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.
Category: Testing
Testing
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Testing
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ATS/ERS PFT Standards Updated
The ATS and ERS have updated their pulmonary function tests technical standard series to address the uncertainty around the interpretation of tests.
Testing
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Siemens Healthineers CliniTest Antigen COVID Test Authorized by FDA
The Siemens Healthineers CliniTest Rapid COVID Antigen Self-test has received FDA authorization (EUA) for unsupervised self-testing by individuals age 14 and older. The test is also authorized for adult-collected pediatric samples for children ages 2-13.
FDA Authorizes OTC Flowflex COVID-19 Home Test
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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The Infection Control PFT Practices That Saw New Popularity During the Pandemic
The tools and best practices for handling infection control during pulmonary function testing have evolved and changed for the better during the pandemic.
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FDA Clears Siemens Healthineers’ First-of-its-kind CT Scanning Device
The US FDA has cleared the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner.
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Less-sensitive COVID-19 Tests May Still Achieve Optimal Results if Enough People Tested
A computational analysis of COVID-19 tests suggests that, in order to minimize the number of infections in a population, the amount of testing matters more than the sensitivity of the tests that are used.
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Frequent Antigen Testing Detects COVID-19 at Lower Cost
Antigen tests and PCR tests were equally effective in detecting SARS-CoV-2 infection when tests were given on a regular cadence every three days.
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Additional Authorization for Opti Medical SARS-CoV-2 Test
The Opti SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI Rapid Lysis Buffer.
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Exalt Single-use Bronchoscope Gets CE Mark in Europe
Boston Scientific Corp has completed CE Mark for the Exalt Model B Single-use Bronchoscope, a single-use device designed for bedside procedures in the ICU, operating room, and bronchoscopy suite.
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FDA Authorizes Symbiotica COVID-19 Self-Collected Antibody Test
The US FDA has issued an EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
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First SARS-CoV-2 Test Granted Marketing Authorization
The FDA granted marketing authorization to the BioFire Respiratory Panel 2.1, the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the COVID-19 public health emergency.
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New COVID Test Pooling Strategy Offers Early Outbreak Detection
Researchers have proposed a new quantitative strategy for pooling COVID-19 tests in order to monitor spread and detect outbreaks early within closed communities, such as nursing homes or universities.
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FDA Authorizes First Molecular Non-Prescription, At-Home COVID-19 Test
The US FDA has issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter Use.
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COVID-19 Nasal Swab Test May Not be Best For Those Who’ve Had Sinus Surgery
People who have had major sinus surgery should consult their ENT doctor before undergoing COVID-19 swab testing, new research indicates.
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