Rapid Self-Test for HIV is Feasible, Accurate, and Reliable

Daniel M. Keller, PhD

November 10, 2009

November 10, 2009 (Philadelphia, Pennsylvania) — With either oral fluids or blood, patients can reliably test themselves for HIV infection using a rapid test and only printed instructions, researchers reported here at the Infectious Diseases Society of America 47th Annual Meeting.

The vast majority found self-testing acceptable, said they would use it at home if it were available, and indicated that they would recommend it to a friend.

With around 20% of the estimated 1.1 million Americans living with HIV/AIDS, as of 2006, unaware that they are infected, researchers at Johns Hopkins University in Baltimore, Maryland, asked whether self-testing for HIV would be acceptable to people at risk and whether untrained people could perform a test and interpret the results accurately.

Using the Johns Hopkins Hospital and the Johns Hopkins Bayview Medical Center emergency departments, the researchers offered patients the same rapid HIV tests that trained healthcare workers used in this setting. These emergency departments serve a socioeconomically disadvantaged inner city population that is more than 75% African American and 15% injection drug users, and has an 11% to 12% HIV infection rate.

Patients 18 to 64 years of age were offered the opportunity for self-testing if they had no previous diagnosis of HIV, had not had an HIV test in the previous 3 months, and could provide informed consent. Two tests were used: the OraQuick Advance test (OraSure Technologies, Inc.), which uses oral fluids obtained by swabbing the upper and lower gums, including at the base of the gums; and the Uni-Gold HIV test (Trinity Biotech PLC), which uses blood obtained by a finger stick.

Charlotte Gaydos, DrPH, professor in the Division of Infectious Diseases at Johns Hopkins, told meeting attendees that 444 patients were offered the opportunity to do a self-test using either method, and 402 (91%) accepted. Most of them (91%) chose the OraQuick test; the rest opted for the Trinity Uni-Gold test. Dr. Gaydos told Medscape Infectious Diseases that she was surprised that anyone chose the finger-stick method.

Large plasticized posters with photographs and diagrams instructed patients how to do the tests and interpret the results. Patients performed the self-tests and trained healthcare workers did an OraQuick test at the same time. Results were available in about 20 minutes.

Dr. Gaydos reported that the self-test results were 99.5% concordant with those obtained by the healthcare workers. Two positive HIV self-test results were in agreement with those obtained by the healthcare workers. One of the self-testers, an African American male, had apparently forgotten that he had tested positive 5 years earlier, as evidenced in his medical record.

One Uni-Gold test initially had an indeterminate result because of insufficient blood. A repeat test, which was negative, was in agreement with the result obtained by the healthcare worker. The result of 1 OraQuick self-test was not in agreement with that obtained by the healthcare worker. Western Blot testing confirmed the seronegative status, which interestingly was the result obtained by the patient.

Based on the results of a questionnaire, about 91% of the patients said they trusted the self-test results very much. Of those who used the OraQuick test, 97% said the sample was not hard to collect, compared with 69% who used the Uni-Gold test. In both groups, 98% to 100% said they would definitely or probably recommend the test to a friend, and about 95% said they would definitely or probably perform the test at home if it were offered over the counter. The median age of the self-testers was 38 to 39 years.

The majority of patients in each group said the samples were not at all painful or unpleasant to collect, the tests were not hard to perform correctly, and they felt very much in control of their health. Few patients (≤10%) had difficulty opening the test kit, collecting the sample of blood or oral fluid, reading or following instructions, reading the results chart, or interpreting the results.

Dr. Gaydos said that the study will continue to enroll patients with an aim to accrue enough patients with additional positive test results. Also, they will accrue more people to undergo finger-stick blood tests to assess results for concordance with those obtained by trained healthcare workers.

Dr. Gaydos said at a news conference that "the real question is . . . if a person did their own HIV test, would they come to care? And it will remain to be seen, I think, in future research whether or not the positive test would be impetus for them to come to get a confirmatory test and to get into care." She noted that detecting infection and beginning treatment earlier at higher CD4 counts can prolong lives.

News conference moderator Michael Saag, MD, director of the Division of Infectious Diseases and director of the Center for AIDS Research at the University of Alabama at Birmingham, and president-elect of the HIV Medicine Association, told news conference attendees that "there are a lot of people in the United States who are HIV-infected who don't know their status and, in general, that's bad news. . . . We have a lot of data that say if people get started on treatment late, their response to therapy is worse and their mortality outcomes are worse." He said that 10-year mortality is less than 5% if the CD4 count is higher than 200 cells/μL, but is about 50% if the count is less than 50 cells/μL when antiretroviral therapy is initiated. "So the data really scream at us that we need to be identifying people earlier and getting them into care earlier," he emphasized.

But self-testing is not without risks. "It could be quite devastating for someone to get a positive test and then not know what to do," Dr. Saag said. "Having counseled hundreds if not thousands of people in my practice over the years, it is a huge, huge challenge to help people get adjusted to it, so I think that would be a major concern." Another concern is that someone might force a partner to take the test, possibly resulting in domestic issues over the coercion or the results.

However, Dr. Saag pointed out the dire nature of the HIV global pandemic. "I think it's appropriate that we take the gloves off and explore as many different approaches [as possible]" he said.

Right now, the 2 rapid HIV tests are not under consideration for self-testing, Dr. Gaydos told Medscape Infectious Diseases. She said she is not aware of plans by either manufacturer to seek US Food and Drug Administration approval for over-the-counter sales.

Dr. Gaydos reports having research contracts with Siemans and Genocea, and being a member of the scientific advisory board for Genocea. Dr. Saag reports financial relationships with Bristol-Myers-Squibb, Pfizer, Tibotec, Avexa, Boehringer-Ingelheim, Monogram, Gilead, Merck , Achillion, Ardea; receiving research support from Pain Therapeutics; and being a consultant/scientific advisor (review panel or advisory committee) for Tobria.

Infectious Diseases Society of America (IDSA) 47th Annual Meeting: Abstract 180. Presented October 30, 2009.