The Los Angeles Time - June 14, 2000
Marlene Cimons, Los Angeles Times

The Atlanta-based CDC estimates that 25 percent of those who get AIDS tests -- about 10,000 people each year -- never come back for the results. Those who are infected go untreated, spreading the virus unknowingly. The new tests -- which give results in minutes, rather than days or weeks -- could change that, allowing treatment with new drugs almost immediately.

Several of the new, so-called rapid HIV tests are moving toward FDA approval. But CDC officials who deal with the AIDS epidemic say they could move even faster.

"I think the FDA is being overcautious, which is wasting time and costing lives," said Dr. Bernard Branson, a medical epidemiologist with the CDC who has studied the impact that rapid tests would have on the AIDS epidemic.

CDC researchers, using a mathematical model, have estimated the potential impact of using rapid testing at publicly funded HIV test sites. Their findings show that in one year, nearly 700,000 more people -- including more than 8,000 infected individuals -- would learn their HIV status if rapid tests were used.

The tests under development are more user-friendly, requiring no equipment and little technical expertise. Some work on whole blood, some on oral fluids. And they are inexpensive, costing less than $2 -- which makes them an attractive option, not just for clinics, but for hospital delivery and emergency rooms and in developing countries that lack laboratories and other technology, Branson said.

Whatever the reason some people fail to return for test results -- denial, fear, inconvenience -- the situation poses a vexing problem for public health experts, who regard early identification of infection as one of the most important factors in AIDS treatment.

As a result, the FDA is taking heat not just from its sister public health agency, but from others in the AIDS network, including those who work in clinics, and from state and regional public health officials.

"The waiting period is one of the cruelest elements of HIV testing," said Lee Klosinski, director of education for AIDS Project/Los Angeles. "It is the best reason for expediting this technology."

Dr. Jay Epstein, director of the FDA's office of blood research, defended his agency. "We understand there is an unmet need," he said. "But it's not a simple thing. The public needs assurance that the (new tests) will meet standards of accuracy and consistency of manufacturing."

Epstein said the FDA is taking steps to expedite approval, explaining that rapid-test proponents "misunderstand" the regulatory requirements for licensing of the new tests. To that end, an FDA advisory committee will take up the matter tomorrow in an attempt to clarify what is expected in the way of studies -- and results.

He said clinics can apply in special circumstances for permission to use the new tests before they are licensed. "We are trying to show flexibility and cooperate with CDC."

The FDA has asked its Blood Products Advisory Committee to recommend that the rapid tests not have to prove that they are equally effective to the test most widely used now nationwide -- known as the ELISA. But the new tests still will have to demonstrate a high level of accuracy.

There is only one rapid test on the market thus far. Known as SUDS, it is made by Illinois-based Abbott Laboratories. It works in about 10 minutes, but its accuracy is highly dependent on the level of training of the person who gives it.

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