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.
