LabCorp secures FDA EUA status for COVID 19 at home test kit
Laboratory Corporation of America (LabCorp) has secured emergency use authorisation from the US Food and Drug Administration (FDA) for its COVID-19 at-home test kit.
The FDA has re-issued the EUA status for the COVID-19 RT-PCR test to allow the testing of samples self-collected by patients at home using Pixel by LabCorp COVID-19 test home collection kit.
The EUA status enables to collect nasal swab specimens with the support of LabCorp’s test home collection kit. It will be conducted based on the COVID-19 questionnaire of a healthcare provider.
LabCorp president and CEO Adam Schechter said: “LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise.”
LabCorp will initially provide the kits to healthcare workers and first responders of the COVID-19 disease
The company will offer the at-home test kits via Pixel by LabCorp platform. The kits will be initially supplied to healthcare workers and first responders who are expected to be exposed to COVID-19 or may be symptomatic.
The LabCorp home self-collection kit is comprised of a specific Q-tip-style cotton swab for patients, which will be used to collect the sample.
According to FDA, the authorisation is only applicable to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit.
The FDA Commissioner Dr Stephen Hahn said: “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.”
In March, LabCorp introduced a test for Coronavirus Disease 2019 (COVID-19), in a bid to help better deal with the current public health crisis.
The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test has been designed to identify the presence of the underlying virus that causes COVID-19.
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