Interesting information that appeared on abcnews.com regarding the announcement this week about Calypte's urine test for HIV-1:
"Easier, Cheaper, Less Risky HIV Urine Test Hits the Market "
June 3 - At one of the nation's largest HIV testing centers, the Los Angeles Gay and Lesbian Center, Keith Waterbrook was happy to hear this week that the FDA has approved the first urine test for the AIDS virus.
Waterbrook is health-services director at the facility, which tests some 10,000 people each year. He uses both blood and oral tests, but both have drawbacks that may keep some people from getting tested.
Many people have declined testing because of the pain, cost and inconvenience of having their blood drawn. And while the oral test is painless and easy to administer, it costs three times as much as the blood test.
"If we can reduce some of the barriers to getting tested, " says Waterbrook, "then we'll have more people tested and the better off we are."
Cuts Healthcare Worker Risk
The urine test, developed by Calypte Biomedical of Berkeley, received final Food and Drug Administration approval Monday. It detects HIV antibodies in urine, which doesn't contain the virus itself. Because it eliminates the risk of accidental needle sticks and other exposure-related dangers for healthcare workers, it should make the process of HIV detection safer, as well as cheaper and easier for patients.
In clinical studies conducted by Calypte, the test had a 99.7 percent accuracy rate. It even detected HIV antibodies in patients whose blood tests came back HIV negative, indicating that the blood test is imperfect as well.
"We're talking about diagnostic tests that are unbelievably accurate, " says Bill Boeger, CEO of Calypte, "compared to the Pap smear, the mammogram, the prostate cancer test. Their results are about 70 percent accurate."
Worldwide Implications
The World Health Organization estimates that nine out of 10 HIV-infected people around the world don't know they have the virus, in part because they can't afford to be tested. Boeger believes the urine test may prove itself most valuable in developing nations.
The urine test will cost only about one-tenth as much as the HIV blood test, he says. Urine cups are only a penny or two each, and the test eliminates the need for a technician to draw blood and special bio-hazard disposal costs associated with blood samples.
Calypte plans to launch a new clinical trial involving 50,000 patients in the near future, to test a home version of the urine HIV test. Meanwhile, the just-approved urine tests will be available in doctors' offices and hospitals as early as next week. |
