Authors: Evan Liggett, MD, Shintaro Chiba, MD
Ellume Limited received FDA emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home rapid diagnostic test for COVID-19 on December 15, 2020.
The Ellume COVID-19 Home Test is a lateral flow immunoassay that uses liquid obtained from dipping a nasal swab from an individual 2 years of age or older into the included processing fluid, then runs that fluid along a surface with antibodies to SARS-CoV-2 antigens. The Bluetooth-connected analyzer then transmits the results to the individual’s smartphone using the dedicated app. Time to result is approximately 15-20 minutes. Additionally, using a HIPAA-compliant cloud connection, the test results are reported to health authorities. The approximate cost for this product is $30.
The FDA has authorized over 200 diagnostic tests for COVID-19 since the beginning of the pandemic, but the Ellume Home Test is the first to allow an individual to test at home without a prescription. This type of test has the potential to offer a substantial benefit in COVID-19 hotspots, and in areas where large gatherings take place, as it can allow users to quickly detect infection and self-isolate or seek medical attention before exposing others.
Like any test, false positive and false negative results can happen. According to the FDA, the test correctly identified 96% of positive samples and 100% of negative samples from individuals who reported concerning symptoms. In those without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. The positive predictive value (PPV) and negative predictive value (NPV) of a test are affected by the prevalence of the disease in the population and the FDA reminds individuals to self-isolate and seek medical attention if they test positive.
The Ellume COVID-19 Home Test includes a sterile mid-turbinate nasal swab with child adapter, a dropper, processing fluid, and a Bluetooth-connected analyzer. It provides animated on-screen instructions through the app. Results are displayed automatically on the screen in 15 minutes and there is real-time reporting through a HIPAA-compliant cloud connection.
The Ellume COVID-19 Home Test is suitable for asymptomatic or symptomatic individuals age 2 and above.
- COVID-19 Response.” Ellume, 22 Dec. 2020, www.ellumehealth.com/covid19-response/.
- Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19.” S. Food and Drug Administration, FDA, 15 Dec. 2020, www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic.