The US Food and Drug Administration (FDA) confirmed Friday that the first saliva samples from 19 COVID-19 homes had been authorized by the agency, providing a potentially more convenient and less uncomfortable way to diagnose the new coronavirus. Although the FDA has given the green light to more than 80 tests for COVID-19 in its emergency approval program, most are designed for health care workers.
Yet most testing represents a risk, given that anyone who comes in for testing is likely to infect, or be exposed to, other people present. The nature of the most common detection processes also has its challenges. NASOPHARYNGEAL swabs are the most common sampling procedure, but this procedure may be uncomfortable for the patient. Not only is this uncomfortable, but it can also trigger a sneezing reaction, requiring the personal protective equipment to be worn and changed repeatedly.
The saliva-based test uses a different approach. It relies on a SDNA-1000 saliva collection device from Spectrum Solutions LLC, into which subjects spit their saliva. Screw the LID on and shake the vial for 5 seconds. At this point, it can be shipped back to the Rutgers University clinical genomics laboratory for practical testing. According to the FDA, the test will remain limited to prescription testing.
Authorization for use of the test and family saliva samples was made under the FDA's emergency use authorization (EUA) program. This was implemented at the beginning of the new coronavirus pandemic as a rapid tracking of potential treatments, testing and increased use, given that the COVID-19 vaccine has not yet been developed.
This isn't the first time a sample has been taken at home. LABCORP'S COVID-19 RT-PCR test was authorized by the FDA in April. It uses a nasal swab to collect samples, though only from the inside edge of the nasal cavity, not deeper. Like the rutgers test, it requires a doctor's instruction to use, and it still needs to be processed in the company's own laboratory.
In addition, another group of researchers announced in April a new CRISPR based test that they say can be tested at home with almost instant results.