QUICK START GUIDE

 Refer to the Product Information Leaflet

for more complete information. 

This test is intended to be used as an aid to 

the clinical diagnosis of a COVID-19 infection. 

Do not use this test as the only guide 

to manage your illness. 

DO’S 

Follow the App’s instructions carefully when 

performing the test. 

Children aged 2-15 must be tested by an adult 

(18+ years old). 

Children aged 2-12 must be swabbed with 

the Child Adapter in place. 

Only open kit component packaging when 

ready to use the test. 

Only use the kit components provided. 

Keep the Analyzer on a flat surface within 3”

of your phone until the result is available. 

If multiple people are testing, connect the Analyzer 

to your phone and wait 30 secs before another

person connects their Analyzer to their phone. 

Keep test out of reach of children and pets. 

D1012808 G 

DON’TS 

Do not use Test if any of the 

packaging is open or damaged. 

Do not touch the Swab Tip. 

Do not add fewer or more drops 

of the sample fluid than instructed.

Do not add the sample fluid to the

Analyzer before it is connected. 

Do not close the App until your 

result is available. 

Do not perform the test in unstable 

(changing) light conditions. 

The desiccant sachet is not for use 

in the test. 

Regardless of your test result, please consult a healthcare 

professional if your symptoms persist of become more severe. 

GETTING STARTED 

Processing Nasal 

Swab 

Dropper Analyzer 

Fluid 

1 UNBOX COMPONENTS 

Only open the foil packaging when you are ready to 

do the test. Perform the test within 1 hour of opening. 

2 DOWNLOAD & OPEN APP 

Download the free Ellume COVID-19 Home Test App 

from the Google Play, the App Store or visit: 

www.ellumecovidtest.com 

3 ANSWER A FEW QUESTIONS IN THE APP 

This will select the right video and instructions for you 

and enable result personalization. 

4 WATCH INFORMATION VIDEO 

Get familiar with the test. 

Do not perform the test during the video. 

5 FOLLOW INSTRUCTIONS 

The App has step-by-step instructions to guide you 

through the test after the video. 

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has 

been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency 

use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of 

emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, 

Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 

Need help? Visit ellumecovidtest.com or call 1-888-885-6121 

Ellume Limited For invitro diagnostic use. No test component to be used 

57 Didsbury St, East Brisbane, Qld 4169, Australia inside the body except the Nasal Swab as directed. 
Product Information Leaflet

D1013763 F 

Intended use General test information The Ellume COVID-19 Home Test is a rapid, lateral flow

immunoassay intended for the qualitative detection of Please read this leaflet before using the test.

nucleocapsid protein antigen from the SARS-CoV-2 virus. You should follow the Ellume COVID-19 Home Test App

when performing the test. The test is intended to be This test is authorized for non-prescription home use with

used as an aid in the diagnosis of a COVID-19 infection. 

1 Before you start 2 During the test 3 After the test 

Preparing to do the test Do’s and don’ts Your result and what it means for you (Please also see Warnings 

and precautions section)

self-collected direct mid-turbinate nasal swab samples Ensure you have an internet connection Follow the App’s instructions carefully when The Ellume COVID-19 Home Test App will show one of the following results on your phone’s screen:

from individuals aged 16 years or older or adult collected Please consult a healthcare professional to discuss your to run the test. performing the test. Incorrect test use or completing

mid-turbinate results and if additional testing is necessary. swab samples from individuals aged 2 years Ensure your smartphone is compatible: test steps in the wrong order may result in an invalid

or older. This test is authorized for individuals with www.ellumecovidtest.com result or technical problem. Failure to follow directions

symptoms of COVID-19 within the first 4 days of symptom

COVID 19 Home Test – 

What is inside the Box 

may produce inaccurate test results. Ensure your phone is charged onset when tested at least twice over three days with at Correctly collect sample. False negative test results (at least 20% battery) or is charging. least 48 hours between tests and for individuals without may occur if a sample is incorrectly collected Ensure your test is at room temperature symptoms or other epidemiological reasons to suspect or handled. 

COVID-19 when tested when tested at least three times Nasal Swab with Pr 59-77°F (15-25°C). ocessing Dropper Wear a safety mask or other face-covering when over five days with at least 48 hours between tests. Ensure there is no visible damage 

For Emergency Use Authorization (EUA) Only. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

- -

1 the Processing Fluid with any other fluid.

Child Adapter Fluid collecting a specimen from a child or another individual 

The Ellume COVID-19 Home Test does not differentiate to the components’ packaging. Children aged 2-15 years must be tested by an adult 

between SARS-CoV and SARS-CoV-2. Flip-top Tab Wash your hands with soap and water (18+ years old) 

Results or use hand sanitizer. Children aged 2-12 years must be swabbed with the are for the identification of the SARS-CoV-2 Lid

Step by step Instructions 

nucleocapsid protein Child Adapter in place. antigen which is generally detectable

Child Individuals aged 16 years and older can self-swab in mid-turbinate nasal swab specimens during the acute

phase of Swab small children with the help of a second adult. infection. Positive results indicate the presence of Adapter Test

viral antigens, but the clinical correlation with past medical One adult should hold and reassure the child while Pad 

Your test has given an invalid result

or had a technical problem.

You will need to retest with

a new test kit.

What you need to do: 

Visit www.ellumecovidtest or call

1-888-885-6121. You will need to

provide your Analyzer ID and the

Result Code , which are displayed on

the result screen.

INVALID RESULT 

OR TECHNICAL 

PROBLEM 

Swab This leaflet only describes the key steps of the test. the other takes the swab. Tip Step-by-step instructions on how to perform this test history and other diagnostic information is necessary to 

determine Only open kit component packaging when ready infection status. are in the Ellume COVID-19 Home Test App. Button Sample Port to use the test. Once opened, the test should be used

Test result record 

Positive results do not rule out a bacterial infection or wi The App will send you a record of your thin 60 minutes. co-infection with other viruses and the agent detected test result if you input your email Only use the kit components provided. Do not replace may not be the definitive cause of disease. Individuals who

How to use this test 

Unbox components 

YOUR TEST IS POSITIVE 

FOR COVID-19

A positive test result means antigens from SARS-CoV-2

were detected in your sample and it is very likely you

have COVID-19 and are contagious. Your healthcare

professional will work with you to determine how best

to care for you, including any treatments available, based

on your test results along with your medical history

and symptoms.

What you need to do: 

1. You do not need to perform repeat testing. 

2. Consult a healthcare professional immediately 

and tell them you tested positive for COVID-19. 

Provide your healthcare professional with: 

a. Your Test Result Record (sent to you via email, if

selected, and in your COVID-19 Home Test App)

b. The Product Overview for Healthcare Professionals

c. The Fact Sheet for Healthcare Professionals

3. 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, https://www.cdc.gov/ 

coronavirus/2019-ncov/if-you-are-sick/isolation.

html 

4. 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 

www.cdc.gov/coronavirus/2019-ncov

Press the LEARN ABOUT YOUR RESULT button on the

result screen in the App to find out more about your

result.

There is a very small chance 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

professional may suggest you need molecular testing to 

confirm if you have contracted the virus causing

COVID-19. Refer to FAQ 'Can I have a false positive

result?' on our website www.ellumecovidtest.com/FAQ.

A negative test result indicates that the virus that causes COVID-19 was

not detected in your sample. A negative result is presumptive, meaning it

is not certain that you do not have COVID-19. You may still have COVID-19

and you may still be contagious. There is a higher chance of false negative

results with antigen tests compared to laboratory-based tests such as

PCR. If you test negative and continue to experience COVID-19-like

symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek

follow up care with your health care provider.

What you need to do: 

To increase the chance that the negative result for COVID-19 is 

accurate, you should: 

• Test again in 48 hours if you have symptoms on the first day of

testing. If you test negative but continue to have symptoms of

COVID-19, and both your first and second tests are negative, you may

not have COVID-19, however you should follow-up with your

healthcare provider.

• Test 2 more times at least 48 hours apart if you do not have 

symptoms on the first day of testing.

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 professional.

YOUR TEST IS NEGATIVE 

FOR COVID-19

Analyzer address. You can share this record

test positive with the Ellume COVID-19 Home Test should Only open foil packaging when you are ready to do the with your healthcare professional or In vitro diagnostic use only. Keep the Analyzer on a flat surface within 3” of your self-isolate and seek follow up care with their physician or test. Perform the test within 1 hour after opening the employer, for example. Information Product Information Leaflet and Quick Start phone until the result is available. If you receive a call, healthcare provider as additional testing may be necessary. packaging. supplied supports the monitoring answer on speaker. Tilting the Analyzer could result in Refer to the Quick Start Guide for a summary of the key Guide are also included. All negative results are presumptive and confirmation with 2 Download and open the App of COVID-19 infection rates across an invalid result or technical error. information of this leaflet. a molecular assay, the country. if necessary for patient management Find the free Ellume COVID-19 Home Test App If multiple people are testing, connect the Analyzer Read all instructions carefully before performing may be performed. Negative results do not rule out on the Google Play Store, the App Store or use to your phone and wait 30 secs before another person the test. Failure to follow the instructions may result SARS-CoV-2 infection and should not be used as the sole your smartphone’s browser to visit: connects their Analyzer to their phone. in inaccurate test results. basis for treatment or patient management decisions, Use this test: www.ellumecovidtest.com Keep test out of reach of children and pets. 

For more information on EUAs please visit: https://www. including infection control measures such as isolating from As an aid in the diagnosis of COVID-19 infection AND; 3 Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.

Test Intepretation 

Answer a few questions Do not use this test on children under 2 years of age. 

fda.gov/emergency-preparedness-andresponse/mcm- others and wearing masks. Negative results should be If you are concerned that you have COVID-19. in the App Do not add fewer or more drops of the sample fluid

legal-regulatory-and-policy-framework/emergency-use- considered in the context of an individual’s recent Serial testing should be performed in all individuals with This will select the right video than instructed. 

authorization exposures, history and the presence of clinical signs negative results; individuals with symptoms of COVID-19 and instructions for you and to Do not use Test if any of the packaging is open and symptoms consistent with COVID-19. For the most up to date information on COVID-19, please enable result personalization or damaged . and initial negative results should be tested again after 48

visit: www.cdc.gov/COVID19 Individuals who test negative and continue to experience and reporting. Do not touch the Swab Tip. Ensure the swab does not hours. Individuals without symptoms of COVID-19, and COVID-19 like symptoms of fever, cough and/or shortness 4 touch any surfaces before use. A contaminated swab with initial negative results, should be tested again after Watch information video of breath may still have SARS-CoV-2 infection and is a health hazard. In the USA, this product has not been FDA cleared 48 hours and, if the 2nd test is also negative, a 3rd time The video will provide an should seek follow up care with their physician Do not re-use. Test components are single use. or approved; but has been authorized by FDA under overview of what to expect. after an additional 48 hours. You may need to purchase or healthcare provider. Do not use kit past its expiration date printed on the an Emergency Use Authorization (EUA). Do not perform your test additional tests to perform this serial (repeat) testing. Test results will be reported to relevant public health

5 

outside of the box. during the video. This product has been authorized only for the authorities in accordance with local, state, and federal If you test negative but continue to have symptoms Do not add the sample fluid to the Analyzer before

Follow instructions detection of proteins from SARS-CoV-2, not for any requirements, using appropriate LOINC and SNOMED of COVID-19, and both your first and second tests are it is connected. 

Separate step-by-step other viruses or pathogens; and codes, as defined by the Laboratory In Vitro Diagnostics negative, you may not have COVID-19, however you Do not drop the Analyzer. Handle with care. instructions will be available

Status on 

First Day of Testing First Result Day 1 Second Result Day 3 Third Result Day 5 Interpretation 

Positive N/A N/A Positive for COVID-19 

With Symptoms Negative Positive N/A Positive for COVID-19 

Negative Negative N/A Negative for COVID-19 

Positive N/A N/A Positive for COVID-19 

Without Symptoms 

Negative Positive N/A Positive for COVID-19 

Negative Negative Positive Positive for COVID-19 

Negative Negative Negative Negative for COVID-19 

(LIVD) Test Code Mapping for SARS-CoV-2 Tests provided should follow-up with your healthcare provider. Do not close the App until your result is available The emergency use of this product is only 

6 

within the App after the video. Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs

by the CDC. Automatic test result reporting occurs via the If your test is positive, then proteins from the virus that as it may cause a technical problem and you will authorized for the duration of the declaration that and symptoms consistent with COVID-19. Your test result need a new test kit. circumstances exist justifying the authorization Ellume COVID-19 Home Test software application. causes COVID-19 have been found in your sample and • Serial testing should be performed in all individuals with negative results; individuals with symptoms of COVID-19 and After finishing the testing Do not perform the test in unstable (changing) of emergency use of in vitro diagnostics for The Ellume COVID-19 Home Test is intended for non- you likely have COVID-19. initial negative results should be tested again after 48 hours. Individuals without symptoms of COVID-19, and with initial process wait 15 minutes for your light conditions. detection and/or diagnosis of COVID-19 under prescription self-use and/or as applicable, for an adult lay negative results, should be tested again after 48 hours and, if the 2nd test is also negative, a 3rd time after an additional Do not use this test: result to appear on your phone The desiccant sachet is not for use in the test. Section 564(b)(1) of the Federal Food, Drug user testing another aged 2 years or older in a non- 48 hours. You may need to purchase additional tests to perform this serial (repeat) testing. screen. The App will store your Discard the sachet immediately after opening and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless laboratory setting. The Ellume COVID-19 Home Test is only On anyone under 2 years of age; • If you test negative but continue to have symptoms of COVID-19, and both your first and second tests are negative, you result and, if selected, a test the kit component. the declaration is terminated or authorization is for in vitro diagnostic use under the Food and Drug If you are prone to nose bleeds, OR; may not have COVID-19, however you should follow-up with your healthcare provider. result record will be sent to revoked sooner. Administration’s Emergency Use Authorization. If you have had a facial or head injury/surgery in the last • If your test is positive, then proteins from the virus that causes COVID-19 have been found in your sample and you likely your email. This product has not been FDA cleared or approved. 6 months. have COVID-19.
! At all times 

User safety Warnings and precautions 

1 

2 

3 

4 

5 

6 

Invalid test rate 

Test and sample storage and stability Frequently asked questions (FAQs) More about the test Glossary of symbols 

Manufacturer 

Disposal 

7 

8 

9 

10 

11 

Limitations 

Correct swabbing 

Attention all users 

Important 

Chemical 

Name GHS Codes 

Concentration 

(%weight/ 

weight) 

• Do not use this test as the only guide to manage your

illness, particularly if your test has been negative for

COVID-19. and your first test is negative, you should test again High risk groups Please also see Do's and don'ts Store this test in a dry location between 36 - 86°F (2-30°C). What are the potential risks and benefits • Some technologies inside the test are licensed from • The Processing Fluid contains a harmful chemical in 48 hours since antigen tests are not as sensitive as • Read all instructions carefully before performing the test. of this test? Thermo Fisher. Some people are at an increased risk for severe illness with (see table below). Avoid contact of Processing Fluid Ensure the test is at room temperature 59-77°F (15-25°C) molecular tests. If you do not have symptoms and Failure to follow the instructions may result in inaccurate Po • This product contains small amounts of animal COVID-19. This includes the elderly, those with chronic lung with your skin, eyes, nose, or mouth. Do not ingest any tential risks include: prior to testing. received a negative result, you should test at least two test results. sourced materials. or heart disease and other types of chronic disease. kit components. If contact with the Processing Fluid • Possible discomfort during sample collection. Kit contents are stable until the expiration date printed on more times with 48 hours in between tests for a total • In the USA, this product has not been FDA cleared or • This device complies with the emission and immunity For a full list of specific groups of people who may be occurs, flush with copious amounts of water. the outer packaging. Do not use beyond the expiration date. • Possible incorrect results. (see Warnings and Result of three tests. If you have a negative result, it does not approved, but has been authorized by FDA under an requirements described in IEC 60601-1-2. at increased risk visit https://www.cdc.gov/coronavirus. If irritation persists, seek medical advice: Interpretation sections for more information). rule out SARS-CoV-2 infection; you may still be Emergency Use Authorization. This product has been The Test components must remain in the sealed foil Interference from other electronically driven equipment https://www.poisonhelp.org or 1-800-222-1222 Potential benefits include: infected and you may still infect others. It is important If you are in a high-risk group and experiencing symptoms authorized only for the detection of proteins from packaging until use. Once the packages have been is not expected. • The results, along with other information, can help that you work with your healthcare provider to help you should see a healthcare professional as soon as SARS-CoV-2, not for any other viruses or pathogens. The opened, the test should be used within 60 minutes. This equipment has been tested and found to comply with your healthcare professional make informed you understand the next steps you should take. possible, regardless of your result. Your healthcare emergency use of this product is only authorized for the Place samples immediately into Processing Fluid after the limits for a Class B digital device, pursuant to Part 15 of professional will determine if there are any treatments duration of the declaration that circumstances exist recommendations about your care. What does an invalid test result mean? sample collection. Samples should be added to the the FCC Rules. These limits are designed to provide Mixture of H301: Toxic if swallowed available to you. • The results of this test may help you to limit the An invalid result means the test was not able to tell if

H311: Toxic in contact with skin

justifying the authorization of emergency use of in vitro 5-Chloro-2 Analyzer port when instructed by the App. Do not delay, reasonable protection against harmful interference in a - spread of disease to your family and others within EMERGENCY WARNING SIGNS diagnostics for detection and/or diagnosis of COVID-19 methyl-4- otherwise the test may produce an invalid result. you have COVID-19 or not. If the test is invalid, a new residential installation. This equipment generates, uses and your community. under Section 564(b)(1) of the Federal Food, Drug, and isothiazolin- H331: Toxic if inhaled swab should be used to collect a new nasal specimen can radiate radio frequency energy and, if not installed and If at any time you experience any of the following emergency Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the 3-one & H314: Causes severe skin burns For more information on EUAs go here: and the test should be run again, using a new test kit. used in accordance with the instructions, may cause warning signs please seek medical attention immediately: https://www.fda.gov/emergencypreparedness-and- declaration is terminated or authorization is revoked sooner. 2-Methyl-4- and eye damage 0.002 – 0.005 Why is the App asking me for my personal details? harmful interference to radio communications. However, • Trouble breathing isothiazolin- response/mcm-legal-regulatory-and-policy- • Serial testing should be performed in individuals with H317: May cause an allergic skin there is no guarantee that interference will not occur in a • Persistent pain in the chest 3-one (3:1) • There is a higher chance of false negative results with The App will send you a record of your test result if you framework/emergencyuse-authorization negative results at least twice over three days (with 48 reaction particular installation. If this equipment does cause harmful • New confusion or inability to wake or stay awake antigen tests than with laboratory-based molecular input your email address. You can share this record with hours between tests) for symptomatic individuals and (ProClinTM H400: Very toxic to aquatic life What is the difference between a COVID-19 antigen interference to radio or television reception, which can be tests due to the sensitivity of the test technology. This your healthcare professional or employer, for example. • Pale, gray, or blue-colored skin, lips or nail beds 300 three times over five days (with at least 48 hours H410: Very toxic to aquatic life means that there is a higher chance this test will give a and a molecular test? determined by turning the equipment off and on, the user depending on skin tone Information supplied supports the monitoring of between tests) for asymptomatic individuals. You may There are different kinds of tests for the SARS-CoV-2 COVID-19 infection rates across the country. with long-lasting effects is encouraged to try to correct the interference by one This list is not all inclusive. Please consult your false negative result in an individual with COVID-19 as need to purchase additional tests to perform this serial virus that causes COVID-19. Molecular tests detect or more of the following measures: healthcare professional about any other symptoms that For more information on EUAs please visit: compared to a molecular test, especially in samples Will the Test hurt? (repeat) testing. genetic material from the virus. Antigen tests, such as • Reorient or relocate the receiving antenna are severe or may be concerning you. For the most • If you have had symptoms longer than 4 days you should https://www.fda.gov/emergencypreparedness-and- with low viral load. the Ellume COVID-19 Home Test, detect proteins from No, the nasal swab is not sharp, and it should not hurt. • Increase the separation between the equipment current information on emergency warning signs, visit: response/mcm-legal-regulatory-and-policy-framework/ • The performance of this test was established based on Sometimes the swab can feel slightly uncomfortable. consider testing at least three times over five days with the virus. Due to the lower sensitivity of antigen tests, and receiver https://www.cdc.gov/coronavirus emergencyuse-authorization the evaluation of a limited number of clinical specimens If you feel pain, please stop the test and seek advice at least 48 hours between tests. there is a higher chance this test will give you a false • Connect the equipment into an outlet on a circuit collected between October, 2020 and November 2020. A • Children aged 2-15 years must be tested by an adult For the most up to date information on COVID-19, negative result when you have COVID-19 than a from your healthcare professional.

subsequent clinical trial, which is ongoing, was different from that to which the receiver is connected

(18+ years old) please visit: www.cdc.gov/COVID19 molecular test would. commenced in May 2022 when the dominant circulating I have a nosebleed after swabbing my nose. • Consult the dealer or an experienced radio/TV

• Children aged 2-12 years must be swabbed with the What should I do? strain was the Omicron variant. The clinical performance What should I do if my phone cannot connect technician for help This test involves taking a sample from deep inside Child Adapter in place. If your nose starts bleeding, apply pressure to your has not been established for all circulating variants, with the Analyzer? Warning: Any changes or modifications not expressly your nose. When doing the test, pay particular attention • Individuals aged 16 years and older can self-swab. nose until the bleeding stops and consult a healthcare to the instructions on how to swab your nose. Incorrect including Delta variant, but is anticipated to be reflective Follow the on-screen trouble-shooting instructions in approved by Ellume could void the user's authority to • Before disposal of the Analyzer, we recommend

swabbing may lead to a false negative test result. This is of the prevalent variants in circulation at the time and the App or try to connect the Test to a different phone operate this equipment. For a Glossary of Symbols please • Do not use this test on children under 2 years of age. professional. Do not insert the Swab again.

• Wear a safety mask or other face-covering when removing the battery using the following steps:

particularly important if you do not have symptoms. location of the clinical evaluation. Performance at the that you trust. If you cannot connect the Analyzer to How accurate is this test? refer to www.ellumecovidtest.com

collecting a specimen from a child or another individual. • Locate the gap at the end (short side) of the Analyzer, your phone, call 1-888-885-6121. time of testing may vary depending on the variants Swabbing a small child. We recommend swabbing small Clinical studies have shown that antigen tests more • Do not use if any of the test kit contents or packaging close to the button.

children with the help of a second adult. One adult should circulating, including newly emerging strains of Why did I get an invalid result or technical problem? accurately determine whether you are infected with is damaged. • Place a coin in the gap. SARSCoV-2 and their prevalence, which change over time. hold & reassure the child while the other takes the swab. • Do not re-use. Test components are single use. The Ellume COVID-19 Home Test has a sample quality the virus that causes COVID-19 when taken multiple

• Do not use kit past its expiration date. • Twist the coin to break off the bottom end of the • All COVID-19 antigen test negative results are control which makes sure that the Test has enough times across several days. Repeat testing improves Need help? Visit www.ellumecovidtest.com

Analyzer along the perforation in the plastic. presumptive and confirmation with a molecular assay sample (nasal secretions) to generate a reliable test test accuracy. This serial testing approach is or call 1-888-885-6121 • Do not touch the Swab Tip. Ensure the swab does not may be necessary. If you continue to have symptoms recommended to minimize the risk of incorrect • Remove the battery from the plastic clips result. If there is not enough sample the test will give touch any surfaces before use. A contaminated swab TMs are owned by or licensed by Ellume Limited. of the Analyzer. of COVID-19, and both your first and second tests are an invalid result rather than a negative result, which results. For more information on the performance of This test is intended to be used as an aid in the clinical is a health hazard. negative, you may not have COVID-19, however you the test and how the performance may apply to you, No test component to be used inside the

diagnosis of a COVID-19 infection. Do not use this test • Keep test out of reach of children and pets. could be incorrect. It is not common, but technical • Keep the battery out of reach of children body except the nasal swab as directed. should follow-up with a healthcare provider. problems with the Test can also occur. In these please refer to the performance data in the Product • Do not use on anyone prone to nosebleeds, or who has • Do not incinerate as the only guide to manage your illness. Please • If the test is positive, then proteins from the virus that instances, you will need to retest with a new test Overview for Healthcare Professionals, available at had facial or head injury/surgery in the last 6 months. • Dispose of the battery and the remainder of the test Ellume Limited. consult a healthcare professional if your symptoms causes COVID-19 have been found in the sample and or consult a healthcare professional. https://www.ellumecovidtest.com/ • Do not use the test if it has been exposed to household in general waste unless otherwise indicated by 57 Didsbury St, East Brisbane, persist or become more severe, or if you are concerned you likely have COVID-19. resources#downloadable-resources cleaning products (especially bleach). local regulations. What if I have a positive test result? Qld 4169, Australia at any time. Individuals should provide all results • Incorrect test results may occur if a specimen For further FAQs visit www.ellumecovidtest.com/FAQ. • Avoid performing the test in a very dry environment A positive result means that it is very likely you have obtained with this product to their healthcare provider. is incorrectly collected or handled. For up-to-date information on COVID-19 visit (very low humidity) to prevent a build-up of static COVID-19 because proteins from the virus that causes

electricity that could damage the electronics of the test. COVID-19 were found in your sample. You should https://www.cdc.gov/coronavirus.

• When collecting a mid-turbinate nasal swab sample, If you are not recovering, feeling worse, or are concerned self-isolate from others and contact a healthcare The Fact Sheet for Healthcare Professionals and Product

use only the Nasal Swab supplied in the kit. about your health, please consult a healthcare provider for medical advice about your positive result. Overview for Healthcare Professionals are available via the

• No test components to be used inside the body except App, or visit www.ellumecovidtest.com In the most recent clinical study, a total of seven-hundred professional. Regardless of your result, if you develop one What if I have a negative test result? the Nasal Swab, as directed.

Symbol Symbol Title Explanatory Text 

Manufacturer Indicates the medical device

manufacturer 

Date of

Manufacture

Indicates the date when the

medical device was

manufactured 

Indicates the date after

Use by date which the medical device

is not to be used 

Batch code 

Indicates the manufacturer's

batch code to identify the 

batch or lot 

Catalog

number 

Indicates the manufacturer's

catalog number to identify 

the medical device

Part number Indicates the manufacturer’s

part number 

Sterilized using 

ethylene oxide 

Indicates a medical device

that has been sterilized 

using ethylene oxide 

Temperature

limit 

Indicates the temperature

limits to which the medical

device can be safely exposed

Indicates a medical device that 

Do not reuse is intended for one use, or for 

uses on a single patient during 

a single procedure 

Consult Indicates the need for the 

instructions user to consult the instructions 

for use for use 

In vitro Indicates a medical device that 

diagnostic is intended to be used as an in 

medical device vitro diagnostic medical device

Do not use 

if package 

is damaged 

Indicates a medical device 

that should not be used 

if the packaging has been 

damaged or opened 

CE marking Signifies European technical 

conformity 

Medical Device Indicates the item 

is a medical device

Federal 

Communications Meets FCC requirements 

Commission per 47 CFR § 15.247

(FCC) Logo

Bluetooth® Indicates that the device 

Logo is Bluetooth® enabled 

Indicates the device is a self-test

 For self-testing

in vitro diagnostic device. This

means a lay person can use it 

without formal healthcare or

medical experience.

and nineteen (719) tests were performed. Forty (40) of the emergency warning signs (see user safety section) A negative test result indicates that antigens from the Alternatively, you or the healthcare professional can call The Ellume COVID-19 Home Test is a self-test in

Invalid Results were recorded. Overall Invalid Result rate you should seek medical attention immediately. virus that causes COVID-19 were not detected in your 1-888-885-6121. • Keep out of reach of children. The test contains small

vitro diagnostic device. was therefore 5.6%. parts that may present a choking hazard. sample. However, if you have symptoms of COVID-19,

02/2023
 

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Need help? 

Visit ellumecovidtest.com or call 1-888-885-6121 

Test Components 

Processing Fluid Dropper Nasal Swab Analyzer 

Child 

Adapter 

DO NOT USE 

DO USE 

ellume covidtes t .co m 

ellumecovidtest.com 

D1014597 F 

ellume.com 

57 Didsbury St, East Brisbane, 

Qld 4169, Australia 

Ellume Limited 

Your test is 

NEGATIVE

for COVID-19

The Ellume COVID 19 Home 

Test is a digital fluorescent 

immunoassay for the qualitative 

detection of COVID 19 antigens 

from mid turbinate nasal 

swab specimens. 

Determining a negative result requires multiple tests. You may need to 

purchase additional tests to perform serial (repeat) testing. This test is 

more likely to give you a false negative result when you have COVID-19 

than a lab-based molecular test. 

Scan QR code to download free app 

or check your phone is compatible. 

Required:

 Smartphone 

- Internet 

- Ellume App 

Made in USA 

Store in a dry location 

between 36-86 ̊F [2-30 ̊C]

In the USA, this product has not been FDA 

cleared or approved; but has been authorized 

by FDA under an EUA. This product has been 

authorized only for the detection of proteins 

from SARS-CoV-2, not for any other viruses or 

pathogens; and, the emergency use of this 

product is only authorized for the duration of 

the declaration that circumstances exist 

justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or 

diagnosis of COVID-19 under Section 564(b)(1) 

of the Federal Food, Drug and Cosmetic Act, 21 

U.S.C. § 360bbb-3(b)(1), unless the declaration is 

terminated or authorization is revoked sooner. 

Results in 

15 mins 

Easy 

to use 

Fluorescent 

Detection 

technology 

2oC 

36o F 

30 o C 

86oF 

For in vitro diagnostic use. No test component to be 

used inside the body except the Nasal Swab as directed.

In USA - For use under an Emergency Use Authorization (EUA) only. 

TMs are owned by or licensed by Ellume Limited. 

Keep out of reach of children 

As an aid in the diagnosis of 

COVID-19 infection. 

If you are concerned that you have COVID-19. 

With or without symptoms. 

Download and open the free Ellume COVID-19 Home Test App 

on your smartphone and carefully follow the instructions. 

On anyone under 2 years of age. 

If you are prone to nosebleeds. 

If you have had a facial or head injury/surgery 

in the last 6 months. 

Clear 

Results 

in words 

1x Test 

Phone not included 

For Emergency Use 

Authorization (EUA) only 

Suitable for ages 2+ years 

For the most current expiration 

dates of this test, please refer to: 

https://www.fda.gov/covid-tests