Is this saliva test for COVID-19 FDA-approved or authorized?

First, it is important to understand that any diagnostic test has two distinctive parts. Part one is the biosample collection. Part two is the processing, by an accredited lab, of that biosample to render an answer to the diagnostic question presented. Often these two parts get melded together and in totality called a “test”. Spectrum’s saliva collection kit takes care of part one. The individual parts of this process standing on their own are not a “test”.

The FDA makes a distinction between approved and authorized tests and devices. During normal conditions and states of affair, applications for approval on tests and devices are submitted to the FDA for approval. This is a lengthy process that requires many levels of validation, verification, and test trials for both the device manufacturer and/or test provider. This process in general spans anywhere from 18 months to many years. In situations like this COVID-19 pandemic, exceptions are made in the form of “authorizations” the FDA calls them Emergency Use Authorizations (EUAs). The intent of these authorizations is to place new innovative solutions that answer a specific need at the front of the validation line to fast-tracking their integration and usage for the period of time the emergency situation exists. Because this is an accelerated procedure to fill a specific need it’s deemed a temporary authorization, however still bears the weight of an FDA validated process. This means that the FDA has taken the steps to prove its accuracy, viability, and safety in a shortened amount of time.

There are individual EUA’s for every different and authorized type of COVID-19 test available. Deviation from the individual elements or processes that have been authorized by the FDA is not allowed unless authorized by the FDA. In October, Spectrum’s SDNA-1000 saliva collection system secured individual device FDA authorization (EUA 202432). This authorization provides a path for the immediate integration of saliva-based testing into current and authorized COVID-19 testing protocols without the need to apply for new, or amend existing, FDA testing authorizations. Spectrum’s EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning testing that incorporates saliva collected with the SDNA-1000 may be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA.