The first home COVID-19 test using saliva samples has received launch approval, the U.S. FDA confirmed today, adding a potentially more convenient and less uncomfortable method of diagnosing coronavirus. Although the U.S. Food and Drug Administration has approved more than 80 COVID-19 tests as part of its emergency clearance program, the majority are designed for healthcare professionals.
This is a problem when healthcare facilities are overwhelmed with a variety of patents infected with the virus. It is also a risk because anyone who comes in for testing has the possibility of potentially infecting or being infected by other people present.
The nature of the most common test procedure also has its challenges. Nasal swabs are the most common type of sampling, but require a deep swab to reach the right areas. Not only is this uncomfortable, it also triggers a sneezing reaction in which healthcare workers who perform the test must wear and repeatedly replace their personal protective equipment (PPE).
This saliva-based test for the Rutgers Clinical Genomics Laboratory test uses a different method. It is based on the SDNA-1000 saliva collector from Spectrum Solutions LLC, into which the tested person spits. A lid is screwed on and the vial is shaken for five seconds. At this point, it can be returned to Rutgers for the actual testing process. According to the FDA, the test remains prescription-only.
Approval for use of the test and saliva sampling at home is subject to the FDA’s Emergency Use Authorization (EUA) procedure. This was implemented at the beginning of the coronavirus pandemic to speed up potential treatments, tests and more as there is currently no treatment or vaccine for COVID-19.
It is not the first home test. The Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR test was approved in April. Nasal swabs are used, but only from the inner edge of the nose and not deeper. Like the Rutger test, it requires a doctor’s order to be used, and it must continue to be processed in the company’s own laboratories, rather than making a diagnosis at home, for example in the form of a pregnancy test.
It is not offered at the moment, but it is definitely being worked on. In April, a research team announced a new CRISPR-based test method that is said to enable tests at home with an almost instant result.