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.
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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.
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Woman Sentenced to Nine Years for Fraudulent COVID-19 Testing Scheme
An 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.
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Wearable Alerts for Respiratory Infections Spur Few to Get Tested
While wearables can detect potential respiratory infections, a new study shows that only a quarter of individuals follow up with at-home testing.
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FDA Clears Biofire Spotfire Respiratory/Sore Throat Panel Mini
bioMérieux’s Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini received US FDA Special 510(k) clearance and CLIA-waiver, according to the company.
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At-Home Antibody Tests Could Guide Need for COVID Boosters
At-home antibody tests can help determine if individuals have adequate immunity against COVID-19 and potentially guide decisions on the need for booster shots.
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FDA Authorizes Roche 4-in-1 Test for SARS-CoV-2, Influenza A/B, RSV
The FDA issued emergency use authorization to Roche’s cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, the company reports.
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Federal Home Testing Program Expands Nationwide, Adding Flu Services
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.
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AI Used in New COVID-19 Test Improves Accuracy
The 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%.
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Early Test Shortfalls Blur Long-COVID’s True Extent
New 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.
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Long COVID Diagnostic Test Launches in Australia
The test can help physicians diagnose long COVID, differentiate it from diseases with similar symptoms, and provide insights into personalized treatment approaches.
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FDA Grants De Novo Requests for Prescription COVID-19 Antibody Tests
These are the first marketing authorizations for COVID-19 antibody tests using a traditional premarket review process, according to the FDA.
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Laser-based Breathalyzer Sniffs out COVID in Real-Time
When 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.”
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FDA Warns Not to Use Certain SD Biosensor COVID-19 At-Home Tests
Approximately 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.
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FDA Issues EUA for Over-the-Counter COVID-19 Antigen Test
The 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.
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FDA De Novo Clearance for Rapid Antigen Test
The company was the first to receive FDA emergency use authorization for its Sofia 2 SARS Antigen FIA test in May 2020.
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A New Method to Detect RNA Viruses
The method, based on triplex-forming probe technology, opens up new options for detecting viruses like SARS-CoV-2, influenza A, or RSV.
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FDA Okays Lucira COVID-19 & Flu Test, First OTC Home Combo Test
The 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.
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NIH Launches Home Test to Treat, a Pilot COVID-19 Telehealth Program
NIH and ASPR, launch Home Test to Treat, a virtual health intervention to provide free COVID-19 health services in selected communities.
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COVID Antigen Testing Useful for Return-to-Work Guidance
A rapid antigen test can be used to triage healthcare workers for returning to work during periods of acute staffing shortages during COVID surges.
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COVID Antigen Tests Detect Past and Present Variants of Concern
Commercially 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.
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RADx Initiative to Fund Next Generation of COVID-19 Tests
Funding 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).
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School-aged Children can Self-swab for COVID Tests
With 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.
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Just How Accurate Are Rapid Antigen Tests? Two Testing Experts Explain the Latest Data
Even though demand for COVID-19 tests greatly overwhelmed supply earlier in the pandemic, rapid home tests are more available today.
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FDA Authorizes First COVID-Flu-RSV Test Without a Prescription
The 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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