The U.S. Food and Drug Administration (FDA) confirmed Friday that the first COVID-19 home saliva sampling test has been authorized by the agency, providing a potentially more convenient and less convenient way to diagnose the new coronavirus. While the FDA has given the green light to more than 80 COVID-19 tests in its emergency approval program, most tests are designed for healthcare professionals.
Most tests, however, represent a risk, given that anyone who comes in for testing is at risk of infecting or being infected by others present. The nature of the most common detection process also has its challenges. Nasopharyngeal swabs are the most common sampling process, but this process may cause discomfort to the patient. Not only is this uncomfortable, but it can also trigger a sneezing reaction, requiring medical staff to wear and replace personal protective equipment (PPE) repeatedly.
This saliva-based test uses a different method. It relies on Spectrum Solutions LLC’s SDNA-1000 saliva collection device, in which the testee spits saliva into it. Screw the lid on and shake the vial for 5 seconds. At this point, it can be transported back to Rutgers University’s Clinical Genomics Laboratory for practical testing. According to the FDA, the test will remain limited to prescription tests.
Authorization to use this test for home saliva sampling is done under the FDA’s Emergency Use Authorization (EUA) procedure. This was implemented at the beginning of the neo-coronavirus pandemic as a quick track of potential treatments, tests and increased use, considering that the COVID-19 vaccine has not yet been developed.
This is not the first test to collect samples at home. The COVID-19 RT-PCR test of LabCorp was approved by the FDA in April. It uses nasal swabs to collect samples, although only from the inside edge of the nasal cavity, and there is no deeper place. Like Rutgers’ tests, it requires doctor’s instructions to use it, and it still needs to be processed in the company’s own laboratory.
In addition, another group of researchers announced a new CRISPR-based test in April that is said to be available at home for near-immediate results.