HHS Approves Widespread Use of New 20-Minute HIV Test

LOS ANGELES -- Health and Human Services Secretary Tommy Thompson today announced that HHS has approved a Clinical Laboratory Improvements Amendments (CLIA) waiver for the new 20-minute rapid HIV test. AIDS Healthcare Foundation (AHF), the United States' largest AIDS organization, has been a leader in the effort to get the test a CLIA waiver, because it will allow the test to be used in physician's offices and outreach settings that have the greatest potential to reach people at high risk for HIV.

"Secretary Tommy Thompson's and President Bush's leadership on this issue will save countless lives," said Michael Weinstein, AHF president. "Nearly 300,000 HIV positive individuals in the United States are unaware of their status. Today's approval of 20-minute rapid testing eliminates a layer of bureaucracy and offers 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. Each year, 8,000 HIV positive individuals who are tested fail to return for their results. CLIA waived rapid testing will eliminate this problem."

"This is great news," said U.S. Representative Mike Honda (D, San Jose), who was active in advocating for quick approval of the rapid HIV test. "Research shows that HIV positive individuals who know their status are much more likely to take steps to protect their partners. Now that the rapid tests will be widely available, they will play a key role in identifying HIV positive individuals and preventing further infections."

"The new rapid HIV tests, 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 percent of the 40,000 new infections in the U.S. each year," said U.S. Representative Loretta Sanchez (D-Anaheim), who authored a Congressional Hispanic Caucus letter on the issue. "Many high-risk individuals in these communities are not likely to seek out testing on their own. Today, we can bring testing to them."

"Rapid tests have the potential to revolutionize HIV prevention," said Clint Trout, AHF associate director for federal government affairs. "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," he added. "Now that the tests are widely available to family doctors, emergency rooms, and public health testing and counseling programs, they will play a critical role in curtailing the spread of the epidemic."

AIDS Healthcare Foundation is the United States' 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

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