COVID Home Tests: What You Need to Know

Weeks of testing delays and even faulty testing kits crippled the early response to the COVID-19 pandemic in the United States. As Americans fought to get tested and COVID-19 cases rose around the world, a new market emerged—at-home testing for the novel coronavirus.

Testing was hampered by limited test kits, backed-up supply chains, and complicated lockdown orders, but kits that allowed you to collect samples at home and send them to a lab for testing emerged within weeks. Early efforts to offer at-home testing were questionable, or at the very least unapproved by regulators. However, by November 2020, the first completely at-home COVID test was authorized by the Food and Drug Administration (FDA). There are now a number of tests that offer at-home sample collection and lab testing or complete at-home testing for COVID-19.

covid home testing

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What Is COVID-19 Home Testing?

Health leaders looked for ways to test for the virus without exposing people who were sick or healthcare workers. From online screening tools to virtual tracking, curbside testing to mail-in swabs, COVID testing in the United States took many forms throughout the pandemic.

In an effort to reduce regulatory bottlenecks, the FDA granted special authorizations to speed up the approval process for many COVID-related medical devices, including test kits. The FDA issued an emergency use authorization for their use. There are now both mail-in and at-home tests for detecting COVID-19.

What Are the Types of At-Home COVID Tests?

There are a few ways to detect the novel coronavirus in a test. Most recently, antibody tests are being offered to detect past infection or immunity, However, more important is the ability to test for an active coronavirus infection that can be passed on from one person to another. Active COVID-19 infections can be diagnosed using two types of tests: molecular tests and antigen tests.

Molecular Tests

These tests check bodily fluids—usually collected using a throat, nasal, or saliva swab—for genetic material that can only come from the novel coronavirus. Initially, these tests were available only through healthcare facilities—and only with a healthcare provider's order. As the pandemic progressed and more options became available, mail-in and then at-home tests are now being offered. The testing methods have improved, and wait times for test results dropped from days to minutes.

What Is a Molecular Test?

A molecular test checks for certain genes, proteins, or other molecules in a sample of tissue, blood, or other body fluids. The molecular test used to check for COVID-19 is a polymerase chain reaction (PCR) test.

The first fully at-home COVID-19 test approved by the FDA, the Lucira COVID-19 All-In-One Test Kit, is a molecular test. The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. It is approved for use in those 14 years old and over and for adult collection for children ages 2 to 13 at home, but is authorized to be used in people of all ages in healthcare settings.

Those who test negative for COVID-19 but experience COVID-like symptoms should follow up with their healthcare provider since negative results do not necessarily rule out COVID-19.

Antigen Tests

Antigen tests can also detect active coronavirus infections. These tests identify small protein fragments called antigens that the virus sheds. They are commonly used in the diagnosis of respiratory pathogens, including the influenza viruses. These tests provide results in minutes. The same technology is used to detect pregnancy and strep throat.

Antigen tests can be used for screening in high-risk congregate settings in which repeat testing could quickly identify COVID-19 and inform infection prevention and control measures. In this case, and especially in settings where a rapid test turnaround time is required, there is value in providing immediate results with antigen tests.

How Accurate Are COVID Home Tests?

Due to the hasty nature of the approval of many COVID-19 tests, as well as a lack of good data on test results, it's difficult to say how accurate home testing is. The FDA found that some fully at-home COVID tests can be as accurate as 96% for negative test results and 100% for positive test results. For now, the standard PCR test is considered the gold standard in COVID-19 testing.

Some studies have found that antigen tests were effective early in the infection process, but that the sensitivity of these tests decreased as virus shedding slows later in the disease course. Antigen tests are also believed to have higher false-negative rates than molecular tests. Testing accuracy may also be affected by how someone collects the testing sample and how it is processed.

How Much Do COVID Home Tests Cost?

The cost of COVID-19 testing depends mostly on which test you purchase and where you buy it. Rapid tests that could be purchased over the counter and provide quick home results were approved by the FDA throughout late 2020 and early 2021, but major retailers like CVS and Walmart only began stocking shelves with these tests in April 2021.

CVS is selling three at-home COVID tests in its stores, and prices range from about $24 to $39. Walmart sells a number of home COVID testing kits, although many are meant to be shipped to a laboratory for processing. Its fully at-home rapid test sells for $19.88.

Some insurance plans may only cover the cost of a home test or require a healthcare provider's order before covering a test. Telehealth appointments may be an option, followed by an at-home test, but you should check with your health insurance provider about coverage rules and options. Some plans may require you to pay for the test upfront, but you may have the option to submit a claim for reimbursement after making the purchase.

Where Can I Get a COVID Home Test?

COVID home tests are widely available now, from corner drugstores and grocery stores to online retailers. Availability may vary by area, but major retailers like CVS, Walgreens, and Walmart started stocking rapid home tests in stores and on websites in April 2021.

Kits that require a prescription, use home sample collection and lab testing, or use other mail-in methods have been available for some time through a variety of retailers, including online sellers like Amazon and even individual laboratories.

LabCorp's Pixel home collection kit was the first home COVID test kit approved by the FDA. This kit, approved in April 2020, includes a cotton swab for sample collection. Once the sample is collected and sent to the lab, results are sent to the test taker within days. Initially available by prescription only, approval to sell the kit directly to customers 18 years and older without a prescription was granted in December 2020. It is available at major drugstores.

The Lucira COVID-19 All-In-One Test Kit is available by prescription only.

The Ellume COVID-19 Home Test, another completely at-home antigen test for COVID-19, was approved in December 2020. This test is available over the counter at major drugstores.

The first nonprescription at-home molecular COVID-19 test, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, was approved in March 2021, and includes a swab and cartridge to analyze the sample within 15 minutes. It does not require a prescription.

What If My Test Is Positive?

One of the concerns with allowing at-home COVID testing without a prescription involves contact tracing and recording active cases of the virus. If you test positive for COVID-19 using an at-home test, notify your healthcare provider or local health department as soon as possible.

A Word From Verywell

Testing is crucial to controlling the spread of COVID-19. Early testing efforts encountered many problems, but new tools like COVID home tests have been approved for use and make it easier than ever to find out whether you have been infected and avoid spreading the virus. If you have a positive test, be sure to take the appropriate precautions to avoid spreading the disease and seek help from your healthcare provider as soon as possible. Even if you get a negative result from a home test but have COVID-19 symptoms, see your healthcare provider right away for testing and diagnosis.

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Article Sources
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