The Washington Blade; Friday, January 17, 1997
Brian O'Connell

Whitman-Walker Clinic Executive Director Jim Graham said at a Jan. 15 press conference that switching to the OraSure oral specimen collection device is "a pioneering step for us and one we are proud to take."

"This new test," said Graham, "will help us reach people who are averse to blood-based testing with needles."

Graham noted that the clinic has been testing blood samples for HIV antibodies since June 1985, just weeks after the technology first became available.

Clinic officials hailed the advantages of switching to the oral test.

"OraSure is as accurate as blood [tests] and safer to administer," said Dr. Peter Hawley, Whitman-Walker Clinic medical director. "By providing those being tested with an accurate test without blood or needles, we also eliminate the risk to volunteers of accidental needle sticks."

Oral tests for determining the presence of HIV antibodies -- which the body produces in reaction to HIV infection -- have proven to be a highly accurate alternative to blood testing. A study published in the Jan. 15 issue of the Journal of the American Medical Association showed OraSure provided accurate results 99.97 percent of the time, or 3,569 out of 3,570 instances.

OraSure HIV-1 Antibody Testing System, produced by Epitope Inc., is the first and only HIV antibody test to detect antibodies orally. The company received final approval from the U.S. Food and Administration on June 3, 1996.

OraSure does not test saliva. It detects the presence of HIV antibodies in the blood vessels lining the mouth -- a part of the body that contains high concentrations of antibodies. A cotton fiber pad at the end of a plastic stick is pressed between a person's lower gum and cheek for about two minutes. The pad has been treated with a salty solution that helps draw out fluid from the blood vessels. These fluids -- called mucosal secretions -- hold far more virus antibodies than saliva, according to a press release.

While the oral test allows people to avoid a needlestick procedure, the test has been approved by the FDA only for administration by a trained health care worker and is therefore not available for home use. When used by a doctor's office or health clinic, the oral sample is sent to laboratories and results can be determined within three days. The Whitman-Walker Clinic will have equipment on-site to analyze the samples and have results available within two days, said Hawley.

Hawley said the clinic is thrilled to make the switch because of the advantages of no longer using needles to gain blood samples. Not only does he believe the oral test will now allow the clinic to reach more people, increasing the number of people aware of their HIV status, but it will eliminate any chance of accidental needle pricks by clinic volunteers handling the blood samples -- something that Hawley said "terrifies" him.

He said the prohibitive cost associated with the oral device's normal $8-per-kit pricetag had previously made switching from blood testing impossible. Blood testing currently costs less than 50 cents per test. However, OraSure agreed to cut its price to $4-per-kit and then SmithKline Beecham Consumer Healthcare, which is conducting the national marketing of the oral test device, made a $25,000 donation to the clinic to cover the remainder of the initial costs involved.

"That's what they had to do to get us to do that," said Hawley. "Our costs for drawing blood are less than 50 cents each time and we couldn't afford to do this otherwise."

He said the arrangement was a win-win situation. The clinic is happy to have access to the new technology and OraSure will benefit from having the well-known clinic's imprimatur.

"I understand they're talking to others about making this same switch, they just made Washington their lead-off location," said Hawley. "We're sort of their premiere place."

He said the clinic believes that by the time the $25,000 subsidy for purchasing the oral devices runs out, the U.S. Centers for Disease Control and Prevention will have begun covering the costs involved with oral HIV testing with federal grant money.

Karen Nill, a marketing manager at OraSure, said the company is talking to several other major HIV testing sites about replacing the traditional blood-based testing with oral tests. She said the company approached Whitman-Walker first because of its national reputation for providing HIV/AIDS services. She also said that SmithKline Beecham will launch a $500,000 public awareness campaign in the Washington area by the spring that will tout the clinic's move.

Graham said 5,175 people came to the clinic for HIV antibody testing in 1996 and he believes that number will grow by 20 percent this year as a result of the switch to oral testing.

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