Quest Diagnostics, Secaucus, NJ, has received FDA emergency use authorization for the company’s self-collection kit for covid-19. The kit will enable individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider.
The self-collection kit allows an individual to swab the front part of the nostril and may be used on adults as well as children (when supervised by an adult). Specimens are shipped overnight via FedEx at room temperature. Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test, which received an emergency use authorization in March.
“Covid-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection,” says Steve Rusckowski, chairman, chief executive officer, and president of Quest Diagnostics. “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.”
“We plan to utilize this device with a range of populations, from state-run programs and employers to healthcare providers and individuals,” says Jay G. Wohlgemuth, MD, senior vice president and chief medical officer of Quest Diagnostics.
The self-collection kit was developed to be very consumer friendly. Key features of the new kit include the following:
- Self-collection by individuals, at home, with a consumer-friendly nasal swab approach.
- Overnight shipping to the individual and back to Quest Diagnostics with FedEx, leveraging their extensive logistics network.
- Specimens shipped at room temperature, eliminating the need for ice packs.
- Availability for children less than 18 years of age (with adult supervision).
- Results reporting through the myQuest patient portal and mobile app.
- Test data reported by Quest Diagnostics to the relevant departments of health as required.
The company plans to make the self-collection kits available through several channels, beginning with healthcare providers, patient care and healthcare workers, and the return-to-work testing programs of states and organizations. Over time, the kits may also be made available to other employers as well as to individual users of the company’s QuestDirect consumer-initiated platform.
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.
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.
For more information, visit Quest Diagnostics.