Branchburg-based ZEUS Scientific announced Wednesday the submission for an Emergency Use Authorization to the U.S. Food and Drug Administration for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to COVID-19 virus.
ZEUS’s lateral flow test uses patient serum, plasma or whole blood and provides results in 15 minutes.
Assay performance has been confirmed by testing sample cohorts from healthy donors, confirmed positive COVID-19 patients and cross-reactive samples acquired from heavily afflicted regions in both China and the United States.
The request for EUA is under review by the FDA and if received, ZEUS expects to have the test available to ship to customers in early May 2020.
Rapid detection of cases and contacts, appropriate clinical management, infection control, and community mitigation efforts are critical to respond effectively to the COVID-19 pandemic.
Results from the ZEUS test will help address the urgent health concerns surrounding the public health threat posed by COVID-19. Identifying individuals with specific antibodies to the SARS-CoV-2 virus provides valuable diagnostic information relating to previous exposure to the SARS-CoV-2 virus.
ZEUS Scientific has more than 40 years of in vitro diagnostic experience providing high-quality diagnostic solutions.
The company’s New Jersey-based, FDA-inspected manufacturing facility is certified and audited to International Organization for Standardization (ISO) standards, FDA Quality System Regulations and in vitro diagnostic device (IVD) standards.
In addition to the rapid in vitro diagnostic test, ZEUS also announced development of a corresponding enzyme-linked immunosorbent assay (ELISA) test system, also for detection of antibodies to SARS-CoV-2.