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Frequently Asked Questions
The Ellume COVID-19 Home Test is a type of test called an antigen test. When you have COVID-19, the SARS-CoV-2 virus (the virus that causes COVID-19) can be present in your nasal secretions. The Ellume COVID-19 Home Test can detect small parts of SARS-CoV-2 virus in your nasal secretions. These small parts of the SARS-CoV-2 virus are known as proteins or antigens.
There are different kinds of tests for the virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the Ellume COVID-19 Home Test detect proteins from the virus. Antigen tests are very specific for the SARS-CoV-2 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19 than a molecular test would.
Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection. Antibody tests are not suitable to diagnose an active COVID-19 infection.
For more information on COVID-19 testing, please see the following link:
https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics
No. The Ellume COVID-19 Home Test cannot be reused.
There are no approved available alternative antigen tests. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here: https://www.fda.gov/medical-devices/device-advice-comprehensiveregulatory-assistance/medical-device-databases
A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
No one has access to the personal information in the secure cloud.
Two things happen when your data is uploaded.
- It is transmitted to public health authorities such as the HHS and state authorities for mandatory COVID-19 test result reporting via our integration partner. Our integration partner is legally bound to handle your data appropriately under a HIPAA business associate agreement, for public health authority data reporting. If you have chosen to share your information with an organization via the organization IDs and patient codes, your data is shared with them.
- All personal information is removed and stored in secure storage by the system (in case retransmission to authorities is required). No one is looking at this data.
See answer above, no one is looking at your personal information. Ellume's cloud is hosted on Microsoft Azure services in the United States.
Ellume has no interest in users’ personal information except to fulfil our mandatory health authority data reporting requirements and provide services that you have requested of us. We do not analyze, sell or access your personal information in any other way. You can find out more by reading our privacy policy (https://www.ellumecovidtest.com/privacy)
For information on testing requirements for international travel please visit the CDC website - https://www.cdc.gov/coronavirus/2019-ncov/travelers/internationaltravel/index.html
Before you travel in the US:
Make sure you understand and follow all airline and destination requirements related to travel, mask wearing, testing, or quarantine which may differ from US requirements. Please check requirement here - https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html
The performance of the Ellume COVID-19 Home Test was established in a prospective clinical study comparing Ellume COVID-19 Home Test results to a FDA Emergency Use Authorized high sensitivity PCR (molecular) test and correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. This clinical study was conducted in the USA from October 2020 to November 2020. The performance of the test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations. Clinical performance of the test has not been established with subsequent variants of COVID-19 including the Delta and Omicron variants.
A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Your healthcare provider will work with you to determine how best to care for you based on your test results along with medical history and your symptoms.
What you need to do:
- Consult a healthcare professional and tell them that you tested positive for COVID-19. Provide your healthcare professional with:
- Your Test Result Record (sent to you via email, if selected, and in your COVID-19 Home Test app)
- The Product Overview for Healthcare Professionals
- The Fact Sheet for Healthcare Professionals
If you have no symptoms, your healthcare professional may recommend a confirmatory test. Please see FAQ ‘Can I have a false positive test result?’
- You should self-isolate at home as per CDC recommendations to stop spreading the virus to others.
Please consult the CDC recommendations regarding self-isolation:
- If you are in a high risk group it is very important to see your Healthcare Professional as there may be treatment options available to you. Further information can be found at https://combatcovid.hhs.gov or https://www.cdc.gov/coronavirus/2019-ncov.
There is chance that this test can give a positive result that is wrong (a false positive result) especially if you use the test when there are very few COVID-19 infections in your local community. Your healthcare provider may suggest you need molecular testing to confirm whether you have contracted the virus causing COVID-19. Visit FAQ ‘Can I have a false positive result’ on our website.
This means antigens from the virus that causes COVID-19, were not detected in your sample. A negative result does not rule out COVID-19. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. For example, you may get a false negative result if you did not perform the test correctly or if the level of antigen from the virus causing COVID-19 was below the test’s detection limits.
There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19. If you test negative and continue to experience COVID-19 like symptoms of fever, cough, and/or shortness of breath you should seek follow up care with your health care provider. If you do not have symptoms of COVID-19 and test negative, you should test again with at least 24 hours and no more than 48 hours between tests.
Your healthcare professional will determine the best way to care for you based on your test results, likelihood of COVID-19 infection, symptoms and medical history. Your healthcare provider may suggest you need molecular testing to confirm whether you have contracted the virus that causes COVID-19. Confirmatory testing is especially important for people without symptoms.
It is important that you work with your healthcare provider to help you understand the next steps you should take.
Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. Testing for asymptomatic individuals should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
There is a chance that this test can give a positive result that is incorrect (a false positive result).
Anyone who receives a positive test result needs to consult a healthcare professional. If you have any doubt about your test result, please discuss it with a healthcare professional. This is especially important if you belong to a high-risk group (See FAQ Who is considered high risk for severe disease? On our website) or develop emergency warning signs. The healthcare professional will work with you to determine how best to care for you based on your test result along with your medical history and symptoms.
The percent of positive test results that are true positives (also known as Positive Predictive Value or PPV) varies with how common infection is in a population. As the number of infections in the community decreases, the number of test results that are false positives increases. When numbers of infections are low (low prevalence), false positive results may be more likely than true positive results. For example, if prevalence of infection in a community is 5%, 37 out of 100 positive results from the Ellume COVID-19 Home Test would be false positives. If disease prevalence is only 1%, 75 out of 100 positive results would be false positives. It is difficult to determine how many infections are in asymptomatic individuals and false positive results may be more likely if you do not have symptoms of infection.
If you do not have symptoms of COVID-19 and get a positive result, your test results should be confirmed with a molecular SARS-COV-2 test. Positive results from the Ellume COVID-19 Home Test are presumptive in asymptomatic patients, and have a higher risk of being false positives, particularly if you do not have a known SARS-CoV-2 exposure and/or live in an area known to have low numbers of SARS-CoV-2 infections. The CDC recommends that persons who receive a positive antigen test should isolate until they can be confirmed by a molecular test.
The overall invalid result rate on first test for the 209 subjects that performed testing in a clinical study in October and November 2020 was 8% (17/209). Nine (9) of the seventeen (17) invalid results recorded were generated by the Analyzer as a failsafe control to indicate to the user that insufficient sample had been collected for the test to give a valid result. All 9 were generated by asymptomatic subjects. It is therefore very important that a user with no symptoms pays close attention to sampling technique to avoid having to retest with additional tests.
Please see the following link for the current recommendations for quarantine and isolation:
The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October 2020 and November 2020. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Clinical performance of the test has not been established with subsequent variants of COVID-19, including the delta and omicron variants. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. We are continually monitoring if mutations impact our Test.
No, the Ellume COVID-19 Home Test should not be used in children under the age of two. The test has not been validated for use in this age group, and the swab is specifically designed for children over age two and may not collect acceptable samples from younger children. If you are concerned that your under two year-old child has COVID-19 you should see a healthcare professional for advice and further management.
Your test result is saved within the COVID-19 Home Test App and if selected, the app will email you a record of your test result. You can share this record as a proof of COVID-19 testing with your healthcare professional, for example. Your date of birth and zip code are information you are required to provide because they are shared with the relevant health authorities to support monitoring of COVID-19 infection and test positivity rates across the country. Other personal information may be shared with the relevant health authorities however only if you choose to enter details in the optional information fields.
No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from your healthcare provider.
Potential benefits:
- The results can detect if you have COVID-19 or not.
- The results, along with other information, can help your healthcare professional make informed recommendations about your care.
- If positive for COVID-19 you can help limit the spread of the disease by self-isolating at home and avoiding other family members.
- If positive for COVID-19 you can advise those you have been in close contact with, or locations you have visited in the last 14 days, to test for possible COVID-19 infection.
Potential risks:
- Possible discomfort or other complications (e.g. minor nosebleed) that can happen during sample collection.
- Possible incorrect test result (either false positive or false negative). See below for more information.
You will be able to receive calls on speaker but you must keep your phone within 3 inches of the Analyzer while the test is running. Please note that the Analyzer will need to remain on a flat surface. We recommend keeping the Ellume COVID-19 Home Test App on the screen until you have received your result. Leaving the app may result in the test being interrupted and not obtaining a result. If that happens, the test kit cannot be reused and you will need to acquire a new test kit to perform another test.
No. The test is only compatible with smartphones included on the list of compatible devices.
The test is only compatible with smartphones included on the list of compatible devices.
Once you open the foil packaging, you have one hour to do the test.
You need to insert the Swab as far back into your nasal cavity as possible to increase the likelihood of detecting COVID-19. Insert the Swab into your nostril until the cap of the Swab touches your nose. If the individual is a child aged 2-12 years, insert the Swab until the Child Adapter touches their nose. Do not insert the Swab any further if you experience sharp pain or severe discomfort. Do not use this test on children under the age of 2 years.
Swabbing both nostrils gives you the best chance of collecting sufficient sample to generate an accurate result. It has been observed in some cases that only one nostril has detectable virus, so it is important to collect from both nostrils. Correct swabbing is important to obtain a correct result.
The Swab is sterile and safe to use and the Cap (or Child Adapter for children 2-12 years old) will prevent you from inserting it too far into your nose and causing injury. You may experience some discomfort when swabbing your nose but this is to be expected. Do not insert the Swab any further if you experience sharp pain.
Yes. The Ellume COVID-19 Home Test can be used with or without any noticeable symptoms of COVID-19. You need to gently rub the tip of the Swab around the inside of your nose cavity 3 times in each nostril to ensure you get sufficient sample to obtain an accurate result.
People who are at increased risk of severe disease and have COVID-19 may be suitable for specific treatments to prevent them getting sicker and needing hospitalization. Please see your healthcare professional if you are experiencing COVID-19 like symptoms and are in one of these groups regardless of your test result. You can also visit https://combatcovid.hhs.gov or www.cdc.gov/coronavirus/2019-ncovfor more information.
If your nose starts bleeding, apply pressure to your nose until the bleeding stops and consult a healthcare professional. Do not insert the Swab again.
It’s smaller than the standard nasopharyngeal swab you may have seen or experienced. And ours is unique to Ellume.
Our patented Nasal Swab is a mid-turbinate swab, which means it is inserted a little under 2 inches into your nose and 1 inch into a child’s nose, which is shallower than the nasopharyngeal swab used when testing for COVID-19.
We use our patented Child-Protector, a soft fixture attached to the base of the swab, to ensure you don’t swab your child too deeply.
Yes, vaccinated individuals can use the Ellume COVID-19 Home Test. However, clinical performance has not been studied in vaccinated individuals.
If you have been vaccinated and you receive a positive result from the Ellume COVID-19 Home Test, please treat this as a positive test result, follow the on-screen instructions and consult a healthcare professional.
Follow the on-screen trouble-shooting instructions in the App. If you are still unable to connect, call our toll-free Customer Helpline 1-888-885-6121.
Plug your phone into charge and turn it back on. Ensure the Analyzer is still on (the green light should be flashing/blinking). If it is turned off, press the power button once to turn it on. Then open the App and the Analyzer will automatically reconnect to your phone and display the current state of the test.
A flashing red Analyzer light indicates that the battery of the Analyzer is too low to perform the test. Call our toll-free Customer Helpline 1-888-885-6121.
A solid red Analyzer indicates that the Analyzer is faulty. Call our toll-free Customer Helpline 1-888-885-6121 to request a replacement test
This will result in an invalid result. You must dispense the Processing Fluid into the Dropper. You will need to acquire a new test kit
Ensure the Swab is screwed into the Dropper as tightly as possible. Some force will be required to do this. Then try again holding the Dropper completely vertical. If this does not solve the problem, call our toll-free Customer Helpline 1-888-885-6121 for assistance.
If the Analyzer is having problems connecting to your phone:
- Hit the Troubleshooting button in the app and follow the instructions.
- Ensure Bluetooth and Location are ON in settings (allow Bluetooth access).
- Remove your phone case.
- If you connected your phone to the Analyzer manually (through Bluetooth in settings) disconnect and follow the instructions.
- Connect the Analyzer to a different phone you trust and follow the instructions.
If you’re still unable to connect, please call our Customer Support team on 1-888-885-6121
Squeeze 5 drops of fluid out of the Dropper into the Sample Port of the Analyzer. If there is less fluid in the Dropper, squeeze in as much as you can. Using less than 5 drops may cause the test to give an inaccurate result or not produce a result at all. You will need to acquire a new test kit.
No. Once the Swab Cap has been screwed into the Dropper it will lock in place and you should not attempt to remove it. You should only insert a dry sterile Swab into your nose. Once screwed into the Dropper, the Swab will be wet with the Processing Fluid and no longer sterile. Avoid contact with the Processing Fluid and do not insert the wet Swab into your nose. You will need to obtain a new test kit
You should wipe the liquid off your phone as per the recommendations of your phone manufacturer. Please note that you may not have sufficient liquid remaining to perform the test. If that happens, you will need to obtain a new test kit.
Wipe up the liquid with a tissue or paper towel and dispose into general waste. Wash the affected area with soapy water. Avoid contact with the fluid with your skin. The reagent in the Processing Fluid contains ProClin® 300 which may cause an allergic skin reaction in some people. If the solution makes contact with the skin or eye, wash/flush with copious amounts of water. If skin irritation or rash occurs seek medical advice/attention.
No, you will need to collect a new sample. You will need to obtain a new test kit.
Code 20:
Got a ‘Code 20’ or ‘Not enough sample for an accurate result’ message?
You should retest with a new test or consult a healthcare professional. If you receive this message, please contact our Customer Support team via the Customer Support section of this website or on 1-888-885-6121.
Code 29:
This indicates there was a problem or damage to the Analyzer and the test could not run an accurate test.
When you power on the analyzer it runs a series of internal quality control checks to ensure everything is running as it should. If the analyzer finds there is some internal damage, it presents a Code 29.
This is important as it ensures we do not run a result when the test may not be operating as planned.
Please call our Customer Support team to organize a replacement. Call us on 1-888-885-6121
Code 14:
This indicates the test has been instructed to start running (by pressing the Run Test button within the app) but no sample has been detected within the Analyzer.
This could mean that there is damage within the analyzer, preventing it from detecting the sample you added, or could mean you didn’t add sufficient sample to the analyzer. You should retest with a new test.
Please call our Customer Support team so we can investigate further. Call us on 1-888-885-6121. You will require a new test kit.
Code 9:
This indicates that fluid from the sample was added to the Analyzer too early in the test process.
This could mean that there is damage within the Analyzer preventing it from operating correctly or could mean you added your sample out of sequence with the test instructions.
Please call our Customer Support team so we can investigate further. Call us on 1-888-885-6121. You will require a new test kit.
Code 32:
This indicates there was a problem or damage to the Analyzer and the test could not run an accurate test
When you power on the Analyzer it runs a series of internal quality control checks to ensure everything is running as it should. If the Analyzer finds there is some internal problem or damage, it presents a Code 32.
This is important as it ensures we do not run a result when the test may not be operating as planned.
Please call our Customer Support team to organize a replacement. Call us on 1-888-885-6121.
Compatible devices
The Ellume COVID-19 Home Test is compatible with most Bluetooth®enabled smartphones.
Apple iPhones:
Minimum supported capabilities: an ARM64 iPhone device with Bluetooth® running iOS 12 or later.
Inclusions:
- iPhone 5s
- iPhone 6
- iPhone 6 Plus
- iPhone 6s
- iPhone 6s Plus
- iPhone SE
- iPhone 7
- iPhone 7 Plus
- iPhone 8
- iPhone 8 Plus
- iPhone X
- iPhone X Max
- iPhone XR
- iPhone 11
- iPhone 11 Pro
- iPhone 11 Pro Max
- iPhone SE (2nd Generation)
- iPhone 12
- iPhone 12 mini
- iPhone 12 Pro
- iPhone 12 Pro Max
- iPhone SE (3nd Generation)
- iPhone 13
- iPhone 13 mini
- iPhone 13 Pro
- iPhone 13 Pro Max
The test is not compatible with iPad, iPod Touch, iPhone 5 (Armv7s devices).
Android phones:
Minimum supported capabilities: an Android smartphone with Bluetooth® 4.0 or later and XHDPI (720x1280px) resolution running Android API 23 (version 6.0) or later.
The test is not compatible with Android tablets.
On March 16, 2022 the U.S. Food and Drug Administration re-issued Ellume’s Emergency Use Authorization (EUA) for the Ellume COVID-19 Home Test.*
See revised letter and labelling available for download or printed copy below.
Downloadable resources
FDA EUA Letter
Fact Sheet for Healthcare Professionals*
Product Overview for Healthcare Professionals*
Quick Start Guide
Product Information Leaflet
*For a free printed copy please contact our Customer Support team.
* Revisions to the intended use to: “self-collected direct mid-turbinate nasal swab specimens from individuals aged 16 years or older with symptoms of COVID-19 within the first 7 days of symptom onset,” “adult-collected mid-turbinate nasal swab specimens from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset,” and “with self-collected mid-turbinate nasal swab specimens from individuals aged 16 years or older, or adult-collected mid-turbinate nasal swab specimens from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two to three days with at least 24 hours (and no more than 48 hours) between tests,”
and updates to the letter and authorized labelling for consistency with language used in more recent authorizations.
