Food and Drug Administration officials say antibody tests should not be used because someone is exempt from Code 19.
He says tests determine if someone has contracted the corona virus and if they have had enough immunity.
The officials added that the tests also have a false-positive rate compared to other tests.
He also noted that people who show antibodies to these tests should still be vaccinated against Covid 19.
Food and Drug Administration (FDA) officials say it is a bad idea to use COVID-19 antibody test results to assess a person’s immunity or immunity.
The federal agency last week issued a statement from a trusted trade source stating that the experiment was not a reliable indication of a person’s immunity to COVID-19, even after the person had been vaccinated. Also
“Antibody tests can play an important role in identifying individuals who may be infected with the SARS-Co-2 virus and may have developed an immune response,” said Dr. Tim Stanzel, of the Office of In-In-Diagnostic Diagnosis. The director said. In the statement, radiological health at the FDA’s Center for Instruments and Radiological Health.
He added, “However, antibody tests should not be used at any time to determine immunity or protection against COVID-19, and especially if a person is receiving the COVID-19 vaccine. Later. ” “The FDA will monitor the use of authorized SARS COVI 2 antibody tests for purposes other than identifying people with an integrated immune response to SARS COVI 2 from a recent pre-infection.”
The agency noted that currently the authorized COVID-19 antibody tests have not been approved to diagnose immunity or protection against the disease.
It also said that tests should be ordered only by health professionals who are familiar with the use and limitations of the test.
Checking
Antibodies are blood proteins that the body produces in response to the presence of a specific antigen.
Antibodies are chemically added to fight off invaders, including bacteria, viruses and other foreign substances that appear in the blood.
Experts say antibody tests have been used during epidemics to determine if someone is at risk of contracting the virus, which helps determine who should be quarantined.
“However, the mere presence of antibodies to a virus does not mean that an individual has immunity to re-infection,” Ian Chen, CEO of Ebpro, a biotech developer based in Boston, told HealthLine.
“Each individual test needs to demonstrate a link between a positive antibody test and a protective immunity,” he said. “It has been shown to treat a variety of viral infections, such as the hepatitis B virus, but it needs to be determined by medical tests and epidemiological studies to determine COVID-19.”
Chen said antibody tests also have a high false-positive rate.
“If the current antibody test is associated with immunosuppression and the risk of misdiagnosis of antibodies, due to the current lack of understanding, it is not advisable to have a positive antibody test alone,” he said. Avoid any vaccines. “
Covid-19 is so relatively new that the data needed to test antibodies that actually prevent the virus is still being developed.
“The challenge for current antibody tests is that very few of them actually test to be neutral (receptor binding domain antigen) IgG antibodies, the only antibodies that are actually SARS-co. -2 prevents infection, “Gerald Commissioning, CEO of the research company Todos Medical, told HealthLine. “Most antibody tests test for nucleoside antigen IgG antibodies, which cannot neutralize the virus, and so it makes no sense to rely on them to determine the status of immunity.”
“The FDA has never talked about relying on antibody tests to determine amnesty, just before its exposure is determined. With significant confusing and contradictory information, this makes sense. The market doesn’t understand that, “he added.
The commission said antibody tests should not be used to avoid the vaccine, but they could be useful in considering whether anyone should receive a booster shot in the future.
“[This] is effectively the same concept, because if you have an infection, the question is when does the immunity expire?” They said. “Given how different each person’s immune system is, time may not be the best factor in determining whether a booster is needed.”
Even when vaccines are administered, researchers will have their hands full for a while, searching for the inside and outside of COVID-19.
“A lot of work is being done to understand the extent to which antibody levels need to be rendered ineffective in order to establish immunity,” the commission said. “But we don’t have that data yet.”