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In late April 2020, the Food and Drug Administration (FDA) began issuing Emergency Use Authorizations for at-home coronavirus test kits. These authorizations came after the FDA issued warnings in late March of that year to companies who were selling at-home test kits that were not FDA-approved. Multiple companies have received Emergency Use Authorization (EUA) to sell at-home coronavirus test kits: LabCorp, Everlywell, Quest Diagnostics, and Hims & Hers.
These EUAs have been issued in response to the global COVID-19 pandemic, and the need to increase testing capacity and accessibility.
Currently, the at-home testing kits that are available are for sample collection only. They are not diagnostic tests that will give individuals a positive or negative result on the spot.
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 in the healthcare setting, 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. There are also tests available that can provide results onsite in minutes.
At-home tests adapt this process by allowing individuals to collect their own nasal swab or saliva samples. Individuals then mail their specimens to labs for testing, typically using a provided, pre-paid shipping label. Depending on the company, results are available within a few days via app, email, or phone.
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. The FDA has not currently authorized any at-home serology tests.
As the coronavirus spreads, increased testing is critical to accurately identify how many people have contracted COVID-19, providing adequate care to those who are ill, and stopping the transmission of the disease.
Although testing capacity at healthcare facilities around the country has increased, availability and accessibility varies based on location.
At-home testing allows more people to get tested, while decreasing exposure for healthcare workers and patients. With people being encouraged or required to stay home and maintain social distancing, getting tested for the coronavirus without leaving home is ideal.
Also, 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.
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:
If you suspect that you have contracted the coronavirus, and want to get tested, you should first contact your healthcare provider or your local or state public health department.
Currently, the CDC offers these guidelines for prioritizing who should be tested for the coronavirus:
According to the World Health Organization (WHO), individuals who are experiencing the following severe symptoms should seek medical attention immediately:
The most common symptoms of COVID-19 are:
Other notable, yet less common symptoms, include:
COVID-19 symptoms can appear anywhere from 2-14 days after infection, although on average individuals begin to show symptoms 5-6 days after infection.
Read more: When to Get Tested for COVID-19
|Centers for Disease Control and Prevention (CDC)||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)||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)||The APHL is a nonprofit organization in the United States that represents laboratories that protect public health and safety.|
|State Departments of Health||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.|