A human eye. Photo: Petr Novák/Wikipedia

Researchers at Israel’s Sheba Medical Center have teamed up with AdOM Advanced Optical Technologies, an ophthalmic medical device company, to study whether the surface of the eye can reveal a COVID-19 infection.

Israel’s largest medical center said that the study will be conducted to test if AdOM’s Tear Film Imager (TFI), a device which measures the eye’s tear film, can effectively diagnose and determine COVID-19 status. The study will compare the 40-second, noninvasive and inexpensive TFI eye exam to the COVID-19 PCR diagnostic test.

“We have already seen that the TFI has high sensitivity and specificity compared to a PCR in a previously conducted pilot study,” stated Prof. Eyal Zimlichman, Deputy Director General at Sheba Medical Center’s ARC Innovation Center, and chief investigator of the trial. “Our goal is to have hundreds of patients who are asymptomatic or symptomatic with COVID-19, irrespective of the variant and even those who have recovered, to see how the TFI device compares to the existing PCR standard of care.”

“If successful, this fundamental study could serve to endorse the TFI technology for virus detection by regulatory authorities,” Zimlichman added.

In a previous concept study carried out by Israel’s Wolfson Medical Center, the TFI device correctly diagnosed COVID-19 positive or negative patients, when compared to PCR testing. For this new trial, 500 patients are expected to participate over a testing period of 30 days.

In 40 seconds per eye, the TFI simultaneously measures the muco-aqueous and lipid sublayers of the eye’s tear film, at a resolution depth of a few nanometers. The device has already shown an ability to detect and quantify a virus within the surface of the eye, AdOM has said.

“The world urgently needs new diagnostic tools to help assess and diagnose aggressive viruses in a non-invasive manner, and with speed and efficiency.  However, the test also needs to meet the rigors of high sensitivity which is the hallmark of an approvable diagnostic device,” said Raanan Gefen, CTO of AdOM.

“If proven to have high correlation to PCR, this can be a game changer, as the TFI device can be utilized as a point of care diagnostic in many venues such as airports, sporting arenas, and businesses who want to have a simple, non-invasive test to determine the status of entering crowds,” he added.