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.
According to Spectrum Solutions, the company's saliva-based COVID-19 home test will be rolled out to the United Kingdom as part of the country's efforts to test its entire population, weekly.
New federal guidance says that insurers do not have to fully waive cost sharing for COVID-19 screening tests.
The FDA issued an emergency use authorization for the GWU SARS-CoV-2 RT-PCR Test to George Washington University’s Public Health Laboratory.
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The FDA authorized a Quest Diagnostics COVID-19 test for “pooled” samples, allowing four people to be tested with one assay.
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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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The US FDA revoked the emergency use authorization of the DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test from Chembio Diagnostic System Inc, due to performance concerns with the accuracy of the test.
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The US FDA issued an emergency use authorization for the Illumina COVIDSeq Test, the first COVID-19 diagnostic test utilizing next generation sequence technology.
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The CDC is seeking emergency use authorization for a new diagnostic test that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus.
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Researchers at Johns Hopkins have found that the chance of a false negative COVID-19 result is greater than 1 in 5 and, at times, far higher. The researchers caution that the predictive value of the reverse transcriptase polymerase chain reaction test (RT-PCR), which may not always yield accurate results.
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The FDA has added a voluntary EUA template for at-home sample collection kits for COVID-19 tests to its website.
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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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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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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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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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