Tru-Immune: Semi-Quantitative Surrogate Viral Neutralization Test (sVNT)
This semi-quantitative neutralizing antibody test for the virus that causes COVID-19 (SARS-CoV-2) allows users to determine how effective their immune systems are at neutralizing or ‘blocking’ the virus.
Why Are Tru-Immune Results Important?
Tru-Immune reports the neutralizing or blocking capacity of your current immune response.* As we continue to learn more about COVID-19, natural immunity, and vaccine effectiveness, it’s important to know your level of protection. The Ethos Tru-Immune test analyzes the neutralizing or blocking capacity of your current immune response against the virus that causes COVID-19, whether you’ve recovered from COVID-19, received the primary vaccine series, or received a booster.
What Makes Tru-Immune Different?
Other tests that are “prefabricated” to detect certain antibodies such as IgG, IgM and IgA do not provide information on protective immunity. The Tru-Immune test detects the presence of neutralizing antibodies, which are key biomarkers of immunity that will guide personal health decisions and public health decisions, and help establish a clear path forward.
How Are My Results Reported?
As a semi-quantitative test, your results will be reported as a percentage range, indicating your ability to block the virus that causes COVID-19. Results above 20% indicate that protective immunity has been established. Higher percent inhibition indicates a higher quantity of neutralizing antibodies.
- Negative: 0-20% inhibition, Protective immunity not established.
- Positive: 20-40% inhibition, Protective immunity established.
- Positive: 40-60% inhibition, Protective immunity established, the quantity of your neutralizing antibodies is MODERATE.
- Positive: 60-80% inhibition, Protective immunity established, the quantity of your neutralizing antibodies is HIGH.
- Positive: >80% inhibition, Protective immunity established, the quantity of your neutralizing antibodies is VERY HIGH.
*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. 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.