FDA Authorizes First COVID-19 Test Where Results Can Be Read Directly From Testing Card
The BinaxNOW COVID-19 Ag Card is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
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FDA Authorizes BD Veritor 15-min COVID-19 Antigen Test
The US FDA has authorized the BD Veritor Plus SARS-CoV-2 assay, a rapid, point-of-care, antigen test manufactured by Becton Dickinson.
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High Altitude Simulation Test: Everything Else Is Just a Guess
HAST is an inexpensive diagnostic test that effectively calculates a patient's supplemental oxygen needs for traveling at high altitude. So why aren't more health care facilities offering it?
FDA Okays Everlywell COVID-19 Test Home Collection Kit
The US FDA issued an emergency use authorization for the Everlywell COVID-19 Test Home Collection Kit, an at-home sample collection kit that allows screened patients to collect and send a nasal swab sample for testing.
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FDA Issues Alert for Potential False Negatives for Abbott COVID-19 Test
The US FDA issued a public alert that the Abbott ID Now point-of-care test may return false negative results for COVID-19 patients.
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First Antigen Test Authorized for COVID-19
Antigen diagnostic tests quickly detect fragments of proteins found on or within SARS-CoV-2 by testing samples collected from the nasal cavity using swabs.
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First Saliva-based COVID-19 Test Authorized for At-home Collection
The FDA issued an emergency use authorization for the Rutgers COVID-19 laboratory developed test that uses saliva samples self-collected by patients at home.
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Rheonix COVID-19 Test Gets FDA OK
Rheonix Inc has received emergency use authorization from the FDA for the Rheonix COVID-19 MDx Assay, which can provide same-day results.
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QuestDirect COVID-19 Antibody Test Available to Consumers
Quest Diagnostics has launched a consumer-based COVID-19 antibody test called QuestDirect, which can be ordered online without the need for a doctor’s visit.
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New High-speed COVID-19 Antibody Test Launched
Genalyte has released its rapid SARS-CoV-2 Multi-Antigen Serology Panel, a COVID-19 diagnostic that can detect antibodies in patients who have had the virus.
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First At-home COVID-19 Test Kit Authorized by FDA
LabCorp’s Pixel COVID-19 Test home collection kit allows patients to self-swab their nose and mail their sample to LabCorp for testing.
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FDA Approves Synthetic Swabs for Coronavirus Testing
The US FDA has approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19. The swabs can be used for self-administered home testing for coronavirus, the FDA says.
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Abbott COVID-19 Antibody Tests Begin Shipping
Abbott has launched a COVID-19 IgG antibody test with plans to ship 1 million tests this week and 4 million tests in total for April.
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FDA Authorizes First Saliva-based Coronavirus Test
The FDA has granted emergency use authorization (EUA) for the Spectrum DNA SDNA-1000...
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Siemens RapidPoint 500e Blood Gas Analyzer Cleared by FDA
The Siemens Healthineers RAPIDPoint 500e Blood Gas Analyzer has received clearance from the US FDA.
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