The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Quest Diagnostics Self-Collection Kit for coronavirus 2019 (COVID-19).
The EUA granted users the ability to self-collect nasal specimens at either home or in a healthcare setting, to be shipped overnight at room temperature to certified testing sites.
More notably, collected specimens can be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test to have received EUA from the FDA earlier in March. The use of RT-PCR testing aids diagnosing infection of the COVID-19 virus.
Quest Diagnostics now intends to make the kits available through several channels including for patient care and healthcare workers, as well as for states and organizations aiming to bolster return-to-work testing programs. Eventually, the kits could be made available to other employers or individual users.
“The company will prioritize healthcare workers, first responders, law enforcement personnel and others critical to pandemic response to ensure they have timely access to the kit,” they stated. “The company expects to have more than a half-million kits available by the end of June, with plans to make additional kits available on an ongoing basis.”
The kit aims to improve on more invasive, “uncomfortable” methods of COVID-19 testing made available in the last months, while contributing to the currently limited supply of testing materials being made available in the US currently.
"We plan to utilize this device with a range of populations, from state-run programs and employers to healthcare providers and individuals," Jay G. Wohlgemuth, MD, senior vice president and chief medical officer of Quest Diagnostics, said in a statement. "Our scientists at our advanced diagnostics laboratory in San Juan Capistrano, California developed the technology, which has been validated in real-world studies."
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