US FDA authorizes first at-home coronavirus sample collection kit

The US Food and Drug Administration (FDA) has given authorization to the first coronavirus test that allows people to collect their own samples at home, using a nasal swab, before sending them off to a lab for analysis.

Hyderabad: The US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to LabCorp allowing it to test self-collected nasal swab samples from patients for coronavirus disease with its COVID-19 RT-PCR Test.

FDA first granted LabCorp an EUA for the test on 16 March, but limited sample collection to upper and lower respiratory specimens collected by healthcare providers.

In a statement, FDA Commissioner 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."

The LabCorp said that its at-home collection kits will initially be used for health care workers and first responders who may have been exposed to the virus or have symptoms.

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The company plans to make the kits, which require the patient to fill out a questionnaire and obtain a recommendation from a health care provider, more broadly available in the coming weeks. It is unclear how many kits LabCorp is immediately distributing or can manufacture moving forward.

It is pertinent to mention here that the EUA permits at-home sample collection, the testing itself must be conducted at LabCorp’s Center for Esoteric Testing and other Clinical Laboratory Improvement Amendments (CLIA) certified high complexity laboratories designed by the company.

The EUA also includes several conditions for LabCorp to follow, including providing fact sheets for health care providers and patients and standard operating procedures for performing the tests to authorized laboratories.