{"id":40876,"date":"2021-02-01T15:33:02","date_gmt":"2021-02-01T20:33:02","guid":{"rendered":"https:\/\/sciencebusiness.technewslit.com\/?p=40876"},"modified":"2021-02-01T15:33:02","modified_gmt":"2021-02-01T20:33:02","slug":"u-s-supports-home-smartphone-covid-19-test","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=40876","title":{"rendered":"U.S. Supports Home Smartphone Covid-19 Test"},"content":{"rendered":"
\"Ellume<\/a>
Ellume home Covid-19 test kit (Ellume LLC)<\/figcaption><\/figure>\n

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<\/a>, the White House senior advisor for Covid-19 response, said the Departments of Defense and Health and Human Services awarded Ellume<\/a>, 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.<\/p>\n

Ellume, in Brisbane, Australia and Valencia, California, makes a home Covid-19 test kit<\/a> 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.<\/p>\n

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<\/a>, 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.<\/p>\n

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\u00a0 and children more than two years old.<\/p>\n

Winner of RADx Covid-19 test challenge<\/h4>\n

In today’s White House briefing<\/a>, 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.”<\/p>\n

Ellume is a winner in the Rapid Acceleration of Diagnostics<\/a>, 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<\/a>, NIH started RADx in April 2020\u00a0as 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.<\/p>\n

In October, Ellume was one of six companies to reach the final RADx competition stage<\/a>, 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.<\/p>\n

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