The federal government has expanded the Home Test to Treat program, a virtual health program offering free COVID-19—and now influenza—health services to eligible participants nationwide.
The company was the first to receive FDA emergency use authorization for its Sofia 2 SARS Antigen FIA test in May 2020.
Even though demand for COVID-19 tests greatly overwhelmed supply earlier in the pandemic, rapid home tests are more available today.
C. Michael White, a professor of pharmacy practice, and Adrian V. Hernandez, a clinical epidemiologist, both from the University of Connecticut, explain how the Biden administration’s new “test to treat” initiative will make use of pharmacies.
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Researchers at the University of Florida and National Yang Ming Chiao Tung University in Taiwan have developed a 30-second COVID test that can detect coronavirus infection in as sensitively and accurately as the gold standard PCR test.
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E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA.
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Base10 Genetics is recalling the RNAstill MTM specimen collection kits because they were distributed without proper premarket clearance from the FDA.
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The US FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART), according to an agency alert.
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The Siemens Healthineers CliniTest Rapid COVID-19 Antigen Self-Test is now available in the United States. The test received FDA authorization in January 2022.
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A new study, published this week in JAMA Internal Medicine, shows that people using COVID home test kits may fail to self-quarantine or may quarantine unnecessarily because they misinterpret the implications of test results.
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Mild symptoms, poor knowledge of nearby testing sites, and certain demographic factors have been identified as barriers to COVID-19 testing.
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The FDA has warned consumers to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.
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The earliest batch of COVID-19 tests distributed by the US CDC exhibited false positive reactivity of negative controls due to flaws in assay design and contamination in one of the assay components, according to a CDC internal investigation.
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Even though COVID-19 testing has become part of most people’s everyday conversation, many people still have questions about the difference between antigen and PCR tests, including when and how to use them.
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The FDA has issued an emergency use authorization for the Acon Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test.
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