An Israeli company said Wednesday that it received European approval for its rapid coronavirus test and it was poised to help kickstart international travel.
The handheld SpectraLIT machine eliminates the need for complex lab equipment by shining light through samples and giving immediate results using the spectral signature.
This means that staff in airport booths who are currently tasked with collecting test samples and dispatching them to labs will simply have a machine at hand and be able to give passengers results after just 20 seconds of analysis.
The system, which is being piloted at 36 hospitals worldwide, received European Medical Devices Directive approval for a swab version of its test, which allows it to start rollout across the European Union.
This represents a regulatory green light for most of the technology used in its flagship product: a gargle test that eliminates the need for swabbing and generates results from a mouthwash sample.
“This is an important milestone for fast testing,” Eyal Zimlichman, a senior doctor at Sheba Medical Center who helped develop the technology, told The Times of Israel.
“Despite the global rollout of vaccination efforts, COVID-19 still needs rapid diagnostic solutions to take steps back to normality, including international travel, and this represents an important milestone.”
Handheld antigen tests are becoming more widely available, but authorities are reluctant to deploy them in places like airports due to concerns about accuracy. The US Food and Drug Administration says that such tests are “less sensitive and less specific than typical molecular tests run in a lab.”
Zimlichman said that SpectraLIT consistently achieves relatively high accuracy — 70-80 percent — and is an important addition to the market because it will be very cheap. He said the accuracy of the artificial intelligence system was likely to increase over time.
Eli Assoolin, who led the development team, said he now expects the swab version and gargle version of his test to be widely rolled out, including at airports, in the coming months.
“We think that the mouthwash test will soon be a solution that is widely used across the world,” he said, adding that the swab test approval is also important, as it allows cheap and reliable testing with minimal equipment.
Instead of relying on chemicals and lab processes to make coronavirus RNA readable by detection devices, as with regular swab tests, the small SpectraLIT machine shines light through the sample and onto a special chip to determine whether a person is COVID-positive.
Part of the light is absorbed, and the rest is captured by the sensors. The process is known as determining the sample’s spectral signature: matter reflects different light signatures, depending on its composition.
The test was developed by Assoolin’s company Newsight together with Sheba Medical Center under the freshly formed Virusight Diagnostic.
The company delayed a deployment in airports that was planned for late 2020, after the outbreak of several mutated COVID-19 variants, but Assoolin said that the software has now been adjusted to cover all strains and can easily be recalibrated to detect new variants.
He added that the artificial intelligence platform can also be tweaked to detect other pathogens, meaning he believes it is a solution that will be deployed in future health crises.
“Virusight’s artificial intelligence is actually a diagnostic platform for many potential cases of pathogen diagnosis, able to change the way the world deals with pandemics,” he said.