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Although a number of companies have been working to develop at-home test kits for COVID-19, the Food and Drug Administration (FDA) has not yet approved any at-home tests for distribution and use. Currently, all testing for COVID-19 in the U.S. is being done through hospitals or health clinics, at the discretion of state and local health departments and individual clinicians, per guidelines from the Centers for Disease Control and Prevention (CDC).
In response to the global COVID-19 pandemic, and the need to increase testing capabilities, several U.S. companies that manufacture at-home test kits for other conditions developed kits that individuals could use at home to collect their own samples. Individuals would then send their sample to a lab, where it could be tested for evidence of COVID-19. In late March, some companies started to sell these kits. However, the FDA issued its warning that they had not authorized these tests, and that consumers should not purchase or use them.
As a result of this warning, some companies paused their distribution or development of at-home tests. Others are distributing them to hospitals and clinics for professional use, while others are seeking an Emergency Use Authorization to allow them to send kits directly to consumers at home.
The approaches to at-home coronavirus testing differ slightly between companies, but generally they are similar to the tests being administered in hospitals and health clinics.
In these tests, healthcare workers take a nasal swab from a patient, then send the specimen to a lab to be tested for genetic material for SARS-CoV-2, the virus that causes COVID-19. The test is conducted through a process called polymerase chain reaction, or PCR. This process can take a few hours, although new tests are being produced that can provide results in minutes.
At-home tests adapt this process by allowing individuals to collect their own nasal swab samples. Individuals can then mail or deliver their specimens to labs for testing, and results would be available in a few days.
Another type of at-home test in development is a serology test, which uses a blood sample to detect antibodies that the immune system makes when exposed to SARS-CoV-2.
As the coronavirus spreads, increased testing is critical to accurately identifying how many people have contracted COVID-19, providing adequate care to those who are ill, and stopping the transmission of the disease.
However, testing capabilities in the U.S. have been limited, not only because tests themselves have been in short supply, but because healthcare facilities are running low on the protective gear that healthcare workers need to wear when administering the tests.
At-home testing would allow more people to get tested, while decreasing exposure for healthcare workers and patients. While people are being encouraged or required to stay home and maintain social distancing, getting tested for the coronavirus without leaving one’s house is ideal.
Furthermore, more test results mean more data for epidemiologists, doctors, and other health experts to study and use in their efforts to stop the spread of the disease and find ways to treat and vaccinate for it.
Although more testing for COVID-19 is critical, and there are many benefits of at-home testing, the FDA has not yet authorized any at-home testing for a number of important reasons.
The main concern with at-home tests is accuracy. When tests are not administered by or under the supervision of a trained healthcare professional, there is an increased risk of error that could lead to a false negative. This means that test results show the individual does not have COVID-19, when in fact they actually do. With a disease as new and contagious as COVID-19, a false negative can be particularly harmful. The FDA warns that inaccurate test results may cause patients to delay medical treatment while behaving as if they are not sick, causing further spread of the disease.
A number of issues can lead to inaccurate test results, including:
The FDA cited concerns with messaging in its warning to companies to stop producing the tests, including what instructions companies will give to consumers while they wait for their test results, and if they test positive for COVID-19. Another complicating factor is that labs, already overwhelmed by tests coming in from healthcare facilities around the country, are running low on materials needed to process test results.
The FDA acknowledged that expanding the availability of COVID-19 tests is critical to public health and safety, and that they are working with companies to develop a broader range of tests, including those that can be used at home. For now, however, they are advising consumers against purchasing at-home test kits.
If you suspect that you have contracted the coronavirus, and want to get tested, you will need to contact your healthcare provider or your local or state public health department. Because of testing limitations, there are guidelines in place for who can get tested for COVID-19.
Currently, people who fall into the following groups are being prioritized for testing:
Most individuals who display mild symptoms (cough, fever, tiredness, shortness of breath, body aches) are encouraged to contact their doctor, self-isolate, and treat their symptoms with over-the-counter medicines. Per the above guidelines, it is unlikely that they will receive a COVID-19 test.
Individuals who display any of the following symptoms of severe illness should seek medical attention immediately:
Read more: When to Get Tested for COVID-19
|Centers for Disease Control and Prevention (CDC)||https://www.cdc.gov/coronavirus/2019-ncov/index.html||The CDC is the United States’ leading national public health organization. Its mission is to protect public health and safety through the control and prevention of disease, injury, and disability in the U.S. and abroad.|
|World Health Organization (WHO)||https://www.who.int/||A specialized agency of the United Nations, WHO is responsible for international public health. Headquartered in Geneva, Switzerland, it has field offices worldwide.|
|Association of Public Health Laboratories (APHL)||www.aphl.org||The APHL is a nonprofit organization in the United States that represents laboratories that protect public health and safety.|
|State Departments of Health||https://www.fsis.usda.gov/wps/wcm/connect/fsis-content/internet/main/topics/recalls-and-public-health-alerts/additional-recall-links/state-departments-of-public-health/ct_index||Each state in the U.S. has its own department of health. These public health departments are currently coordinating efforts for COVID-19 testing and treatment.|