At-Home Testing for Covid-19

As we turn the corner to 2021, great strides are being made to make testing safer and more accessible to consumers—a big step forward to Stop the Spread of Covid-19.

At-home test kits

New to the mix are self-administered, at-home Covid-19 test kits where people collect samples via a nasal swab, saliva collection, or throat swab and send them to an authorized lab. Results will be published to an online account set up in advance.

Currently, all emergency-use authorized (EUA) at-home Covid-19 test kits are molecular, as most experts agree that results from molecular (PCR) tests are highly accurate and do not need to be repeated, unlike results from antigen tests, which are often false negatives. (EUA is an authorization by the FDA that allows unapproved products to be used during a public health crisis.)

The benefits

Currently, there is an overwhelming demand for testing, which is taxing resources and creating logistical obstacles. Accurate and accessible testing is necessary to address and control this pandemic. Eliminating delayed results and letting people know in a timely manner that they have tested positive can help stop the paralyzing impact of Covid-19.

At-home tests eliminate the need for long waits in a doctor’s office or testing center, and can help stop symptomatic people from unnecessarily exposing the general public and immunocompromised individuals to potential infection.

This latest development in Covid-19 testing has many people asking about the legitimacy of at-home Covid-19 test kits.

Some facts

The FDA has authorized a select group of diagnostic companies to sell at-home Covid-19 test kits directly to consumers who would like to test from the comfort of home.

Given the surge in infections and the rapidly increasing demand for tests, most of these companies are prioritizing test kits for those who may have already been exposed, are at high risk, or are currently experiencing Covid-19 symptoms.

But authorized does not mean approved—an important distinction.

Companies that have received emergency use authorization from the FDA:

• Everylywell
• Hims & Hers
• LetsGetChecked
• P23 Labs
• Phosphorus
• Picture, by Fulgent Genetics
• Pixel, by LabCorp
• Vault
• Vitagene

The majority of these companies claim their tests offer a sensitivity of at least 98 percent or higher. Most at-home tests are not covered by insurance. An exception is Pixel, which does not require prepayment and will either bill your insurance company or seek reimbursement from federal funds.

Beware of scams

Please contact your health care provider for guidance about finding an at-home test. There are fraudulent at-home test kits—not authorized by the FDA—offering low prices or availability without a prescription.

Fraudulent test kits and health claims pose serious health risks during a public health crisis. The FDA asks the public to report fraudulent Covid-19 test kits.

You can stay up-to-date on individually-authorized EUAs for at-home Covid-19 diagnostic tests can be found here.

Only Lucira’s test has been approved by the FDA for self-administered at-home testing.

To date, only one at-home test has been approved for use by the FDA. It comes from Lucira, a California biotechnology company. The FDA also authorized Lucira’s test for medical settings like doctor’s offices, hospitals, and urgent care centers.

On November 17, Lucira’s All-In-One kit became the first rapid, at-home test to be approved by the FDA. It requires a prescription, and will retail for around $50, about a third of the cost of other tests currently available.

Lucira’s test is expected to be available shortly on a limited basis in Florida and California and reach the national market in early spring.

Before the pandemic, Lucira was focused on developing similar technology for an at-home flu test. Lucira reports that the reliability of positive and negative test results from their at-home test is on par with other tests available.

Other at-home kits are available online and at retailers like Costco, but they are considerably more expensive, at $100–$150, and require users to mail samples to a lab and wait up to two days for results.

How the Lucira test works

This is the first test that can be self-administered and provide immediate results at home. The test works by swirling a self-collected swabbed sample in a solution in a vial, plugging the vial into a portable, battery-operated device that uses a light to indicate the test result within 30 minutes. A positive test result can be generated in as few as 11 minutes.

This molecular test will be available by prescription to people 14 and older who have symptoms that could indicate Covid-19. The FDA said patients under 14 can be given the test if it is administered by a healthcare provider.

Another company, OraCure—noted for its HIV at-home test—has been working for the past nine months on a Covid-19 at-home test and hopes to get FDA approval in January.

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