Lucira Health has developed an at-home COVID-19 test kit that achieves PCR-quality molecular accuracy in 30 minutes or less.
Infectious infections may be prevented by bringing accurate and easy-to-use self-testing into the comfort of your own home.
The FDA has not certified or approved this home test kit. Under EUA, this home test kit has been approved by the Food and Drug Administration.
Only SARS-CoV-2 nucleic acid may be detected in nasal swabs with this home test kit, not any other viruses or diseases.
Section 564(b)(1), 21 USC 360bbb-3(b)(1), authorizes the emergency use of IVDs for detection and diagnosis of COVID-19 during the declaration that circumstances warrant the use of IVDs for such purposes as detection and diagnosis.
Take Control of Your Health
During a significant uncertainty in our daily lives, Lucira is there for you. You may trust our expertise in COVID-19 testing and home diagnostics to help you improve your health.
Diagnostic tests may now be performed at your convenience, whenever and wherever you like, without needing an appointment at the clinic.
At-home testing and reliable findings may be yours in minutes with our diagnostic tools because there is no time to waste on your health.
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Lucira Health FAQs
Where can I get Lucira COVID-19 Test Kits?
Lucira may be purchased straight from our website in the US and Canada. If you’re a healthcare practitioner or person in the United States or a resident of Canada, please visit our online shop.
The drug has also been used in Israel, Puerto Rico, Singapore, and Taiwan. Contact Sales if you have any questions about our overseas offerings.
Is insurance going to pay for this test?
If you have private insurance, you should be able to get full or partial reimbursement for Lucira testing in most circumstances. This may vary by insurer.
At least eight at-home tests per month per member will be covered by private insurers starting on January 15, 2022, and recommended providers will also be available at no charge.
For tests that are not protected by your insurance company’s preferred provider scheme, they will nonetheless partly pay you for them.
Lucira will send you an email receipt with all of the necessary information for reimbursement from your insurance company when you place a purchase. To get compensation, follow the guidelines provided by your insurance provider.
Medicare Part B, Medicaid, and the Children’s Health Insurance Program (CHIP) cover home tests provided by participating qualifying pharmacies or healthcare professionals.
Can you provide me with further information on the accuracy of PCR quality?
Detection of SARS-CoV-2, which produces COVID-19, may be done with the Lucira Check It COVID-19 Test Kit. The test only determines whether you are infected, not if you are immune or if you have antibodies.
While the test is ongoing, the virus’s genetic material is amplified similarly to PCR lab testing. Using Lucira’s amplification approach, you may get results that are on par with some of the most sensitive PCR tests in the lab.
Are there any new COVID variations that the test can detect?
In addition to Omicron and all the potentially harmful BA subvariants, Lucira finds all the exciting and concerning COVID-19 variations.
Regular monitoring of SARS-CoV-2 strains is carried out by Lucira, which will keep an eye on new varieties.
Please visit www.lucirahealth.com/technical-brief for the most up-to-date information.
Can I take the exam several times?
This one-time use kit includes everything you’ll need to perform one Covid-19 test.
How long does it last on the shelf?
The test kit currently has a 12-month shelf life. For further information, see our Note on Shelf Life Extension.
What space is needed for storage?
Lucira may be stored and used between 59 and 86 degrees Fahrenheit/15 and 30 degrees Celsius.
For whom is the COVID-19 at-home exam authorized?
All adults above the age of 14 and children under the age of two are eligible for the test; an adult takes provided samples.
Do you think this test will tell me whether I’ve had COVID-19 in the past or not?
No. You cannot use this test to confirm immunity or discover antibodies to SARS-CoV-2 or COVID-19.
If I’ve been vaccinated, can this test be used on me?
Your Lucira test results will not be affected if you have been vaccinated. The Lucira test may be performed if you have been vaccinated and wish to be tested for COVID-19.
Is it necessary for me to get the advice of a medical practitioner before making a purchase or performing a test?
No, this test does not need a doctor’s prescription. You should, however, see your physician if you have any concerns about your health. If you get a good result, make an appointment with your doctor.
Are there any restrictions on travel to take this COVID test?
Further facts and limitations should be confirmed with your airline or vacation destination since they may differ from one location to the next.
Compared to other molecular tests, Lucira delivers results that are on par with or better than those of different tests.
If you need to confirm negative COVID-19 status for travel, you may use our LUCI PASS, a guaranteed Lucira test result on your phone.
The Lucira test makes use of what kind of technology?
The Lucira test uses RT-LAMP, a kind of molecular amplification. SARS-CoV-2 viral DNA is amplified during the Lucira test as if it were being done in the laboratory.
Molecular diagnostics, such as PCR and the Lucira test, may identify a positive sample with better sensitivity than antigen testing because of the amplification during these tests.
Consequently, Lucira’s precision is on par with the Hologic Panther Fusion, a lab PCR test with the best sensitivity1.
Lucira Community Testing Studies 07A-CLI 006 Fall 2020 and 07A-CLI 007 Winter 2021 (n=394) did not include samples with deficient viral levels (>37.5 Ct).
What do a COVID test’s sensitivity and specificity mean?
The capacity of a test to identify an infected person as positive is known as sensitivity. Tests that can distinguish between those who are infected and those who aren’t are considered specific.
Whether or not I have COVID symptoms, may I utilize this test?
Check Lucira People with and without symptoms may both benefit from it.
Lucira’s Check It COVID-19 Test Kit can identify the SARS-CoV-2 virus similar to some of the most significant PCR tests conducted in clinical settings and high-complexity laboratories, regardless of whether or not you have symptoms.
Compared to one of the most accurate PCR tests, the Lucira test obtained 98 percent specificity in two Community Testing Studies, including 404 people with and without COVID-19 symptoms.
Ninety-four percent of symptomatic people and 90 percent of asymptomatic people had a high degree of sensitivity.
Only ten samples with meager amounts of virus (>37.5 Ct.) were included in the 92 percent sensitivity across all models.
Is there a difference between PCR and Lucira tests and antigen tests?
COVID tests come in two flavors: molecular and antigen. Detection of a current COVID-19 infection is the goal of both tests.
Their methods, on the other hand, are distinct. In contrast to antigen assays, PCR and Lucira can identify the SARS-CoV-2 virus in a sample with substantially lower viral levels than antigens.
Amplifying the virus’s genetic material is a procedure that takes place during molecular assays. Because of this, even if just a little quantity of SARS-CoV-2 virus is present, molecular testing may determine whether someone is infected.
SARS-CoV-2 virus levels in a sample must be substantially more significant in an antigen test than in a molecular test to identify a positive result.
Antigen tests are less expensive than molecular testing. The amount of beginning virus required by antigen tests to detect a positive is 34 times more than that of molecular tests like Lucira.
Researchers in the UK and India have shown that antigen tests used there are less sensitive than molecular testing and may more often result in false negatives2.
There is no need for further testing to validate the results of molecular tests deemed diagnostically conclusive.
They are more sensitive and reliable because they can identify the SARS-CoV-2 virus in a broader range of viral loads.
- As of June 1, 2021, 20 FDA-approved antigen tests have a median detection limit of 0.01%.
- Mahase E (2020). According to experts, it is not recommended for the “test and release” technique. Journal of the Royal Medical Society, 371:m4469. In S. Debroy (2021, June 21). Covid-19: Research found that 34% of RAT findings were false negatives, which became positive when tested by RT-PCR.
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