Israeli firm’s handheld Covid test gets European approval
SpectraLIT's device, which is being piloted at 36 hospitals, got European Medical Devices Directive approval, which allows it to start rollout across the EU
An Israeli company has received European approval for its rapid coronavirus test which it is hoped will 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,” said Eyal Zimlichman, a senior doctor at Sheba Medical Center at Tel HaShomer in Ramat Gan, Tel Aviv, who helped to develop the technology.
He 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 owing to concerns about accuracy. The US Food and Drug Administration says such tests are “less sensitive and less specific than typical molecular tests run in a lab”.
Zimlichman said 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.
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