The SDNA-1000 saliva collection device serves as a noninvasive way to collect, neutralise, stabilise, and transport testing samples
FDA authorisation has confirmed device’s efficiency in diagnosing Covid-19.. (Credit: visuals3Dde from Pixabay)
Spectrum Solutions has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SDNA-1000 saliva collection device to be used for the unsupervised self-collection of saliva for Covid-19 testing.
The FDA authorisation, which is based on the totality of scientific evidence, has confirmed the device’s efficiency in diagnosing Covid-19.
It serves as a noninvasive way to collect, neutralise, stabilise, and transport testing samples post-collection at ambient temperatures for over 10 days with no degradation in sample efficacy.
The Spectrum Solutions SDNA-1000 saliva collection system has been developed to avoid user collection errors.
It also eliminates the requirement for any bio-sample temperature-controlled storage or transport, as well as maintain critical bio-sample consistency for PCR testing.
Spectrum Solutions’ device is said to be the first device to secure FDA EUA authorisation for saliva-based Covid-19 testing.
Spectrum Solutions COO Bill Phillips said: “We have been anticipating this new FDA authorization in favour of the noninvasive self-collection of saliva.
“It brings with it the opportunity for testing service providers to significantly and conveniently expand access to easy at-home Covid-19 early detection in a more over-the-counter retail approach.”
In January this year, Spectrum Solutions secured CE mark approval for its SDNA-2000 and SDNA-3000 saliva collection devices for IVD molecular diagnostic testing across Europe.
The approval allows the integration of Spectrum SDNA-2000 model with over the counter at-home testing kits.
Spectrum stated that it has facilitated multiple organisations such as healthcare, education, government, and civic organisations, in addition to Major League Baseball, Minor League Baseball, and Little League in the development of ongoing testing programmes.