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Blood Test to Detect HIV in 20 Minutes Nears Approval


Federal regulators are expected to give final approval soon to an easy-to-use finger-prick blood test that can diagnose HIV infection in 20 minutes. The action will come more than four years after public health officials declared the urgent need for such a tool.

People familiar with the approval process say the Food and Drug Administration has resolved lingering technical and manufacturing issues that have held up approval.

AIDS advocacy groups have accused the FDA of dragging its feet while reviewing tests that have been proved extremely accurate and used in 90 other countries. Some of the proposed blood tests are as easy to use as a home pregnancy test or blood sugar monitors for diabetics.

The test proponents say the delays have endangered the public's health because nearly a third of those who test positive for HIV each year never return to find out their results, which can take as long as two weeks to process. When that happens, infected people go untreated and spread the virus unwittingly to others.

"The potential for saving lives by using this technology, we think, is revolutionary," said Clint Trout, associate director of federal government affairs for Los Angeles-based AIDS Healthcare Foundation. "We think that the rapid test could be for prevention what protease inhibitors have been for treatment."

FDA officials declined to comment on their timeline. The agency granted preliminary approval in May to two rapid HIV tests, pending inspections of manufacturing plants and approval for the products' labeling.

It is not clear when the approval announcement will be made but some people familiar with the process say it could come within the next two weeks.

The first test slated to be approved is OraQuick, manufactured by OraSure Technologies of Bethlehem, Pa., people familiar with the process said.

When the test detects the presence of HIV antibodies, it displays two red bars on a small strip enclosed in plastic. The device is designed for just one use, and the company has not disclosed its price.

With approval near, the debate has shifted to a separate issue that could determine whether the rapid HIV test is widely used.

AIDS activists and public health experts want the federal government to waive requirements that the tests be performed only in technically sophisticated labs.

Though not advocating home use, those advocates say they want the test to provide quick results to sex-club visitors, homeless people at shelters and emergency room patients. Those target populations are among the most likely not to return for their results after they are tested.

Supporters also want to offer rapid tests to late-term pregnant women. If a woman tests positive for HIV before or during delivery, she and her baby can be treated with medications, reducing the chances of transmitting the virus by two-thirds or more.

The military is interested in using rapid HIV tests on the battlefield. When there are many casualties, doctors often request immediate blood donations from fellow soldiers, and there's little time to test for infections.

Despite these arguments, an advisory panel to the FDA has recommended that the government require the tests be performed at sophisticated laboratories. The panel found that untrained personnel often fail to follow manufacturers' test instructions and may lack the skills to interpret the results.

"Until it can be demonstrated that individuals performing this test out on the street have a significantly high degree of accuracy in performing the test, the potential danger to the person being tested is simply too high at this point," said Dr. Jared Schwartz, a pathologist and spokesman for the College of American Pathologists, a medical specialty society that also accredits labs.

Dr. Nelson Michael, a strong backer of rapid tests, disagrees with that reasoning.

"These tests are ridiculously simple," said Michael, chief of molecular diagnostics and pathogenesis at Walter Reed Army Institute of Research. "You basically defeat that ease of testing if you demand that the test be executed in sophisticated laboratories."

The Centers for Disease Control and Prevention has been seeking advice from both sides on ways to allow widespread use of the tests while ensuring accurate results, said Dr. Bernard Branson, a medical epidemiologist with the agency. The agency held a conference in Atlanta earlier this month to discuss the topic.

The stakes are high. Each year, more than 20 million people are tested for HIV, including 2 million in publicly funded clinics. Federal health officials estimate that 40,000 people contract the virus each year, and 900,000 people are living with it.

The standard test for HIV, known as ELISA, takes a minimum of five hours to process, and sometimes as long as overnight. But because the test often is sent to labs--where it is run in batches--results often are not available for days or even weeks.

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