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April 22, 2020 (Newswire.com) –
ZEUS Scientific announces today the submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to the SARS-CoV-2 (novel 2019 Coronavirus).
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 is a trusted partner with over 40 years of in vitro diagnostic experience providing high-quality diagnostic solutions. Our New Jersey-based, FDA-inspected manufacturing facility is certified and audited to ISO 13485 (2016), FDA Quality System Regulations (1996: 21 CFR § 820) and IVD 98/79/EEC. In these difficult times you can count on ZEUS to apply our expertise and assist in the fight against COVID-19.
In addition to this rapid in vitro diagnostic test, ZEUS is also pleased to announce development of a corresponding ELISA test system, also for detection of antibodies to SARS-CoV-2. Further updates in conjunction with this higher throughput, automatable option will be provided in the near future.
For more information please visit ZeusCovid.com or email [email protected] to ensure early access to the rapid test system when issuance of a EUA has been received and the product is released for sale.