Rapid HIV testing – controversy in the US – and access in the UK

1 July 2003. Related: Diagnostics.

The recent availability of more rapid HIV tests has suggested that their introduction could reduce the numbers of people who fail to return for results, which in the UK may vary from 35% – 95% depending on clinic and risk group of the person being tested.

The new technology has increased the possibility for testing out of routine clinic settings and this in turn has also initiated debate about the counselling and support protocols that were developed in the 80s. The context for the following article from the Boston Globe, is the introduction of pilot studies using rapid testing in public settings in Seattle.

CDC recommendations

In April, The US Centres for Disease Control and Prevention (CDC) released a revised HIV/AIDS prevention strategy, which targets the estimated 200,000 people in the United States who are HIV-positive but are unaware of their status. The agency urged local health departments to use the rapid HIV test — which was approved by the FDA in November 2002 for use in about 40,000 hospitals and clinics with laboratories — in all federally funded clinics, as well as places such as homeless shelters, jails and substance abuse treatment centres.

In February, President Bush announced expanded availability for OraSure Technologies’ OraQuick HIV test, which offers results that are 99.6% accurate within 20 minutes, to more than 100,000 doctors’ offices and public health clinics. AIDS groups had advocated making the test more widely available to the general public. The CDC also recommended simplifying the pre-test counselling process. However, the CDC does not yet have recommendations on the use of the rapid test or what type of counselling should accompany the test, leaving such decisions up to local health authorities.

Working in counselling

The speed and portability of the new HIV test means that some people may find out they are HIV-positive in places where counselling and other services may not be immediately available, Fred Swanson, executive director for Gay City Health Project, said. Local health officials say that they can successfully combine counselling and testing in public locations.

The health department has drafted its own protocols for using the rapid test. “Our big challenge, and one of the big goals for the Centres for Disease Control, is to try to increase the number of people with HIV infection who know that,” Chaffee said, adding, “One, because people who have HIV and don’t know it are losing the benefits of good medicine. … And two, we know from a variety of studies that when people know they have HIV infection, they are much more careful with their sexual and needle-sharing partners.”

Although Washington state law requires pre- and post-test counselling, the law is not specific as to what the counselling should entail, according to the Globe. “Are recipients of positive test results going to be able to internalise the information they’ve received around the (new) test when they don’t have any time to mull the information over?” Paul Feldman of Seattle’s Lifelong AIDS Alliance asked. Swanson said that although he is worried about possible negative effects of using the rapid test in public settings, he said that he is reassured by the fact that the rapid testing will not occur immediately in gay bathhouses and sex clubs. “What’s exciting to me is that the local health department recognizes that there may be some challenges, and as such is doing a trial run,” he added (Boston Globe, 5/30).

Source: Kaiser Daily HIV/AIDS report

http://www.kaisernetwork.org
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=18002

Boston Globe
http://www.boston.com/globe/

Quality Assurance Guidelines for testing using the OraQuick Rapid HIV-1 Antibody Test has just been published on the HIV/AIDS Prevention web site. This PDF document is available at
http://www.cdc.gov/hiv/rapid_testing/materials/QA_Guidlines_OraQuick.pdf

The document’s appendices, which discuss government regulations and provide sample forms, are available at
http://www.cdc.gov/hiv/rapid_testing/materials/QA_Guidelines_OraQuick_Appendix.pdf

comment

Although receiving an HIV diagnosis is still a traumatic event, the medical reality has changed significantly from the 1980s when many testing protocols were first developed. From an individuals’ medical perspective an earlier diagnosis allows both better medical intervention, including accurate detection of infection with drug-resistant virus.

Rapid tests have been available for several years in the UK (Abbott, Determine) but still have not been widely adopted – even though the unit cost is very low. This produces a result within 20 minutes from a fingerprick sample and allow patients to receive results within an hour. This minimises the stress associated with the delay of receiving test results which in the UK still routinely take up to a week. They also increase the percentage of people who return for their results which, again in the UK, can be as little as 35%.

From a public health perspective this would reduce risk of further infections, which may be largely driven by people unaware of their HIV status, especially considering the high viraemia associated with recent infections. Pre and post test counselling can still be provided in this setting, with people receiving an HIV-positive diagnosis more likely to benefit from more significant support.

Including HIV and hepatitis within the routine serology testing at GUM clinics, with HIV becoming an ‘opt-out’ rather than ‘opt-in’ test, increased uptake of HIV testing from 35% to 65% in one study, and identified two cases of previously undiagnosed HCV.

http://bmj.com/cgi/content/full/326/7400/1174

HIV testing with results within an hour is already available in the UK in very few clinics (John Hunter, London Lighthouse, Victoria Clinic and Soho clinic for gay men). Pre-test counselling and offer of follow-up counselling is provided as required.