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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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 Clears First Over-the-Counter COVID-19 Antigen Test
The US Food and Drug Administration cleared for marketing the first over-the-counter antigen test for COVID-19.
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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. Â
Read MoreFDA Issues EUA for COVID-19 Home Antigen Test
The over-the-counter test can be used for serial testing for people who have symptoms within the first five days of symptoms or for people who do not have symptoms.
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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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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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SARS-CoV-2 Antigen Levels Linked to COVID Severity, Outcomes
The amount of SARS-CoV-2 antigen measured in the blood of patients hospitalized with COVID-19 is associated with illness severity and other clinical outcomes, according to a new study published in the Annals of Internal Medicine.Â
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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 Warns Against Use of Skippack Medical COVID Antigen Tests
The US FDA is warning consumers and healthcare providers to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) because these tests are not authorized, cleared, or approved by the FDA.
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FDA Warns Consumers Over Counterfeit Home COVID Tests
The FDA says it is “aware” of counterfeit home COVID tests being distributed or used in the US and warns consumers to be on the lookout.
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Are Rapid Antigen COVID Tests Useful for Variants?
While rapid antigen COVID tests remain a useful tool for the detection of COVID-19 infections, continuous assessment and updating is likely needed in the context of variants of concern.
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Recall for Celltrion DiaTrust COVID Rapid Tests
Celltrion USA is recalling up to 311,000 affected POC DiaTrust COVID Rapid Tests because the tests may have been distributed to unauthorized users.
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Class I Recall for E25Bio Tests for COVID-19
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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FDA: Stop Using LuSys Laboratories COVID-19 Tests
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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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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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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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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