FDA Authorizes Lucira Over-the-Counter COVID-19 and Flu Test

Lucira Health developed the first over-the-counter (OTC) at-home molecular diagnostic test that detects both influenza A and B viruses as well as SARS-CoV-2, the virus causing COVID-191 . This innovative test provides results in approximately 30 minutes using self-collected nasal swab samples, offering a convenient way for individuals to identify respiratory infections from home2 . The availability of such a combination test is a significant advancement in managing overlapping symptoms of flu and COVID-19, which often complicate clinical diagnosis3 .

High Sensitivity and Accuracy

Lucira’s COVID-19 & Flu Home Test uses nucleic acid amplification technology, specifically real-time loop-mediated isothermal amplification (LAMP), which is a molecular method similar to PCR (polymerase chain reaction) tests4 . Unlike many antigen-based rapid tests, which detect viral proteins, Lucira’s test identifies viral RNA, providing higher sensitivity and specificity5 . This molecular approach allows for more accurate detection of SARS-CoV-2 and influenza viruses in symptomatic individuals.

The test kit includes all necessary components, such as batteries, enabling users to perform the test entirely at home without additional equipment6 . After sample collection via anterior nasal swabs, the device automatically processes the sample and delivers qualitative positive or negative results within about 30 minutes7 . The test is authorized for non-prescription home use in individuals aged 14 years or older for self-collection, and for children aged 2 years or older when collected by an adult8 9.

Clinical evaluations have demonstrated that Lucira’s test achieves high sensitivity rates: over 88% for SARS-CoV-2 detection and approximately 90% for influenza A virus5 2. Negative results for SARS-CoV-2 and influenza B are considered presumptive and may require confirmation with an authorized molecular test if needed for patient management2 9. Limited clinical data on influenza B detection prevented definitive conclusions on its performance for this strain10 .

Compared to rapid antigen tests, which often have sensitivities around 80% for symptomatic COVID-19 cases and a higher chance of false negatives, molecular tests like Lucira’s offer PCR-quality detection with greater reliability5 11. The Lucira COVID-19 test showed a positive percent agreement of 94.1% compared to rapid antigen tests, which ranged between 81.6% and 83.5% 1. This improved accuracy is crucial for timely diagnosis and treatment.

💡 Did You Know? Lucira Health's innovative at-home molecular diagnostic test detects influenza A or B and SARS-CoV-2. It became the first over-the-counter combination test authorized by the US Food and Drug Administration (FDA). 1

The test’s binary results indicate only the presence or absence of viral nucleic acid without quantifying viral load6 . Its microfluidic technology spins the sample to separate and identify virus molecules, enhancing detection efficiency1 . This method is expected to maintain accuracy even as SARS-CoV-2 continues to mutate, since the targeted RNA regions are less prone to change12 .

Key features of Lucira’s molecular test:

Uses nucleic acid amplification (LAMP) technology for high sensitivity4 5
Provides results in approximately 30 minutes at home7 2
Detects SARS-CoV-2, influenza A, and influenza B viruses2 12
Authorized for self-collection in individuals 14+ years old8 9
Demonstrated clinical sensitivity exceeding 88% for COVID-19 and 90% for influenza A5 2

“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”
— Jeff Shuren, M.D., J.D., U.S. Food and Drug Administration2

Cost and Availability Concerns

Despite the technical success and FDA authorization of Lucira’s combination COVID-19 and flu test, its availability in the U.S. market remains uncertain due to significant financial and regulatory challenges faced by the company13 . Lucira Health filed for Chapter 11 bankruptcy just days before receiving FDA clearance for the test, complicating plans for production and distribution13 .

The company had prepared stock for a 2022 launch but awaited regulatory approval before entering the market13 . Following the bankruptcy filing, Lucira has been seeking partnerships to restart manufacturing and distribution efforts13 . These operational hurdles have delayed consumer access to the test despite its potential benefits.

Pricing for the Lucira test in the U.S. has not been determined and may be influenced by market re-entry strategies and partnerships13 . In contrast, Health Canada authorized the test in mid-2022, with retail pricing near CAD 98, providing a reference point for potential costs14 . However, affordability remains a concern, especially as government subsidies and insurance coverage for at-home COVID-19 tests are expected to change after the COVID-19 public health emergency ends15 .

Federal programs that provided free COVID-19 tests are set to expire with the conclusion of the emergency declaration, potentially increasing out-of-pocket costs for consumers15 . Insurance coverage for at-home tests may vary, creating disparities in access depending on individual plans15 .

Factors affecting access and affordability:

Lucira Health’s bankruptcy and financial restructuring delayed market entry13
Uncertain U.S. pricing and distribution plans pending partnerships13
Health Canada authorized the test with retail pricing near CAD 9814
Expiration of federal free COVID test programs may raise consumer costs15
Insurance coverage for at-home tests may become inconsistent post-emergency15

“Often, when an individual begins to feel sick, they wait a few days before calling their doctor. And then, the doctor might not have an appointment for two days. By that point, if they have the flu, it is past the window for taking Tamiflu, an antiviral treatment that can lessen symptoms, but it should be started within 48 hours of symptom onset.”
— Scott Roberts, MD, Yale Medicine18

Benefits of At-Home Flu Testing

At-home testing for influenza and COVID-19 offers several advantages, especially when symptoms overlap and clinical diagnosis is challenging16 . Both illnesses share common symptoms such as fever, cough, sore throat, fatigue, muscle pain, and headaches, making it difficult to distinguish between them without testing3 . Rapid and accurate diagnosis at home empowers individuals to make timely health decisions and seek appropriate treatment17 15.

Lucira’s combination test allows users to detect influenza A, influenza B, and SARS-CoV-2 from a single nasal swab, simplifying the testing process during respiratory illness seasons2 12. Early identification of the specific virus can guide appropriate antiviral treatments, which are most effective when started promptly—within 48 hours for flu antivirals like Tamiflu and within five days for COVID-19 treatments such as Paxlovid18 3.

“It’s always a good idea to get tested and know what you have if you suspect you might have one of these very contagious illnesses.”
— Neil Maniar, Northeastern University19

Home testing also reduces the burden on healthcare facilities by limiting unnecessary visits and minimizing exposure risks to others in clinical settings15 . Knowing the infection status helps individuals isolate appropriately to prevent transmission and supports public health efforts to control outbreaks17 16.

Advantages of at-home flu and COVID-19 testing: