The Food and Drug Administration (FDA) has just authorized a novel home test for COVID-19 that doesn’t require repeated testing like many others. ACON Laboratories Flowflex COVID-19 Home Test was granted an emergency use authorization Monday by the FDA.

The statement came two days before the Biden administration announced its plans to purchase $1 billion worth of rapid, at-home COVID-19 tests and take other steps to quadruple the number of tests available to Americans by December.

According to Fox News, the ACON over-the-counter antigen tests can be used at home without a prescription. Since March, the FDA has authorized more than 400 COVID-19 tests and sample collection devices. While most of these tests require serial or repeated testing within a few days, the ACON test does not, based on data for asymptomatic people.

However, the FDA warned that while these at-home diagnostic testing kits are important, they do result in more false-positive and false-negative tests than the more sensitive and accurate PCR tests. According to Yale Medicine, unlike antibody tests that spot previous COVID-19 infections, diagnostic tests include two categories: molecular and antigen. Molecular tests are considered to be more accurate than the rapid, antigen tests.

Nearly 200,000 Ellume COVID home tests were recalled recently because of their likelihood to give a false-positive result.

Antigen tests can be done in 15 minutes at doctor’s offices, pharmacies, even at home. They are appropriate when fast results are needed for screening purposes, but most healthcare providers rely on the molecular tests when more information is needed or because the patient has COVID-19 symptoms.

The most widely used molecular test is called the polymerase chain reaction or PCR.

“PCR and similar tests look for the COVID virus’ RNA,” explains Dr. Sheldon Campbell, associate director of Yale Medicine’s Clinical Microbiology Lab. “They tend to be quite sensitive, but even among these, they are on a continuum of sensitivity and vary a whole lot.”

A test that is deemed highly sensitive will be able to catch more people who have a disease and generate fewer false-negative results, says Yale Medicine. Antigen tests are much simpler, say experts, and resemble pregnancy tests. They work by detecting pieces of protein from the SARS-CoV-2 virus, the virus that causes COVID-19. After a sample specimen is obtained from the nose, or sometimes the throat, it is placed on a test strip or cartridge that’s been treated with a reagent. A colored line will indicate the results. The results are generated often within 15 minutes but since this test needs a higher level of virus than PCR tests, it generates more false results.

However, healthcare experts diligently support the use of at-home antigen tests to help combat COVID-19.

“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” said Jeffrey E. Shuren, the director of the FDA’s Center for Devices and Radiological Health, according to Fox News. “We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”

ACON Laboratories released a statement saying that its nasal swab test will soon be available in major retail stores and online and could be used by individuals 14 years or over, or with adult-collected nasal swabs from children as young as two years old.

The company added that unlike other home tests that require testing twice within a two-to-three-day period, a process known as serial screening, the Flowflex COVID-19 Antigen tests is authorized for use as a single test for people with or without symptoms.

“This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing,” said ACON in a statement.