U.S. Supports Home Smartphone Covid-19 Test

Ellume home Covid-19 test kit (Ellume LLC)

1 Feb. 2021. The U.S. government is funding large-scale production of Covid-19 home test kits that send results to the user’s smartphone. At a briefing today, Andy Slavitt, the White House senior advisor for Covid-19 response, said the Departments of Defense and Health and Human Services awarded Ellume, the test’s developer, will start sending 100,000 test kits a month to the U.S. through July, and awarded $230 million to scale-up manufacturing for millions of tests for use in the U.S.

Ellume, in Brisbane, Australia and Valencia, California, makes a home Covid-19 test kit that individuals can purchase and use without a prescription. The tests employs a mid-turbinate nasal swab that collects a specimen from the back of the nostril, but not as deep into the nose and throat as a nasopharyngeal swab used in reverse transcription – polymerase chain reaction or RT-PCR tests that requires a trained clinician. After collecting a sample, the user puts the swab into a digital analyzer unit that returns results in 15 minutes. The analyzer unit is connected via Bluetooth to an Ellume smartphone app that displays the results.

The Ellume test analyzes specimens for antigen proteins associated with the SARS-CoV-2 virus causing Covid-19 infections. While RT-PCR tests are rated the gold standard for SARS-CoV-2 diagnostics, since they directly detect the virus, antigen tests are considered good enough for fast screening for Covid-19 infections. In December 2020, Food and Drug Administration granted the Ellume test an emergency use authorization, citing the test’s ability to correctly identify 96 percent of positive SARS-CoV-2 samples and 100 percent of negative samples in people with symptoms.

For samples from individuals without symptoms, the test returns correct results 91 percent of the time in people testing positive for SARS-CoV-2 and 96 percent for persons testing negative. FDA authorizes the Ellume test for adults  and children more than two years old.

Winner of RADx Covid-19 test challenge

In today’s White House briefing, Slavit noted Ellume will send 100,000 test kits a month to the U.S. from February to July. In addition, says Slavitt, the “departments of Defense and HHS awarded $230 million to Ellume in order to scale the capacity of this test. Thanks to this contract, they will be able to scale production to manufacture 19 million tests a month by the end of the year, 8.5 million of which are guaranteed to the U.S. government.”

Ellume is a winner in the Rapid Acceleration of Diagnostics, or RADx, program, a challenge competition established by National Institutes of Health to make tests for SARS-CoV-2 viruses more widely available and return results faster. As reported by Science & Enterprise, NIH started RADx in April 2020 as crowd-sourced challenge to find the best candidates for point-of-care and at-home Covid-19 diagnostics that can translate into large numbers of inexpensive and easy-to-use tests, in a relatively short period of time.

In October, Ellume was one of six companies to reach the final RADx competition stage, receiving contracts from HHS’s Biomedical Advanced Research and Development Authority scale-up and manufacturing. Ellume’s award at that time covered tests designed for clinical as well as home use.

More from Science & Enterprise:

• Gates Funding Home-Based Crispr Covid-19 Diagnostic
• Inexpensive Chip Detects Covid-19, Other Pathogens
• Simpler Method Devised to Validate Covid-19 Tests
• FDA Grants Emergency Clearance for Home Covid-19 Test
• Covid-19 Saliva Test Earns FDA Emergency Clearance

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