The US Food and Drug Administration has granted an emergency use authorization (EUA) for the Covid-19 laboratory developed test (LDT), at Rutgers Clinical Genomics Laboratory (RCGL).
The LDT from RCGL is a diagnostic test featuring an option of using saliva samples collected by patients at home, to detect SARS-CoV-2, the coronavirus strain that causes Covid-19.
The FDA authorization allows the molecular-based LDT to test the saliva samples collected from patient, using a designated self-collection kit.
RCGL’s new Covid-19 diagnostic test will use self-collected saliva sample
The FDA authorisation for RCGL’s LDT would facilitate testing of a saliva sample collected from the patient using the Spectrum Solutions’ SDNA-1000 Saliva Collection Device.
The saliva sample collected by the patients will be returned to the laboratory in a sealed package for testing.
RCGL’s test is said to be the only authorised Covid-19 diagnostic test that makes use of saliva samples, and the test is done only under prescription.
The FDA authorisation only permits the testing of saliva specimens, which are collected using the SDNA-1000 Saliva Collection Device, at the RCGL using the molecular LDT Covid-19 test.
The authorisation builds on the last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.
In April, the FDA re-issued the EUA for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
FDA Commissioner Stephen M Hahn said: “Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19.
“This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site.
“We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”
