Every Saturday The CSPH highlights news or recent research in the field of human sexuality. This week we’re discussing OraQuick, the HIV test that was recently unanimously approved by the FDA for over-the-counter use.
OraQuick, produced by the Pennsylvania-based pharmaceutical company OraSure Technologies, is the first rapid HIV testing product available in the United States for receiving instant results at home. Traditionally, to get an HIV test, one would have to go to a doctor’s office or sexual health clinic, have their cheeks swabbed for saliva samples or have a blood sample taken, or else purchase a kit to take their own sample at home and send the results into a lab for testing. Results, depending on the procedure and the sophistication of the laboratory interpreting the results, could take anywhere from sixty seconds to several weeks. OraQuick, however, utilizes similar measures taken in a clinical setting—the test itself is one of the rapid tests used by medical professionals in their offices—but without the visit to the doctor.
To take an OraQuick test, individuals swab their upper and lower gums and insert the sample into a vial of test fluid, all provided by the test. If they test positive for HIV, two colored lines develop on the test strip—similar to a home pregnancy test—after 20 to 40 minutes. Also included in the package is an information booklet that directs test-takers to call the OraQuick HIV support center (available 24 hours a day, seven days a week and bilingual in English and Spanish) for counselling on their test results and referrals to further medical services.
The test has a high rate (99.98%) of specificity, meaning that it accurately produces a negative result when the test taker is HIV-negative almost 100% of the time; its sensitivity—the number of cases where the test will show a positive result when the individual is HIV-positive—is less high with a percentage of 92.98%. In practice, the FDA estimates that this means that the test would come back positive for one person out of 5000 who was actually HIV-negative, while it could show as many as one out of every 12 HIV-positive test-takers as negative for the virus.
While the rate of false negatives is not insubstantial, the FDA reported in their approval that they did not believe this was a reason not to approve the test. They believed that its over-the-counter availability would make the test much more accessible to individuals who might never otherwise choose to get tested, and so could still substantially contribute to determining previously unknown cases of infection.
As a product that could soon be available in such mainstream locations as CVS, Walgreens, and Walmart, this new test has the potential to remove a number of the barriers that currently exist to prevent individuals from getting tested. For many, these include an inability to visit the doctor for a variety of reasons—lack of health insurance, cannot take time off of work, cannot find childcare—and the stigma of visiting a sexual health or HIV clinic.
At the same time, however, there are still a number of challenges individuals might face in attempting to access OraQuick over-the-counter. Because of the intense stigma that individuals with HIV/AIDS are burdened with, and because of the fear and misunderstanding of the conditions and methods of transmission, asking for or even being seen with an HIV test might be too large a feat for many individuals. As well, there are financial issues to consider as the home test is more expensive than the one that is sold to medical professionals; while the latter costs $17.50, the former is expected to be higher in price, up to $60. Though this price increase is stated by the company to pay for the additional costs of the trained, around the clock hotline, it may still be too costly for many of those most in need of the tests.
Additionally, though this point has appeared nowhere in the discussions of this over-the-counter test development, it should be noted that it is conceivable that, as has happened with the over-the-counter availability of emergency contraception, pharmacies might attempt to use “conscience clauses” as a means of not offering the test. Because of HIV’s link with sexual activity and intravenous drug use, as well as its stereotypical ties to the gay male community, religious or conservative providers may decide not to carry the test, thus further limiting individuals’ abilities to access HIV testing.
The OraQuick test is not perfect: the higher rate of false negatives is concerning in that individuals may believe themselves to be uninfected and go on to become sick or infect more people through their ignorance, and the access issues are real. However, if this test can be used to bring more individuals into the doctor’s office, and if it can open conversations between patients and their providers or individuals and their partners, it will be performing a great service. If its availability can normalize this aspect of sexual health even a little bit, or can make individuals less afraid of doing what is healthy for them because they are concerned about who might find out, it will be an important moment in the history of sexual health in this country. Testing is one of the primary means of fighting HIV infection, and this test’s ability to bring more people more knowledge about their status has the potential to identify thousands of additional cases of HIV each year, bringing people towards the proper safer sex and health-promoting strategies they should practice to keep themselves healthy.