N1 Fragment Antibody testNotification to retestAccess to full laboratory reportManagement Dashboard for Operations Team and Site
EVE Patient App
The neutralizing antibody test has been authorized by the FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist for justifying the authorization of emergency use in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564 (b) (1) of the Act, 21 U.S.C. 360bbb-3 (b) (1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
The semi-quantitative and Delta neutralizing antibody components of the test have been modified under CLIA guidelines to report total blocking activity percentages (%), quantification of blocking antibodies in IU/ml, anti-Delta variant neutralizing antibody blocking activity percentages (%), automation, and finger stick specimens.
This N1 fragment antibody test was developed, and its performance characteristics determined, by Healix Pathology, LLP laboratory (CLIA# 06D2174124). It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA and is qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.
This testing was performed in the Healix Pathology, LLP laboratory (CLIA# 06D2174124), located at 4800 Fournace
Place, Suite BW3, Bellaire, TX 77401.