Three scientists from Ortho-Clinical Diagnostics Inc, Rochester, NY, have received Johnson & Johnson’s top award for their pioneering work on an FDA-approved blood-screening test that detects a parasite now increasingly prevalent in blood donations in the United States.
Johnson Medals for research and development were awarded to Paul Contestable, principal scientist; Phil Hosimer, research fellow; and Harold Warren, director, research and development.
The trio collaborated on the development of a blood-screening test for Chagas’ disease—a blood-borne, parasitic infection that can cause lethal heart and intestinal conditions.
Ortho’s T. cruzi ELISA test system detects the presence of circulating antibodies raised by the body in response to infection caused by the blood parasite Trypanosoma cruzi, or T. cruzi.
Hosimer developed a process for creating an antigen source that would recognize all circulating antibodies to T. cruzi. Contestable led the development of the assay using the coated antigen developed by Hosimer. Warren helped ensure the product would stand the test of time in manufacturing and that it would flow readily through the manufacturing process.
In clinical trials, the test demonstrated 100% sensitivity with parasite positive and serological positive populations, and demonstrated an observed specificity of greater than 99.99 percent.
Since the FDA licensed the test in December 2006, some 260 blood donations nationwide have tested positive for exposure to the parasite known to cause Chagas’ disease. Blood donations that tested positive have come from 35 states, with the highest concentrations in California, Florida, and Texas, according to data compiled by the American Association of Blood Banks. Since testing began earlier this year, 17 Chagas-seropositive blood donations reported in the state of New York have been removed from the blood supply.
The American Red Cross was among the first blood collection agencies in the country to begin testing donations for Chagas’ disease in early 2007. Today, roughly 70% of US blood donations are being screened for Chagas’ using Ortho-Clinical Diagnostics’ test, according to the company.
The disease is endemic to most countries in Central and South America, and Mexico.
Transmission occurs through insect bites, blood transfusions, organ transplants, and via infected pregnant women to children in utero. Early infection is usually mild and unrecognized, but persists lifelong and may lead to organ damage, particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide. Infection also can be severe in people whose immune systems are suppressed, such as organ transplant recipients.
