Along with vaccination, masks, social distancing and other precautions, at-home COVID-19 antigen tests continue to be an important part of that safety calculation. In fact, accessibility to at-home tests is a key element of today's announcement by the Biden Administration aimed at supporting better detection and prevention of COVID-19 this winter. Add in the annual flu season, which experts predict may be worse than usual, and at-home testing will provide more clarity to individuals, as the flu and COVID share many similar symptoms.

Today we received good news with the Biden administration announcement that they plan to purchase 500 million rapid COVID-19 tests and distribute them free of cost to Americans. There are now multiple at-home testing products available from which consumers can choose. The difficulty that comes with this influx of new products is determining which product best serves consumers and their families is more confusing than ever.

"People are eager to return to a sense of pre-COVID normalcy after spending last year's holiday season separated from their families and friends. But they are also understandably anxious, particularly with the arrival of the Omicron variant, to make sure they're doing everything they can to protect their families during those holiday gatherings – including stocking up on at-home COVID tests to help everyone stay safe while they're together. The difficulty is knowing which at-home test to choose, each with important differences that aren't always immediately obvious or easy to decipher," said Dr. Sean Parsons, Founder and Chief Executive Officer of Ellume.

Parsons continued, "Together with public health officials and our colleagues in the medical community, Ellume is committed to providing education to consumers as they seek to better understand their options for regular at-home COVID testing. Understanding the available options serves to help us all enjoy this long-awaited holiday season safely."

WHAT CONSUMERS SHOULD KNOW WHEN CONSIDERING AT-HOME COVID ANTIGEN TESTS:

What are the differences between lab-based molecular tests (PCR) and rapid home antigen tests?

• Antigen and PCR tests are the two primary types of tests used to detect current, active infections of the SARS-CoV-2 virus. Each has differences including:
• Performance: PCR tests have better performance than rapid antigen tests
• Time to Result: Laboratory-based PCR results typically take at least 24 hours, while antigen tests typically take 15-30 minutes to provide a result.
• How Results are Generated: Antigen tests detect parts of the virus (proteins on the virus surface) that produce an immune response.¹ PCR tests detect genetic material from the virus.²
• Location for Testing: Antigen tests can be performed at home, by the general public or in the doctor's office, without the need for specialized lab-based equipment or training. While there are a few molecular based home tests, generally PCR tests are performed by healthcare professionals in a doctor's office or testing site or by trained personnel in a laboratory.
• Both types of tests have an important role to play in combating the pandemic: Antigen tests are useful for frequent, inexpensive and wide-spread testing or where results are required quickly; PCR tests are better utilized in situations where certainty in the result is essential such as in healthcare settings, treatment of high-risk individuals and in confirming antigen test results.

What should I look for as I'm comparing at-home rapid antigen tests?

• Single Use vs Serial: While the majority of antigen home tests require serial testing (i.e. two tests days apart to confirm results), there are a very few that require one test only.
• The Ellume Difference: The Ellume COVID-19 Home Test is one of the few home tests that require a single test only for symptomatic or asymptomatic people, due to its high sensitivity in clinical trials in both groups, with a demonstrated sensitivity of 96% in symptomatic and 91% in asymptomatic individuals.
• Point of Care Tests vs Designed for Home Use: Many antigen self-tests were born from existing point-of-care tests that have been modified for use at home for people who have not been specifically trained in testing.
• The Ellume Difference: The Ellume COVID-19 Home Test was designed specifically for untrained, at-home use. Extensive studies were conducted to ensure excellent usability and comprehension for users.
• Swabbing: The majority of rapid antigen home tests use a standard nasal swab. These swabs, while commonly available, are designed to collect shallow samples from the nostril walls. However, samples pulled from deeper in the nasal passage are known to have a higher viral concentration and are more likely to obtain a more accurate result. In addition, new generation "flocked" swabs provide superior sample collection resulting in a higher sample yield and a more accurate result. Traditional fiber (non-flocked) swabs collect and retain significantly less sample.³
• The Ellume Difference: For its test, Ellume developed a high-quality swab specifically for consumer use that includes a patented, comfortable flock-tip and accompanying child adaptor to ensure safety and comfort. In addition, Ellume's test also collects a slightly deeper mid-turbinate nasal swab, versus a standard nasal swab, offering the best compromise between sample quality and patient usability and acceptance. Samples pulled from deeper in the nasal passage have higher viral concentration and may lead to a more accurate diagnosis.⁴
• Digitally Connected Tests vs Analogue: Most available home-tests are simple, visually read lateral flow strip tests, while the newer generation of tests now include digitally connected apps that display an individual's results directly on the user's smartphone. In addition, simple strip tests require the user to visually interpret sometimes faint lines to obtain their result, which can be highly subjective and open to misinterpretation. More recently, a few of the simple strip test products incorporated a new/additional step that includes asking the user to take a photo of their result which was then interpreted by the app.
• The Ellume Difference: The Ellume COVID-19 Home Test uses a customized app, which provides an instructional video and guides users through each step of the testing process to ensure the self-testing process is simple, safe and minimizes human error. The Ellume test automatically generates a fully digital result displaying the word "positive" or "negative," without the need for test lines to be interpreted, or photos to be taken. Additional information about next steps, links to the CDC, and customer support are provided to support the user after testing is complete.
• Internal Controls: Internal controls indicate when an adequate human sample has been collected and added to the test to ensure the test produces a reliable result. The majority of tests do not have a mechanism to ensure users are swabbing effectively. Without an internal control, the user will receive a negative result if too little sample has been collected, increasing the risk of a false negative result.
• The Ellume Difference: Ellume offers an internal sample integrity control system to help ensure sufficient sample has been collected for the most accurate results.
• Reporting: The U.S. Government mandates that all COVID-19 test results be reported to public health authorities to allow them to track COVID-19 outbreaks as they occur, but many of the simpler tests do not include an automatic reporting function. These tests simply instruct the user to contact their healthcare provider to report the result. 
• The Ellume Difference: Ellume simplifies the process for users by automatically sharing the result with HHS and other public health authorities, providing important information to identify COVID-19 outbreaks in real time. Personal data shared is kept to a minimum (i.e. date of birth, state and zip code) to protect consumer identity and privacy.

A RECAP - THE ELLUME COVID-19 HOME TEST:
In developing its Ellume COVID-19 Home Test (ECHT), Ellume took a different approach than many other products on the market – one that provides increased sensitivity without the cost, complexity and accessibility issues of a laboratory-based molecular (PCR) test. The ECHT was the first rapid home antigen test clinically proven for use with and without symptoms and continues to be one of the only rapid antigen tests approved for both – with sensitivity (ability to detect a positive case) and specificity (ability to determine a negative case) rates higher than other antigen home tests currently on the market. The ECHT is also the only test that uses fluorescent technology, a detection technology otherwise used by healthcare professionals, which provides superior sensitivity. The test's swab/dropper format employs slightly deeper swab collection, offering the best compromise between sample quality and patient usability/acceptance. Utilizing an app that guides the user through the test steps and displays the results within 15 minutes, the ECHT also includes a sample integrity control system to minimize the risk of false negative results.