Rapid HIV test proposed for at-home use

When Joseph Inungu, MD, DrPH, wanted to determine his HIV status, he used an over-the-counter home test kit to collect a blood sample and mail it in for laboratory analysis. He then received his results by phone.

"I didn't want to wait in a clinic for something I could do myself," said Dr. Inungu, a professor in the school of health sciences at Central Michigan University.

Now, a proposal by one HIV test manufacturer may make it possible for this testing process to take place entirely at home. No blood would be drawn and no sample would have to be mailed off. Rather, the test would detect HIV antibodies in a sample of oral fluid. And, a patient could get the results within 20 minutes, without talking to anyone.

It's an approach that is being greeted by physicians with both enthusiasm and trepidation.

"It's probably a good idea, but I have mixed feelings," said Jess Fogler, MD, assistant clinical professor in family and community medicine at the University of California, San Francisco. "Traditionally this whole system has been bracketed by pre- and posttest counseling because it's a very charged diagnosis."

OraSure Technologies Inc., which manufactures the rapid test, made a presentation this month to the Food and Drug Administration's Blood Products Advisory Committee to explore the possibility of making it available over the counter for at-home use.

The committee did not make any formal recommendations for or against, although the panel is expected to advise the agency about the kind of research that must be considered before giving it the nod.

Company officials said they intend to pursue an application for OTC availability of the rapid test in order to increase the number of people who are aware of their infection status.

"We think that expanding access to HIV testing is important to gain greater control of this disease," said OraSure president and CEO Douglas Michels. "There are a number of people who are not comfortable going to a clinic, and we think there is a strong interest or demand for an at-home HIV test."

According to data from the Centers for Disease Control and Prevention, about a quarter of those infected with the virus do not know they have it. This fact has long concerned physicians and public health officials because, as a result, many people are diagnosed after the available treatments are most effective. It also represents a missed opportunity to change people's behavior to prevent spread.

"How can we identify those who are undiagnosed and bring them into medical care?" said Daniel Kuritzkes, MD, chair of the HIV Medicine Assn. "More and more people are presenting at advanced stages of the disease. It's so important to get people diagnosed earlier." The organization has not taken a position for or against the at-home test.

The rapid test was approved for use in the health care setting in March 2004, and it is becoming more popular. The American Medical Association started working this past summer with other medical societies and interested groups to increase use of the rapid test, in accordance with CDC guidelines for quality control and pre- and posttest counseling.

Reasons for discomfort

But while the rapid test is seeing increased acceptance in medical settings, making it available for use at home is controversial. The AMA opposes approval of home test kits unless they are linked to proper laboratory evaluation and counseling services, and many physicians are uncomfortable with the concept.

Some doctors hope that the test's availability will make testing more accessible and eliminate some of the barriers, particularly for people who have never been tested. For example, the results of a survey of attitudes to a theoretical instant home HIV test, published in the May 2003 American Journal of Preventive Medicine, found that only a third of respondents would consider using it, although the likelihood increased among respondents who had never been tested before.

"This will provide the confidentiality that they're looking for," said Dr. Inungu, who presented to the committee on the psychosocial issues associated with testing. "This is a good opportunity for us to think outside the box and add another tool to the arsenal we already have."

But physicians also say getting HIV results at home is far from ideal. Those who have delivered positive test results say patients are often devastated. Physicians are also concerned how these patients will get linked to follow-up testing and medical care.

"There are a lot of resources we can offer patients," said Dr. Fogler, who also staffs the Stanley Jackson HIV Clinic at San Francisco General Hospital.

"We can be there for them while they come to terms, which is quite important. ... They think that they have been given a death sentence, but it's not true. There are a lot of things we can do to help."

But the key issue for many public health agencies and physicians is not the test itself but the packaging. HIV can be a complicated issue. Experts want to be assured that the necessary information can be understood.

"It is important that the instructions be test-marketed among those at highest risk: people of color, younger individuals and people of a lower socioeconomic status," said Tri Do, MD, MPH, immediate past president of the Gay and Lesbian Medical Assn. "There is serious potential for misuse."

The CDC and several HIV medical societies have not taken a position on at-home use, and many physicians are reserving their final judgments until more specifics about directions and presentation are known.

"We don't know enough at this point," said CDC spokeswoman Jessica Frickey. "There are a lot of questions that need to be answered."

OraSure is working to address these issues and others raised by the committee and is in talks with the American Social Health Assn. to establish a toll-free hotline linked to this test.