State College resident Tom Donohue believes so strongly that the new HIV test should be available over the counter that he took his argument to the Food and Drug Administration (FDA) earlier this month.
The 26-year-old founder of the nonprofit AIDS awareness organization Who's Positive traveled to Gaithersburg, Md., on Nov. 3 to testify before an FDA advisory committee.
Donohue, who was diagnosed with HIV two years ago, told the committee he supports the new test, called OraQuick, because it would break down a lot of the barriers that prevent young people from getting tested.
"People would still be getting counseling and maintaining their anonymity," he said. "Unfortunately, a lot of people would test positive and keep the results to themselves, which I do not encourage, but that is a personal choice."
In 2004, the FDA approved the new HIV test, which delivers results in 20 minutes, for administration by health care officials, but Penn State's University Health Services (UHS) is not offering it.
Although it will not be using OraQuick, UHS has resumed free oral testing for HIV, which stopped Sept. 7 because of a shortage of the reagent needed to produce results. The shortage ended Nov. 7.
Richard McGarvey, spokesman for the Pennsylvania Department of Health, said the shortage started with the manufacturer.
"The reagent's manufacturers did not expect such a high demand, but that changed once manufacturing caught up," McGarvey said.
UHS Supervisor Diana Ramos said the Office of Health Promotion and Education will be testing for HIV until Nov. 18 and then begin again at the start of the spring semester.
"Results can take up to three weeks, so if I tested students all through November, the semester would be over and students would leave before they received their results," she said.
Ramos said it is hard to determine an exact time frame for results now because the labs are backed up with tests accumulated before the shortage.
Ramos said the test currently used at UHS, which returns results in two to three weeks, is produced by OraSure, which also developed the new OraQuick test that uses a saliva sample to detect HIV antibodies.
UHS will not be implementing the OraQuick test because a faster return on results would not allow trained counselors enough time to deliver the results to the patient, Ramos said.
Donohue, who attends Penn State intermittently and works with OraSure to advocate the new test, said OraSure is planning a free hotline and Web database that people could call after taking the test to get counseling and information.
He added that 80 percent of Penn State students surveyed during one of his speaking visits said they would support an over-the-counter test.
"I would love to see UHS do what they can to get the rapid test available on campus," Donohue said.
He said he is optimistic that the FDA will permit OraQuick to be sold over the counter.
Because UHS is funded by the Pennsylvania Department of Health, it is required to comply with the policy of giving results with the presence of a trained counselor, Ramos said.
The department does not consider university counselors qualified to report positive results because they are undergraduate students with an insufficient level of training, Ramos said.
"There should always be a counselor available to deliver a positive status in order to give treatment and counseling options to an HIV-positive individual," Global AIDS Initiative President Katie Koehler said.
However, students would be able to use the OraQuick test on their own if the FDA approves it for over-the-counter sale.



