Accurate and Reliable results in 15 MINUTES!
The ZEUS Rapid SARS-CoV-2 IgM/IgG Test System is a rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibody to the SARS-CoV-2 (novel 2019 Coronavirus) in human serum, plasma or whole blood. The system is built on a colloidal gold-based immunochromatographic lateral flow test strip. This test is for in vitro diagnostic use only as an aid in the diagnosis of previous exposure to the SARS-CoV-2 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. On April 28th, 2020 ZEUS Scientific officially notified the U.S. FDA that it has validated the ZEUS Rapid SARS-CoV-2 IgM/IgG Test System and intends to begin distributing this product to laboratories. ZEUS has met the requirements defined in the guidance documents provided by the FDA applicable to serological assays designed to detect antibodies to the SARS-CoV-2 virus (novel 2019 coronavirus).
|# of tests per kit:||25 individual tests|