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FDA Authorizes First Rapid At-Home COVID-19 Testing Kit

FDA Authorizes First Rapid At-Home COVID-19 Testing Kit

The test is available by prescription, costs about $50 and provides results within 30 minutes.

Updated on November 18, 2020 at 11:00am EST.

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first at-home COVID-19 self-test that provides rapid results.

The test made by Lucira Health, dubbed the COVID-19 All-In-One Test Kit, is a single use nasal swab test that is intended to detect SARS-CoV-2, the coronavirus that causes COVID-19, in 30 minutes or less.

The California-based company’s test will be available by prescription only. It’s expected to cost about $50.

The FDA authorized the test for home use among people age 14-years and older with suspected cases of COVID-19. The test is also authorized for use in doctors’ officers, hospitals, ERs and other urgent care facilities. When administered by a healthcare professional, it can be used to test children younger than 14-years old for the coronavirus.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. in a November 18 news release. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

How do you take the test?
The Lucira self-testing kit comes with a test device, a sample vial, a swab and written instructions. The device requires two AA batteries to operate.

Users open the swab and rotate it within each nostril five times. Next, the swab is stirred in the vial, which is then inserted inside the device. A “ready” light will blink until a “positive” or “negative” green light appears.

The company says that during clinical trials this "swab, stir and detect" design enabled users to perform the test in about two minutes.

Once the swab is taken, test results are provided within 30 minutes, but a positive result may be revealed even more quickly—in as few as 11 minutes, Lucira reports

In order to monitor public health, patients are required to report their test results to the doctor that prescribed the test.

”Being able to quickly determine if a person is infected or not has been a global problem,” said John Chou, a physician with the Palo Alto Foundation Medical Group and a Principal Investigator on the Lucira Health Community Testing Study in a November 18 news release. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”

Can you trust the results?
In a word, yes.

Until now, there were two types of diagnostic tests for COVID-19 being used: a polymerase chain reaction (PCR) test and an antigen test. Both of these tests check for the coronavirus itself, using saliva or a respiratory sample collected by nasal or throat swab.

A healthcare provider will take the sample from your nose and the back of your throat with a six-inch swab. If you are coughing up mucus, that may be tested as well.

PCR tests look for evidence of genetic material from the virus. Antigen tests are designed to detect fragments of proteins found on or inside the virus.

PCR tests are typically more accurate than antigen tests but take longer—hours or days—to process. Antigen tests, on the other hand, can provide results within minutes. Although positive antigen test results are very reliable, these tests tend to miss more cases than PCR tests. So, a negative antigen test result may need to be confirmed with a PCR test. 

The Lucira at-home COVID-19 test is a molecular (real-time loop mediated amplification reaction) test.

It works by extracting genetic material from the virus and amplifying it. During clinical trials, the Lucira test was highly accurate when compared to a previously FDA-authorized high sensitivity SARS-CoV-2 test.

“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,” said Lucira Health CEO Erik Engelson. “Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected.”

Lucira’s test had a 94 percent positive percent agreement (PPA) and a 98 percent negative percent agreement (NPA). This means it accurately detected the vast majority of coronavirus infections and accurately ruled out the vast majority of negative cases.

Once samples with extremely low levels of the virus were excluded, the test accurately detected all positive COVID-19 cases.

When will the test be widely available?
Lucira’s single-use device has been in development for the past five years. Initially, it was intended to help test for the flu. When the pandemic began, Lucira shifted its focus to testing for COVID-19.

In the near-term, the Lucira home test kit is expected to be available to patients served by Sutter Health in Northern California and Cleveland Clinic Florida in the Miami-Ft. Lauderdale region.

By early spring 2021, the test is expected to be available nationally through health care providers.

By the second quarter of 2021, Lucira says it plans to amend its EUA or file a new EUA so people who suspect they’re infected with COVID-19 can communicate with a medical professional online through a dedicated website to receive a prescription and overnight delivery of the test kit.

Medically reviewed in November 2020.

Sources:
U.S. Food and Drug Administration. “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home.” Nov 17, 2020.
Lucira Health. “Breaking News: Lucira Health Receives 1st FDA Authorization for COVID-19 Self-Testing at Home.” Nov 18, 2020.
U.S. Food and Drug Administration. “FDA Authorizes First Prescription At Home Molecular Test for COVID-19. Nov 17, 2020.
U.S. Food and Drug Administration. “FAQs on Testing for SARS-CoV-2.”
U.S. Food and Drug Administration. “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).”
U.S. Food and Drug Administration. “Coronavirus Disease 2019 Testing Basics.” Nov 6, 2020.

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