NEW YORK — A new, next-level coronavirus-antibody test that measures not just antibodies’ presence but also how much protection they afford are on the way.
The test, which on Wednesday received emergency-use authorization from the U.S. Food and Drug Administration, measures the number of neutralizing antibodies that the body’s immune system has produced after exposure, reported CNBC. While previous tests have measured antibody levels, this one zeroes in on the antibodies that attack two specific aspects of the novel coronavirus.
This “new generation” of test, the COVID-SeroKlir, was developed by Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and diagnostics start-up RenalytixAI. Test kits are being manufactured in partnership with Bio-Techne Corp., the company said in a statement.
Earlier tests provided something of a yes or no answer — positive or negative. Others approved over the summer showed certain levels of antibodies, CNBC said. The newest one measures the level of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19.
The test showed 98.8% sensitivity and 99.6% specificity for detecting COVID-19 antibodies against two key elements of the virus, meaning that “98.8% of all positive diagnoses are accurate and 99.6% of all negative diagnoses are correct,” CNBC explained.
Although it’s not the first test to measure antibody levels, it may be the most precise.
What the test does do is provide more information on this new pathogen that has infected more than 60 million worldwide and killed upward of 1.4 million people, at least 261,223 of them in the U.S.
“The ability to quantify what the antibody levels are helps us understand what level of antibody is correlated with being protected from infection,” Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security and who was not involved in the Kantaro test, told CNN on Wednesday.
It could also aid in vaccine development, Adalja told CNN, because knowing how many antibodies are still present after a period of time will help determine when someone needs a booster shot.
As promising as the new test is, it still does not provide definitive answers about immunity, health experts have said, particularly for the novel coronavirus, which has yet to reveal its deepest secrets.
“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity,” Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said in a July statement, when the FDA approved earlier tests that measured antibody levels in general. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”
