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The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.
In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test to permit testing of samples that were self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Dr. Stephen Hahn.
CORONAVIRUS OUTBREAK LEADS TO NASAL SWABS BEING 3D-PRINTED
Coronavirus testing is in the spotlight as America fights to contain the outbreak. Data compiled by the CDC indicate that, since the start of April, up to 140,000 coronavirus tests a day have been conducted in the U.S.
“This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline,” explained the FDA, in its statement. “Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.”
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As of Tuesday morning, more than 2.49 million coronavirus cases have been diagnosed worldwide, at least 787,960 of which are in the U.S. The disease has accounted for at least 171,255 deaths around the world, including at least 42,364 people in the U.S.
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