Top News Stories for the Week of November 23

COVID-19 Testing Demand Surges Again, From Thanksgiving Travelers and Rising Infections

Wall Street Journal

Some people are finding it difficult to find available COVID-19 testing appointments at urgent and primary care facilities, while others are waiting hours in line to submit samples. The rising demand is caused by an increase in COVID-19 cases nationwide, by people wanting to get tested prior to the Thanksgiving holiday, and mandated travel requirements by some U.S. and overseas locations. In the New York tri-state area, it now takes 2-4 days to receive lab-based test results, says Natasha Bhuyan, MD, director of primary-care chain One Medical's regional medical director for the West. The company has operations nationwide and has redirected staff who usually conduct check-ups to instead collect patient samples. Nationwide, the average turnaround time for tests sent to commercial labs is now 1.92 days, compared with 1.68 days in October and 2.32 days in August, according to the U.S. Department of Health and Human Services.

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HHS Launches Pilot Program of Fast Molecular POC Test for COVID-19

HHS News Release

The Department of Health and Human Services (HHS) will test portable, cartridge-based COVID-19 molecular test kits made by Cue Health in five states. The Cue COVID-19 Test is a nasal swab point-of-care (POC) diagnostic tool that generates results in about 20 minutes. During the week of Nov. 9, HHS distributed 27,000 test kits, which included the Cue Sample Wand (nasal swabs), Cue COVID-19 Test Cartridges, and 600 Cue Health Monitoring Systems. Roughly 4,500 test kits and 100 cartridge readers were distributed to Florida, Louisiana, New Jersey, and Texas, and 9,000 test kits and 200 cartridge readers were sent to Alaska. The tests will also be used internally at the Department of Defense (DOD). The pilot program is part of a $481 million contract with Cue Health, Inc., awarded Oct. 13 by HHS in collaboration with DOD. The public-private partnership enables Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021. The contract includes delivery of 6 million COVID-19 tests and 30,000 cartridge readers to the U.S. government to support the domestic COVID-19 response. The Cue COVID-19 Test detects the virus's RNA. A trained health professional takes a sample from the lower part of the nose using the Cue Sample Wand nasal swab, inserts it into the Cue COVID-19 Test Cartridge, which is coupled to the Cue Health Monitoring System. After the cartridge reader analyzes the specimen, the device transmits the results to the Cue Health App on a linked mobile smart device.

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Lab Directors Discuss Unprecedented Challenges and Scrambling for Solutions During COVID-19 Pandemic

360Dx

During the recent virtual annual meeting of the Association for Molecular Pathology, lab directors discussed their experiences during the pandemic. Anthony Tran, the public health laboratory director of Washington, D.C., said when the city government said it would set up drive-through and walk-up clinics, he realized the lab required an automated system. His lab had been collaborating with Hologic as a clinical trial site for another assay, so its staff members were already trained to operate a newly installed Panther Fusion system. Tran's lab also replaced its fax and paper-based system with a web portal-based one as it monitored hundreds, sometimes thousands, of nasopharyngeal swab swabs in tubes. Teresa Karre, medical director of microbiology and serology at Nebraska Methodist Hospital and Children's Hospital and Medical Center in Omaha, noted that in her lab's case, allocation hindered its ability to validate pooling. She noted, "Also, our positivity rate right now is over 30 percent, so I don't think we would gain any efficiencies if we were to do [pooling] at this point, unfortunately." Karre said the lab is also encountering more demands to report cycle threshold data. Michael Bachman, associate director of the clinical microbiology lab at the University of Michigan and Michigan Medicine in Ann Arbor, said his team is now using five RT-qPCR tests on different systems, including lab-based, point of care molecular, and antigen.

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