FDA gives emergency approval a new test that can measure a patient’s levels of antibodies thought to ‘neutralize’ coronavirus in the hopes of discovering how much is enough to prevent reinfection
- The FDA has authorized one of the first tests that measure the level of coronavirus neutralizing antibodies produced by the immune system
- Unlike binding antibodies, which only attach to the virus, neutralizing antibodies prevent the virus from entering and infecting cells
- Researchers say the test gives correct positive results 98.8% of the time and correct negative results 99.6% of the time
The US Food and Drug Administration (FDA) authorized on Wednesday one of the first of a new type of coronavirus antibody test.
Hailed as ‘new generation’ of test, it has the ability to measure the specific number of neutralizing antibodies produced by the immune system, reported CNBC.
Previous tests approved by the FDA have only told people whether or not they had COVID-19 and estimates the presence of binding antibodies, which only attach to the virus.
Researchers say the new test can be used to study if there is a link between the level of neutralizing antibodies somebody has and immunity from being infected by the coronavirus in the future.
These are also the same antibodies produced after a vaccination, and the test can be used to determine how well-protected someone is after receiving a coronavirsu jab, the first of which are expected to be rolled out next month,
The FDA has authorized one of the first tests that measure the level of coronavirus neutralizing antibodies produced by the immune system (file image)
The test, called COVID-SeroKlir, was developed by Kantaro Biosciences, LLC, a joint venture between the Mount Sinai Health System in New York City and Renalytix, an artificial intelligence-diagnostics company
Dr Erik Lium, the chief commercial innovation officer at Mt Sinai, told CNBC the companies plan to manufacture about 10 million tests per month.
‘We think that our test is really one of the first in a new generation of antibody tests that provide much more meaningful information to individuals and clinicians on whether an individual’s been infected and developed an immune response,’ he said.
Neutralizing antibodies are made by a type of immune system cell called a B-cell, which is found in bone marrow.
They are often confused with binding antibodies, which bind to a virus and flag its presence to the immune system.
From there, the body sends white blood cells to destroy it.
But neutralizing antibodies can attach to a virus and interfere with it’s ability to infect cells without the help of other immune system cells.
They prevent the the pathogen from changing its structure and shape, and don’t allow it multiply – therefore neutralizing its capability.
Known as IgG antibodies, they are produced in the late stages of infection and may remain for up to months and possibly years after a person has recovered.
According to a press release, the antibody test has a sensitivity rate of 98.8 percent and a specificity rate of 99.6 percent.
This means only 1.2 percent of all tests are false positives and 0.4 percent are false negatives.
The FDA warns that antibody tests do not mean people should stop following measures such as wearing masks and social distancing because the relationship between antibodies and immunity is unknown.
But Lium said COVID-SeroKlir could be used to detect people with high levels of neutralizing antibodies that may be able to wait to received a COVID-19 vaccine.
‘As we understand the relationship between the amount of antibodies that an individual has to these key components of the virus and immunity, a test like this can really start to provide peace of mind once we understand that relationship in the coming months,’ he told CNBC.