The Federal Drug Administration (FDA) has approved the first second-generation, 20-minute HIV test. HIV tests currently in use take one to two weeks to yield results. Public health agencies and AIDS service organizations have been eagerly awaiting the new “rapid” tests because they can be used in innovative ways to reduce the number of new infections, which currently stands at 40,000 each year.
“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,” said Secretary Thompson at a Washing press conference announcing approval of the rapid test. “With this new test, in less than half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus.”
“AIDS Healthcare Foundation is proud to have spearheaded this effort and coalition is support of rapid testing,” said Michael Weinstein, AIDS Healthcare Foundation's President. “This is a practical example of working through the process to get something done and we thank Tommy Thompson and the Administration for their leadership shepherding this important and potentially life-saving tool through the approval process.”
While applauding the FDA for it's approval of the tests, a broad, growing coalition of public health officials, health organizations, and HIV/AIDS groups are now calling for the FDA and the Centers for Medicaid and Medicare Services (CMS) to make the newly approved rapid tests widely available through a “waived” status under the Clinical Laboratories Improvement Act (CLIA.)
Supporters include the President Bush's Advisory Council on HIV/AIDS (PACHA), The Congressional Black Caucus (CBC), U.S. Representatives Tom Coburn (ret.), Mike Honda and Loretta Sanchez, Earvin “Magic” Johnson, Jr., and over 100 HIV/AIDS organizations including AIDS Healthcare Foundation, AIDS Project Los Angeles, Florida AIDS Action, Gay Men's Health Crisis, the National Alliance of State and Territorial AIDS Directors (NASTAD,) and the National Minority AIDS Council. Accurate, easy to use rapid tests, which will soon be approved by the FDA, yield results in twenty minutes, as opposed to current tests, which must be sent to a laboratory and take a week or longer.
“The new rapid HIV tests, if they are made widely available to family doctors and public health programs, have the potential to dramatically reduce the spread of HIV in the African American and Latino communities, which represent 74 per cent of the 40,000 new infections in the U.S. each year,” said U.S Representative Loretta Sanchez (D-Anaheim). “Many high-risk individuals in these communities are not likely to seek out testing on their own, and so we must bring testing to them.”
In an October 22, 2002 letter to U.S. Secretary of Health and Human Services Tommy Thompson on the subject, the Congressional Black Caucus noted, “Currently, individuals testing for HIV must wait for one to two weeks for their results. By eliminating the waiting period, rapid testing has a vital role in Centers for Disease Control and Prevention (CDC) goals of reducing the number of HIV infections each year from 40,000 to 20,000 and ensuring that 95 per cent of those who are infected know their status.”
Although opponents claim that the higher level of federal oversight with a “moderately complex” status under CLIA is necessary to ensure the tests are performed accurately, supporters point out that every state already has testing and counseling networks that are well trained, experienced, and supervised by the states. “These tests are simple and easy to perform,” said Laura Hanen, Director of Government Relations for the National Alliance of State and Territorial AIDS Directors (NASTAD). “States already heavily regulate counseling and testing programs to ensure their quality with all states requiring pre and post test counseling,” she added. “States health departments have two decades of experience in HIV/AIDS counseling and testing and are ideally qualified to roll out rapid tests to the communities that need them. However, without a “waived” status under CLIA, 90 per cent of the states have told us they will either not be able to implement rapid tests, or will only be able to offer them on a very limited basis.”
“A moderately complex classification under CLIA would add nothing to the elaborate structures of protections already present in laws and regulations in every state,” said James Driscoll, Ph.D., federal affairs advisor to the National AIDS Treatment Advocacy Project (NATAP.)