Q: Was this test designed for people who are blind or have low vision? / Q: Why is this test considered more accessible for users who are blind and have low vision?

A: The Ellume COVID-19 Home Test was not originally designed for people who are blind or have low vision. However, it is one of the few tests that was specifically designed for consumers rather than trained healthcare professionals. A lot of research, design, and testing was put into the development of this test to ensure it is as usable and people centric as possible.

As a result, our test was identified by the National Institutes of Health (NIH) and the National Federation of the Blind (NFB) as one of the most accessible rapid antigen home tests available.

While our test was not designed specifically for users that are blind or have low vision, we are working closely with our partners at the NIH, the NFB, and numerous accessibility design agencies to make our test even more accessible.

What makes our test one of the most accessible:

1. Our smartphone app used in conjunction with users’ smartphone and screen reader functionality enables users to follow the digital instructions and receive their digital results.
2. Results in words are clearly displayed by the app meaning there is no need to interpret visual test lines on a test strip. The digital result can also be shared easily with healthcare providers, employers, educators and more.
3. A direct link to the Customer Support helpline is provided to the user through the app menu.
4. Our test components are large and stable, and do not need to be inserted in the carton packaging when performing the test, unlike many standard rapid antigen tests. The components are designed for easy handling which minimizes the risk of spillage.
5. The Patented dropper system makes combining the sample and processing fluid simple. The nasal swab screws directly into the dropper creating an easy-to-use system to dispense the sample fluid into the analyzer.

Q: How does the Ellume COVID-19 Home Test work for people who are blind or have low vision?

A: The Ellume test instructions and results are presented digitally through the Ellume COVID-19 Home Test app. This means that, by using their own smartphone and screen reader functionality, users who are blind or have low vision are able to follow our test instructions and receive their results. Our app guides users through each step of the testing process, then presents their results in words and supplies further information and next steps relevant to their result.

Our test also has additional accessible elements, like large, stable test components, a swab and dropper combination, and child safety adapter for safe swabbing.

Please contact our Customer Support team if you would like a team member to talk you through the test components and how to take the test. The test does require the use of a smartphone app and sharing of the minimum amount of personal data as required by the US Health Department.

Q: Can I use this test without a smartphone or without an app?

A: We’re sorry but the test and app must be used together.

We’re often asked why our test uses a smartphone app. There are a number of very good reasons:

• Through extensive user studies we found that our digital instructions support users to accurately and effectively perform our test. This helps give reliable results.
• Our app allows us to provide you with digital results in words taking the guess work out of interpreting faint lines on a test strip, unlike many other rapid COVID tests.
• Our digital results can be stored on your phone (for proof of testing), sent to your email account, and easily shared with others (like employers and educators) if desired.
• Receiving your results through our app means you will access timely information from the Centers for Disease Control and Prevention (CDC) and the Health Department because we can provide updates to the guidance and next steps.
• Critically, our smartphone app means users who are blind or have low vision can follow our test instructions and receive their results by using their smartphone with screen reader functionality.
• Our app also enables health departments to receive aggregated data on the positivity and negativity rates in the US, supporting their response to the spread of COVID.

Please find a list of compatible smartphone devices here.

If you have any questions or concerns, please feel free to contact [] Customer Support team .

Q: What components are included in the test box?

A: Included in your test kit is:

Digital Bluetooth ®analyzer:

• This is an oblong, foil-wrapped package; you can feel a solid object inside. It is the narrower of the two foil-wrapped items in the package. (Approximately 1.5" wide and 6" long). You can open this from either end. If it is difficult to tear open, you could use scissors to cut either end just inside the crimped edge without fear of damaging the object inside. Inside, you will find the analyzer, which is a rectangular plastic stick with a round, slightly recessed rubber button at one end and a small open well at the other end. The flat side without the dip or rubber button is the underside, and this should be placed on a flat surface with the dip and button facing upwards.

The dropper:

• This is also a foil pouch. You can feel an object inside with solid, but non-uniform edges. This package is approximately 2.5" wide and just over 5" long. You also can open this from either end or use scissors to cut either end just inside the crimped edge. Inside is a plastic rectangular tray holding the dropper, which is a hard plastic object with one threaded end. The tray also may include a small package of desiccant – this is not needed for the test.

The nasal swab with a removable child adapter:

• Before touching the Nasal Swab, and all components, please wash your hands thoroughly to reduce the chance of contaminants interfering with the test.
• This is in a plastic package with a paper cover. It's about 3" long and 1.5" wide. The plastic portion has two sections. The smaller section encloses the swab itself -- be careful not to touch the swab when opening the package. To open, hold the package with the paper side facing up and the small section of the plastic package facing away from you. Open by pulling the tab at the top right-hand corner toward you. The nasal swab may need a bit of a tap to free from its plastic bubble. The swab has three parts. At one end is a hard plastic section with a lid that flips open - you can feel the hinge on one side and a slight, smooth depression on the other side. At the other end is a one-inch swab tip - be careful not to touch the swab. In between is a soft, removable rubber adapter for use with children aged 2-12 years old. This needs to be removed if the test is going to be used on a person 13 years and above.
• Before touching the Nasal Swab, and all components, please wash your hands thoroughly to ensure there is no interference with the test.
• To remove the nasal swab, please use the wide end plastic base of the swab, or the rubber child protector to remove the swab, without touching the narrow tip of the swab.

The processing fluid:

• This is a very small plastic capsule – it is easy to miss in the box. It is about 2" long and half an inch wide. One end is a flat, smooth rectangle. The other end is triangular and crimped. Between the two ends is a tube. You'll open this by twisting the triangular end off, but do not do this until you are ready to use the fluid.

Product information leaflet:

• This is a folded piece of paper with key steps and guidance on running the test.

Quick start guide:

• This is a thinner, folded piece of paper with quick instructions to get started.

Our Customer Support team can assist you in identifying each of the components and provide support in conducting the test. For more information or support, please contact our Customer Support team.

Q: How do I connect the analyzer to the Bluetooth on my smartphone?

A: Please carefully follow the step-by-step instructions within the app. It is important to follow the steps in conjunction with the app to ensure the test provides an accurate result. Connection to your smartphone happens in Step 2 of the process. On Step 2 you will be asked to press and hold the power button to connect the analyzer to your smartphone via Bluetooth.

When the phone and the analyzer connect, you will receive a message in the app and via your screen reader that the phone is connected.

Please do not manually connect the analyzer and your smartphone via Bluetooth in your settings. Please only connect to Bluetooth when instructed in the in-app instructions.

Q: How will I know if there is enough fluid in the sample port?

A: We recommend you first locate the dip where the sample port is situated with recently washed hands. Once you locate the port you can use your thumb and index finger of your non-dominant hand as a reference to help align the dropper to the sample well. We recommend giving the dropper a number of strong squeezes (6 squeezes) to ensure all fluid from the dropper is in the analyzer. This should be sufficient fluid to run the test accurately. The test has advanced technology to identify if there was not sufficient fluid to run an accurate test so you can be assured your result is accurate.

Q: Can this test be used for users that are blind or have low vision, who exclusively use a Braille display?

A: The Ellume app will take users through a training video, followed by step-by-step instructions. The training video is designed to give users an overview of how the test works. Users should not perform the test during the video. A Braille display will not work during the training video. However, the step-by-step instructions guide users through each step of the testing process and these instructions have text which is accessible by Braille display.

Q: How do I remove the child adapter from the swab?

A: On the swab component, feel for a rubber ring near the base of the swab. Feel for the gap in the rubber ring where it is not joined and pull the ring away from the swab at that gap. This will remove the child adapter from the swab. The child adapter should only be removed prior to collecting a sample from someone who is 13 years or older.

Q: How do I remove the swab from the blister packaging?

A: It is strongly recommended that all users wash their hands thoroughly, with soap and water or hand sanitizer, before using this test. We understand touch is an important part of the testing process for users who are blind or have low vision and washing hands thoroughly will help reduce the chance of contaminants interfering with test accuracy.

To remove the nasal swab, please peel back the paper cover and use the wide end plastic base of the swab, or the rubber child protector to remove the swab, without touching the narrow tip of the swab.

Q: How should users that are blind or have low vision order the Ellume COVID-19 Home Test?

A: Consumers who are blind or have low vision can order the Ellume COVID-19 Home Test free-of-charge by calling 1-800-232-0233 or by visiting: https://acl.gov/covid19/tests-people-who-are-blind-or-have-low-vision or https://special.usps.com/testkits/accessible

Each order will include 12 rapid antigen tests and will ship free, while supplies last. For more information or support, please contact our Customer Support team.

For additional Ellume tests:

If you are covered by Medicare:

• Medicare will pay for up to eight Ellume COVID-19 Home Test kits per month. This includes people with Medicare Advantage plans. This is in addition to the 12 free tests available to people who are blind or have low vision through the Administration for Community Living. This includes people with Medicare Advantage plans.
• Call ahead to make sure your local retailer has the Ellume tests in stock.
• Call 1-800-MEDICARE (1-800-633-4227) with any questions.

If you have private insurance:

• Your insurer may provide reimbursement for the Ellume COVID-19 Home Test kits.
• Call your plan to learn more about how they will reimburse you for the cost of tests.
• Call ahead to make sure your local retailer has them in stock.

Check out our knowledge base for tips and best practices, and answers to common questions.

Processing Fluid and Desiccant

What is the small rectangular package with crystals under my Dropper? That is a desiccant sachet. They are commonly used in many products to help absorb moisture and to protect goods from condensation. It is critical to keep our test components dry and free from humidity, which is why we use the desiccant sachet and the foil packaging. Do not open or use the desiccant in any part of your test. Please dispose of the desiccant in general waste - it has done its job and you don’t need it for any part of your test.

Data & result sharing

Your privacy is important to us which is why providing information to support COVID reporting is optional. This information is used to support the health authorities in monitoring the COVID-19 infection rates around the country. The information you supply voluntarily is used to support you in the use of the test. Your email is used to provide you with a copy of your result and additional information, which you can share as a proof of testing.

How to swab

We know it’s not pleasant, but it’s much more comfortable than many swabs used for PCR COVID-19 tests. Our swab is specifically designed to enable untrained individuals to safely take a good-quality sample. A good sample is key for any test to generate a reliable result. This is why our swab is slightly deeper than your nostril, includes a child adapter, and our app features animated instructions to make sure everyone can take a good sample. Please listen to the information video in full then follow the instructions in the app – do not swab yourself until you are instructed within the app.

• For individuals aged 13 years and over, remove the child adapter from the swab.
• Insert the Swab into your nostril until the cap of the Swab touches your nose. It is important to insert as far as possible to ensure you get a good sample.
• If the individual is a child aged 2-12 years, insert the Swab until the Child Adapter touches their nose.
• Sweep the tip of the swab around the walls of your nasal cavity 3 times. Insert the swab in your other nostril and repeat.
  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.
• 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.

COVID-19 variants

Does the Ellume Test detect the COVID-19 variants?

The Ellume COVID-19 Home Test detects the commonly occurring known variants to date. The Ellume COVID-19 Home Test targets a protein deep in the virus (the nucleocapsid protein), which remains largely unchanged in the latest variants, including the Delta and other known strains. Ellume is confident our test will continue to detect infections caused by the current and emerging variants.

What should I do if I spill some Processing Fluid onto myself or the area where I’m using the product?

A spill should be wiped up taking care to avoid contact of Processing Fluid with your skin, eyes, nose, or mouth. If the Processing Fluid contacted your skin, eyes, nose or mouth, wash/flush with copious amounts of water. The reagent in the Processing Fluid contains ProClin® 300 which may cause an allergic skin reaction in some people. If irritation persists seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.

Frequently asked questions

Check out our list of FAQ's, maybe someone else has already asked that question.