PRNewswire - October 24, 2002

"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 70 percent 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% of those who are infected know their status."

"The potential for saving lives by using this technology, we think, is revolutionary," said Clint Trout, associate director for federal government affairs at AIDS Healthcare Foundation, the nations' largest AIDS organization. "We think that the rapid test could be for prevention what protease inhibitors have been for treatment," he added. "The elimination of the week long waiting period will be the elimination of significant barriers to testing for many high-risk individuals. However, some federal bureaucrats want to lock the tests up in sophisticated laboratories, where they will be useless to the communities that need them the most," he added. "Only if the tests are widely available to family doctors, emergency rooms, and public health testing and counseling programs will they be of any use in curtailing the spread of the epidemic."

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% 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).

"Nearly 300,000 HIV positive individuals in the United States are unaware of their status," said Trout. "CLIA waived rapid tests would offer us new and innovative ways to test and identify these individuals, so they can enter care and take steps to prevent the disease from passing to others. Also, 8,000 HIV positive individuals who are tested each year fail to return for their results. CLIA waived rapid testing will eliminate this problem. We call on the FDA and Centers for Medicaid Services (CMS) to release HIV rapid tests with a CLIA waiver immediately."

The following organizations also support a "waived" status under CLIA for HIV "rapid" tests: Adolescent AIDS Program, Children's Hospital at Montefiore, African Services Committee, AIDS Alliance for Children Youth and Families, AIDS Community Care Team, AIDS Education Project, Department of Psychiatry, John A. Burns School of Medicine, University of Hawaii, AIDS Foundation of Chicago, AIDS Healthcare Foundation, AIDS Network of Western New York, AIDS Project Los Angeles, AIDS Research Alliance, AIDS Service Center, AIDS Treatment Center at Stony Brook, New York, Albert Einstein College of Medicine, American Academy of HIV Medicine, American Public Health Association, Another Ministry Outreach, The Association of Maternal and Child Health Programs, Association of Nurses in AIDS Care, BASIC, Inc., Being Alive South Bay, Bienestar Human Services, California Prevention and Education Project , Catholic HIV/AIDS Ministry Archdiocese of Los Angeles, Center for Women Policy Studies, The Catalyst Foundation, Charles R. Drew University of Medicine and Scientific Center for AIDS Research, Education and Services, Chicago Department of Public Health, Division of STD/HIV/AIDS, Children's AIDS Fund, The CHOW Project, The Coral Life Foundation, Duval County Health Department, State of Florida, East Bay AIDS Advocacy Foundation, East Bay AIDS Center, Elizabeth Glaser Pediatric AIDS Foundation, Florida AIDS Action, Foundation for Research on Sexually Transmitted Diseases, Inc., Foothill AIDS Project, Gay Men's Health Crisis, Global Campaign for Microbicides, Gregory House Programs, Hands United Together, Hawaii CARES - HIV/AIDS Care Consortium, Hawaii State Department of Health, The Health Planning Council of Southwest Florida, Inc., HIV Medicine Association, Hoffmann-La Roche, Inc., Human Rights Campaign, Infectious Diseases Society of America, L.A. Department of Public Health- Office of AIDS Program & Policy, L.A. Gay & Lesbian Center, Latino Commission on AIDS , Laurence A. Pagnoni & Associates, Long Island Minority AIDS Coalition, Los Angeles Shanti Foundation, Malama Pono: Kaua'i AIDS Project , The Magic Johnson Foundation, The Massachusetts Asian AIDS Prevention Project, Maui AIDS Foundation, Minnesota AIDS Project, Montrose Clinic, National Alliance of State and Territorial AIDS Directors, National Association of People with AIDS, National Minority AIDS Council, Native American Community Services of Erie and Niagara Counties, Inc., New Jersey Public Health Association, New York State HIV Prevention Planning Group, North Coast AIDS Project, Ohio AIDS Coalition, Philadelphia Department of Public Health- AIDS Activities Coordinating Office, Project Inform, St. John's Riverside Hospital, San Francisco AIDS Foundation, San Francisco Department of Public Health, The Sexuality Information and Education Council of the U.S., Southern Tier AIDS Program, Inc., Stop AIDS Project, Tarzana Treatment Centers, Inc., Title II Community AIDS National Network, Treatment Action Group, UCLA Center for Clinical AIDS Research and Education, The Wall-Las Memorias, Western Colorado AIDS Project, Whittier Rio Hondo AIDS Project, Whitman-Walker Clinic, William F. Ryan Community Health Center, Women Organized to Respond to Life Threatening Disease

AIDS Healthcare Foundation is the US' largest provider of specialized HIV/AIDS medical care. AHF serves thousands of patients in California, New York and Florida regardless of their insurance status or ability to pay. In addition, AHF currently operates two free AIDS treatment clinics in Africa: the Ithembalabantu (Zulu for "people's hope") Clinic in KwaZulu Natal, Durban, South Africa & the Uganda Cares Healthcare Center in Masaka, Uganda.

SOURCE AIDS Healthcare Foundation

Web Site: http://www.aidshealth.org

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