The world received an important tool in the fight against AIDS with the U.S. Food and Drug Administration's recent approval of the first complete urine test system for HIV-1. The highly accurate test, invented by researchers at New York University School of Medicine, promises to broaden the acceptance and availability of HIV testing worldwide.
Urine testing offers important advantages compared to blood-based HIV tests, including greater safety and ease of use for health-care workers, lower cost of sample collection, and stronger consumer acceptance.
"The new test is extremely useful and should expand the reach of HIV testing," says the lead inventor, Alvin Friedman-Kien, M.D., Professor of Dermatology and Microbiology at NYU and a pioneer in the field of AIDS. "Most people don't want to have their blood drawn, but anybody will give you a urine specimen. And in developing countries, where they don't have the personnel and the sterile needles and syringes for drawing blood or the equipment to test it, a urine test will be a real boon."
Since HIV is not spread through urine, urine-based testing eliminates the risk of infection to health-care workers through accidental exposures. Another advantage of the new test is its simplicity. The patient need only provide a urine sample, which requires no preservation and can remain stable for 55 days at room temperature. The test itself is performed with commonly available technologies and instrumentation.
The urine test, which is being manufactured and marketed by Calypte Biomedical Corp. of Berkeley, Calif., under an exclusive license from NYU, should promote greater public acceptance of HIV testing. Surveys show that people avoid HIV tests, at least in part, because of a fear of needles. It is estimated one-third of Americans infected with the AIDS virus are unaware of their HIV status.
"It's important that people get tested," says Dr. Friedman-Kien. "First, we know that triple therapy started early delays and may even prevent the onset of HIV disease. Second, people who are made aware that they are infectious may not spread the disease as rapidly to other people. In addition, increased testing will tell us more about the epidemiology of HIV. The true incidence of this disease is not thoroughly known or understood."
Even less HIV testing is done abroad. According to the World Health Organization and UNAIDS, 30 million people worldwide are infected with HIV, yet only 10 percent know their HIV status. This should change with the availability of the urine test, which will cost only about one-tenth as much as HIV blood tests because of savings in the collection, storage, and disposal of samples.
According to Dr. Friedman-Kien, Chinese scientists have already expressed strong interest in the urine test system. "This could be one of our greatest tools in helping to confine the AIDS epidemic - especially in places like China, India and southeast Asia, which have some of the fastest growing populations of HIV-infected people in the world. From a public health management perspective, these nations don't yet have even basic information on how and where AIDS is impacting their peoples. The urine test system will provide them with a cost-effective, practical way to get that vital data."
"In my opinion, the urine HIV testing system is highly reliable and readily accepted by the patients," says Professor Luc Montagnier, codiscoverer of HIV and a member of Calypte's scientific advisory board. "We can collect and transport urine samples from the field to the laboratory very safely, because unlike blood, the urine of HIV-infected people contains only HIV antibody, not the infectious virus itself."
"Another potential use of this test," Professor Montagnier adds, "would be to use it for urine antibody monitoring, which should allow for better follow-up of patients and volunteers in future clinical trials of treatments and vaccines."
In 1988, Dr. Friedman-Kien was the first to observe that antibodies to HIV appear in the urine. Based on this finding, he developed a urine-based test for HIV, which was awarded a patent in 1992.