Tru-Immune: semi-quantitative surrogate Viral Neutralization Test (sVNT)
This semi-quantitative neutralizing antibody test for the SARS-CoV-2 virus allows users to determine how effective their immune systems are at neutralizing or ‘blocking’ the SARS-CoV-2 virus. Tests that are “prefabricated” to detect certain antibodies such as IgG, IgM and IgA do not provide information on protective immunity. The new Tru-Immune test detects the presence of neutralizing antibodies, which are key biomarkers of immunity that will guide public health decisions and help establish a clear path forward.
Tru-Immune reports the neutralizing or blocking capacity of your current immune response.*
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
*Ethos laboratories has notified the FDA that they have validated Tru-Immune and have started patient testing as set forth in Section IV.A of the FDA’s Policy for Coronavirus Disease-2019 Tests. The FDA has not yet reviewed the laboratory’s validation and issued an EUA for the laboratory’s test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#labs-ivd Ethos setting for use designation is “H” CLIA to perform high-complexity testing.