Quest Wins EUA for COVID-19 Self-Collection Kit

Quest Diagnostics has won emergency use authorization for a self-collection kit for COVID-19. The Secaucus, NJ-based company said its test is for 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 children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack). Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March. RT-PCR testing aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19. "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, said in a 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." Quest won its first EUA for a COVID-19 test in early March. The company went on to begin performing antibody testing for COVID-19 using blood samples. This move came as Quest announced it would furlough about 9% of its workforce.    
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 IVD Source Type: news