Ellume will be the first OTC diagnostic test for SARS-CoV-2 that can be done completely at home.
It's a rapid antigen test for patients age 2 and up...with or withOUT symptoms. Ellume gives results in about 15 minutes...and costs about $30 out of pocket.
Point out that Ellume requires access to a smartphone. The Ellume app walks users through the test...including how to get a mid-turbinate sample, which is deeper than a nasal swab.
The app also connects to the test's analyzer via Bluetooth...provides results...and reports them to public health as required.
Explain that Ellume may be a good alternative if PCR testing is limited in your area. Ensure patients understand pros and cons.
But in patients withOUT symptoms, false positives are more common.
Also educate to think twice about any negative result...especially in patients WITH symptoms. False negatives can be a problem with antigen tests. For example, Ellume's sensitivity may be as low as 80%.
If possible, recommend a confirmatory PCR test when Ellume's results don't turn out as expected...including patients withOUT symptoms who test positive and patients WITH symptoms who test negative.
Reinforce to quarantine while awaiting PCR results.
CDC now says exposed patients can stop quarantine after 7 days if they remain symptom-free AND have a negative antigen or PCR test day 5 or 6 post-exposure. Explain Ellume can be used in this case.
But a PCR test may still be required before traveling, resuming school or sports, etc. Advise checking before buying Ellume.
- www.fda.gov/media/144592/download (1-26-21)
- www.fda.gov/media/144593/download (1-26-21)
- www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html (1-26-21)
- MMWR Morb Mortal Wkly Rep 2021;69(5152):1642-7
- www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-options-to-reduce-quarantine.html (1-26-21)