AdOM Advanced Optical Technologies and Israel’s Sheba Medical Center have launched the world’s largest study for the detection of Covid-19 on the surface of the eye.
The study will compare AdOM’s Tear Film Imager (TFI) — a quick, noninvasive and inexpensive exam — to the PCR diagnostic test, the current standard.
A successful proof of concept study at Wolfson Medical Center in Holon already demonstrated high specificity and sensitivity of the TFI vs. PCR in Covid-19 patients.
The validation trial at Sheba – Israel’s largest medical center – will test the TFI on about 500 patients over the next 30 days.
In just 40 seconds, the TFI simultaneously measures the muco-aqueous and lipid sublayers of the eye’s tear film, at a resolution depth of a few nanometers. These sublayers play an important role in the identification and treatment of specific eye conditions such as dry eye syndrome.
The TFI is used in countries including the United States and Japan. It’s one of the only commercially available devices that can identify and quantify a virus within the surface of the eye.
“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,” said chief investigator Dr. Eyal Zimlichman, deputy director general and chief innovation officer at Sheba Medical Center’s ARC Innovation Center.
“The world urgently needs new diagnostic tools to help assess and diagnose aggressive viruses in a noninvasive manner, and with speed and efficiency,” said Raanan Gefen, CTO of AdOM, which is based in Lod.
“However, the test also needs to meet the rigors of high sensitivity, which is the hallmark of an approvable diagnostic device. Different SARS variants as well as aggressive flu variants are threatening the world population and we are developing the TFI virus detection technology for high sensitivity within these large groups.”
If the TFI does prove to have high correlation to PCR, Gefen envisions it as a future point-of-care diagnostic in venues such as airports, sporting arenas and businesses.