The F.D.A., a day after issuing an emergency OK to Roche's antibody test, said in a statement that it was stepping up its scrutiny of antibody tests.
"High-quality antibody tests (a type of serological test) can help us understand a person’s and population’s exposure to COVID-19. A person who has been exposed to, and recovered from, COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood. These tests may be important for guiding our next steps in the fight against this pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease," explained the F.D.A. in a statement.
“We, unfortunately, see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” they continued. “Some test developers have falsely claimed their serology tests are F.D.A. approved or authorized. Others have falsely claimed that their tests can diagnose Covid-19 or that they are for at-home testing.”
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