Ellume COVID-19 Home Test

What is included in the Box

• Nasal Swab with Child Adapter
• Flip-top Lid
• Child Adapter
• Swab Tip
• Analyzer
• Processing Fluid
• Dropper
• Button Tab
• Sample Port
• Product Information Leaflet and Quick Start Guide

When to use this kit

• As an aid in the diagnosis of current COVID-19 infection.
• If you are concerned that you have COVID-19.

Do not use this test:

• On anyone under 2 years of age.
• If you are prone to nosebleeds.
• If you have had facial or head injury/surgery in the last 6 months.

Unbox components

Ensure all packaging is intact. Do not use the test if there is visible damage to the foil packaging.

Preparing to do the test

• Ensure you have an internet connection for the App.
• Ensure you are using a compatible smartphone. Visit www.ellumecovidtest.com for a list.
• Ensure your phone is charged (at least 20% battery) or charging.
• Ensure your test is at room temperature (59-77°F or 15-25°C).
• Open foil packaging only when ready to test. Use within 1 hour after opening.
• Wash your hands with soap and water or use hand sanitizer.
• Keep the Swab clean, avoiding touching the Swab Tip.

Do's and Don'ts

• Follow the App's instructions carefully.
• Download and open the Ellume COVID-19 Home Test App from the Google Play Store, App Store, or visit www.ellumecovidtest.com.
• Answer questions in the App to select the right instructions and enable health authorities to monitor infection rates.
• Watch the info video in the App for an overview. Step-by-step instructions follow in the App.
• Wait 15 minutes for your result to appear on your phone screen after finishing the testing process.
• Children aged 2-15 years should be tested by an adult.
• Children aged 2-12 years should use the Child Adapter.
• Keep kit parts out of reach of children (choking hazard).
• Use only provided test components. Do not replace Processing Fluid.
• Keep the Swab clean; avoid touching the Swab Tip.
• Immediately after taking the sample, screw the Swab into the Dropper.
• Keep your phone within 3 inches of the Analyzer until the result is available. Answer calls on speaker.
• Keep the Analyzer on a flat surface; tilting may cause an error.
• Keep foreign substances away from the test. Contact with bleach may cause incorrect results.
• Do not perform the test in direct sunlight.
• Avoid contact with Processing Fluid. Do not ingest Processing Fluid.
• Do not perform the test within 30 feet of another person using an Ellume COVID-19 Home Test.
• Do not close the App during processing, as it will cause an error and require a new test kit.

Correct Swabbing

This test requires a sample from deep inside your nose. Pay close attention to swabbing instructions, especially if you have no symptoms, as incorrect swabbing can lead to inaccurate results.

Swabbing a small child: We recommend a second adult helps to hold and reassure the child while the swab is taken.

Your result and what it means for you

The Ellume COVID-19 Home Test App will display one of the following results:

• + YOUR TEST IS POSITIVE FOR COVID-19: Indicates a very likely current COVID-19 infection. Consult a healthcare professional as soon as possible, providing your Test Result Record and relevant fact sheets from the App. Self-isolate at home as per CDC recommendations (www.cdc.gov/coronavirus).
• YOUR TEST IS NEGATIVE FOR COVID-19: Indicates it is unlikely you currently have COVID-19. Proteins from the virus were not found in your sample. You may have had COVID-19 previously (antibody test needed for confirmation). Consult a healthcare professional if symptoms develop or persist.
• A TEST ERROR HAS OCCURRED: Retest with a new kit or consult a healthcare professional. Self-isolate at home. Call the Ellume toll-free helpline 1-888-885-6121 with your Error Code, Lot Number, and Analyzer ID.

Test results record

A record of your test result and detailed information will be emailed to you if selected in the App. Results are also accessible within the App. This record can serve as proof of test result.

Disposal

To remove the battery: Locate the gap at the end of the Analyzer (short side, near power button), insert a coin, twist to break off the bottom end, and remove the battery. Dispose of the battery according to local regulations and keep it out of reach of children. Do not incinerate. Dispose of the remainder of the test in general waste.

High Risk Groups

Individuals aged 65+, those in long-term care, and people of all ages with certain underlying medical conditions (e.g., cancer, diabetes, heart conditions, immunocompromise) are at higher risk for severe disease. Refer to https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html for the most current information.

EMERGENCY WARNING SIGNS

Seek immediate medical attention for trouble breathing, persistent chest pain, new confusion, inability to wake or stay awake, or bluish lips or face. Refer to https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html.

Warnings and Precautions

• Do not use on anyone under 2 years of age, or those prone to nosebleeds or with recent facial/head injury/surgery.
• Do not use past the expiration date or reuse components.
• Do not use if foil packaging is opened or damaged. Open packaging only when ready to test.
• Use within 60 minutes of opening Analyzer and Dropper packaging.
• Do not use if exposed to household cleaning products, especially bleach.
• Keep Analyzer on a flat surface; do not drop.
• Do not perform the test in direct sunlight.
• Add exactly five drops into the Analyzer; incorrect amounts may yield false or invalid results.
• Do not perform the test within 30 feet of another Ellume COVID-19 Home Test user.
• Do not close the App during processing.
• Ensure test is at room temperature (59-77°F or 15-25°C) before testing.
• Follow in-app instructions for accurate results.
• Processing Fluid contains ProClin® 300, which may cause allergic skin reactions. If contact occurs, wash/flush with water. Seek medical advice if irritation or rash occurs.
• Inadequate sample collection may lead to test errors. Pay attention to technique, especially if asymptomatic.
• Keep out of reach of children (small parts are a choking hazard).
• Do not use this test as the sole guide for illness management, especially if the test is negative.
• For in vitro diagnostic use only.
• Avoid testing in very dry environments to prevent static electricity buildup.
• Test results may be less reliable when COVID-19 prevalence is very low in the community.
• No test components should be used inside the body except the Nasal Swab as directed.
• This product has been authorized by FDA under an EUA for the detection of SARS-CoV-2 proteins.

Frequently Asked Questions (FAQs)

• Antigen vs. Molecular vs. Antibody Tests: The Ellume test is an antigen test, detecting virus proteins. Molecular (PCR) tests detect genetic material. Antibody tests detect antibodies from past infection.
• How the Test Works: Detects SARS-CoV-2 virus parts in nasal secretions.
• App Connection Issues: Follow on-screen troubleshooting or call 1-888-885-6121.
• Personal Details in App: Used for test result records and to support health authority monitoring of COVID-19 rates.
• Phone Battery Dies During Test: Plug in phone, turn it back on. Ensure Analyzer is on (flashing green light). Reopen App; it should reconnect.
• Flashing Red Analyzer Light: Analyzer battery is too low. Call 1-888-885-6121.
• Solid Red Analyzer Light: Analyzer is faulty. Call 1-888-885-6121.
• Nosebleed After Swabbing: Apply pressure until bleeding stops. Consult a healthcare professional. Do not reinsert the Swab.
• No Fluid from Dropper: Ensure Swab is screwed tightly into Dropper. Hold Dropper vertically. If problem persists, call 1-888-885-6121.
• For further FAQs, visit www.ellumecovidtest.com.

Clinical Performance

In a clinical study, the Ellume COVID-19 Home Test correctly identified 96% of positive and 100% of negative samples in symptomatic patients, and 91% of positive and 96% of negative samples in asymptomatic individuals.

Invalid Test Rate: The overall invalid result rate was 8% (17/209) in a clinical study. Nine invalid results were due to insufficient sample collection, particularly in asymptomatic subjects. Careful sampling technique is important to avoid retesting.

What is COVID-19?

COVID-19 is a contagious respiratory illness caused by the SARS-CoV-2 virus. Illness can range from mild to severe, and some infected individuals may be asymptomatic. Older adults and those with underlying medical conditions are at higher risk for severe illness. Symptoms may include fever, cough, shortness of breath, fatigue, muscle aches, headache, loss of taste/smell, sore throat, congestion, nausea, vomiting, and diarrhea. The virus spreads mainly through respiratory droplets and can survive on surfaces.

For a full list of symptoms, visit: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

How does the virus spread?

The virus spreads primarily through respiratory droplets from coughing or sneezing. Droplets can land on surfaces or be inhaled. Touching contaminated surfaces and then touching the face can also lead to spread. Spread is more likely in close contact (within 6 feet). Community spread is occurring in many areas.

When can I be with others again after testing positive?

• If asymptomatic: After 10 days of self-isolation since the positive test result.
• If symptomatic: After at least 10 days since symptoms first appeared, at least 24 hours with no fever (without fever-reducing medication), and other symptoms have improved (except loss of taste/smell).

For current CDC self-isolation recommendations, visit: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html

What can I do to stay healthy?

• Wash hands often with soap and water or hand sanitizer.
• Clean frequently touched surfaces daily.
• Wear a face covering when around others if social distancing is difficult.
• Sneeze or cough into your elbow or a tissue, and wash hands.
• Avoid close contact with sick people, especially if in a high-risk group.
• If sick, isolate yourself in a separate room and avoid sharing personal items.

When should I seek medical attention?

Seek immediate medical attention for emergency warning signs: trouble breathing, persistent chest pain, new confusion, inability to wake/stay awake, or bluish lips/face. Also seek medical attention if you are in a high-risk group, symptoms persist or worsen, or you have concerns.

For up-to-date information, visit the CDC COVID-19 website: https://www.cdc.gov/coronavirus/2019-ncov/index.html