World’s First Quantitative Surrogate Viral Neutralization Test Evaluates COVID-19 Protective Immunity in US

The world’s first quantitative surrogate Viral Neutralization Test (sVNT) to evaluate COVID-19 protective immunity in the US will measure and quantify the neutralizing capacity of antibodies against the SARS-CoV-2 virus.

The test, marketed as Tru-Immune, is being offered by Ethos Laboratories (Newport, KY, USA) in partnership with GenScript (Piscataway, NJ, USA). Unlike other tests currently on the market, Tru-Immune detects the presence and magnitude of neutralizing antibodies that prevent infectivity of the COVID-19 virus. The Tru-Immune lab test will identify patients with the most effective antibody response capable of inhibiting virus replication. This information has not previously been available and will pave the way for blood centers across the US to recruit patients who have recovered from COVID-19 and exhibit the greatest potential to inhibit the virus.

Tests that are "prefabricated" to detect certain antibodies such as IgG, IgM and IgA, can limit sensitivity, while the Tru-Immune test detects all antibody neutralizing capacity and provides quantitative data on how effective a person’s antibodies are at preventing the virus from interacting with its cellular target. If test results indicate the presence of neutralizing antibodies, then the person has been exposed and has an immune system that is capable of inhibiting the virus if exposed again. Longitudinal studies and serial testing will be required to better understand how long the protective antibody response lasts in recovered patients and this information will be the key to developing effective vaccine strategies. The commercialization of the new Tru-Immune serological test will assist government officials and medical authorities to determine population health immunity levels for re-entry into the workforce and establish a "new normal" for American society.

"Tru-Immune is the first test to evaluate protective immunity to the SARS-CoV-2 virus that does not require the use of live virus, cell culture or even pseudovirus," said Joshua Gunn, CSO of Ethos Research and Development. "These significant technical innovations allow us to process samples in less than three hours whereas traditional viral neutralization tests can take three-five days to produce results. Serological assays capable of detecting anti-SARS-CoV-2 antibodies have flooded the market but are not capable of measuring the viral neutralizing capacity of these antibodies."

"We are excited to offer the first quantitative surrogate viral neutralization test to evaluate Immunity to COVID 19," said Todd Bladel, COO of Ethos Laboratories. "This test was validated using PCR confirmed positive control samples and exhibited sensitivity and specificity of 100%. Tru-Immune will provide a level of actionable data that has not been previously available. We feel strongly that this novel test will play a central role in the penultimate chapter of COVID 19 by providing quantitative information about protective immunity, aiding vaccine development, and guiding patient selection for convalescent plasma therapies to treat the critically ill."

Related Links:
Ethos Laboratories
GenScript