Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
The Associated Press - Tuesday, December 10, 1996 17:14:00 PM.
Jane E. Allen, AP Science Writer
Gen-Probe Inc. hopes by 1999 to provide blood banks nationwide with the three-hour lab test, Frank Nordhoff, the company's president and chief executive, said Tuesday.
The hope is to reduce the amount of tainted, donated blood from recently infected donors that slips through testing and gets to patients through transfusions.
"Currently, maybe as many as 200 transfusions out of 12 million blood donations may still transmit hepatitis C. This should prevent more than half of them," said Dr. Peter Page, senior medical officer for the American Red Cross Biomedical Services.
"There may be as many as 20 HIV transmissions per year out of 12 million donations," he added. "This should prevent more than half of those."
The test, being developed under a $7.7 million contract from the National Heart, Lung and Blood Institute, detects the deadly viruses in newly infected individuals who have not yet developed antibodies that are the traditional signposts of infection.
The Gen-Probe test instead picks up the viruses' genetic material, either DNA or RNA, which shows up in the blood sooner than the antibodies, Nordhoff said.
The test will allow labs to eliminate blood from donors whose infection is so recent that it can easily escape detection. It takes 22 days from the day of infection for most antibody tests to detect HIV; a quicker test, to pick up a protein in the virus, still takes 16 days.
The Gen-Probe technology can pick up HIV in just 11 days, Page said. For hepatitis C, the 70 days in which the virus cannot be detected by existing tests will be trimmed to 25 days.
The Red Cross estimates that five out of every 100,000 units of donated blood test positive for HIV. For hepatitis C, a virus discovered in 1989 that is a major contributor to cirrhosis of the liver and liver cancer, that figure increases to 150 per 100,000 units.
"As a practicing physician who orders blood transfusions, this is welcome news," said Dr. Scott Hitt, chairman of the Presidential Advisory Council on AIDS and HIV, and an internist with Pacific Oaks Medical Group in Beverly Hills, the nation's largest AIDS practice.
Gen-Probe officials said the U.S. Food and Drug Administration has promised a speedy, four-month review of the test.
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