The Lucira Check It COVID-19 Test Kit is a single-use test kit intended for self-collection at-home by individuals 14 and older to detect the virus that causes COVID-19.
Authorized Labeling
- Lucira CHECK-IT COVID-19 Test Kit EUA
- Lucira CHECK-IT COVID-19 Test Kit HCP
- Lucira CHECK-IT COVID-19 Test Kit IFU
- Lucira CHECK-IT COVID-19 Test Kit IFU (Home Test)
Frequently Asked Questions
Can you tell me more about Lucira’s PCR quality molecular accuracy?
The Lucira Check It COVID-19 Test Kit is a diagnostic test to detect the virus that causes COVID-19. Therefore, the test detects if you have an active infection. However, it does not confirm immunity or detect antibodies. Specifically, it is a molecular test that amplifies the virus’s genetic material while the test is running just like PCR lab tests. Importantly, Lucira’s amplification method provides 98% accuracy compared to one of the highest sensitivity lab PCR tests.
Can this test detect new SARS-CoV-2 variants?
Yes, this Lucira Check It COVID-19 Test Kit has been shown to detect 99% of known COVID-19 variants. Regularly, Lucira Health is doing testing to make sure that this Lucira COVID test can detect emerging strains as well. In the meantime, we keep a Technical Brief that lists the new strains that this test can detect. This product can detect the omicron variant (also known as B.1.1.529) first detected in South Africa.
What’s the shelf life?
Currently, the test kit has a 12-month expiration. Importantly, the FDA requires real time aging studies for this kind of statement. Therefore, Lucira has real time aging studies underway and expect to update the expiration dating every three months.
How many times can I use this test?
Each Lucira Check It COVID test kit is a single-use and comes with everything needed to run 1 COVID-19 test.
Is this test covered by insurance?
We recommend that you reach out to your insurance carrier directly to discuss reimbursement.
Are there any important documents I should read before taking this test?
While not required, here are a few documents of interest:
- This test is only approved for use under the Food and Drug Administration’s Emergency Use Authorization.
- In addition, if you’re interested in learning the details of all of the variants this Lucira test can detect, you can find more information here.
- Also, the extended instructions for using the Lucira Check It COVID-19 test could be useful.
- However, if you still have more questions, there is an extended FAQ document from Lucira here.
How do I interpret my test results?
It is very likely you have COVID-19 and it is important to be under the care of a healthcare provider. It is likely you will be asked to isolate yourself at home to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive). Your healthcare provider will work with you to determine how best to care for you based on your test results along with your medical history and your symptoms.
A negative result means the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result with all other aspects of your history such as symptoms and possible exposures to decide how to care for you. It is important you work with your healthcare provider to help you understand the next steps you should take.
Please take a look at the instructions for sample collection for this Lucira Check It COVID test in this video, or this one and in this document. In addition, the CDC also has some very useful instructions for nasal swab collections here.
Important Things to Note:
- During set up, disinfect the surface where you will open the collection kit. Remove and lay out contents of kit. Read instructions before starting specimen collection.
- In addition, Wash hands with soap and water. If soap and water are not available, use hand sanitizer.
- Importantly, for this test to work properly, it is important you swab BOTH nostrils.
- Remove swab and hold with handle end. Do not set swab down.
- Tilt head back and gently insert swab tip until it is fully inside your/patient nostril and you meet resistance.
- Once swab tip is fully inside nostril, roll the swab 5 times around the inside walls of your nostril. The swab should be touching the walls of the nostril as you rotate.
- Repeat swab step in other nostril.
- Rotate 5x in BOTH nostrils.
- Make sure to roll around inside walls to collect a good sample.
- Adults must swab children ages 2-13 for this Lucira COVID test.
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Note: These products and services are not returnable. Check your kit expiration date upon receipt. Using expired test kits is not recommended because they may provide inaccurate results.