"Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results," Department of Health and Human Services Secretary Tommy G. Thompson said at a news conference. "With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow progression of their disease and to take precautionary measures to help prevent the spread of the virus," he said.
The test is called OraQuick Rapid HIV-1 Antibody Test and is made by OraSure Technologies Inc., of Bethlehem, Pa. It consists of a vial and a test stick similar in size to the thermometer found in most household medicine cabinets. It works by testing for antibodies or immune system cells fighting the human immunodeficiency virus. Dr. Murry Lumpkin, FDA's principal deputy commissioner, said it takes approximately three months for an individual to develop antibodies after initial HIV exposure.
To take the test, a patient pricks his or her finger and a single drop of blood is transferred to the vial where it is mixed with a solution. The testing stick then is inserted into the vial. If, after 20 minutes, HIV antibodies are detected, the stick will display two reddish-purple lines. If no antibodies are found, the stick will display only one colored line. If no lines appear, it means the test was performed inaccurately.
Asked by United Press International if OraQuick ever would be made available over-the-counter so individuals could test for HIV at home, Lumpkin replied, "That's not something we're looking at at this point in time." He said researchers will learn more about the test's marketing potential as soon as it becomes used routinely in public health clinics around the country.
One obstacle to rapid HIV self-testing is the FDA has labeled OraQuick of "moderate complexity" under the 1988 Clinical Laboratory Improvements Amendment. This means only CLIA-certified facilities and CLIA-certified staff can administer OraQuick, thereby limiting who has access to the test. Thompson encouraged the manufacturer to apply for a CLIA waiver quickly so it could be made more widely available.
"If the FDA finds that the company's data proves that the OraQuick test is both easy and safe to use, it can get a CLIA waiver," Thompson said. "Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers."
OraQuick also has implications in prenatal care. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Md. and who has been working on the AIDS epidemic since it broke out 20 years ago, said OraQuick could be key in identifying pregnant women and women in childbirth who are HIV positive.
"This has enormous implications for (treating) mother to child transmissions," Fauci said.
Another benefit of the OraSure test is its low-maintenance appeal. Unlike other HIV tests it does not require refrigeration or large blood samples. Earlier and current HIV tests typically require patients to wait up to two weeks for results -- and many do not return to get the results.
"Clearly when you're in the trenches (of fighting AIDS) ... there's a real psychological barrier with the diagnosis of HIV," Fauci said. A 20-minute test could break down that anxious barrier of waiting for a life-changing diagnosis, he explained.
When the OraQuick test produces a positive indication, AIDS experts said the patient will need additional testing to confirm those results.
According to the Centers for Disease Control and Prevention in Atlanta, about one-fourth of the 900,000 HIV-infected people in the United States -- roughly 225,000 individuals -- are unaware they carry the virus.