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The US Food and Drug Administration (FDA) is in opposition to antibody testing for SARS-CoV-2 testing to settle immunity or protection from COVID-19, especially amongst individuals who’re vaccinated.
More a reminder than a brand unusual protection, the FDA advised in opposition to the use of the antibody take a look at outcomes for these indications in a Security Dialog announced at the present time.
“The FDA is reminding the public of the barriers of COVID-19 antibody, or serology, testing and providing further ideas about the use of antibody assessments in folks that obtained a COVID-19 vaccination,” Tim Stenzel, MD, PhD, director of the Establish of enterprise of In Vitro Diagnostics and Radiological Health within the FDA’s Heart for Gadgets and Radiological Health, acknowledged in a commentary.
“Antibody assessments can play a actually unheard of role in figuring out folks who can also had been exposed to the SARS-CoV-2 virus and can contain developed an adaptive immune response,” he added. “On the other hand, antibody assessments must mute no longer be feeble at the present to settle immunity or protection in opposition to COVID-19 at any time, and particularly after a person has obtained a COVID-19 vaccination.”
Now not all antibodies are created equal. The company outlined that antibodies from prior SARS-CoV-2 infection vary from antibodies introduced on by the COVID-19 vaccines. Subsequently, testing for prior infection antibodies would no longer name of us with antibody protection from immunization.
SARS-CoV-2 antibody assessments must mute be ordered most efficient by healthcare experts who’re conscious of the use and barriers of the take a look at, the company notes.
“The FDA will continue to tune the use of licensed SARS-CoV-2 antibody assessments for functions pretty about a than figuring out of us with an adaptive immune response to SARS-CoV-2 from a fresh or prior infection,” Stenzel acknowledged.
Damian McNamara is a workforce journalist based in Miami. He covers a wide vary of scientific specialties, including infectious diseases, gastroenterology and vital care. Whisper Damian on Twitter: @MedReporter.
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