FDA Clears Visby Medical Flu + COVID Test
Visby Medical's handheld PCR test that differentiates between influenza A, B, and COVID-19 received FDA clearance and a CLIA waiver.
Visby Medical's handheld PCR test that differentiates between influenza A, B, and COVID-19 received FDA clearance and a CLIA waiver.
Visby Medical’s handheld PCR test that differentiates between influenza A, B, and COVID-19 received FDA clearance and a CLIA waiver.
Read MoreAn investigation found that a California laboratory owner fraudulently billed $369 million for unnecessary respiratory pathogen panel tests during the COVID-19 pandemic, receiving $46.7 million in reimbursements.
Read MoreWhile wearables can detect potential respiratory infections, a new study shows that only a quarter of individuals follow up with at-home testing.
Read MorebioMérieux’s Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini received US FDA Special 510(k) clearance and CLIA-waiver, according to the company.
Read MoreAt-home antibody tests can help determine if individuals have adequate immunity against COVID-19 and potentially guide decisions on the need for booster shots.
Read MoreThe FDA issued emergency use authorization to Roche’s cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, the company reports.
Read MoreThe 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.
Read MoreThe test, approved for medical use in the United Kingdom, was found to be highly accurate with a detection rate of 98% and a specificity of 100%.
Read MoreNew data suggests that at least 4 million people with post-viral syndrome similar to long-COVID may indeed have detectable immune responses to support a COVID diagnosis.
Read MoreThe test can help physicians diagnose long COVID, differentiate it from diseases with similar symptoms, and provide insights into personalized treatment approaches.
Read MoreThese are the first marketing authorizations for COVID-19 antibody tests using a traditional premarket review process, according to the FDA.
Read MoreWhen compared to PCR, the gold standard COVID test, breathalyzer results matched 85% of the time. For medical diagnostics, accuracy of 80% or greater is considered “excellent.”
Read MoreApproximately 500,000 tests—which the FDA has “significant concerns” of bacterial contamination—were distributed to CVS Health, as well as about 16,000 tests to Amazon.
Read MoreThe home test can be used for serial testing for people who have symptoms within the first six days of symptoms or for people who do not have symptoms and undergo additional testing.
Read MoreThe company was the first to receive FDA emergency use authorization for its Sofia 2 SARS Antigen FIA test in May 2020.
Read MoreThe method, based on triplex-forming probe technology, opens up new options for detecting viruses like SARS-CoV-2, influenza A, or RSV.
Read MoreThe US FDA issued an emergency use authorization for the Lucira COVID-19 & Flu Test, the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B and SARS-CoV-2.
Read MoreNIH and ASPR, launch Home Test to Treat, a virtual health intervention to provide free COVID-19 health services in selected communities.
Read MoreA rapid antigen test can be used to triage healthcare workers for returning to work during periods of acute staffing shortages during COVID surges.
Read MoreCommercially available rapid antigen tests can detect past and present variants of concern, and researchers have identified potential mutations that may impact test performance in the future.
Read MoreFunding opportunities to develop COVID-19 tests are part of the Rapid Acceleration of Diagnostics (RADx) Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
Read MoreWith age-appropriate instructions, school-aged children can successfully use a nasal swab to obtain their own COVID-19 test specimen, according to research published in JAMA.
Read MoreEven though demand for COVID-19 tests greatly overwhelmed supply earlier in the pandemic, rapid home tests are more available today.
Read MoreThe US FDA authorized use of the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test — the first COVID-Flu-RSV test without the need for a prescription.
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