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US Approves Test for Rapid Diagnosis of HIV

The U.S. government has approved a rapid new test to diagnose HIV in minutes instead of up to two weeks, as current tests require. Health officials say the speed of the test means more people will get into treatment.

Unlike older HIV diagnostics, the new rapid test, named OraQuick, needs no refrigeration, specialized tools, or traditional laboratory and clinical settings. A health worker places a drop of blood from a finger prick in a vial of solution, and reads the result in 20 minutes on a dipstick.

The test does not detect virus. Instead, it detects antibodies that the immune system dispatches to fight HIV.

U.S. Health Secretary Tommy Thompson says the test is more than 99 percent accurate. "It's going to be a wonderful tool for our counselors and people to help us in our fight against HIV-AIDS in the country and in the world," he said.

The U.S. government's chief infectious disease official, Anthony Fauci, says the OraQuick test will encourage the countless people who fail to return for traditional test results to get into immediate treatment, and help reduce HIV spread.

"Speed is clearly of the essence. This test adds an extra dimension in our armamentarium of the initial diagnosis, care, and ultimate treatment of an HIV infected individual," he said.

Dr. Fauci says the new test can also benefit health care workers exposed to blood from infected patients. In addition, infected women undiagnosed during pregnancy can be tested during labor to determine if their newborns should be treated to keep from acquiring the virus.

"That has enormous implications for the prevention of mother-to-child transmission with the drugs that we have available to us today," he said.

OraQuick is not the first rapid HIV test. An older one gives a result in only 10 minutes. But many health clinics have stopped using it because it is so difficult to use accurately. Because of the importance of rapid HIV diagnosis, several other companies are developing such tests.

The manufacturer of the new test, OraSure Technologies of Bethlehem, Pennsylvania, is not specifying its price, but says it will be competitive with current tests, which average about $20. OraSure's chief executive officer, Mike Gausling, says the firm will sell it cheaper in developing nations.

Although the company has no international marketing strategy, Mr. Gausling says, company representatives will soon go to Africa. "I'm proud that OraSure is part of a trade mission that the United States has organized, and we're one of 12 companies that will be traveling to Ghana and South Africa next week to speak with the leaders in government about how we can bring this innovative product from the United States to the foreign markets," he said.

OraSure is developing a version of the test that can use oral fluids to diagnose HIV instead of requiring a finger prick for blood.