The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) at-home test for both the flu and COVID-19, which can have similar symptoms such as cough and fever.
“The test provides independent diagnoses for COVID-19, Flu A, and Flu B,” Lucira Health, the test’s manufacturer, previously announced.
The Lucira COVID-19 & Flu Test, which is single-use, yields results in about 30 minutes or less from a self-collected nasal swab sample. A single test is listed for $35 on the company’s website. The company says the test is portable and operates on two AA batteries, with “no separate reader or instrument to purchase and maintain.”
The FDA’s emergency use authorization (EUA) is a “major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.
People who have signs and symptoms that suggest a respiratory tract infection or COVID-19 can use the test to see whether they are positive or negative for Influenza A, Influenza B, and COVID-19, the FDA announced on Feb. 24.
People “should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care,” the agency stated, adding that people who test positive for either flu or COVID-19 “should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary.”
Because Lucira is a rapid diagnostic test, there is a risk of false positive and false negative results, the FDA noted.
It also noted that people who test negative but still have a fever, cough, or shortness of breath “may still have a respiratory infection” and should seek follow up health care.
“Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests.”
“The test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals ages 14 years and older or collected by an adult for individuals 2 years of age or older,” according to the FDA.
“The test works by swirling the sample swab in a vial that is placed in the test unit,” after which results will be displayed on the unit in 30 minutes or less, the agency states.
According to the FDA, in people with symptoms, the test (pdf) correctly identified 99.3 percent of negative and 90.1 percent of positive Influenza A samples. It also correctly identified 100 percent of negative and 88.3 percent of positive COVID-19 samples.
For Influenza B, it correctly identified 99.9 percent of negative samples. The FDA noted: “Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.”
Lucira Health said the FDA had granted the test kit an EUA for Point-of-Care (POC) use in a health care setting in November 2022.
The California-based company announced early January this year it had submitted an EUA application for OTC use of its diagnostic test. By Feb. 22, just two days before the FDA granted the EUA for the OTC indication for its test kit, Lucira Health announced that it filed for Chapter 11 bankruptcy protection.
“The company anticipated an EUA for an OTC indication on the COVID-19 and flu test in August 2022, [but] the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022–2023 flu season,” Lucira Health said on Feb. 22 in a press release. “As such, the company’s operations were significantly impacted, leading to the Chapter 11 filing and sale process.”
“The company expects to continue operations during the Chapter 11 process and seeks to complete an expedited sale process with bankruptcy court approval,” the company added. “Lucira intends to use available cash on hand to fund post-petition operations and costs in the ordinary course.”
The available cash-on-hand is about $4.5 million, according to the company’s filing (pdf) to the Securities and Exchange Commission.
It had listed assets of about $146 million and liabilities of about $85 million in its bankruptcy petition, reported Bloomberg.
Shares for Lucira Health Inc. doubled in after-hours trading on Feb. 24 after the EUA was announced for OTC use of its test.