Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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Washington Blade - April 13, 2007
Elizabeth Perry
OraSure Technologies produces the OraQuick Advance Rapid HIV-1/2 Antibody Test, which has been used in public health, drug treatment and outreach clinics around the country since 2004. A round-the-clock telephone hotline and internet accessible counseling and referral system is being developed by Constella Group LLC, which also operates the Centers for Disease Control and Prevention's national HIV/AIDS clearinghouse and call center.
"We need to work thorough the balance of the clinical protocol and then we can submit it to the FDA," said Ron Spair, chief financial officer for OraSure.
A press release from OraSure said lab-based operational studies have been completed but more clinical work needs to be done in the next year or so before it can be granted approval by the FDA.
The test is administered by swabbing the gums to collect a saliva sample, using a finger-stick for a blood sample or via venipuncture (blood drawn from a vein) for a plasma specimen. The sample is inserted into a vial of developer solution and the result is readable in 20 minutes. OraSure literature said the test was first FDA-approved for use in 2002. The company also said the test can detect HIV-1 and HIV-2, the two strains of the virus that can infect humans, with a success rate greater than 99 percent.
In January 2006, the Blade reported oral administration of the test was producing a high number of false positive results California, New York and D.C. A local internal review of some 12 to 15 clinics by the District's Administration for HIV Policy and Programs found there were approximately two to five false positives out of 1,000 tests at each site.
Kim Mills, then-spokesperson for Whitman-Walker Clinic, said that while the D.C. clinic did not experience any rate of false-positives outside of the expected rate, three out of 9,000 tests in sites in Virginia, Maryland and D.C., as well as in outreach vans did experience false positives in 2005.
Spair said OraSure and the Center for Disease Control conducted a thorough analysis of test performance and concluded that the test was performing up to claims on its label as approved by the FDA.
Bruce Weiss, director of Whitman-Walker Clinic of Northern Virginia, said that opening up another avenue for getting people tested for HIV infection is good, but there are some potential disadvantages to home HIV testing. Over-the-counter test kits, in which the consumer mails in the specimen and waits for the results via a phone call, have been available for years, but those ensure the person being tested receives results from a person who can offer counseling.
Rapid testing involves a possible life-altering diagnosis that comes in minutes, whether the consumer is ready for the news or not. Weiss said there is no guarantee that consumers who opt for at-home testing will take advantage of the follow-up counseling and medical referral offered by the companies.
"In a clinic there is an advantage to having someone there with you when you receive the results," he said. "Having someone help you begin to understand the situation and provide counseling. There are many possible reactions to HIV diagnosis."
Another potential problem is inaccurate results, especially if the consumer has engaged in risky behavior just prior to testing and the test doesn't detect HIV antibodies yet, so the test incorrectly reads negative.
"We have a mandate at Whitman-Walker Clinic that when someone tests positive it's called a preliminary positive and must be confirmed by a blood test in a medical lab," Weiss said. "If someone is at home doing this and they test positive, they need to get a confirmatory test done at a doctor or clinic."
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