[October 19, 2020 – Fierce Biotech] With the world watching for whether the current crop of COVID-19 vaccines works, LabCorp has launched a new coronavirus antibody test designed to to determine just that.
The company’s Cov2Quant test is designed to gauge the strength of a person’s immune response to the virus, for use in clinical trials of potential vaccines and therapies. Unlike screening diagnostics that provide a simple positive or negative results, the new test provides a quantitative measurement of the concentration of IgG antibodies in a person’s blood.
The test is currently only available for use in research and has not been authorized by the FDA for wider use.
While more companies are beginning to provide these quantitative tools to assess antibody levels, it is still not known exactly how many antibodies a person needs to be considered immune to the novel coronavirus.
The Centers for Disease Control and Prevention (CDC) is using LabCorp’s test in its epidemiological studies, the company said, aiming to better understand how antibodies are produced by the body after exposure and infection.
The FDA authorized its first, and so far only, quantitative antibody diagnostics in early August, with two tests from Siemens Healthineers. Since the start of the pandemic, the agency has officially greenlit 56 antibody tests in total, ranging from individual lateral-flow cartridges to high-throughput laboratory assays.
Currently, Siemens is working on an international project with the CDC and the EU’s Joint Research Centre to better define how immunity to COVID-19 works, and to help standardize how antibody tests are performed.
This includes establishing which concentrations of which types of antibodies—as well as which of the virus’ proteins they target—combine to provide the most protection against the infection, with quantitative testing providing an essential tool in that effort.