AI powered device detecting SARS-CoV-2 within 20 secs currently under MHRA assessment

An Artificial Intelligence (AI) powered device able to detect SARS-CoV-2 (the virus that causes COVID-19) within 20 seconds is currently under UK MHRA assessment.

What is the test called?

The device is called SpectraLIT.

Who has developed this test?

The SpectraLIT device is a miniature spectrometer with advanced capabilities, operated by AI classification algorithms and developed by Virusight Diagnostic, Newsight’s joint venture with Sheba Medical Center’s ARC Innovation Center, one of the Top 10 Hospitals in the World according to Newsweek magazine. The testing procedure is easy to operate, with immediate results for symptomatic and asymptomatic patients.

Delivered by health technology company, Inventive Health (now knows as Syneos Health). The MHRA approval process is being driven by Inventive Health and is currently focussed on the nasopharyngeal swab with the mouthwash alternative following soon.

How does the device work?

The device uses mass spectrometry to generate high resolution spectral signatures of a sample’s contents. These signatures are interpreted using artificial intelligence as either positive or negative for SAR-Cov-2, the virus that causes COVID-19. Samples can be collected using either a nasopharyngeal swab or non-invasive mouthwash solution.

How does the test compare with PCR testing and where is it likely to be used?

According to Adrian Stevens, CEO, Inventive Health“PCR testing undeniably remains the gold standard but scaling laboratory testing is also troublesome and costly. Likewise, the time needed to perform and receive a result from a lateral flow test renders them impractical for larger groups. Whatever the venue, the ability to receive a highly reliable result in near real-time means SpectraLIT helps open the door to safely resuming normal day-to-day activities.”

“By making point-of-care testing for COVID-19 simple and quick, SpectraLIT can help protect the community as we return to open-border travel, enable sports venues to operate at full capacity, ensure care homes can safely welcome visitors, permit the reopening of nightclubs and reopen schools and universities to face to face learning.”

Is there any information available on the specificity or sensitivity of the test?

There is a limited amount of information on the Med-Tech news website which states:

Early clinical performance reports from the Baylor Scott & White Research Institute as part of the FDA approval process in the United States indicate SpectraLIT is at least 82% accurate in identifying symptomatic cases. However, it is noted that the accuracy is likely higher as the tests included samples over three days old and, as with all technology driven by Artificial Intelligence and Machine Learning, accuracy improves with usage.

Has the test already received regulatory approval elsewhere?

Yes, SpectraLIT has already been granted CE certification by the Obelis European Authorised Representative Center for use across EEA Member State. It is currently undergoing FDA approvals in the United States.

Inventive Health is working closely with government authorities and healthcare clinicians across the globe. As well as the UK, collaborations and trials using SpectraLIT are underway in over 30 countries including Malta, Poland, and Slovakia, across Africa, India, France, Gibraltar, and Mexico with other countries soon to be confirmed.

Source:

Med-Tech News

Israelscienceinfo website

Times of Israel website