Quest Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 nasal specimen self-collection kit.
Quest Diagnostics Self-collection Kit will enable individuals to gather a nasal specimen at home or in a healthcare setting upon deciding by a healthcare provider.
Quest Diagnostics senior vice president and chief medical officer Dr Jay Wohlgemuth said: “We plan to utilise this device with a range of populations, from state-run programs and employers to healthcare providers and individuals.”
The self-collection kit helps an individual to swab the front part of the nostril, and it can also be used on children under the supervision of an adult. Specimens will be shipped overnight through FedEx at room temperature.
Specimens collected using the kit can be tested with Quest’s SARS-CoV-2 RT-PCR test
Specimens collected using the kit can be tested with the company’s SARS-CoV-2 RT-PCR test, which secured EUA status in March. RT-PCR testing enables to diagnose infection with SARS-CoV-2, the virus responsible for the Covid-19 disease.
The new kit offers various benefits, including self-collection with a consumer-friendly nasal swab approach, overnight shipping to the individual and back to Quest Diagnostics with FedEx and specimens shipped at room temperature to eliminate the risk of ice packs.
Other benefits offered by the test include availability for children less than 18 years of age, results provided via the myQuest patient portal and mobile app and Quest Diagnostics will deliver the data to the relevant departments of health based on the requirement.
Quest said that it already tested specimens using a similar collection method in real-world settings in a drive-thru and other onsite Covid-19 testing sites across the US.
Quest Diagnostics chairman, CEO and president Steve Rusckowski said: “Covi-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection.
“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.”
In November 2018, Quest Diagnostics acquires the clinical laboratory services business of Boyce and Bynum Pathology Laboratories (BBPL), a provider of diagnostic and clinical laboratory services in the Midwest.
