STI Quarterly

First rapid over-the-counter home HIV test given OK — Expect to see on shelves in October

The Food and Drug Administration (FDA) has cleared the OraQuick In-Home HIV Test for sale directly to consumers, which makes it the first and only rapid over-the-counter (OTC) HIV test approved in the United States. The test can detect antibodies to HIV-1 and HIV-2 with an oral swab, and it provides a confidential in-home testing option with results in as little as 20 minutes.

The OraQuick In-Home HIV Test is an over-the-counter version of Bethlehem, PA-based OraSure Technologies' OraQuick ADVANCE HIV 1/2 Antibody Test, a rapid HIV test used in hospitals, clinics, community-based organizations, and clinician offices. The OTC test is expected to be available for purchase in October 2012 at more than 30,000 U.S. retail outlets throughout the country and online, say OraSure officials. Pricing for the new test has not yet been determined; however, it is expected to be higher than the $17.50 list price of the version used in hospitals, clinics, and physician offices due to the consumer education and customer support needed for the OTC product.

Each test kit will include detailed information on HIV and HIV testing, including step-by-step directions on how to use the OraQuick test. The company also is developing a toll-free customer support center and comprehensive consumer website. The round-the-clock support center will be staffed with representatives who can answer questions in English and Spanish about HIV/AIDS, describe how to use the test and interpret the results, and provide direct referral to care if needed. A comprehensive consumer website will be launched in October to provide access to resources and referral to follow-up counseling and medical care.

Some 1.2 million people in the United States are living with HIV infection, and about one in five are not aware they are infected, according to the Centers for Disease Control and Prevention. The federal agency estimates there are 50,000 new HIV infections every year; many of these new infections are transmitted from people who are unaware of their HIV status.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a press release accompanying the approval. "The availability of an over-the-counter home-use rapid HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

The federal agency's approval was announced two months after a 17-member FDA advisory panel voted unanimously that the benefits of the test were greater than any possible risks. (Editor's note: An additional step in HIV prevention has emerged with the FDA's July 2012 approval of once-daily oral Truvada, in conjunction with condoms and other safer-sex measures, for use for HIV prevention in men who have sex with men, persons in discordant couples, and other individuals at risk for acquiring HIV through sexual activity. Contraceptive Technology Update issued an ebulletin on the approval. To receive future bulletins, provide your email address to AHC Media customer service at (800) 688-2421 or Look to the upcoming issue for further information on pre-exposure prophylaxis.)

How does it work?

The approved package labeling calls for an OraQuick In-Home HIV Test user to be age 17 or older to use the diagnostic device. Bolded information explains that "a positive result with this test does not mean that you are definitely infected with HIV, but rather that additional testing should be done in a medical setting. A negative result with this test does not mean that you are definitely not infected with HIV, particularly when exposure may have been within the previous three months." Users who want to be tested earlier than the three-month period are advised to see their local healthcare provider. Those who do not know where to be tested can call the OraQuick support center to get in touch with a local healthcare provider or clinic. The support center will be using information provided by the CDC's National Prevention Information Network (NPIN) referral system dataset. To add your facility to the NPIN list, go to its web page, Click on "Add Your Testing Site."

Package instructions call for test users to not eat, drink, or use oral care products, such as mouthwash, toothpaste, or whitening strips, 30 minutes before starting the test. Users should remove dental products such as dentures or any other products that cover the gums prior to the oral collection.

The test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place the sample into a developer vial. Test results are available within 20 to 40 minutes.

Check the results

Clinical trial data submitted for the FDA approval shows that 5,662 persons were screened and processed through two visits before receiving a test kit. At the first visit, trial participants underwent screening and informed consent; blood samples were collected for testing with an FDA-approved enzyme immunoassay, with the sample retained for further testing by Western blot if required. At the second visit, participants were presented with the OraQuick product. They could decide whether to take the test home for use, thus the situation mimicked real-world use in that participants were allowed to opt out of the study similar to a consumer choosing not to purchase the product after reading the box.

In the clinical trial, the specificity of the test registered relatively high, 99.98% (95% confidence interval [CI]: 99.90–100%), and above the FDA committee's recommended threshold. However, sensitivity dropped in comparison to professional use of the kit to 92.98% (95% CI: 86.64–96.92%), with 86.64% for the lower bound of the 95% CI. Sensitivity is a measurement expression for the tests for false-negative results.

The expected performance of 92% for test sensitivity (the percentage of results that will be positive when HIV is present) means that one false negative result would be expected out of every 12 test results in HIV-infected individuals. Be sure to counsel that patients should never use a negative test result to decide on whether to engage in behavior that puts them at risk for HIV infection.

The expected performance of 99.98% for test specificity (the percentage of results that will be negative when HIV is not present) means that one false positive would be expected out of every 5,000 test results in uninfected individuals.

"We believe the rapid antibody HIV test recently approved by the Food and Drug Administration for sale over the counter holds great promise as a self-directed tool for people to learn their HIV status," said Judith Aberg, MD, chair of the Arlington, VA-based HIV Medicine Association in a statement accompanying the FDA approval. "We also urge continued research and education in heavily affected areas and with low income and minority populations disproportionately affected by HIV to determine how the test instructions and accompanying support materials can raise the accuracy of the test results closer to the level obtained by professionals."

Results of a recently published meta-analysis, which compared studies worldwide, showed that OraQuick HIV1/2 test had the same accuracy (99%) as blood-based specimens in adults for high-risk populations. The test sensitivity was slightly reduced (97%) for low-risk populations.1

Public health impact?

The oral HIV test has become one of the most popular tests because of its acceptability and ease of use, observed Nitika Pant Pai, MD, MPH, PhD, a medical scientist at the Research Institute of the McGill University Health Centre and assistant professor of medicine at McGill University, both in Montreal. The oral test is non-invasive, pain-free, and convenient, and it produces results in 20 minutes. Pai served as lead author for the meta-analysis, and she has performed research on point-of-care tests.

Getting people to show up for HIV testing at public clinics has been difficult because of visibility, stigma, lack of privacy, and discrimination, noted Pai in a release accompanying the meta-analysis publication. A confidential testing option such as self-testing could bring an end to the stigmatization associated with HIV testing, she says.

"There is a huge global momentum for alternate HIV self-testing strategies that can inform people of their status," stated Pai.

Public health officials already are looking at different ways to integrate at-home testing into ongoing efforts to stem the AIDS epidemic in the United States. At the May 2012 FDA Blood Products Advisory Committee meeting, Kevin Cranston, director of the Bureau of Infectious Diseases in Massachusetts's Department of Public Health, said his agency proposes a local project in the large urban center of Massachusetts to make the kit available to a number of at-risk communities, as well as marketing to young gay and bisexual men to promote quarterly home testing to those at high risk.

"The Mass Department of Public Health is convinced that this device and the option of rapid determination of HIV status in an anonymous home-based setting would be a valuable adjunct to existing public efforts to control the HIV epidemic and give HIV-positive persons early access to the benefits of medical care," Cranston told committee members.


  1. Pai NP, Balram B, Shivkumar S, et al. Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12(5):373-380.