Coronavirus: FDA approves nasal self-collection kit for emergency use

May 28, 2020

More than 500,000 of the new kit from Quest Diagnostics will be made available by the end of June.

The U.S. Food and Drug Administration (FDA) has given emergency authorization the Quest Diagnostics Self-collection Kit for COVID-19, according to a news release.

The release says the kit will allow a patient to swab the front part of their nostril, can be used on children under adult supervision, and will be shipped overnight by FedEx at room temperature.

These samples can be tested using the Quest Diagnostics SARS-CoV-1 RT-PCR test, which preciously received emergency authorization from the FDA, according to the release.

"COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection," Steve Rusckowski, chairman, CEO and president of Quest Diagnostics, says in the release. "The self-collection kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods."

The new kit was developed to be consumer friendly by allowing specimen collection at home without the need to involve a healthcare worker to deliver or observe the collection, according to the release.

The kit will be available through several channels, including for healthcare providers for patient care and healthcare workers as well as for states and organizations for return-to-work testing programs. The kits may also be made available over time to other employers and individual users of the company’s QuestDirect consumer-initiated platform. Quest Diagnostics plans to prioritize healthcare workers, first responders, law enforcement personnel, and others critical to pandemic response to ensure they have timely acess, the release says.

More than half a million of the kits are expected to be available by the end of June with plans to make more kits available on an ongoing basis, according to the release.

"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 says in the release. "Our scientists at our advanced diagnostics laboratory in San Juan Capistrano, California developed the technology, which has been validated in real-world studies."