Dr. Yaari: The procedure is entirely manual, you don’t even need electricity for illumination, just a pipette to take the drops of saliva and place in the testing kit. In developing countries, that could be a big deal.In one of those cruel medical ironies, the hepatitis C virus (HCV) is most commonly found in developing countries, where blood tests and other costly methods of detection are less available.
More than 170 million people are infected with the HCV virus around the world, including 4 million Americans and 9 million Europeans. Infection by the hepatitis C virus becomes persistent in about 70 percent of people afflicted, leading to problems such as cirrhosis and cancer of the liver.
That’s why the news that Israeli researchers have developed a test for the HCV based on a simple sample of saliva is so important and far-reaching. The findings of scientists at Soroka University Medical Center in Beersheva were recently published in the online edition of the Journal of Virological Methods. It suggests mass screening for the liver disease may be possible in the future in parts of the developing world where blood testing is less feasible.
“The procedure is entirely manual, you don’t even need electricity for illumination, just a pipette to take the drops of saliva and place in the testing kit. In developing countries, that could be a big deal,” said Dr. Arieh Yaari, head of the investigative team at Soroka.
Yaari explained to ISRAEL21c that the study was conducted in collaboration with Israeli company Orgenics, which since 1982, developed over 30 reliable and easy to use diagnostic test kits for infectious diseases.
“What we did was take one of Orgenics’ kits originally designed for blood testing and converted it to saliva testing,” he said, adding that the benefits of saliva testing over blood testing were multifold.
“Saliva is easy to obtain, especially from babies. And you don’t need skilled people, anyone can take a swab or spit. Taking blood from babies is not easy, but saliva is coming out of their mouths all the time.”
The virus was first identified in 1989. Current diagnosis methods are based on detecting antibodies against the virus in blood serum. This means that testing for the infection requires expensive equipment and puncturing the skin.
According to the report, “the aim of the present study was to develop a rapid, sensitive, economical, and easy-to-perform test for the detection of anti-HCV antibodies in saliva.”
Yaari and his team, including Dr. Marina Margalit, a biologist from Ben Gurion University of the Negev, examined the saliva-based test’s efficacy on 37 dialysis patients. People on dialysis have a high incidence of hepatitis C and tend to have compromised immune response levels, much like sick people in developing countries.
“People in dialysis units resemble poor people from developing countries in regards to their antibodies and immunology systems – they’re generally undernourished and immuno-suppressed – their immunology systems don’t work like healthy people,” said Yaari.
The saliva test was 100 percent successful at detecting HCV in patients with symptoms of infection. It performed better than the blood serum test at detecting infected people who had yet to develop symptoms.
The traditional serum test picked up just 63 percent of asymptomatic HCV-infected people. However, the new saliva-based test detected 94 percent of this group.
Following the success of the study, Yaari said he’s initiated further studies with over 60 patients, in order to confirm the results. At Orgenics, the company that developed the testing kit, there was also enthusiasm over the results.
“The results have been encouraging,” said Dr. Ouriel Faktor, the R&D manager at the company’s Yavne headquarters. “While the initiative is – for the time being – only for research, when it’s successful like this, it does the raise the possibility of using the results for commercial considerations.”
According to Faktor, the saliva test is based on the same patented platform as all of Orgenics’ kits devoted to infectious diseases – the ImmunoComb.
Named for its comb shape, the platform mimics an antibody blood test known as the ELIZA test – (enzyme-linked immunosorbent assay) commonly used to detect HIV antibodies in blood samples.
“The ELIZA test is an involved testing process using sophisticated machinery, and from our inception over 20 years ago, our aim was to provide Third World countries that can’t afford machines like that the ability to conduct rapid testing with a simple manual process,” Faktor told ISRAEL21c.
Meeting stringent performance/containment demands, Orgenics’ HIV system is used by the World Health Organization for its global campaign against AIDS. And last month, the company joined former US President Bill Clinton’s HIV/AIDS Initiative (CHAI) in lowering the prices of HIV diagnosis kits. As a result of their agreements with the Clinton Foundation, countries will be able to reduce the cost of HIV diagnosis by 50%.
“We’re proud to be part of the Clinton initiative. Since we founded Orgenics, we’ve been involved in HIV testing – and as science continues to improve, we come out with better tests,” said Faktor.
Just as their commitment to HIV testing has brought the company to the forefront of the industry, the results of the Soroka study could soon result in an effective, and inexpensive test to detect hepatitis C. For researcher Yaari, however, the commercialization of the research will not take place before its proper time.
“Only now, with the results of our study in, will we even begin to think about approaching the FDA about gaining approval,” he said.
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