ORLANDO — Testing for hepatitis was one of the many subjects of the day as the joint meeting of the International Federation of Clinical Chemistry and Laboratory (Milan, Italy) and the American Association for Clinical Chemistry (AACC; Washington) got under way on Sunday.
The opening plenary session at the Orange County Convention Center, titled "The Natural and Unnatural History of Hepatitis C," was delivered by Harvey Alter, MD, of the National Institutes of Health (NIH; Bethesda).
Earlier in the day, Robert Dufour, MD, chief of pathology and laboratory medicine services at the Veterans Administration Medical Center (Washington), took on the topic of both hepatitis C (HCV) and hepatitis B (HBV).
"Who's doing [hepatitis] testing is changing, and even if you're not doing it now, you may be in the future," Dufour — who also is emeritus professor of pathology at George Washington University Medical Center — told his workshop audience.
He noted that when the VA decided to test all of its healthcare patients for hepatitis, his lab's workload increased by a whopping 500%.
And it's not just who's doing the testing that's changing, but where. Previously most hepatitis testing was done with serological testing, but today, much of the process is automated with instruments from the major diagnostic equipment firms, such as Abbott Laboratories (Abbott Park, Illinois) and Bayer Diagnostics (Tarrytown, New York).
And there is no doubt about the prevalence of the disease.
According to Dufour, chronic HCV affects about 2% of the U.S. population, or 2.7 million people. Chronic HBV is less prevalent, but still with a large number with the disease — about 1 million U.S. residents, most born outside the U.S.
Both variants may lead to cirrhosis, which can be deadly, and liver cancer, or hepatocellular carcinoma (HCC).
Cirrhosis, Dufour said, is expected to increase fourfold over the next 30 years and HCC incidence has doubled over the past 20 years, with an expected threefold increase over time.
Also, chronic HCV progresses to cirrhosis in 20% to 30% of cases, and then it may progress further to HCC. Men are more likely to develop cirrhosis than women.
However, Dufour said that with new, more effective therapies available today, "We may be able to alter that paradigm."
He went on to note that hepatitis C "is the most common reason for developing HCC in the U.S., Japan and Europe.
The five major serologic tests for HBV, which are still those "most widely used for hepatitis testing," Dufour said, are HBsAg, HBeAg and three antibody tests: Anti-HBs and two varieties of Anti-HBc.
For example, HBsAg is the first serologic marker to appear, on average about one to two months after exposure. It is present at least four to six weeks before an antibody response develops, according to Dufour.
Anti-HCV is the major screening test for HCV and is "the first antibody test we generally do," he said.
Dufour also discussed molecular testing alternatives for HCV and HBV. Some of the methods for the HBV DNA test, which measures copies/mL or pg/mL, are hybrid capture; branched DNA2.O; liquid hybridization; branched DNA 3.0 and Cobas Amplicor.
Also at AACC, Abbott Laboratories (Abbott Park, Illinois) reported that it has entered into a licensing agreement with Nephromics (Chestnut Hill, Massachusetts) for patents related to the development of in vitro tests to diagnose preeclampsia. Financial and other terms of the agreement were not disclosed.
Abbott obtains semi-exclusive rights to commercialize products using Nephromics' patents covering two proteins for detecting and monitoring preeclampsia. Currently, no specific diagnostic exists to determine this disease that threatens the lives of thousands of pregnant women each year, according to Abbott.
William Brown, PhD, vice president, diagnostic assays and systems development at Abbott, said that the goal is to develop "prenatal tests that could be utilized for early risk stratification of pregnancy complications." Such tests will be developed for use on the company's Architect immuno-assay and clinical chemistry system, he said.
Abbott develops medical devices, diagnostics, pharmaceuticals and nutritionals, marketing its products in 130 countries.