can use the Zika virus samples to ascertain whether their tests can help distinguish Zika infection from similar diseases.
The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene.
For the three months ended June 30, the point-of-care infectious disease diagnostics firm posted $4.1 million in total revenues, up from $3.3 million in Q2 2016.
The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.