Designed to run on the company's Sentosa real-time PCR system, the test has been approved for identifying and differentiating Zika in patients.
Chembio's point-of-care DPP Zika System, including an IgM/IgG assay and micro reader, provides quantitative results in 15 minutes from 10μl of fingertip blood.
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.