Rapid antigen tests are available over-the-counter, such as iHealth from Amazon and BinaxNOW from Abbott. Examples include the Cue COVID-19 test and the Lucira Check It COVID-19 test. These tests are different from the ones above because you perform the test yourself and get your results in 30 minutes or less. While many at-home PCR tests require sample processing at a lab, there are also a few fully at-home rapid PCR tests. A provider from the company will follow-up with results and next steps 1-2 days after the sample is received through an app, email, or by phone. The sample is generally collected via a nasal swab or by spitting into a vial and sent to a lab.
Then you will be sent a test along with instructions on how to collect a sample. *Result times are subject to change based on testing demandĪt-home collection PCR tests generally require you to complete some type of questionnaire or online consultation to assess your COVID-19 risk first. These tests are not included in the Biden-Harris reimbursement plan. PCR testsįDA-authorized at-home collection COVID-19 PCR tests are available from a number of companies. More information about the different types of COVID-19 tests available can be found here. Antigen tests are aimed at detecting specific proteins found on the surface of the virus. Molecular tests will detect if SARS-CoV-2 genetic material is found in yoursample. They work differently to confirm if you’re infected with SARS-CoV-2, the virus that causes COVID-19. There are two types of at-home tests for COVID-19: molecular (PCR) and antigen tests. These two organizations working together will streamline the approval process so more companies can manufacture test kits and get more kits on the shelves sooner. The National Institute of Health (NIH) and the FDA are working together to be able to bring more tests to market faster. This means you’ll collect your sample and perform the test yourself at home. Others are authorized to be used completely at home (sometimes called self-tests). This means you’ll collect a sample and mail it to a lab for your results. Some at-home tests are authorized for at-home collection only. Others like Vault, Vitagene, and hims & hers are all selling an FDA -authorized test developed by RUCDR Infinite Biologics.
Several testing companies including Amazon (iHealth) and LabCorp (Pixel) obtained an EUA for their own at-home COVID-19 tests. It’s an authorization that allows unapproved products to be used during the public health crisis. Receiving an EUA does not mean that the product is officially FDA-approved. The FDA has authorized at-home COVID-19 tests under an Emergency Use Authorization (EUA). Are at-home COVID-19 tests authorized by the FDA? Here’s what you need to know about at-home test kits.
A number of companies are selling at-home tests authorized by the FDA. These are tests that anyone can order and complete without physically visiting a provider. Now, as the Omicron variant is dominating the COVID-19 landscape, at-home test kits are in high-demand. However, tracing infected individuals was and continues to be an important step in preventing new infections. And while testing supply eventually ramped up, shortages continue to occur with regional increase in demand. This was largely due to a shortage of diagnostic testing capabilities. At the start of the COVID-19 pandemic, not nearly enough Americans were being tested for the coronavirus disease (COVID-19).