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FDA Clears OTC Antigen Test for COVID

The U.S. Food and Drug Administration has authorized the first over-the-counter antigen test for COVID-19.

ACON Laboratories’ Flowflex COVID-19 Antigen Home Test is indicated for use by symptomatic people within six days of symptom onset. It is also the first test cleared to use in children under the age of 18.

The ACON test is now the second COVID-19 test to successfully complete a traditional FDA premarket review pathway after it was authorized for emergency use in 2021.

"This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home," said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Antigen tests, often called rapid tests, detect proteins called antigens from SARS-CoV-2, the virus that causes COVID-19 disease. However, they are less accurate than molecular tests, especially in an early infection or in asymptomatic people.

In a trial reviewed by the FDA, the ACON test correctly identified 89.8% of positive and 99.3% of negative samples in symptomatic individuals.

The test is intended to be used at least twice over three days, with at least 48 hours between tests. This means people who receive initial negative test results should be re-tested once between 48 and 72 hours after the first test.

According to the Centers for Disease Control and Prevention, the symptoms of COVID-19 may include:

  • Fever or chills
  • Cough
  • Shortness of breath or difficulty breathing
  • Fatigue
  • Muscle or body aches
  • Headache
  • New loss of taste or smell
  • Sore throat
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea

The OTC antigen test can help reduce the spread of COVID-19 by allowing the detection of the virus at home.

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