NEW! ZEUS ELISA SARS-CoV-2 Total Antibody Test System EUA Submitted, Validated, and Ready for distribution
ZEUS Scientific Announces NEW ZEUS ELISA SARS-CoV-2 Total AntibodyTest System
ZEUS Scientific announced today the submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its in vitro ELISA diagnostic test for the semi-quantitative detection of Total (IgG, IgM, IgA) antibodies to the SARS-CoV-2 (novel 2019 Coronavirus) in human serum and plasma. ZEUS notified FDA that the test has been validated according to their guidelines established for serological assays, meeting the criteria to be distributed and is available now.
The new Total Antibody test is the third SARS-CoV-2 antibody test released by ZEUS joining the recently released IgG ELISA and the IgM/IgG rapid device. ZEUS is well positioned to meet the needs of laboratories looking to implement automated antibody testing, rapid antibody testing, or those looking to incorporate an orthogonal testing algorithm for positive results to increase positive predictive value all from the same manufacturer. Additionally, ZEUS now offers the flexibility of simultaneously testing for SARS-CoV-2 IgG, IgM and IgA antibodies or testing for IgG only. Some laboratories may be targeting the IgG response which typically takes longer to develop but may offer protection from future infection.
The ZEUS ELISA SARS-CoV-2 Total Antibody Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Assay performance has been validated using FDA’s current EUA guidelines. The assay utilizes a dual antigen combination of recombinant S1 receptor binding domain (RBD) viral protein and recombinant nucleoprotein for optimal performance. Using PCR as the reference testing demonstrates 100% clinical sensitivity and 97.1 % clinical specificity. The average days between the PCR test result and the specimen draw was 15.97 days, the earliest being 3 days. Using serology as the reference the assay achieved 98% sensitivity and 100% specificity. Combining both PCR and Serology as “Clinical Truth”, the ZEUS ELISA SARS-CoV-2 IgG Test System performed as follows, sensitivity 98.8% and specificity 99.1%. Additionally, as per FDA EUA guidance, submitted data includes studies using normal pre-pandemic donors and potentially pre-pandemic cross reactive donors, specificity in these two cohorts was determined to be 100%.
The SARS-CoV-2 Total Antibody Test System assay follows ZEUS’s universal ELISA assay protocol. This protocol offers a high degree of flexibility with incubation times (20-30 minutes for sample incubation and conjugate incubation, 10-15 minutes for TMB substrate incubation) allowing for simple, efficient, and flexible automation programming on open pipetting systems. ZEUS has validated the assay on the Dynex suite of instruments (DS2®, DSX®, Agility™), The Agility offers the highest throughput and takes advantage of the SmartKit™ Gold packaging, providing the ability to fully automate the procedure from sample to result in a throughput meeting all laboratory requirements. The new Test System also includes our proprietary SAVe Diluent, a unique component which changes color when serum is added ensuring no well is missed!
Test with Confidence. Test with ZEUS.
For over 40 years, laboratories have trusted ZEUS Scientific to provide high quality in vitro diagnostic immunoassays for numerous infectious diseases. With over 125 FDA cleared assays in our menu, our company has a proven skillset of developing, manufacturing and distributing a family of products to aid in the diagnosis of complex infectious agents including a variety of known viral pathogens. We have concentrated our focus to the COVID-19 pandemic and the SARS-CoV-2 virus.
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