FDA Approves New Rapid HIV Test; Thompson Urges OraSure To Apply for Waiver to Allow Wider Distribution
The FDA yesterday approved a rapid HIV test that provides results in 20 minutes and is easier to use than existing rapid test kits -- two aspects that experts say will reduce the number of people who are unknowingly infected and will boost the number who are treated for HIV infection, AP/USA Today reports. The test, called OraQuick, is manufactured by OraSure Technologies. To use OraQuick, a health worker places blood taken from a finger prick into a vial of developing solution. A "sticklike testing device" is inserted into the vial and changes color to indicate the test results; one reddish line means that the person is HIV-negative, while two reddish lines indicate that the person may be infected with HIV and a confirmation test is needed (AP/USA Today, 11/7). Because the test detects the presence of antibodies to HIV and not the presence of the virus itself, there may be a "window" period of several weeks to several months in which a person can be infected with HIV but still test negative on OraQuick (Brown, Washington Post, 11/8). OraSure CEO Mike Gausling said he did not know how much the test would cost, but he added that it would probably be less expensive than the saliva test manufactured by OraSure, which costs about $20 (Gay Stolberg, New York Times, 11/8). Although OraQuick is currently approved for use in about 40,000 facilities, mainly hospitals and clinics with laboratories, federal officials have asked OraSure to apply for a waiver to make the test available at other locations. AIDS groups have advocated for making the test available at smaller outreach clinics and mobile testing sites in order to make the test more accessible to the general population (Lueck, Wall Street Journal, 11/8). HHS Secretary Tommy Thompson also urged OraSure to seek a waiver allowing wider distribution of the test. If the waiver is obtained, the test "could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers. ... So I ask them to please apply now," Thompson said (Washington Post, 11/8). Before the waiver can be granted, however, OraSure must conduct another clinical trial to see whether "untrained people" can administer OraQuick "as reliably as health professionals." Gausling said the company has submitted a testing proposal to the FDA for this purpose. It will take about 45 days for the first 50,000 OraQuick tests to reach the market, Gausling said (New York Times, 11/8). The test will not be available for home use (Washington Post, 11/8).
Quick, Easy and Accurate
Although OraQuick is not the first rapid HIV test on the market, the rapid test currently available is "so difficult to use that hardly any clinics offer it," AP/USA Today reports (AP/USA Today, 11/7). OraQuick is 99.6% accurate, making it the first "highly reliable" rapid HIV test, although a standard test, which takes up to two weeks to provide results, is still required to confirm a positive OraQuick result. Public health experts said that OraQuick will be beneficial for several reasons. The test may reduce mother-to-child HIV transmission by allowing doctors to test pregnant women for the virus while they are in labor, and the test will also allow health care workers exposed to blood to quickly determine whether they need post-exposure prophylaxis treatment (New York Times, 11/8). In the long term, health officials say that rapid HIV testing will greatly increase the number of people who get tested for HIV, as well as the number who receive their test results. Approximately 25% of the 900,000 estimated HIV-positive people in the United States are not aware that they have the virus, and about 50% of all people who get tested for HIV do not return to clinics to get the results of the test. HIV-positive people who are tested and diagnosed quickly can promptly receive treatment and make behavioral changes to lower the risk of transmitting the virus to others. "It is definitely a great step forward in terms of prevention. The whole idea of making testing more convenient as a general approach to HIV prevention is a good one," Ronald Valdiserri, deputy director of the CDC National Center for HIV, STD and TB Prevention, said (Washington Post, 11/8). AIDS groups also praised the approval of the test. "This is a real sea change. These results are so important ... that we really want to find ways to get them out to people as quickly as possible," Lee Klosinski, director of programs at AIDS Project Los Angeles, said (Ornstein, Los Angeles Times, 11/8). "Rapid tests have the potential to revolutionize HIV prevention. ... The elimination of the week-long waiting period will be the elimination of significant barriers to testing for many high-risk individuals," Clint Trout, associate director for federal government affairs at the AIDS Healthcare Foundation, said (AHF release, 11/7).
CBS's "Evening News" last night reported on the FDA approval of the new HIV test (Rather, "Evening News," CBS, 11/7). A video excerpt of the segment is available in RealPlayer online.
NPR's "Morning Edition" today also reported on the test (Knox, "Morning Edition," NPR, 11/8). The full segment will be available in RealPlayer Audio online after noon ET.