On 15 December 2020, the FDA published an emergency use authorization for the first OTC fully at-home test to diagnose COVID-19. This is the first diagnostic test for coronavirus that can be utilized completely at home without requiring any prescription and promptly returns the results.

This lateral flow antigen test is designed to detect fragments of proteins of the active virus from nasal swab samples in subjects (aged two years and older) with symptoms or devoid of symptoms. This test runs a liquid sample along a given surface with reactive molecules and thus may play a vital role in response to the pandemic. Compared to typical molecular tests run in a laboratory, this test is less specific and less sensitive.

Like other antigen assessments, a small proportion of positive and negative results from this analysis maybe not true. Thus, for subjects devoid of symptoms, the positive outcomes should be treated as presumptively positive until verified by another assessment immediately. This is specifically authentic if there are lesser infections in a certain community, as false positive outcomes can be more common when these tests are utilized in populations where there is a low prevalence of SARS-CoV-2 infection.

According to the FDA, all the tests can experience false positive and false negative outcomes. Subjects with positive results should self-isolate and look for further care from their medical care professionals. Negative-test subjects who witness the symptoms of coronavirus should follow up with their medical care provider as negative outcomes do not preclude a subject from SARS-CoV-2 infection.

To detect certain antigens (viral proteins), a mid-turbinate nasal swab (sample is collected further back compared to the common nasal swab, but not as far back as nasopharyngeal swabs, which are only suitable for usage by a skilled medical professional) is utilized in this test. In subjects with and without symptoms, the percentage of positive and negative samples accurately recognized by the test is depicted in the table below:

An analyzer that links with a software application on a smartphone aids subjects to carry out the assessment and elucidate the findings. The results are delivered in less than 20 minutes to the individuals through their smartphone.

The mobile application requires subjects to enter their birth date and zip code, with optional fields including e-mail address and name and reports the results as relevant to public health authorities to supervise the prevalence of the disease. The FDA continues to actively work with test developers to broaden accessibility to coronavirus testing and aids further development of coronavirus tests that can be completely utilized at home.