Kaisernetwork.org (Washington, DC)
5 September 2008
(Page 2 of 2)
Seattle Department Finds OraSure HIV Test To Be Less Accurate Than Label Claims
[Sep 05, 2008]
A report by Public Health -- Seattle and King County in Washington state has found that testing with OraSure Technologies' OraQuick test provides less accurate results than the label claims, Bloomberg reports. The OraQuick test is the only rapid test licensed to screen both oral fluids and blood for HIV, according to Bloomberg. Bob Wood, director of the HIV/AIDS control program at the Seattle-based department, said that in 5,460 tests, OraQuick failed to detect at least 8% of 133 people found to be HIV-positive with a comparable diagnostic. This compared with the 0.7% rate given on the test's label.
Elliot Cowan, chief of FDA's Center for Biologics Evaluation and Research Office of Blood Research and Review, said the agency has asked OraSure to investigate the issue. "We're keeping an ear to the phone and making sure they're doing what they're supposed to do," Cowan said, adding, "The ultimate goal is that the package insert appropriately represents the performance of the test." According to Bloomberg, CDC, which recommends testing with blood over oral fluids, also has contacted Seattle officials. Nonetheless, the agency sent a letter to physicians on Aug. 20, voicing support for oral fluid HIV testing and stating that the test has performed well "overall" and is important for increasing the number of people tested for HIV. Richard Wolitski, acting director of CDC's Division of HIV/AIDS Prevention, said, "At this time, based on all the available data, we're not changing our recommendations regarding oral fluid rapid testing."
OraSure Chief Science Officer Stephen Lee said the company tracks the performance of its test and routinely investigates complaints. Lee also said OraSure keeps FDA informed of all the product information it gathers. "All the data that we've accumulated indicates the product continues to perform according to its FDA-approved claims," Lee said.
Wood said that the department has sent its data to physicians and clinics in the area along with a recommendation to test blood rather than oral fluids when possible. "Our recommendation is that people shouldn't use rapid oral tests if they can avoid it, but there are some situations where it can't be avoided and it's better than nothing," Wood said.
According to Wood, Seattle in 2003 began back-up testing of samples screened with OraQuick. A laboratory test, called EIA, showed that OraQuick missed 10 out of 133 patients with HIV antibodies in their blood. Lee said that studies have shown rapid tests to be less sensitive than lab antibody tests, adding that other rapid tests have produced similar results. Seattle officials also tested the samples with a more accurate test that looks for HIV's genetic material. The test can detect more HIV cases because the virus appears in blood before antibodies, according to Bloomberg. When compared with the RNA test, OraQuick missed 17% of cases, according to Wood, who added that the results might be published in a journal in the future (Lauerman, Bloomberg, 9/3).
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Across The Nation
Orlando Sentinel Profiles Home for Transgender People Living With HIV
[Sep 05, 2008]
The Orlando Sentinel on Wednesday profiled the region's first residential home for transgender people living with HIV, which advocates say helps a "unique community that faces discrimination, ignorance and a disproportionate share" of HIV/AIDS cases. Keith Theriot, program manager for Orlando's Housing and Community Development Department, said that the population is "particularly complicated," adding that officials "really want to have a safe and stable environment for our clients that are in need." Michael Vance -- executive director of the Gay, Lesbian, Bisexual Community Center of Central Florida -- said, "When they become homeless, they cannot go to a female homeless shelter because biologically they still have male parts." He added, "But if they go to male shelters, they are often abused, ridiculed and sexually abused."
According to the Sentinel, accommodations for the house were arranged by the city of Orlando's Housing Opportunities for Persons with AIDS program, and the rent is paid by the Center for Multicultural Wellness and Prevention. Residents at the home -- which opened July 1 and is full with four residents -- can access drug rehabilitation services, counseling and medical care to help them become self sufficient. Shannon Minter, legal director for the National Center for Lesbian Rights, said that because many states lack explicit antidiscrimination laws to protect transgender people, they often lose their jobs. "Their options are to die in the streets -- that is literally what happens," Minter said, adding, "There are a significant number of trans-women who are forced into sex work in order to survive, and many end up with HIV." According to the Sentinel, the National Center for Transgender Equality estimates that about three million U.S. residents identify themselves as transgender (Hernandez, Orlando Sentinel, 9/3).
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I am not surprised by these findings, specifically regarding the continued increase of HIV infection amongst gay men. Within the gay community, especially with gay youth, the contraction of HIV/AIDS is no longer a frightening concept. That, and with the growing popularity of crystal meth use at clubs like the one *Biloves dotcom*, the practice of safe sex has dramatically decreased. For this problem to end, young gay men need to wake up and become more preoccupied with their health rather than the insignificant and superficial things.